Reported trial results for Alzheimer's Disease
Every Alzheimer's Disease trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
103 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
-
NCT05318976 · results posted 29 June 2026
According to the results reported on ClinicalTrials.gov, this trial looked at an experimental treatment called XPro1595 in people with early or mild Alzheimer's disease. A total of 207 participants were enrolled — 140 received XPro1595 injections (at a dose of 1.0 mg/kg) and 67 received a placebo (an inactive dummy injection). Of those, 120 in the XPro1595 group and 62 in the placebo group completed the 24-week study. The trial was primarily measuring changes in a combined score of six thinking and memory tests, known as the EMACC, over that period. Several secondary measures were also tracked, including a doctor-rated scale of day-to-day functioning (CDR-SB), a questionnaire completed by a carer about everyday thinking abilities (E-Cog), a rating of behavioural and mood symptoms (NPI-12), and a personalised goal-attainment score. The reported data shows that on the primary measure — the EMACC thinking and memory score — both groups showed very small changes from their starting point over 24 weeks. The XPro1595 group's score changed by +0.05 (on a standardised scale where 0 is the group's starting average) and the placebo group changed by +0.07. On the carer-rated everyday thinking questionnaire (E-Cog, scored 1–4 where higher means more decline), the XPro1595 group changed by −0.02 and the placebo group by −0.09. On the doctor-rated functioning scale (CDR-SB, scored 0–18 where higher means greater impairment), the XPro1595 group changed by +0.21 and the placebo group by +0.33. For the behavioural symptoms score (NPI-12, scored 0–144 where higher means more symptoms), the XPro1595 group changed by −0.40 and the placebo group by +0.50. On the personalised goal scale (scored around 50 meaning goals were met on average), the XPro1595 group scored 46.81 and the placebo group scored 45.19. The reported data shows small numerical differences between the two groups across all of these measures, though what those differences mean clinically is not described in the submitted results data. No information about statistical significance (that is, whether the differences seen could simply be due to chance) was included in the data submitted to ClinicalTrials.gov that was available for this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03876314 · results posted 12 June 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 180 older adults across two groups: 98 in a Physical Activity Condition (PAC) and 82 in a Usual Care Control (UCC). The trial was measuring whether a physical activity programme was associated with changes in certain thinking and memory skills over about 12 months. Participants were tested at the start of the trial (pre-test), at around 6 months (mid-test), and at around 12 months (post-test). By the end of the trial, 76 people in the PAC group and 67 in the UCC group completed all measurements. The reported data shows results across six thinking and memory tests. For the Stroop Interference test — which measures how quickly someone can manage competing information, where a higher time in milliseconds means more difficulty — the PAC group recorded 123, 127, and 115 milliseconds at the three time points, while the UCC group recorded 127, 107, and 105 milliseconds. For the Trail Making Test — another measure of mental flexibility recorded in seconds, where a higher number means more difficulty — the PAC group recorded 19, 17, and 14 seconds, while the UCC group recorded 18, 18, and 17 seconds. For two card-sorting and attention tests scored on a 0–10 scale (higher is better), both groups scored between roughly 7.9 and 8.3 across all time points. For a reasoning accuracy test scored from 0 to 1, both groups scored around 0.50–0.54 across all time points. For a memory word-recall test scored out of 15 (higher is better), both groups scored around 10–12 across all time points. The reported data shows scores across all these tests remained broadly similar between the two groups throughout the 12-month period, though the data as reported here does not include the statistical analysis needed to draw conclusions about whether any differences between groups were meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT05744401 · results posted 25 February 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05744401) enrolled 197 people in total across four groups receiving different doses or dosing schedules of a drug called AL002. The groups were: 41 people receiving 15 mg/kg, 49 receiving 40 mg/kg, 43 receiving 60 mg/kg, and 64 in a "titration cohort" (meaning they started on a lower dose and had it gradually increased). The trial was primarily measuring how many participants experienced various types of adverse events (unexpected medical occurrences, which can include anything from side effects to illnesses), as well as certain specific brain changes visible on MRI scans. The reported data shows that completion numbers were low across all groups — only 4, 7, 5, and 3 participants finished in each respective group, with the large majority not completing the study (reasons for this were not detailed in the data provided). On the MRI brain changes measured, the reported data shows that a type of brain swelling called ARIA-E was recorded in 23 participants in the 15 mg/kg group, 23 in the 40 mg/kg group, 17 in the 60 mg/kg group, and 7 in the titration group. A related type of finding involving small bleeds on MRI (called ARIA-H) was recorded in 30, 30, 25, and 9 participants across those same groups respectively. Serious adverse events were reported in 2, 2, 5, and 11 participants across the four groups. No abnormal findings from physical examinations, vital signs, or heart tracings were recorded across any group, and suicidal risk events (measured by a standard questionnaire) were reported for 1 participant in the lowest-dose group and none in the others. The reported data shows these figures represent counts of occurrences rather than conclusions about whether the drug caused them. Some data points for certain sub-categories of adverse events were not broken down further in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT06831812 · results posted 24 February 2026
According to the results reported on ClinicalTrials.gov, this trial tested a vaccine called AV-1959R, which is being investigated as a potential approach to Alzheimer's disease. It targeted a protein called amyloid-beta (Aβ), which builds up in the brains of people with Alzheimer's. A total of 16 people took part, divided into four groups: six received a lower dose (100 micrograms) of AV-1959R, six received a higher dose (300 micrograms), and four received a placebo (a harmless comparison injection with no active ingredient). All 16 participants completed the trial. The reported data shows that the primary outcome — safety and tolerability over 26 weeks — was measured by counting participants who experienced adverse events (unwanted health events) and serious adverse events. In the 100 microgram group, 5 out of 6 participants reported some kind of adverse event, compared to 1 out of 2 in the matching placebo group. In the 300 microgram group, all 6 participants reported an adverse event, compared to 2 out of 2 in that group's placebo. The reported data shows zero serious adverse events across all four groups. For the secondary outcome, the trial measured whether the vaccine produced an immune response — specifically, whether the body made antibodies (proteins that recognise and respond to a target) against amyloid-beta. Antibody levels were measured using a score called an "endpoint titer." The reported data shows that the 100 microgram vaccine group had an average antibody score of 71,175, while their placebo group scored 126. The 300 microgram vaccine group recorded an average of 60,439, compared to 115 in their placebo group. No further breakdown of these figures was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04857060 · results posted 12 January 2026
According to the results reported on ClinicalTrials.gov, this trial looked at a programme called Advance Care Planning (ACP) — a process where people discuss and document their wishes about future medical care. The trial used a "stepped wedge" design, meaning different groups of participants switched from receiving usual care to receiving the ACP programme (which involved a trained educator and a video-assisted discussion) at different time points across the study. In total, across all steps, thousands of patients and a smaller number of caregivers (family members or support people) took part — with patient numbers in the usual care and intervention phases ranging from the tens to nearly 1,700 per group, and caregiver numbers ranging from 4 to 54 per group. The reported data shows that for the main thing being measured — whether a conversation about goals of care was recorded in the patient's hospital electronic health record during their hospital stay — 3,744 participants in the ACP educator-led, video-assisted group had such a record documented, compared with 2,396 participants in the usual care group. For a secondary measure looking at how many patients had new written medical orders about resuscitation preferences (such as "do not resuscitate" or preferences around feeding tubes and dialysis) recorded between the start of the study and 12 months, the reported data shows higher counts across most preference categories in the ACP group compared with the usual care group, though the data as submitted does not clearly label each individual category. For the caregiver-focused measures at 12 months — including knowledge of advance care planning (scored 0–6), confidence (scored 3–15), communication satisfaction (scored 10–100), and decisional satisfaction (scored 12–60) — the reported data shows the same scores for both the ACP group and the usual care group: 4, 15, 31, and 40 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04592874 · results posted 29 October 2025
According to the results reported on ClinicalTrials.gov, this trial tested an investigational drug called AL002 in people with Alzheimer's disease. A total of 356 people took part, split across four groups: three groups received different doses of AL002 (15 mg/kg, 40 mg/kg, or 60 mg/kg), and one group received a placebo (an inactive treatment). The main thing the trial was measuring was how scores on a standard Alzheimer's assessment tool — called the CDR-SB — changed over roughly two years. The CDR-SB runs from 0 (normal) to 18 (severe dementia), with higher scores meaning greater impairment. The trial also tracked several other thinking and daily-living assessments as secondary measures. The reported data shows that on the primary measure (CDR-SB), all four groups — including the placebo group — had higher (worse) scores over time. By around the 96-week mark, the reported average score increases from the starting point were approximately 2.61 points for the 15 mg/kg group, 2.93 points for the 40 mg/kg group, 2.12 points for the 60 mg/kg group, and 2.25 points for the placebo group. The reported data shows similar patterns across the secondary measures: scores on memory and thinking tests (MMSE, RBANS, ADAS-Cog13, ADCOMS) and a daily-living scale (ADCS-ADL-MCI) also changed over time across all groups, with the numbers for each AL002 dose group generally sitting close to those of the placebo group at each time point. It is worth noting that a notable number of participants — particularly in the AL002 groups — did not complete the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT05771428 · results posted 15 October 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05771428) tested an investigational drug called ABBV-552 at three different doses (1 mg, 5 mg, and 15 mg) compared to a placebo (an inactive treatment) in people with Alzheimer's disease. A total of 263 people started the trial across the four groups, and most completed it — 63 in the placebo group, 61 in the 1 mg group, 61 in the 5 mg group, and 60 in the 15 mg group. The main thing being measured was how participants' thinking and memory abilities changed over 12 weeks, using a standardised test called the ADAS-Cog 14, which scores cognitive (thinking and memory) ability on a scale from 0 to 90, where a higher score means greater difficulty. The reported data shows that after 12 weeks, scores on the ADAS-Cog 14 changed slightly across all four groups. A negative number here means the score went down compared to the start — in other words, participants showed a small improvement on average. The placebo group's average score changed by −1.26 points, the 1 mg ABBV-552 group by −1.28 points, the 5 mg group by −1.68 points, and the 15 mg group by −1.01 points. These are small movements across a 90-point scale. No secondary outcome measure data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03446001 · results posted 4 September 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03446001) looked at a drug called TRx0237 in people with Alzheimer's disease. A total of 598 participants were enrolled across three groups: 266 received a control (comparison) treatment, 80 received TRx0237 at 8 mg per day, and 252 received TRx0237 at 16 mg per day. The trial ran in two phases — a blinded phase (where participants did not know which treatment they were on) and an open-label phase (where all participants received TRx0237 at 16 mg per day). The main things being measured were changes in thinking and memory abilities, changes in the ability to carry out everyday activities, and the number of participants who experienced adverse events (unwanted health occurrences). The reported data shows the following for the 16 mg/day group compared to the control group. On the thinking and memory scale (scored 0–70, where higher means greater difficulty), both groups showed a small increase from their starting scores: the control group changed by +1.71 points and the TRx0237 16 mg/day group changed by +1.34 points. On the daily activities scale (scored 0–78, where higher means better ability), both groups showed a small decline: the control group changed by −0.77 points and the TRx0237 16 mg/day group changed by −0.62 points. For adverse events, the reported data shows 17 serious adverse events in the control group and 18 in the TRx0237 16 mg/day group, and 146 non-serious adverse events in the control group compared to 131 in the TRx0237 16 mg/day group. The reported data also shows results from several secondary measurements. Brain shrinkage over time was reported as −11,137 mm³/year in the control group and −11,163 mm³/year in the TRx0237 16 mg/day group. A brain scan measurement related to energy use in a specific brain region showed a change of −0.025 in the control group and −0.026 in the TRx0237 16 mg/day group. Shrinkage in another brain region was reported as −741 mm³/year in the control group and −711 mm³/year in the TRx0237 16 mg/day group. No results for the 8 mg/day group were reported in the outcome measure data on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03507790 · results posted 11 August 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03507790) tested an investigational drug called CT1812 in people with Alzheimer's disease. A total of 153 people took part — 51 in each of three groups: one group received a lower dose of CT1812 (100 mg), one received a higher dose (300 mg), and one received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring how many participants experienced unwanted health events (called adverse events) after starting treatment, and secondarily looking at changes in certain biological markers measured in the fluid around the brain and spine (cerebrospinal fluid, or CSF). The reported data shows that, out of 51 people in each group, 36 in the 100 mg group, 42 in the 300 mg group, and 39 in the placebo group experienced at least one adverse event during the study. When looking at serious adverse events specifically, the reported numbers were 11 in the 100 mg group, 16 in the 300 mg group, and 7 in the placebo group. For the secondary measures, the trial looked at changes in several proteins in the CSF from the start of the study to around day 182. The reported data shows varying increases and decreases across the three groups for different proteins — for example, changes in one marker (neurogranin) were reported as +48.6 ng/L (100 mg group), +38.3 ng/L (300 mg group), and −831.2 ng/L (placebo group). Results for the other CSF markers also varied across groups. For the ratio of two forms of amyloid protein (Aβ42/40), the reported changes were +0.019 (100 mg), −0.024 (300 mg), and −0.002 (placebo). No further breakdown of what each individual CSF protein measurement represents was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04556097 · results posted 5 August 2025
According to the results reported on ClinicalTrials.gov, this trial involved four groups of participants. Two groups were made up of people with dementia (PWD) — 206 in the intervention group and 187 in the control group. The other two groups were nurse care managers (NCM) — 15 in each group. The trial was measuring whether a care programme made a difference to how often people with dementia visited the emergency department, and how much distress their carers experienced, over a six-month period. The reported data shows that in the six months after the programme, people in the intervention group visited the emergency department an average of 0.056 times per person per month, compared with 0.075 times per person per month in the control group. For carer distress, the trial used a questionnaire called the NPI-Q, where scores range from 0 to 60 and a higher score means greater distress. The reported data shows that carers in the intervention group had an average distress score of 10.86, while carers in the control group had an average score of 11.68. It is worth noting that not all participants completed every stage of the study — for example, only 35 people in the intervention group and 26 in the control group completed the six-month follow-up survey. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03706261 · results posted 1 August 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 145 participants in total, with 126 completing the study and 19 not completing it. The trial was investigating brain imaging measurements — specifically, it used two different radioactive tracers (substances that can be tracked by a scanner) to look at deposits in the brain associated with memory and brain health. One tracer, called 18F-MK-6240, was used to measure a protein called tau, and the other, called 18F-Florbetaben, was used to detect a substance called amyloid. The study aimed to explore whether these brain measurements were linked to memory, sense of smell, and blood vessel health in the brain. The reported data shows that, across all participants, the average measurement for the tau tracer (18F-MK-6240) was 1.27 on a scale called SUVR (standardised uptake value ratio — a way of comparing how much of the tracer was absorbed in a target brain region compared to a reference region). For the amyloid tracer (18F-Florbetaben), the reported data shows that 12 out of the 145 participants were found to have a positive result for amyloid, meaning the scan suggested the presence of amyloid deposits in their brains. No further breakdown of results by subgroup or other outcome measures was included in the data submitted. It is worth noting that this trial appears to have been primarily an observational measurement study, and the data submitted to ClinicalTrials.gov covers only these two reported outcomes. Any additional findings were not reported in the structured results available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05063539 · results posted 28 July 2025
According to the results reported on ClinicalTrials.gov, this trial tested an investigational drug called LY3372689 in people with early symptomatic Alzheimer's disease. Participants were randomly assigned to receive one of two doses of the drug (0.75 mg or 3 mg) or a placebo (an inactive treatment used for comparison). A total of 327 people started the treatment phase — 110 in the 0.75 mg group, 109 in the 3 mg group, and 108 in the placebo group. The trial used several rating scales to measure changes in thinking and daily functioning over time, and included both an overall group of participants and a smaller subgroup defined by intermediate levels of a brain protein called tau. The reported data shows that the primary outcome — a combined score measuring both thinking ability and daily functioning (called the iADRS, scored from 0 to 144 where lower means worse) — was listed as "not available" for all three groups, meaning those particular figures were not reported in the submitted data. For the secondary outcomes, the reported data shows changes on a scale measuring disease severity across six areas of daily life (CDR-SB, scored 0–18 where higher means worse): in the intermediate tau subgroup, scores changed by 0.91 points (0.75 mg group), 2.14 points (3 mg group), and 1.05 points (placebo group). In the overall population, the reported changes were 1.54, 2.81, and 1.48 points respectively. For a cognitive test (ADAS-Cog13, scored 0–85 where higher means worse), the reported changes in the intermediate tau subgroup were 4.00 (0.75 mg), 4.91 (3 mg), and 5.14 (placebo); in the overall population they were 5.58, 7.61, and 5.95 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04408755 · results posted 30 May 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04408755) looked at a medication called AVP-786 (tested at two different doses — a lower dose called AVP-786-18 and a higher dose called AVP-786-42.63) compared to a placebo (a dummy pill with no active ingredient) in people with agitation related to Alzheimer's disease. A total of 184 people enrolled and went through an initial placebo lead-in phase; 173 completed that phase and 173 were then randomly assigned to one of three groups — 56 to placebo, 60 to the lower dose, and 57 to the higher dose — for the main comparison period. The trial was primarily measuring changes in the frequency of agitated behaviours (using a 29-item questionnaire called the CMAI, where higher scores mean more frequent agitation) and tracking any unwanted medical events (adverse events) that occurred during treatment. A secondary measure looked at a clinician's overall rating of how severe agitation appeared (on a 1–7 scale). The reported data shows that for the two primary agitation score outcomes (the CMAI questionnaire change and the clinician severity rating change), no numerical results were submitted to ClinicalTrials.gov — those figures were not reported in the structured data available. Regarding unwanted medical events, the reported data shows that in the main comparison period, 20 out of 56 placebo participants, 15 out of 60 lower-dose participants, and 17 out of 57 higher-dose participants experienced at least one treatment-emergent adverse event. Serious adverse events were reported in 1 placebo participant, 3 lower-dose participants, and 2 higher-dose participants. No further detail about the nature of these events was included in the submitted data. Because the key agitation score numbers were not submitted to ClinicalTrials.gov, it is not possible to describe what those measurements showed. The only figures available are the adverse event counts outlined above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04994483 · results posted 25 May 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04994483) enrolled 804 people with Alzheimer's disease — 403 in the simufilam 100 mg group and 401 in the placebo (dummy pill) group. The trial ran for 52 weeks and was measuring changes in cognition (thinking and memory), daily functioning, and behaviour-related symptoms using several standardised rating scales. By the end of the study, 310 people in the simufilam group and 325 in the placebo group had completed the full 52 weeks. The reported data shows the following changes in scores from the start of the trial to Week 52. On the primary cognitive scale (ADAS-Cog12, where higher scores mean worse cognition), scores increased by 2.79 points in the simufilam group and 3.19 points in the placebo group. On the primary daily functioning scale (ADCS-ADL, where lower scores mean greater loss of function), scores decreased by 3.26 points in the simufilam group and 3.76 points in the placebo group. On the secondary combined cognitive and functional scale (iADRS, where lower scores mean worse performance), scores decreased by 5.53 in the simufilam group and 6.49 in the placebo group. The reported data shows that on the behavioural symptom scale (NPI), scores increased by 0.54 in the simufilam group and 0.90 in the placebo group. On the MMSE thinking and memory test (lower scores indicate more impairment), scores decreased by 1.95 in the simufilam group and 2.14 in the placebo group. On the CDR-SB overall impairment scale (higher scores indicate more impairment), scores increased by 1.04 in the simufilam group and 0.85 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT05575076 · results posted 14 May 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,081 people who had previously completed one of two earlier simufilam studies. All participants received simufilam at a dose of 100 mg. The trial was an open-label extension study, meaning everyone received the same treatment with no placebo comparison group. Of the 1,081 people who started, 300 completed the study and 781 did not complete it. The main thing the trial was set up to measure was how many participants experienced adverse events (that is, any unwanted or unexpected medical occurrences) over the longer term while taking simufilam. The reported data shows that in the group taking simufilam 100 mg, four separate counts of participants experiencing adverse events were recorded. The figures reported were 299, 198, 63, and 519 participants respectively across these categories. However, the data as submitted to ClinicalTrials.gov does not include labels clearly describing what each of these four numbers specifically refers to (for example, whether they represent mild, moderate, or severe events, or other subcategories), so it is not possible to describe each figure in further detail without risking misrepresentation. The trial did not report any secondary outcome measure data in the structured results provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
-
NCT05516134 · results posted 29 April 2025
According to the results reported on ClinicalTrials.gov, this trial involved 51 people across three groups: 26 people receiving the treatment (25 of whom completed the study), 9 family members, and 16 staff members. The trial was measuring how engaged people with dementia appeared during activities, using a tool called the Menorah Park Engagement Scale (MPES). This scale observes and scores different types of engagement — such as actively participating, passively watching, being distracted by something unrelated, or not engaging at all (for example, sleeping or staring into space). It also recorded visible signs of pleasure, like smiling or laughing. A secondary measure looked at quality of life using a 28-item questionnaire called DEMQOL. The reported data shows the following changes in average scores from the baseline (standard activities) period to the treatment period, for the treatment group. On the scale used (0 to 2), "constructive engagement" — actively doing or commenting on the activity — went up by 0.83 points (where a higher score is considered a better outcome). "Passive engagement" — watching or listening to the activity — went up by 1.2 points (where, for this type, a lower score is considered better). "Other engagement" — attention directed away from the activity — went down by 1.24 points (a lower score is considered better here). "Non-engagement" — sleeping or staring into space — went down by 0.17 points (again, lower is considered better). Visible pleasure went up by 0.31 points (where higher is considered better for this measure). For the quality-of-life questionnaire (scored 28–112, higher being better), the reported average change was an increase of 2.40 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05310071 · results posted 23 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05310071) enrolled 1,024 participants in total — 344 in the placebo group and 680 in the aducanumab group. The trial was studying aducanumab, a medicine being investigated for Alzheimer's disease. It measured changes over roughly 78 to 106 weeks (about one and a half to two years) across several scales that assess memory, thinking ability, and day-to-day functioning. Notably, the reported data shows that zero participants in either group were recorded as having "completed" the study, and all participants were listed as "not completed," though no further explanation for this was provided in the submitted data. The reported data shows the following numbers across the scales measured. On the primary measure — a six-category thinking and function scale called the CDR-SB, where higher scores mean greater impairment — the placebo group's score changed by +0.67 and the aducanumab group's score changed by +1.56 from the start of the trial (meaning both groups showed some worsening, with the aducanumab group showing a larger increase on this scale). On a combined cognition-and-daily-function scale (iADRS, where lower scores mean worse performance), the placebo group changed by −14.667 and the aducanumab group by −7.796. On a daily activities scale (ADCS-ADL-MCI), the placebo group changed by −5.0 and the aducanumab group by −0.4. On a cognitive test (ADAS-Cog13, where higher scores mean worse performance), the placebo group changed by +9.667 and the aducanumab group by +7.396. On a general cognitive status test (MMSE, where lower scores mean worse performance), the placebo group changed by −6.0 and the aducanumab group by −1.2. Finally, on a behavioural symptoms questionnaire (NPI-10, where lower scores mean fewer symptoms), the placebo group changed by −8.3 and the aducanumab group by −1.8. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
-
NCT04948450 · results posted 6 April 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total — 30 in an intervention group and 30 in a control group. The trial was measuring two main things: how well participants stuck to their scheduled sessions (called "adherence") and how many stayed in the study all the way through (called "retention"). It also looked at several aspects of thinking and memory, including overall mental function, planning and organisational skills (executive function), and attention. The reported data shows that, for adherence, the intervention group attended approximately 85.4% of their planned sessions — no equivalent figure was reported for the control group. For retention, 1 person in the intervention group and 3 people in the control group did not complete the study. For overall cognitive (thinking) function, measured on a scale of 0–70 where higher scores mean greater difficulty, the reported data shows two sets of scores for each group (likely before and after the study): the intervention group scored 28 and then 27.3, while the control group scored 24.5 and then 29.1. For the clock-drawing test of planning skills (scored 0–10, where higher is better), the intervention group scored 0.5 and then 2.3, and the control group scored 2.3 and then 2.7. For attention tests scored out of 12 (higher is better), both groups recorded similar figures across two timepoints, ranging roughly between 8.9 and 9.5 on one test, and between 2.5 and 3.0 on another. No data was reported indicating which scores were taken at the start versus the end of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04241068 · results posted 21 February 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04241068) looked at a single group of participants receiving a medicine called aducanumab. A total of 1,696 people started the main treatment period, of whom 1,118 finished it. A further follow-up phase then began with 1,041 participants, and 508 of those completed it. The trial was primarily measuring safety-related events — in other words, it was tracking unwanted medical occurrences and other health events that happened while people were taking the medicine. The reported data shows that during the main treatment period, 1,549 out of 1,696 participants experienced at least one treatment-emergent adverse event (that is, an unwanted medical occurrence that happened after starting the medicine), and 318 experienced a serious such event (meaning it was life-threatening, required hospitalisation, caused significant disability, or was otherwise considered medically important). The reported data also shows that 168 participants stopped taking the medicine due to an adverse event, and 129 withdrew from the study entirely because of one. In addition, two specific types of brain-imaging abnormalities were tracked: a swelling-related finding called ARIA-E was reported in 422 participants, and a bleeding-related finding called ARIA-H was reported in 505 participants. Finally, 19 participants were reported to have developed antibodies in their blood directed against the medicine itself (known as antidrug antibodies). It is important to note that this trial had only one treatment group — there was no comparison group receiving a different treatment or a dummy pill — so the reported numbers describe what was observed in people receiving aducanumab, without a direct comparison point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT06424236 · results posted 4 February 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT06424236) enrolled 73 participants across three groups. All participants had previously taken part in a double-blind study where they received one of three treatments — a placebo, a drug called solanezumab, or a drug called gantenerumab — and then moved into an open-label extension (OLE) phase where everyone received gantenerumab. The trial was measuring changes in brain scans and thinking/memory tests over up to 156 weeks (about three years). Of the 73 who started, only 13 completed the study — 4 from the placebo group, 2 from the solanezumab group, and 7 from the gantenerumab group. The reported data shows that the main thing being tracked was a brain scan measure of amyloid — a protein linked to dementia — called the PiB-PET C-SUVR score (a ratio where a higher number means more amyloid in the brain). By week 156, all three groups showed a reduction in this ratio from their starting point: the placebo-then-gantenerumab group dropped by about 0.77, the solanezumab-then-gantenerumab group dropped by about 1.18, and the group that had been on gantenerumab throughout dropped by about 0.27. For the thinking and memory tests — including the CDR Sum of Boxes (a scale from 0–18, where higher is worse), the global CDR score, a daily living scale, and the MMSE (a 0–30 thinking test, where lower is worse) — the reported data shows scores generally changed over time across all three groups, with the direction and size of those changes varying between groups and time points. A separate brain scan measuring a different protein called tau also showed changes across all groups over the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03461276 · results posted 3 February 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03461276) involved 124 participants in total — split evenly into two groups of 62 — and ran in two parts. Part A lasted 18 to 24 months, and Part B lasted a further 18 months. The trial was testing an experimental vaccine called ABvac40, which is designed to prompt the body to produce antibodies (proteins made by the immune system) against a substance called Aβ40, which is associated with Alzheimer's disease. The main thing the trial set out to measure was the change in the level of those antibodies in participants' blood after receiving the vaccine or a placebo (an inactive dummy injection). The reported data shows that, for the primary (main) outcome — the average peak increase in antibody signal measured in the blood — the placebo group recorded a value of 0.12 units, while the ABvac40 group recorded a value of 3.27 units, using a standard laboratory measurement scale. Regarding the secondary (additional) outcomes, the reported data shows how many participants left the study early due to side effects: 4 in the placebo group in Part A, 2 in the ABvac40 group in Part A, 0 in the ABvac40 group in Part B, and 1 in the placebo/booster group in Part B. The trial also tracked how many participants had notable abnormalities picked up in physical check-ups, neurological (brain and nerve) check-ups, and blood tests across all groups; the numbers for those measures ranged from 0 to 12 participants depending on the group and the type of check, as detailed in the full results record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04730635 · results posted 28 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04730635) enrolled 44 people in total — 29 in the donepezil (medication) group and 15 in the placebo (dummy treatment) group. Most participants finished the study: 28 in the donepezil group and 14 in the placebo group completed it, with one person dropping out from each group. The trial was looking at whether donepezil had any effect on a specific type of visual memory test called the One Card Learning task, which asks participants to recognise patterns and is used to assess memory, in people with mild cognitive impairment or mild Alzheimer's disease. The main thing being measured was how much each participant's score on that memory test changed over 8 weeks. The reported data shows that, on the primary (main) outcome, participants in the donepezil group had an average improvement in their correct response rate of 0.055 (out of a possible proportion of 1.0), while participants in the placebo group had an average improvement of 0.034. For the secondary (additional) outcomes, which looked at the variability — that is, how much individual scores spread around the average — the reported figures were similar between the two groups and were presented using a mathematical transformation, making them harder to interpret directly in everyday terms. No figures were reported for the placebo group on the final secondary outcome, as that analysis only included the donepezil group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
-
NCT05602727 · results posted 15 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05602727) tested an investigational drug called MK-1942 in people with Alzheimer's disease. A total of 99 participants were enrolled — 35 received the lower dose (5 mg), 31 received the higher dose (15 mg), and 33 received a placebo (a dummy treatment with no active ingredient). The trial ran for 12 weeks and measured changes in thinking and memory abilities, day-to-day functioning, and overall clinical impression, as well as tracking unwanted medical events that occurred during the study. The reported data shows the following numbers for the main thinking and memory test (scored 0–70, where higher scores mean greater impairment, and a negative change means improvement from the start of the trial): the 5 mg group's score went up by 2.9 points (suggesting more impairment compared to the start), the 15 mg group's score went down by 0.6 points (suggesting slight improvement), and the placebo group's score went up by 0.8 points. For the clinician's overall impression of change (scored 1–7, where 4 means no change, lower means improvement, and higher means worsening), the 5 mg group scored 5.4, the 15 mg group scored 5.8, and the placebo group scored 5.3 at week 12. For daily living activities (scored 0–78, where lower scores indicate greater difficulty), changes from the start of the trial were: –1.7 for the 5 mg group, –3.0 for the 15 mg group, and +1.2 for the placebo group. Regarding unwanted medical events during the study, 17 participants in the 5 mg group, 21 in the 15 mg group, and 18 in the placebo group experienced at least one such event. The number of participants who stopped taking the study medication because of an unwanted medical event was 4, 6, and 3 in the 5 mg, 15 mg, and placebo groups respectively. It is also worth noting that a large proportion of participants did not complete the study — roughly 22–23 out of each group of around 31–35 people did not finish. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04325204 · results posted 8 October 2024
According to the results reported on ClinicalTrials.gov, this trial looked at a faith-based programme called "Faith-HAT" for pairs of people — one person living with dementia and their carer (called "dyads"). The trial enrolled 27 carers and 27 people living with dementia (54 people in total). The study was measuring whether the programme was practical to run — specifically, how quickly researchers could recruit participants, how often participants used the programme, and how many people stayed in the study through to the end. It also measured carers' feelings of burden, stress, and symptoms of depression using standard questionnaires, before and after the six-week programme. The reported data shows that of the 27 carers and 27 people living with dementia who started, 26 in each group began the intervention and 17 in each group completed the study. Regarding recruitment, the data indicates that 14 carers and 14 people living with dementia were recruited within one timeframe, and 13 carers and 13 people living with dementia in another (the exact timing details were not fully broken down in the submitted data). All 17 carers and 17 people living with dementia who completed the study reported using the Faith-HAT programme at least two days per week. For the carer questionnaires, the reported data shows the burden score (out of 88) went from 36.47 to 32.76, and the stress score (out of 56) went from 31.94 to 30.76. For the depression questionnaire, the reported data shows no measurements were submitted to ClinicalTrials.gov — that data was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05256134 · results posted 9 July 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05256134) enrolled 25 people in total — 12 in the placebo group and 13 in the gantenerumab group. Gantenerumab is a medicine that was being investigated for Alzheimer's disease. The trial was measuring changes in thinking and memory abilities over time, as well as how long it took for participants' condition to progress. Notably, the reported data shows that none of the participants completed the study — all 25 are listed as having not completed it — which is important context for interpreting the numbers below. The reported data shows the following for the primary outcome, which was a combined score across five memory and thinking tests (called the PACC-5, where a higher score means better performance): the placebo group's score changed by −0.052 and the gantenerumab group's score changed by −0.119 from their starting point, meaning both groups showed a small decline on average. For the secondary outcomes measuring daily living abilities (A-IADL-Q-SV, where higher is better), the placebo group changed by −1.3 and the gantenerumab group by −0.4. For a self-reported memory difficulties questionnaire (CFIa participant version, where higher means more difficulty), the placebo group changed by +0.3 and the gantenerumab group by +0.9. The study partner version of the same questionnaire showed −0.8 for placebo and +0.2 for gantenerumab. The two outcomes measuring time to disease progression were listed as "not available" — meaning those figures were not reported in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04437511 · results posted 20 May 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04437511) enrolled 860 people in the donanemab group and 876 in the placebo group, with 853 and 874 respectively going on to receive at least one dose. The trial was studying donanemab, an investigational treatment for Alzheimer's disease, and was measuring changes in participants' thinking abilities and capacity to carry out daily activities over time. Participants were assessed using several standardised rating scales, with the main focus on a combined score called the iADRS (which blends tests of memory and thinking with measures of everyday functioning), as well as additional thinking and memory tests. The reported data shows that on the primary iADRS scale (which runs from 0 to 144, where lower scores mean worse performance), both groups declined from their starting scores over the course of the trial. In the overall population, the donanemab group's score declined by an average of 10.19 points, compared with 13.11 points in the placebo group. In a subgroup of participants with lower-to-moderate levels of a brain protein called tau, the donanemab group declined by an average of 6.02 points versus 9.27 points in the placebo group. The reported data for the secondary measures showed a similar pattern: on a standard cognitive test called the MMSE (scored 0–30, lower is worse), the overall population declined by 2.47 points (donanemab) versus 2.94 points (placebo); and on another cognitive scale called the ADAS-Cog13 (scored 0–85, higher means worse), the overall population increased by 5.46 points (donanemab) versus 6.79 points (placebo). These figures represent the average adjusted changes across the groups as submitted to the registry — they describe what was measured and recorded, not a conclusion about whether the treatment should be used. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04374253 · results posted 8 May 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04374253) enrolled a total of 1,382 participants across four groups. Participants had previously taken part in related studies (called the GRADUATE trials) and were divided based on whether they had received gantenerumab (a drug being investigated for Alzheimer's disease) or a placebo, and whether they went on to join a follow-on study period called the "Graduate OLE" (Open-Label Extension). The trial was primarily measuring safety-related events — things like unwanted medical occurrences, brain imaging changes, and reactions at the injection site. The reported data shows that, looking at general unwanted medical events (called adverse events), 13 out of 15 placebo participants who joined the OLE experienced at least one, compared with 510 out of 696 placebo participants who did not join the OLE; in the gantenerumab groups, 25 out of 28 (OLE participants) and 487 out of 643 (non-OLE participants) experienced at least one. For serious adverse events, the numbers were 2, 72, 4, and 54 respectively across those same four groups. The reported data also shows that brain scan changes known as ARIA-E (fluid build-up visible on MRI) were recorded in 6, 104, 5, and 27 participants across the four groups, while a related type of brain scan change called ARIA-H (small deposits of blood breakdown products) was recorded in 3, 85, 4, and 40 participants. Injection-site reactions were reported in 3, 63, 1, and 80 participants respectively. A small number of participants left the study due to an unwanted medical event: 0, 9, 1, and 7 across the four groups. Regarding suicidal thoughts or behaviour (measured using a structured interview tool called the C-SSRS), small numbers of participants across all groups recorded a score indicating some level of concern, with the largest single figure being 11 participants in each of the two larger non-OLE groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03095417 · results posted 27 March 2024
According to the results reported on ClinicalTrials.gov, this trial looked at whether different combinations of physical exercise, cognitive (brain) training, and stretching-based activities had any measurable impact on thinking and physical abilities in older adults. A total of 153 people started the trial and were split into four groups: one group did both physical exercise and cognitive training; a second did physical exercise with a cognitive control activity; a third did cognitive training with stretching; and a fourth did cognitive control and stretching activities only. By the end of the study, 109 participants had completed it, with between 24 and 30 people finishing in each group. The reported data shows that the main thing being measured was cognitive (thinking and memory) ability, assessed using a standardised test called the RBANS, which produces a z-score — a number that shows how someone's result compares to an average of zero, where a higher number means a better outcome. At the 3-month mark, z-scores ranged from -0.21 (physical exercise plus cognitive training group) to 0.28 (physical exercise plus cognitive control group). At 6 months, z-scores ranged from 0.21 (cognitive training plus stretching group) to 0.36 (physical exercise plus cognitive control group). For physical performance — measured on a 0 to 12 scale, where higher is better — scores at 3 months ranged from 4.92 to 8.18 across the groups, and at 6 months ranged from 5.00 to 7.07. For cardiovascular fitness — counted as the number of steps a person could march on the spot in 2 minutes — scores at 3 months ranged from 27.67 to 47.30, and at 6 months ranged from 32.36 to 40.00 across the four groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03444870 · results posted 30 January 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03444870) looked at a drug called gantenerumab compared to a placebo (an inactive treatment) in people with Alzheimer's disease. The main part of the trial — called the double-blind treatment (DBT) period — involved 486 people in the placebo group and 499 people in the gantenerumab group from the global study, plus a smaller separate group of 68 participants from China. The trial ran for approximately 116 weeks (just over two years). The main thing being measured was how participants' thinking and everyday functioning changed over time, using a standard assessment tool called the CDR-SB, which scores impairment from 0 (no impairment) to 18 (severe impairment) — a higher score means greater difficulty. The reported data shows that, at the end of the double-blind period, the CDR-SB score had increased (meaning more impairment compared to the start) by an average of 3.65 points in the placebo group and 3.35 points in the gantenerumab group. For the China extension group, the CDR-SB figures were not reported in the submitted data. The reported data also shows results for several secondary measures. On a cognitive test called the ADAS-Cog13 (scored 0–85, higher is worse), scores increased by an average of 9.82 points for placebo and 8.57 points for gantenerumab. On a daily activities scale called the ADCS-ADL (scored 0–78, higher is better), scores decreased by an average of 12.32 points for placebo and 11.21 points for gantenerumab. On a functional activities questionnaire (FAQ, scored 0–30, higher is worse), scores increased by 8.13 points for placebo and 7.28 points for gantenerumab. On the MMSE cognitive test (scored 0–30, lower is worse), scores decreased by an average of 5.18 points for placebo and 4.86 points for gantenerumab. A small open-label extension phase followed, in which 10 people who had been on placebo and 19 who had been on gantenerumab continued receiving gantenerumab, but no outcome measure numbers were reported for this phase in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04339413 · results posted 18 January 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04339413) involved two groups of participants — 59 people in the "SCarlet RoAD" group and 57 people in the "Marguerite RoAD" group — who received the investigational medicine gantenerumab. The trial was primarily measuring a range of safety-related outcomes, including unwanted medical events (called adverse events), serious medical events, reactions at the injection site, certain types of brain imaging abnormalities, signs of suicidal thoughts or behaviour, and whether participants' immune systems produced antibodies against the medicine. The reported data shows that, out of those assessed for safety, 54 people in the SCarlet RoAD group and 49 people in the Marguerite RoAD group experienced at least one adverse event (an unwanted medical occurrence). Serious adverse events were reported in 11 people in the SCarlet RoAD group and 10 people in the Marguerite RoAD group. Injection-site reactions were reported in 14 people in the SCarlet RoAD group and 7 in the Marguerite RoAD group. The reported data shows that no participants in either group experienced brain imaging abnormalities related to fluid build-up (ARIA-E) or blood deposits (ARIA-H). Regarding suicidal thoughts or behaviour, 3 participants in the SCarlet RoAD group and none in the Marguerite RoAD group reported any such experience across the categories measured. Antibodies against the medicine were detected in 3 people in the SCarlet RoAD group and 1 person in the Marguerite RoAD group. It is also worth noting that only 1 participant across both groups completed the trial, with the vast majority not completing it; the reasons for non-completion were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05202223 · results posted 29 December 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT05202223) involved a single group called "Harmony at HOME," which enrolled 80 participants. The trial was measuring changes in caregivers — people looking after someone with Alzheimer's disease — across several areas, including their sense of personal control (called "caregiver mastery"), feelings of burden, stress, satisfaction, and the behavioural symptoms of the person they were caring for. Of the 80 people who started, 52 completed the study and 28 did not. The reported data shows that the main thing being measured was caregiver mastery, using a tool called the Pearlin Mastery Scale, which runs from 4 to 16, where a higher number means a greater sense of personal control over one's life. Three separate score readings were recorded for the group — 12.6, 13, and 13 — though the data as submitted does not clearly label which reading corresponds to which point in time (for example, before or after the programme), so it is not possible to describe the change in scores with full certainty. For the other things being tracked — caregiver burden, caregiver stress, caregiver satisfaction, and the behavioural symptoms of the person with Alzheimer's disease — no numerical results were included in the data submitted to ClinicalTrials.gov, so those figures cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02008357 · results posted 28 December 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02008357) enrolled 1,169 participants across two groups during the main double-blind phase: 578 people received the study drug solanezumab, and 591 received a placebo (an inactive treatment used for comparison). The trial was measuring whether solanezumab had any effect on cognition and daily functioning in people who showed early biological signs associated with Alzheimer's disease but had not yet developed noticeable symptoms. After the main phase ended, many participants moved into an open-label extension period, where both groups received solanezumab. The reported data shows that the main outcome measured was change in a combined thinking and memory score called the PACC — a composite of four different cognitive tests, where a score of zero represents no change from the starting point and a more negative number indicates a greater decline. By the end of the double-blind period, the solanezumab group's average score had changed by −1.43, while the placebo group's average score had changed by −1.13 — meaning both groups showed a decline from their starting scores, with the solanezumab group showing a slightly larger decline. No figures were reported for the open-label extension phase outcomes. The reported data also shows results for two secondary (additional) measures. On the Cognitive Function Index — a questionnaire about everyday thinking ability scored from 0 to 14, where higher scores indicate more difficulty — the solanezumab group's score changed by +1.94 and the placebo group's by +1.47, meaning both groups reported increased difficulty over time. On a daily activities questionnaire scored from 0 to 45 (where higher scores mean fewer difficulties), the solanezumab group's score changed by −2.29 and the placebo group's by −1.70, indicating a decline in both groups. Again, no figures were reported for the open-label extension phase for these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03226522 · results posted 13 September 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03226522) enrolled 366 people across three groups: 159 received AXS-05, 49 received bupropion, and 158 received a placebo (a dummy treatment with no active ingredient). The trial was looking at agitation in people with dementia, and it measured changes using a tool called the Cohen-Mansfield Agitation Inventory (CMAI). This is a 29-item questionnaire filled out by a carer, which scores how often a person with dementia shows agitated or disruptive behaviours. Scores range from 29 (least frequent) to 203 (most frequent), so a larger drop in score over time means less frequent agitation was reported. The reported data shows changes in CMAI total scores from the start of the trial to the end. The AXS-05 group had an average decrease of 15.4 points, the bupropion group had an average decrease of 10.0 points, and the placebo group had an average decrease of 11.5 points. In plain terms, all three groups showed a reduction in their average agitation scores over the course of the trial. No secondary outcome measure data was included in the results provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03919669 · results posted 3 August 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 27 people across three groups: 6 healthy volunteers, 8 people with mild cognitive impairment (early-stage memory and thinking difficulties), and 13 people with dementia. One healthy volunteer did not complete the study; all others finished. The trial was measuring changes in brain scans using a radioactive tracer called [18F]MK-6240, which is designed to detect a protein called tau in the brain. Tau build-up is associated with Alzheimer's disease. The study also looked at whether any changes seen on those scans matched changes in participants' scores on standard thinking and memory tests. The reported data shows that the primary outcome — the change in the brain scan "uptake ratio" (a number representing how much tracer was detected, where a higher number suggests more tau) — was 0.00 for healthy volunteers, 0.10 for the mild cognitive impairment group, and 0.12 for the dementia group. For the secondary brain scan measures, slightly different figures were reported across separate time points, ranging from small decreases (–0.07) to increases of up to 0.24 depending on the group and time period. For the thinking and memory tests, the reported data shows correlation figures (a way of measuring whether two things tend to change together, on a scale of –1 to +1, where 0 means no relationship) of 0.02 with the ADAS-cog test, 0.23 with the CDR scale, and 0.43 with the MMSE — all measured across all participants combined. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02346201 · results posted 13 June 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02346201) involved 200 people with Alzheimer's disease — 99 in the methylphenidate group and 101 in the placebo group. The trial was measuring apathy (a lack of motivation or interest) in people with Alzheimer's disease over six months. Two main things were tracked: a caregiver-reported apathy score (called the NPI apathy subscale, where higher numbers mean more apathy) and a clinician's overall impression of whether the person's apathy improved, stayed the same, or got worse. By the end of the study, 89 people in the methylphenidate group and 92 in the placebo group had completed the trial. The reported data shows that, on the NPI apathy score, the methylphenidate group's score dropped by an average of 4.5 points from where it started, while the placebo group's score dropped by an average of 3.1 points. Both groups showed a reduction in their scores over the six months. For the clinician's overall impression, the reported data shows that 39% of people in the methylphenidate group were rated as showing at least some improvement, compared with 32% in the placebo group. The trial did not report additional detail on whether these differences between the two groups were considered statistically meaningful (that is, unlikely to be due to chance). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04491006 · results posted 12 June 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04491006) enrolled 77 people across three groups: 24 received a placebo (a dummy treatment with no active ingredient), 27 received a lower dose of a drug called ATH-1017 (40 mg), and 26 received a higher dose of ATH-1017 (70 mg). The trial was measuring brain activity using a test called P300 — a way of recording how the brain responds to sound cues, which can reflect how well working memory is functioning. It also measured thinking and memory abilities using a standard questionnaire called the ADAS-Cog11, where scores range from 0 (no impairment) to 70 (severe impairment). These measurements were taken at the start of the trial (Day 1, called "baseline") before any treatment effect could occur, so they represent a starting snapshot of each group. The reported data shows the following baseline brain activity readings (measured in milliseconds — the time it takes the brain to respond to a sound): the placebo group averaged 361.5 ms, the 40 mg ATH-1017 group averaged 382.3 ms, and the 70 mg ATH-1017 group averaged 375.3 ms. For the thinking and memory questionnaire at baseline, the reported data shows the placebo group scored an average of 23.0, the 40 mg group scored 22.4, and the 70 mg group scored 20.7. Because these are starting-point measurements taken before the trial treatments were properly underway, they describe where participants began rather than any change over time. No outcome data beyond these baseline figures was included in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04309500 · results posted 16 February 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04309500) enrolled 20 people in total across four groups: 5 people whose brain scans showed amyloid protein (a marker sometimes associated with dementia risk), 5 people whose scans did not show amyloid, and 5 "co-participants" (such as a family member or support person) paired with each of those groups. The trial was measuring how well participants and their co-participants understood and remembered the results of their brain scan and related tests — including information about their personal results and what those results might mean for their risk of developing dementia. It also measured whether people reported any symptoms of depression after receiving that information. The reported data shows that, when asked questions about their personal test results immediately after receiving them, amyloid-positive participants answered about 82% of questions correctly on average, while amyloid-negative participants scored around 95%. At one week later, those scores were reported as approximately 69% and 91% respectively, and at six weeks later, approximately 70% and 91%. Co-participants scored similarly high, ranging from around 86% to 96% across time points and groups. For questions about what the results *meant* for dementia risk, participants scored between roughly 68% and 90% depending on their group and time point, while co-participants of amyloid-positive individuals scored between 93% and 100%, and co-participants of amyloid-negative individuals scored between 63% and 68%. The reported data shows that depression symptom scores (on a scale of 0–15, where higher means more symptoms) remained low across all groups and time points, generally ranging from about 0 to 2.5 for participants and 0 to 0.75 for co-participants, though the small number of people in each group means these figures should be interpreted with care. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03932812 · results posted 16 December 2022
According to the results reported on ClinicalTrials.gov, this trial involved 82 people in total — 42 in the intervention group (who worked with an "Options Counselor" health educator) and 40 in a control group. All participants were caregivers, and the trial was measuring things like how burdened they felt in their caregiving role, their knowledge of available community services, symptoms of depression, unplanned visits to a doctor, and the size and nature of their social support networks. Participants were surveyed at the start of the study, at three months, and at six months. By the end of the study, 25 people remained in each group, meaning a notable number did not complete all follow-up surveys. The reported data shows that caregiver burden (measured on a scale of 0–36, where higher numbers mean more burden) started at similar levels in both groups (around 19 for the intervention group and 18 for the control group). At three and six months, both groups reported noticeably higher burden scores than at the start — the intervention group scored around 32 and 31, while the control group scored around 27 and 29. For knowledge of community services (scale 8–40, higher is more knowledge), both groups showed similar scores across all time points, starting around 25 and rising to around 29–30. For depressive symptoms (scale 0–30, higher means more symptoms), scores were low at the start (around 4 and 3), rose sharply at three months (around 19–20 in both groups), then dropped again at six months (around 7 and 6). Unplanned doctor visits were low across all time points in both groups. For social support, the count of people providing positive support was similar at the start but showed some variation over time; the count of people involved in negative interactions also varied across time points and groups. The reported data shows numbers across several measures at three different time points, but the dataset does not include information about whether any differences between the two groups were considered statistically meaningful (that is, whether they might have occurred by chance). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03352557 · results posted 8 November 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03352557) tested a drug called BIIB092 (also known as gosuranemab) in people with Alzheimer's disease. The trial had two main phases: a placebo-controlled (PC) period lasting up to 78 weeks, where 654 people were assigned to receive either a dummy treatment (placebo) or one of four different doses of BIIB092; and a longer-term extension (LTE) period from around week 80 to week 173, where 521 participants continued on active doses of BIIB092. The primary thing the trial was measuring was how often participants experienced adverse events (AEs) — that is, any unwanted medical occurrence during the study — and serious adverse events (SAEs), which are more severe medical events such as hospitalisation or life-threatening situations. The reported data shows that during the placebo-controlled period, adverse events were recorded in roughly 83–89% of participants across all groups, including the placebo group (84.6%). Serious adverse events were reported in approximately 10–12% of participants across all groups, including 12.1% in the placebo group. During the longer-term extension period, adverse events were reported in roughly 55–69% of participants depending on the dose group, and serious adverse events were reported in approximately 2–11% of participants across those groups. The reported data also shows that very few participants developed detectable antibodies against BIIB092 in their blood — ranging from 0% in most dose groups to 1.9% in the placebo group. For one of the secondary measures — a standard cognitive assessment called the CDR-SB, which scores memory and thinking ability on a scale from 0 to 18 — the reported data shows that average scores increased (meaning more impairment) across all groups over 78 weeks, ranging from about 2.92 to 3.24 points in the BIIB092 groups and 3.07 points in the placebo group, though the spread of individual results within each group was also noted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00722046 · results posted 7 November 2022
According to the results reported on ClinicalTrials.gov, this trial tested a drug called PF-04360365 (given by drip into a vein) in people with Alzheimer's disease. The trial had two parts (Part A and Part B) and tested several different doses of the drug compared to a dummy treatment (placebo). In total, 198 people enrolled across all groups, with numbers ranging from 25 to 32 per group. The trial was measuring how the drug moved through the body (in blood and in the fluid around the brain and spinal cord), as well as tracking any unexpected medical events or changes seen on brain scans. The reported data shows that when it came to unexpected medical events (called adverse events), the numbers of participants who experienced at least one such event were high across all groups — for example, 24 out of 25 treated participants in several of the lower-dose groups, and 27–32 out of 31–32 participants in the higher-dose groups, including the placebo group. Serious adverse events (more significant medical occurrences) were also recorded for some participants, with numbers ranging from 3 to 8 across the groups where this was reported; however, the data for the remaining groups was not fully reported in the structured results. For brain scan (MRI) changes, very few new abnormalities were detected — only one participant (in the 0.5 mg/kg group) showed a new finding. Regarding how the drug appeared in the blood, the reported data shows that blood levels increased with higher doses — for instance, two hours after the infusion on Day 1, the average blood concentration ranged from about 1,731 nanograms per millilitre (ng/mL) in the lowest dose group up to about 187,953 ng/mL in the highest dose group. The reported fluid around the brain (cerebrospinal fluid) concentration was zero across all dose groups at the time it was measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04623242 · results posted 22 September 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04623242) was part of the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) study, which looked at two experimental drugs — gantenerumab and solanezumab — in people who carry a rare genetic mutation that causes early-onset Alzheimer's disease. A total of 262 people took part across five groups: 52 received gantenerumab, 52 received solanezumab, 40 were mutation-carriers who received a placebo (an inactive treatment), 49 were non-carriers who received a placebo, and 69 were in an observational group. Not everyone finished the study — 39 completed in the gantenerumab group, 36 in the solanezumab group, 30 in the mutation-positive placebo group, and 26 in the mutation-negative placebo group. The reported data shows that the main thing being measured was a combined score from four thinking and memory tests, called the DIAN Multivariate Cognitive Endpoint (DIAN-MCE). This score was compared between each treatment group and the mutation-carrier placebo group — a ratio above 1.0 would suggest the treatment group scored higher on the combined tests relative to the placebo group. The reported ratio for gantenerumab compared to placebo was 1.063, and for solanezumab it was 1.255. For the secondary measures, the reported data shows scores on thinking and function scales recorded at multiple time points across both treatment and placebo groups. For example, on the CDR Sum of Boxes scale (where lower scores indicate better function, ranging from 0 to 18), gantenerumab participants had reported scores ranging from 0.74 to 4.61 across visits, compared to 0.44 to 5.76 for the mutation-positive placebo group. A brain imaging measure of amyloid (a protein associated with Alzheimer's disease) showed reported changes of -0.006, -0.106, and -0.334 for gantenerumab participants across three timepoints, compared to 0.103, 0.134, and 0.306 for the placebo group, where higher scores indicate a worse disease stage. Scores for solanezumab on similar measures were also reported across multiple visits, though what these numbers mean clinically was not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03712787 · results posted 22 September 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03712787) tested a drug called tilavonemab across four groups of participants, with different dose combinations. A total of 363 people took part — 87 in the lowest-dose group, 97 in the second group, 88 in the third group, and 91 in a group that started on a placeholder (placebo) before moving to the active drug. The trial's primary focus was on monitoring participants' experiences during the study, including any unwanted medical events (called adverse events), blood test results, brain scans, and assessments of suicidal thoughts or behaviours. The reported data shows that, when it came to unwanted medical events that arose during the study period, 54 people in the lowest-dose group, 66 in the second group, 59 in the third group, and 57 in the placebo-then-active group experienced at least one such event. Serious medical events — those involving hospitalisation, being life-threatening, or other significant outcomes — were recorded in 9, 8, 10, and 7 participants across the four groups respectively. Events that led a participant to stop taking the study drug were recorded in 7, 10, 15, and 5 participants across the groups. For brain MRI scans, new small bleeds in the brain were detected in 4, 5, 11, and 5 participants across the groups respectively, while brain swelling was detected in very small numbers (1, 1, 0, and 0 participants). Blood test results flagged as potentially significant were recorded for only a small number of participants, and chemistry-related blood test flags were reported as zero across all groups. Regarding the structured assessment of suicidal thoughts or behaviours, 4, 3, 8, and 4 participants across the groups recorded some level of suicidal ideation during the double-blind phase; no suicidal behaviours were reported in any group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02880956 · results posted 26 August 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 453 people in total across four groups: 116 received a placebo (an inactive treatment), 108 received a lower dose of ABBV-8E12 (300 mg), 116 received a middle dose (1,000 mg), and 113 received a higher dose (2,000 mg). The trial was measuring how participants' thinking and daily functioning changed over time using a dementia rating scale called the CDR-SB, which runs from 0 to 18 — a lower score is considered more desirable. The trial also tracked unwanted medical events that occurred during the study, and measured how the drug moved through the body at different doses. The reported data shows that CDR-SB scores increased (meaning symptoms worsened) across all four groups over the course of the trial. At the final reported time point, the average score change from the starting point was 1.90 for the placebo group, 1.88 for the 300 mg group, 1.85 for the 1,000 mg group, and 1.81 for the 2,000 mg group. Regarding unwanted medical events during the study, the reported data shows these were recorded in 108 placebo participants, 94 in the 300 mg group, 108 in the 1,000 mg group, and 104 in the 2,000 mg group. Serious unwanted events were recorded in 28, 32, 31, and 33 participants in those same groups respectively. For the secondary measurements looking at how the drug moved through the body, the reported data shows that higher doses were associated with higher levels of the drug detected in the blood, which is expected when a larger amount is given. The time it took for the drug to reach its peak level in the blood was broadly similar across all three doses — around 2.5 to 3 hours after the first dose. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02051608 · results posted 16 June 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT02051608) involved people with a particular condition and was conducted in two parts. In Part 1 (a double-blind phase, where neither participants nor researchers knew who received which treatment), 195 people received a placebo and 192 received gantenerumab, a drug being studied. Of those, 134 and 136 respectively completed Part 1. Part 2 was an open-label extension (OLE), meaning everyone knew they were receiving gantenerumab — 119 participants who had previously been on placebo switched to gantenerumab, and 111 who had already been on gantenerumab continued on it, with 49 and 50 completing Part 2 respectively. The trial was primarily measuring how many participants experienced unwanted medical events, antibody reactions to the drug, and how many stopped treatment due to those events. The reported data shows the following figures from Part 1: around 80.5% of placebo participants and 82.8% of gantenerumab participants experienced some kind of adverse event (an unwanted medical occurrence during the study); serious adverse events were reported in 12.3% and 12.0% of those groups respectively. Antibody responses to the drug (where the body produces a reaction against the study medicine itself) were detected in 3.6% of the placebo group and 11.5% of the gantenerumab group. In Part 2, the reported data shows that 91.5% of participants who switched from placebo to gantenerumab experienced an adverse event, compared with 95.4% of those who continued on gantenerumab; serious adverse events were reported in 24.8% and 38.0% of those groups. Adverse events led to stopping treatment in 12.0% of the switched group and 15.7% of the continuing group. Antibody responses to the drug in Part 2 were reported in 2.6% and 2.8% of participants in each group. Blood concentration levels of gantenerumab were also measured at several time points during Part 1, with values ranging from approximately 2.06 to 7.66 micrograms per millilitre across those time points, though the specific timing of each measurement was not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03289143 · results posted 16 March 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03289143) enrolled 457 people across four groups to study a drug called semorinemab in people with Alzheimer's disease. Participants were randomly assigned to receive either a placebo (an inactive treatment) or one of three different doses of semorinemab, without knowing which they were receiving. The trial ran for approximately 73 weeks and was primarily measuring changes in thinking, memory, and daily functioning using several standard rating scales. The reported data shows that on the main measure — the CDR-SB, a scale from 0 to 18 where a higher score means greater disease severity — all groups showed an increase from their starting point over 73 weeks. The placebo group's average score increased by 2.19 points, while the three semorinemab dose groups increased by 2.36, 2.36, and 2.41 points respectively. On the secondary measures, similar patterns were observed across groups: scores on memory and thinking tests (RBANS and ADAS-Cog-13) and day-to-day activity scales (Amsterdam iADL and ADCS-ADL) all changed in ways that indicated some decline across all groups over the study period, with the reported numbers being broadly similar between the placebo and semorinemab groups. The reported data also shows that between 88.8% and 94.7% of participants in the double-blind groups experienced at least one adverse event (an unwanted health occurrence noted during the trial), though the trial data does not break down the nature or seriousness of these events in the figures provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03290326 · results posted 3 March 2022
According to the results reported on ClinicalTrials.gov, this trial involved 10 participants, all of whom completed the study with no drop-outs. The trial was testing a brain stimulation technique called tACS (transcranial alternating current stimulation), which uses mild electrical signals applied to the scalp. The study was measuring three things: the amount of amyloid protein in the brain (a type of protein deposit associated with Alzheimer's disease), brain electrical activity in a specific frequency range, and performance on a cognitive (thinking and memory) test called the Adas-Cog. The reported data shows that, on average, the group's amyloid protein level in the brain — measured using a brain scan called a PET scan, with a unit called SUVR (essentially a score reflecting the amount of that protein detected) — changed by minus 1.55 SUVR units from before to after the 10 stimulation sessions. A negative number here means the average score was lower after the sessions than before. For brain electrical activity in the gamma frequency range (a specific type of brain wave pattern), the reported data shows an average increase of 23.5% after the sessions compared to before. On the Adas-Cog cognitive test — which runs from 0 to 70, where a higher score means greater difficulty — the average score changed by minus 0.97 points, meaning the group's average score was slightly lower (fewer difficulties reported) after the sessions. It is worth noting that this was a small study of only 10 people with no comparison group, and the trial's own description notes that individual differences between participants were not separately accounted for in these group-level results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01224106 · results posted 13 December 2021
According to the results reported on ClinicalTrials.gov, this trial involved people with early-stage Alzheimer's disease and tested a drug called gantenerumab at two different doses (105 mg and 225 mg) compared to a placebo (a dummy treatment with no active ingredient). A total of 797 people took part in the main double-blind phase (where neither participants nor doctors knew who received which treatment) — 266 received placebo, 271 received the 105 mg dose, and 260 received the 225 mg dose. A smaller group of 154 people then continued into an open-label extension phase, where everyone received gantenerumab at doses up to 1,200 mg and both participants and doctors knew which treatment was being given. The trial measured changes in memory and thinking abilities over about two years, using several different rating scales. The reported data shows that the main outcome measure was a memory and thinking scale called the CDR-Sum of Boxes, where a higher score means worse functioning (the scale runs from 0 to 18). After 104 weeks, the placebo group's score had increased by an average of 1.19 points from their starting point, while the 105 mg gantenerumab group increased by 1.41 points and the 225 mg group by 1.47 points. For the secondary measures, a cognitive test called the ADAS-Cog-11 (scale 0–70, higher is worse) showed average score increases of 3.68 (placebo), 3.52 (105 mg), and 3.97 (225 mg). A memory word-recall test (FCSRT) showed average score changes of −4.05, −4.11, and −6.42 respectively, where a more negative number means a greater decline. The reported data also shows that during the open-label extension phase, 46 out of 49 participants who switched from placebo to gantenerumab experienced at least one adverse event (an unwanted medical occurrence during the study), as did 100 out of 105 participants already on gantenerumab; serious adverse events were reported in 18 and 28 participants in those two groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02477800 · results posted 2 September 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02477800) tested a drug called BIIB037 (aducanumab) in people with early Alzheimer's disease. In the first part of the trial — a placebo-controlled period — 545 people received a dummy treatment (placebo), 547 received a lower dose of BIIB037, and 555 received a higher dose. The trial ran for 78 weeks and measured changes in thinking ability and day-to-day functioning using several standard questionnaires. A second, longer-term extension phase also took place, involving around 850 additional participants who had previously been in the controlled period, though the reported data shows that none were recorded as having completed that extension phase. The reported data shows the following results at 78 weeks. For the main measure — a rating scale called the CDR-SB, which scores thinking and daily functioning from 0 to 18 (higher scores mean greater decline) — the placebo group's score increased by an average of 1.56 points from their starting score, the low-dose group increased by 1.38 points, and the high-dose group increased by 1.59 points. For a memory and thinking test called the MMSE (scored 0–30, where bigger drops mean more decline), the placebo group dropped by 3.5 points, the low-dose group by 3.3 points, and the high-dose group by 3.6 points. On a third thinking test (ADAS-Cog 13, where higher scores mean more decline), the placebo group increased by 5.14 points, while both the low- and high-dose groups increased by around 4.55 points. For a daily activities measure (ADCS-ADL-MCI, where bigger drops mean more difficulty with daily tasks), the placebo group dropped by 3.8 points, while both dose groups dropped by 3.1 points. The reported results are the numerical changes observed across these groups over the course of the trial. No conclusions about whether any differences between groups are meaningful should be drawn from these numbers alone, as the data as submitted does not include the statistical context needed to interpret them further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04023994 · results posted 9 August 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people across six groups. Ten participants received a placebo (an inactive substance), while the remaining 26 received different doses of an investigational drug called RO7126209, ranging from a low dose of 0.1 mg/kg up to a high dose of 7.2 mg/kg. The trial was primarily measuring how often participants experienced any unwanted medical events (called adverse events) after receiving the drug or placebo, and it also tracked how the drug moved through the body over time. The reported data shows that the percentage of participants who experienced at least one adverse event varied across the groups. In the placebo group, 80% of participants recorded an adverse event. Among those receiving RO7126209, the figures were: 75% in the 0.1 mg/kg group, 50% in the 0.4 mg/kg group, 83.3% in the 1.2 mg/kg group, and 100% in both the 3.6 mg/kg and 7.2 mg/kg groups. The reported data also shows how much of the drug was present in participants' blood at various points. At the end of the infusion, blood levels of RO7126209 rose with each higher dose — from 1.80 µg/mL at the lowest dose up to 160 µg/mL at the highest. Similarly, measures of how much drug the body was exposed to over 24 hours and over longer periods also increased steadily as the dose went up. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03131453 · results posted 5 August 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03131453) enrolled 1,145 people across three groups: 456 people received a higher dose of the investigational drug CNP520 (50 mg), 233 received a lower dose (15 mg), and 456 received a placebo (a dummy treatment with no active ingredient). The trial was designed to measure whether CNP520 could delay or prevent the progression to mild cognitive impairment or dementia caused by Alzheimer's disease, and to track changes in thinking and memory over time using several standardised tests. Importantly, the study was stopped early, and as a result none of the participants were recorded as having completed the trial in the usual sense. The reported data shows that because the trial ended early, only a small number of disease progression events were observed, and the main time-to-event analysis (tracking how long before someone received a diagnosis) could not be fully completed. For the cognitive test known as the APCC — a combined thinking and memory score out of 100 where higher is better — the reported changes from the start of the trial showed a decline of around 3.1 points in the higher-dose group, 2.9 points in the lower-dose group, and 1.7 points in the placebo group (these figures relate to one of the reported time points). On a separate memory and thinking battery (the RBANS, scored 40–160), the reported total score changes at one time point were approximately −9.8 for the higher-dose group, −9.7 for the lower-dose group, and −5.2 for the placebo group. On a dementia severity scale (CDR-SOB, scored 0–18 where higher means greater severity), small increases of around 0.08–0.20 points were reported across all groups depending on the time point. The reported data shows that for the everyday functioning questionnaires (filled in by participants and their study partners), the score changes across all three groups were small and varied across the different time points reported. No statistical comparison results were included in the submitted data for these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02565511 · results posted 8 July 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02565511) enrolled 480 people across two groups testing different investigational approaches aimed at people at genetic risk of Alzheimer's disease. Cohort I tested a vaccine called CAD106 (42 people) against a placebo (23 people), while Cohort II tested a drug called CNP520 (251 people) against a placebo (164 people). The trial was measuring whether these treatments could delay the onset of mild memory and thinking problems or dementia linked to Alzheimer's disease, and whether they could slow decline on a range of thinking and memory tests. Importantly, the trial was terminated early, meaning none of the participants completed the study as originally planned. The reported data shows that because the study ended early, only a small number of "events" (defined as a confirmed new diagnosis of mild cognitive impairment or dementia due to Alzheimer's disease) were recorded, and a full time-to-event analysis could not be carried out. For the main cognitive test score (the APCC, a combined measure of thinking and memory out of 100, where higher is better), the reported data shows small changes across all groups at various time points; for example, in Cohort II, CNP520 participants showed a change of around −3.3 to −4.1 points compared with placebo participants showing changes ranging from −1.0 to +2.4 points. For secondary measures — including tests of everyday memory and thinking skills, a dementia rating scale, and a broader neuropsychological battery — the reported numbers showed small shifts in various directions across all groups and time points, with no consistent pattern clearly described in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04079803 · results posted 1 June 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT04079803) enrolled 64 people in total, split across three groups: 22 people received a placebo (a dummy tablet with no active ingredient), 21 received a 100 mg dose of a drug called simufilam (also known as PTI-125), and 21 received a 50 mg dose of simufilam. Nearly everyone who started the trial finished it — only one person in the 50 mg group did not complete it. The trial was measuring changes over 28 days in six specific proteins found in cerebrospinal fluid (the fluid surrounding the brain and spinal cord). These proteins — including amyloid beta-42, total tau, p-tau181, neurogranin, neurofilament light chain, and YKL-40 — are substances that researchers look at as potential markers of brain health in conditions like Alzheimer's disease. The reported data shows the average change in each protein's level from the start of the trial to day 28, measured in picograms per millilitre (a very small unit of concentration). For amyloid beta-42, levels went up by 4.8 in the placebo group, 12.5 in the 100 mg group, and 16.2 in the 50 mg group. For total tau, levels changed by −3.2 (placebo), −18.7 (100 mg), and −14.6 (50 mg). For p-tau181, the changes were −0.63, −3.1, and −2.4 respectively. For neurogranin, the changes were −50.5, −648, and −527. For neurofilament light chain, changes were −10.0, −76.3, and −49.7. For YKL-40, changes were −0.96, −22.3, and −20.4. A negative number means the level of that protein went down on average; a positive number means it went up. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02080364 · results posted 7 May 2021
According to the results reported on ClinicalTrials.gov, this trial tested a drug called azeliragon against a placebo (an inactive dummy treatment) in people with Alzheimer's disease. The trial ran across two separate study groups — called the "A-Study" and the "B-Study." In total, roughly 880 people enrolled across both studies and both groups. The trial was measuring changes in thinking and memory abilities, as well as day-to-day functioning, using several standardised rating scales over the course of the treatment period. The reported data shows the following for the two main (primary) outcome measures. On the ADAS-cog — a scale from 0 to 70 where higher scores mean greater thinking difficulties — scores increased (worsened) from the starting point by 3.8 points in the A-Study azeliragon group and 3.1 points in the A-Study placebo group; in the B-Study, the azeliragon group increased by 3.4 points and the placebo group by 2.5 points. On the CDR-sb — a scale from 0 to 18 where higher scores indicate greater impairment — both the azeliragon and placebo groups in the A-Study increased by 1.4 points, while in the B-Study the azeliragon group increased by 1.3 points and the placebo group by 0.7 points. For the secondary measures, the reported data shows that scores on everyday activities (ADCS-ADL, where lower scores mean greater difficulty) declined by around 5 points in the azeliragon groups and around 3 points in the placebo groups across both studies. On a brief cognition check (MMSE), both groups declined by roughly 2 points. Brain scan measures of hippocampus size and brain metabolism also showed small changes, with figures reported as −0.016 versus −0.014 for the volume measure, and −0.030 versus −0.034 for the metabolism measure, in the azeliragon and placebo groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02727699 · results posted 6 May 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02727699) involved 185 participants in total — 91 received a drug called Xanamem™ and 94 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in thinking and memory in people with Alzheimer's disease, using several well-known assessment tools. Of those who started, 82 in the Xanamem™ group and 89 in the placebo group completed the study. The reported data shows the following for the two main (primary) outcomes: On the ADAS-Cog v14 — a cognitive test scored from 0 to 90, where a lower score means less impairment — scores changed by −1.5 points in the Xanamem™ group and −0.7 points in the placebo group (both slight improvements from their starting points). On a combined score called ADCOMs — which blends results from three different tests into a single number between 0 and 1.97, where lower is better — the Xanamem™ group showed a change of +0.025 and the placebo group +0.019 (both very small increases, meaning slight worsening on this measure). For the secondary (supporting) outcomes, the reported data shows similarly small changes across both groups on memory testing (RAVLT), a dementia rating scale (CDR-SOB), a short mental status test (MMSE), and a behavioural symptom scale (NPI). The numbers for these measures were close between the two groups; where multiple measurements appear in the data for RAVLT and NPI, the full breakdown of what time points or sub-scores they refer to was not clearly specified in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02323334 · results posted 19 April 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02323334) tested a drug called LY3202626 across several groups of participants. In total, 98 people were enrolled across all parts of the study (Parts A through D), divided into different groups that each received varying doses of LY3202626 or a placebo (an inactive dummy treatment). The trial was designed to examine how the drug moved through and was processed by the body, how it affected certain biological markers in the blood and spinal fluid, and to record any serious unwanted events that occurred during the study. The reported data shows that, for the primary outcome — counting how many participants experienced a serious unwanted health event that the investigating doctor considered related to the study drug — the number was zero across all dose groups and the placebo group. For the secondary outcomes, the trial tracked the peak amount of drug detected in the blood (called Cmax), which ranged from 0.169 nanograms per millilitre at the lowest dose (0.1 mg, single dose) up to 92.5 nanograms per millilitre at the highest single dose tested (45 mg). The overall drug exposure over time (called AUC — a measure of how much drug was present in the body across the dosing period) was not reported for the two lowest doses, but for other doses ranged from around 49.9 to 1,680 nanogram-hours per millilitre. The reported data also shows measurements of a protein called amyloid-beta 1-40 — a substance sometimes studied in relation to brain health — in both the blood and spinal fluid. In blood, the lowest recorded level of this protein during the study fell from around 107 pg/mL in the placebo group to as low as approximately 4.2 pg/mL at the highest repeated dose. In spinal fluid, the lowest recorded level fell from around 7,980 pg/mL in the placebo group to approximately 2,980 pg/mL at the highest dose tested in that part of the study. Note that the AUC data was not reported for the 0.1 mg and 0.4 mg single-dose groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02791191 · results posted 19 April 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02791191) enrolled 316 people with mild Alzheimer's disease across three groups: 55 received a 3 mg dose of a study drug called LY3202626, 128 received a 12 mg dose, and 133 received a placebo (a dummy treatment with no active ingredient). The trial ran for 52 weeks and was primarily measuring changes in brain scans using a special imaging technique called a PET scan, which was looking at a protein called tau — a substance that builds up in the brains of people with Alzheimer's disease. It is worth noting that relatively few participants completed the full study: 17 in the 3 mg group, 17 in the 12 mg group, and 13 in the placebo group. The reported data shows that on the primary measure — the change in tau PET scan readings after 52 weeks — all three groups showed a very small increase from their starting point. The 3 mg group had a reported change of +0.02 units, the 12 mg group +0.03 units, and the placebo group +0.01 units, all on a standardised imaging scale. For secondary measures, the reported data shows changes in a blood-based marker related to amyloid (another protein linked to Alzheimer's disease): the 3 mg group had a change of approximately −258.7 ng/L, the 12 mg group −286.1 ng/L, and the placebo group −12.0 ng/L for one form of amyloid measured (Aβ1-40), with similar patterns seen for other amyloid forms measured. Regarding brain scan abnormalities (ARIA), small percentages of participants across all groups had these findings recorded, ranging from 0% to around 7.5% depending on the type and group. Suicidal thoughts (as measured by a standard questionnaire) were reported as treatment-emergent in approximately 7.3% of the 3 mg group, 7.1% of the 12 mg group, and 3.8% of the placebo group, though the data does not allow any conclusions about cause. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
-
NCT00955409 · results posted 25 March 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT00955409) enrolled a total of 160 participants across ten different treatment groups. The groups received varying doses of an experimental vaccine called ACC (at 3, 10, or 30 micrograms), combined in different ways with an immune-boosting ingredient called QS-21, a comparison substance, or a saltwater placebo (PBS). The trial was measuring how often participants experienced unwanted medical events (called adverse events, or AEs) after receiving their injections, as well as tracking levels of a particular immune protein (called IgG antibody) in participants' blood over the course of roughly two years. The reported data shows that for the primary outcome — tracking unwanted medical events — the percentage of participants who experienced at least one such event was high across most groups. In the 3 µg ACC+QS-21 group and the QS-21 comparison group, 100% of participants reported at least one such event. In the combined 10 µg groups, the figure was around 93–94% for the active group and about 93% for the control group. In the 30 µg groups, figures were approximately 79% (active) and 90% (control). Separately, the data also reported the proportion who experienced serious adverse events (those involving hospitalisation, life-threatening situations, disability, or death): these ranged from 0% in one comparison group up to approximately 29% in the 3 µg ACC+QS-21 group. For the antibody (IgG) measurements, the reported data shows that at the start of the trial, levels across all groups were at or near the lowest detectable level (50 units/mL). One group's antibody level later rose to a reported 836.5 units/mL, though complete figures across all time points and groups were not fully reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02670083 · results posted 16 July 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02670083) enrolled 813 people in total — 409 received a placebo and 404 received crenezumab, an investigational drug being studied in relation to Alzheimer's disease. The trial ran for approximately two years (105 weeks) and was measuring changes in memory, thinking, and daily functioning over that time using several standard assessment tools. The reported data shows that the trial was closed early due to a lack of efficacy, and results were only counted up to 29 January 2019 to avoid any bias from that early closure. Of the 813 people who started, only 173 completed the trial (88 in the placebo group and 85 in the crenezumab group). The reported data shows the following changes in scores from the start of the trial to week 105. On the primary measure — the CDR-SB scale, which rates memory and daily functioning on a scale of 0 to 18 (higher scores mean greater difficulty) — the placebo group's score changed by an average of 3.42 points, while the crenezumab group's score changed by an average of 3.59 points. On two cognitive (thinking and memory) tests called the ADAS-Cog-13 and ADAS-Cog-11 (where higher scores mean more difficulty), the reported average changes were 9.55 and 8.43 points respectively for the placebo group, and 9.82 and 8.53 points for the crenezumab group. On a separate dementia severity rating (CDR Global Score, scale 0–3), the placebo group changed by an average of 0.55 and the crenezumab group by 0.50. On the MMSE thinking test (scale 0–30, where higher is better), both groups' scores declined — by an average of 4.63 points in the placebo group and 4.96 points in the crenezumab group. Finally, on the daily activities scale (ADCS-ADL, scale 0–78, where higher is better), both groups' scores declined — by an average of 11.51 points in the placebo group and 13.39 points in the crenezumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03114657 · results posted 16 July 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 806 people in total — 399 received a placebo (an inactive treatment) and 407 received crenezumab, a drug being investigated for Alzheimer's disease. The trial was measuring how participants' thinking, memory, and daily functioning changed over about 77 weeks (roughly a year and a half). It is noted that the study was closed early due to a lack of efficacy, and results were only counted up to a specific cut-off date to avoid the early closure influencing how the data was interpreted. The reported data shows that no participants were recorded as having "completed" the study, which reflects the early termination. The reported data shows the following changes on several rating scales from the start of the study to week 77. On the primary measure — the CDR-Sum of Boxes scale (a 0–18 scale where higher scores mean greater disease severity) — the placebo group's score increased by an average of 3.19 points, while the crenezumab group's score increased by 1.89 points. On a cognitive test called ADAS-Cog-13 (scored 0–85, higher meaning more difficulty), the placebo group worsened by 8.90 points on average and the crenezumab group by 7.16 points. On a daily living activities scale (scored 0–78, where higher is better), the placebo group's score declined by an average of 8.83 points and the crenezumab group's by 6.31 points. Other thinking and memory scales showed broadly similar patterns of change between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01951118 · results posted 13 July 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 121 participants, all of whom received donepezil (a medication commonly used for memory conditions) alongside an "atropine challenge" (a procedure used to test the body's response). Of those 121 people who started, 94 completed the trial and 27 did not finish. Participants were divided into two groups based on their diagnosis: those with Mild Cognitive Impairment (MCI, meaning early-stage memory concerns) and those with Alzheimer's Disease (AD). The trial tracked several measures of memory, thinking, and daily functioning across multiple time points. The reported data shows the following across the measurement periods. For the main outcome — a word memory test called the Selective Reminding Test, where a higher number of words recalled is better — the MCI group's scores ranged from approximately 36 to 40 words (out of a possible 72 across six rounds), while the AD group's scores ranged from roughly 21 to 24 words. For the secondary outcomes, a thinking and memory error test (ADAS-Cog, where fewer errors is better) showed the MCI group making around 9–11 errors and the AD group around 19–23 errors across time points. A clinician's overall impression scale (rated 1–7, where lower is better) showed scores of roughly 3.1–3.3 for the MCI group and 3.6–4.4 for the AD group. A daily functioning questionnaire (FAQ, scored 0–30, where lower means less difficulty) showed the MCI group scoring around 4–5 and the AD group scoring around 11–15. A separate informant-rated everyday cognition scale (ECog, scored 39–156, where lower is better) showed the MCI group scoring around 67–68 and the AD group scoring around 90–104 across time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02245568 · results posted 2 June 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02245568) enrolled 913 participants, all of whom received the study treatment LMTM at doses ranging from 100 to 300 mg per day. Of those who started the trial, 60 participants completed it, while 853 did not complete their participation. The trial was measuring adverse events — that is, any new or worsening health problems that occurred after participants started taking the study treatment, including notable changes in laboratory tests, vital signs, or heart monitoring results. The reported data shows that the primary outcome being tracked was the number of participants who experienced serious or non-serious adverse events during the study. According to the results reported on ClinicalTrials.gov, 734 out of 913 participants were recorded as having at least one such adverse event. No secondary outcome measures appear to have been reported in the data submitted to ClinicalTrials.gov for this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
-
NCT02586909 · results posted 17 April 2020
According to the results reported on ClinicalTrials.gov, this trial involved 1,099 people who were given a treatment called RVT-101 (also known as Intepridine) as a 35 mg tablet. The trial was set up to look at safety-related measurements — specifically, how many participants experienced unwanted health events (called adverse events), as well as any changes noticed in physical check-ups, blood pressure and heart rate readings, heart electrical activity tests (ECGs), and routine blood and urine tests. Of the 1,099 people who started the trial, 151 completed it, and 948 did not complete it. The reported data shows that the primary outcome — tracking these safety-related measurements — recorded figures of 549 and 550 participants across the reported groupings, though the data as submitted does not clearly separate what each of these two numbers specifically represents beyond being counts of participants. No further breakdown of the types or rates of individual safety events appears in the structured results data provided, so those details are not available to describe here. It is worth noting that because such a large proportion of participants (948 out of 1,099) did not complete the trial, the reported numbers reflect only a partial picture of what was originally intended to be measured. The reasons for non-completion were not included in the results data reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02569398 · results posted 10 February 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02569398) enrolled 557 people across three groups: 185 received a placebo (a dummy treatment with no active ingredient), 189 received a low dose (5 mg) of a drug called JNJ-54861911, and 183 received a higher dose (25 mg) of the same drug. The trial ran for 24 months and was looking at whether the drug might slow changes in thinking and memory in people at a preclinical stage — that is, people who did not yet have obvious symptoms but may have been at risk. It is worth noting that the data shows zero participants were recorded as having "completed" the study, with all participants listed under "not completed"; no explanation for this is provided in the submitted data. The reported data shows that the main thing being measured was a combined thinking-and-memory score called the PACC, made up of four different tests. Scores were converted into a standard unit (called a z-score) so the four tests could be added together — a higher score means better performance relative to where participants started. After 24 months, the placebo group's score had changed by +0.096 (a very small improvement from their starting point), while the 5 mg group's score changed by −0.417 (a small decline), and the 25 mg group's score changed by −1.096 (a larger decline). For the secondary measures, the reported data shows that on a self-reported and informant-reported daily functioning questionnaire (CFI, scored 0–14, where higher means more difficulty), both drug groups showed small increases compared with placebo — meaning slightly more reported difficulty. On a separate daily activities scale (ADCS-ADLPI) and a broader thinking assessment (RBANS), similar patterns were reported, with the drug groups generally showing smaller gains or larger declines compared with placebo. For two other secondary measures — the CDR-SB and the NABDLTs — no numerical results were included in the submitted data, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02703636 · results posted 12 September 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 118 people with mild to moderate Alzheimer's disease who had previously tried other memory-related medicines (called cholinesterase inhibitors) without sufficient benefit. All participants received a rivastigmine skin patch using a one-step dose increase approach, and were followed for up to 24 weeks. By the end of the study, 102 people had completed the trial, while 16 did not finish. The trial was measuring changes in thinking and memory abilities, behavioural symptoms, quality of life, and a doctor's overall impression of change over time. The reported data shows that the main measure of thinking and memory was the Mini Mental State Examination (MMSE), a test scored from 0 to 30 where a higher score means better function. Participants started with an average score of around 17.3 out of 30. By week 8, the reported average change from that starting point was approximately +0.29 to +0.33 (a very small increase), and by week 24 the reported average change was approximately −0.32 to −0.36 (a very small decrease). For behavioural symptoms (measured on a scale of 0–120 where higher means more severe), the reported starting average was about 11.4, with a reported change of around −1.81 at week 8 and −0.89 at week 24. For quality of life (scored 13–52, higher being better), the reported starting average was around 34.4, with a reported change of approximately −0.34 at week 8 and −0.16 at week 24. On the doctor's overall impression scale at week 24, the reported data shows that out of 103 participants with available data, the largest group — 43 people — were rated as showing "no change." These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01931566 · results posted 14 August 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01931566) enrolled 3,494 participants across three groups: a "low risk" placebo group (433 people), a "high risk" placebo group (1,516 people), and a "high risk" pioglitazone (a diabetes medication being studied here) group (1,545 people). The trial was measuring how long it took for people — particularly those identified as being at higher genetic risk — to be diagnosed with mild cognitive impairment thought to be caused by Alzheimer's disease (a stage where memory and thinking show early decline). It also looked at changes in thinking and memory test scores and in participants' ability to carry out everyday tasks. The reported data shows that, for the primary outcome, the average time before a diagnosis of mild cognitive impairment was recorded was approximately 905 days in the low-risk placebo group and approximately 1,239 days in the high-risk placebo group. When comparing the two high-risk groups, the reported figure was approximately 1,239 days for those on placebo and approximately 1,261 days for those taking pioglitazone. For the secondary outcomes, the reported change in the combined thinking and memory test score was 0.18 for the high-risk placebo group and 0.17 for the high-risk pioglitazone group (on a scale where higher numbers indicate better cognition). For the everyday tasks measure, the reported change was 0.1 for the placebo group and 0.3 for the pioglitazone group (on a scale of 0–45, where lower scores indicate greater difficulty). It is worth noting that the number of participants recorded as completing the study was very small — only 4, 40, and 39 across the three groups respectively — and the data for some measures was not broken down further in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02972658 · results posted 5 July 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 421 participants across four groups. All participants had Alzheimer's disease and were being studied in relation to a drug called lanabecestat at two different doses (20 mg and 50 mg). The trial was structured so that some participants started on a placebo (an inactive treatment) before switching to lanabecestat, while others received lanabecestat from the beginning. The study measured changes in cognition (thinking and memory), daily activities, and overall functioning using several standardised rating scales. Notably, the vast majority of participants did not complete the trial — only one person out of 421 was recorded as having completed it — which is important context for understanding all of the numbers below. The reported data shows the following changes from the start of the trial to its end across the four groups. On the primary measure — a cognitive test called the ADAS-Cog13 (scored 0–85, where higher numbers mean worse cognition) — scores increased (worsened) by between approximately 8.4 and 10.4 points across all groups. On a daily activities scale (ADCS-iADL, scored 0–59, where lower numbers mean worse ability), scores fell by between roughly 7.4 and 9.2 points across groups. On a separate daily activities questionnaire (FAQ, scored 0–30, where higher means greater difficulty), scores rose by between about 6.3 and 7.1 points across groups. On a combined cognition-and-function scale (iADRS, scored 0–144, where higher means greater impairment), scores worsened by between approximately 15.4 and 18.9 points. On a general cognitive test (MMSE, scored 0–30, where lower means worse), scores fell by between roughly 4.7 and 5.8 points across groups. A second reported ADAS-Cog13 analysis showed score increases of between approximately 12.4 and 16.8 points across groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
-
NCT02284906 · results posted 2 July 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02284906) was an extension study involving 40 participants spread across three groups: a "Low Risk Placebo" group (3 people), a "High Risk Placebo" group (18 people), and a "High Risk Pioglitazone" group (19 people). The study was measuring two things: changes in a broad set of memory and thinking tests over 24 months, and how long it took for participants to receive a diagnosis of Alzheimer's disease dementia. The thinking and memory tests covered areas such as recall, problem-solving, language, and attention. The reported data shows that none of the 40 participants completed the study — all are recorded as "not completed." Because of this, the reported data shows no outcome numbers at all for either the primary measure (the combined thinking and memory test score at 24 months) or the secondary measure (time to an Alzheimer's disease diagnosis). No results figures were submitted for any of the three groups for either outcome. Since no outcome data was reported to ClinicalTrials.gov for this study, it is not possible to describe what the results showed about the thinking and memory tests or about Alzheimer's disease diagnoses. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01571427 · results posted 24 April 2019
According to the results reported on ClinicalTrials.gov, this trial involved 83 older adults split into two groups: 41 people in an "Active Social Engagement Group" and 42 people in a "Control Group." Every single participant who started the trial also completed it — there were no dropouts reported. The trial was measuring changes in several thinking and memory tasks between the start and end of the study, comparing how each group's scores shifted over time. The tasks tested things like general mental function, the ability to recall words, naming animals quickly, generating words starting with certain letters, and completing a dot-connecting task. The reported data shows the following changes in scores (calculated as the end-of-study score minus the starting score, so a positive number means scores went up and a negative number means scores went down). For the general mental function test (MMSE, scored out of 30), the active group's average score changed by −0.51 and the control group's by −0.07. For the animal-naming task, the active group's score changed by +1.75 words and the control group's by −0.38 words. For the letter-word task, the changes were +1.14 words (active group) and +1.26 words (control group). For the immediate word-recall task, the changes were +0.30 words (active group) and +0.53 words (control group). For the delayed word-recall task, both groups changed by approximately −0.20 and −0.19 words respectively. For the dot-connecting speed task, where a negative number means participants completed it faster, the active group changed by −2.80 seconds and the control group by −0.85 seconds. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02553928 · results posted 14 March 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02553928) involved 62 people in total — 30 in a group taking memantine once a day, and 32 in a group taking it twice a day. Memantine is a medicine sometimes used for Alzheimer's disease. The trial was looking at two main things: how many participants experienced unwanted side effects (called adverse events), and whether there were any changes in participants' overall condition as rated by a clinician at 12 weeks. By the end of the study, 28 people in the once-daily group and 29 in the twice-daily group had completed the trial. The reported data shows that, when it came to adverse events (any unwanted or unexpected health events reported during the trial), 15 out of 30 participants in the once-daily group and 16 out of 32 in the twice-daily group reported at least one such event. For the second measure, clinicians rated each participant's overall change in condition using a structured 7-point scale — where a score of 1 means marked improvement and 7 means marked worsening, with 4 representing no change. The reported data shows the once-daily group averaged a score of 3.92 and the twice-daily group averaged 3.60 at the 12-week mark. Both scores sit close to the middle of the scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02585934 · results posted 5 December 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02585934) enrolled 661 people in the RVT-101 group and 654 people in the placebo (dummy treatment) group, making it a large study of over 1,300 participants in total. The trial was measuring changes over 24 weeks in people with Alzheimer's disease across two main areas: thinking and memory abilities (using a scoring tool called the ADAS-Cog-11, where higher scores mean greater difficulty), and the ability to carry out everyday activities (using a tool called the ADCS-ADL, where lower scores mean greater difficulty). The reported data shows that on the ADAS-Cog-11 thinking and memory scale (which runs from 0 to 70), scores in the RVT-101 group changed by an average of +0.39 points from the start of the study to week 24, while scores in the placebo group changed by an average of +0.75 points — meaning both groups showed a small increase (slight worsening) over time. On the everyday activities scale (which runs from 0 to 78), the RVT-101 group showed an average change of −1.06 points and the placebo group −0.97 points, meaning both groups showed a small decline in function. The reported data also shows results for several secondary measures. On a 7-point scale of overall functioning rated by a clinician (where 4 means "no change"), the RVT-101 group averaged 4.18 and the placebo group 4.30 at week 24. On a scale measuring how much assistance participants needed day-to-day (0–15, higher meaning more dependency), both groups increased slightly — RVT-101 by 0.30 points and placebo by 0.17 points. A behavioural symptoms scale (0–144, higher meaning more disturbance) changed by −0.08 in the RVT-101 group and +0.06 in the placebo group. A 13-item version of the thinking and memory test showed changes of +0.26 (RVT-101) and +0.64 (placebo). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02760602 · results posted 24 July 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02760602) enrolled 26 people in total — 13 who received the drug solanezumab and 13 who received a placebo (a dummy treatment with no active ingredient). The trial was designed to look at whether solanezumab had any measurable effect on thinking and memory in people with Alzheimer's disease or mild cognitive impairment. It used several well-known assessment tools to measure things like memory, thinking ability, daily living activities, and behavioural symptoms over time. The reported data shows that, for every single outcome measure recorded in this trial — including the primary measure of thinking and memory (the ADAS-Cog14 scale) and all five secondary measures covering daily activities, mental status, global cognition, functional abilities, and neuropsychiatric symptoms — no numerical results were submitted to ClinicalTrials.gov. The data was not reported for either the solanezumab group or the placebo group. Additionally, the records show that none of the 26 participants who started the trial were recorded as having completed it, with all 26 listed under "not completed," though no further explanation for this is provided in the submitted data. Because no outcome numbers were submitted, it is not possible to describe what the measurements showed for any of the assessed scales in either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01127633 · results posted 3 May 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01127633) looked at a drug called solanezumab, which was being studied in people with Alzheimer's disease. A total of 723 people were assigned to receive a placebo (an inactive treatment) and 734 were assigned to receive solanezumab — 1,457 participants in all. The trial ran for around two years (104 weeks) and measured things like unwanted health events (called adverse events), changes in memory and thinking, ability to carry out everyday tasks, behaviour, and how much time caregivers spent providing care. The reported data shows that for the primary measure — the number of participants who experienced at least one health event considered related to the study drug — 308 people in the placebo group and 299 in the solanezumab group had such an event. For serious health events of any cause, the numbers were 485 in the placebo group and 514 in the solanezumab group. On the memory and thinking scale (scored 0–90, where higher means more difficulty), both groups changed by roughly the same amount — about 17.6 points in each group. On the daily living scale (scored 0–78, where lower means more difficulty), the placebo group's score fell by about 26.8 points and the solanezumab group's fell by about 24.8 points. On the dementia severity scale (scored 0–18, higher meaning more severe), scores increased by about 5.6 points in the placebo group and 5.3 points in the solanezumab group. Behaviour scores and caregiver time data were also reported, with small numerical differences between the two groups across those measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
-
NCT01900665 · results posted 14 March 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01900665) looked at a drug called solanezumab in people with Alzheimer's disease. Just over 2,100 people took part in the main placebo-controlled part of the study — around 1,057 were assigned to receive solanezumab and 1,072 to receive a placebo (a dummy treatment with no active ingredient). The trial measured changes in memory, thinking, and daily functioning using several structured questionnaires and rating scales over time. The reported data shows the following for the main (primary) measure — a 14-item thinking and memory scale called the ADAS-Cog14, where higher scores mean greater difficulty. From the start of the trial, the solanezumab group's score increased by an average of 6.65 points, while the placebo group's score increased by an average of 7.44 points. On the secondary measures, similar patterns were reported across the different scales. For example, on a scale measuring everyday activities (ADCS-ADL, where lower scores mean greater difficulty), the solanezumab group's score fell by an average of 7.42 points compared to 8.77 points in the placebo group. On another thinking scale (MMSE, where lower scores mean greater difficulty), the solanezumab group fell by an average of 3.17 points versus 3.66 points in the placebo group. The reported data shows these differences were generally small across all measures reported. It is worth noting that the open-label period of the trial (where all participants received the active drug) shows zero completions recorded for both groups, and no outcome data for that period was included in the submitted results — so those figures are not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02006654 · results posted 7 February 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 734 people in total — 369 assigned to the placebo (dummy treatment) group and 365 assigned to receive idalopirdine (at 60 mg, or 30 mg for some participants). The trial ran for 24 weeks and was primarily measuring changes in thinking and memory abilities in people with Alzheimer's disease, using a well-recognised testing scale called the ADAS-cog, where a lower score means less cognitive impairment. Secondary measurements looked at overall clinical impression of change, ability to carry out daily activities, and behavioural disturbances. The reported data shows that on the primary cognitive test (scored from 0 to 70), both groups' scores moved slightly in the direction of more impairment over the 24 weeks — the placebo group's average score changed by +0.68 points and the idalopirdine group's by +0.13 points. For the clinician's overall impression of change (scored 1–7, where 4 means "no change"), the reported averages at week 24 were 4.32 for the placebo group and 4.39 for the idalopirdine group. On the daily activities scale (0–78, where a lower score means more difficulty), both groups showed a small decline: the placebo group by −1.72 points and the idalopirdine group by −1.05 points. For behavioural disturbances (0–144, higher meaning worse), both groups showed a small improvement: −0.46 for placebo and −0.74 for idalopirdine. In the subgroup of participants who had notable anxiety symptoms at the start, the anxiety score changed by −1.93 in the placebo group and −1.52 in the idalopirdine group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00710684 · results posted 7 December 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 682 people with Alzheimer's disease across three groups. All participants were already taking donepezil (a commonly used Alzheimer's medicine), and were then randomly assigned to also receive either a placebo (dummy pill), a low dose (15 mg) of an investigational medicine called SB-742457, or a higher dose (35 mg) of SB-742457. The trial ran for 48 weeks and was primarily measuring changes in two things: scores on a cognitive (thinking and memory) test called the ADAS-Cog, and scores on a dementia severity scale called the CDR-SB. Of the 682 who started, 470 completed the study. The reported data shows that at the main 24-week measurement point for the ADAS-Cog thinking and memory test (scored 0–70, where higher means more difficulty), the placebo group's score increased by 1.2 points from their starting point, the 15 mg group's score increased by 0.5 points, and the 35 mg group's score changed by −0.4 points (a slight decrease, meaning slightly less difficulty). On the CDR-SB dementia severity scale (scored 0–18, where higher means greater impairment), all three groups showed increases at 24 weeks: 0.9 points for the placebo group, 0.8 for the 15 mg group, and 0.7 for the 35 mg group. For the secondary cognitive battery test (RBANS, scored 0–311 where lower means more impairment), scores at 24 weeks decreased across all groups: −3.6 for placebo, −5.9 for the 15 mg group, and −4.0 for the 35 mg group. Score changes at weeks 12, 36, and 48 followed broadly similar patterns across the three scales and groups, with the reported data available for each of those time points as well. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00490568 · results posted 13 November 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,461 people who took the study drug, a medication called RSG XR (rosiglitazone extended-release). The trial was an open-label study, meaning all participants knew they were receiving the medication. The main thing the trial set out to measure was the number of participants who experienced unwanted medical events (called adverse events) while taking the medication, and how severe those events were. Only 97 of the 1,461 participants completed the study, while 1,364 did not complete it — the data does not provide a breakdown of the specific reasons for each individual non-completion. The reported data shows that 724 participants experienced at least one adverse event during the treatment period. Of those, 345 were reported as mild, 289 as moderate, and 88 as severe. For the secondary outcomes, the reported data shows that 126 participants experienced a serious adverse event — meaning a medical event serious enough to require hospitalisation, be life-threatening, or cause significant disability — and 20 deaths were reported during the study. Regarding a specific side effect of interest, fluid build-up (oedema), 130 participants were reported to have experienced some form of this. The reported data also shows small changes in blood pressure, heart rate, and body weight over time across multiple check-in points during the study, though a detailed breakdown of each individual time point was not provided in the summary data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01142336 · results posted 28 July 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 49 people in total — 26 in the simvastatin group and 23 in the placebo group (a placebo is a dummy treatment with no active ingredient). Most participants finished the trial: 25 from the simvastatin group and 21 from the placebo group completed the full year. The trial was measuring changes in three specific proteins found in cerebrospinal fluid (the fluid that surrounds the brain and spinal cord) — called Aβ42, total tau, and ptau181 — which researchers collected at the start of the trial and again after one year. These proteins are of interest in Alzheimer's disease research. The reported data shows the following one-year changes in protein levels, measured in units called picograms per millilitre (pg/ml — a very small unit of concentration). For Aβ42, the placebo group showed a change of +5.3 pg/ml, while the simvastatin group showed a change of +0.5 pg/ml. For total tau, the placebo group showed a change of −0.1 pg/ml compared with +1.6 pg/ml in the simvastatin group. For ptau181, the placebo group showed a change of −2.9 pg/ml, while the simvastatin group showed a change of +1.7 pg/ml. These are the raw numbers as submitted; no additional statistical detail (such as whether the differences between groups were considered meaningful by chance) was included in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01429623 · results posted 15 June 2017
According to the results reported on ClinicalTrials.gov, this three-year trial (NCT01429623) enrolled 209 people — 102 who received a drug called ladostigil hemitartrate and 107 who received a placebo (a dummy treatment with no active ingredient). All participants had mild cognitive impairment (MCI), a condition where a person notices some memory or thinking changes but can still manage daily life. The trial was primarily measuring how many people in each group went on to be diagnosed with Alzheimer's disease over the three years, using a standard rating tool called the Clinical Dementia Rating (CDR), where a score of 1 or above indicated a conversion to Alzheimer's. The reported data shows that 14 out of 102 people in the ladostigil group and 21 out of 107 people in the placebo group reached that Alzheimer's diagnosis threshold during the study. On the secondary measures — which tracked changes in mood, thinking, and daily functioning — the reported data shows relatively small numerical differences between the two groups. The mood scale (Geriatric Depression Scale, where lower scores are better) changed by an average of +0.084 in the ladostigil group and +0.242 in the placebo group from their starting points. A combined thinking and memory test battery (scored on a range of −3 to +3, where higher is better) showed an average change of +0.21 in the ladostigil group and +0.17 in the placebo group. A daily functioning scale (scored 0–100, where higher is better) showed an average change of −0.77 in the ladostigil group and −0.40 in the placebo group. It is also worth noting that roughly half of the participants in each group did not complete the full study period, which the data does not fully explain. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02120664 · results posted 9 March 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people across five groups: 10 people with a clinical diagnosis of Alzheimer's disease (AD), 4 with "possible AD", 7 with mild cognitive impairment (a condition where memory or thinking is slightly reduced but not severely), 4 older adults considered "at risk", and 10 young healthy volunteers. One person in the "at risk" group did not complete the trial; all others finished. The trial was measuring how well two different brain-scan tracers — florbetapir (a newer tracer) and Pittsburgh Compound B or PiB (an established tracer) — could detect amyloid, a protein associated with Alzheimer's disease. To compare the two tracers fairly, both sets of scan results were converted into a common unit called a "Centiloid", where a score of 0 represents a typical young healthy brain and a score of 100 represents a typical Alzheimer's-diagnosed brain. The reported data shows the following average Centiloid scores from the florbetapir scans: the clinically diagnosed AD group scored 82.44, the possible AD group scored 50.75, the mild cognitive impairment group scored 81.19, the at-risk elderly group scored 14.93, and the young healthy volunteers scored 5.24. The reported data also shows that when the same participants' PiB scans were converted to Centiloid units, the scores were: 87.18 for the clinically diagnosed AD group, 54.52 for possible AD, 74.33 for mild cognitive impairment, 26.39 for the at-risk group, and 0.73 for young healthy volunteers. A secondary measure looked at how consistent (or variable) the scan results were among young healthy volunteers; the reported coefficient of variation — a figure that describes how spread out the results were — was 1.01 for PiB scans and 0.98 for florbetapir scans. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01193608 · results posted 23 February 2017
According to the results reported on ClinicalTrials.gov, this trial tested a drug called AAB-003 in 88 people in total. Participants were divided into five groups, each receiving a different dose of AAB-003 (ranging from 0.5 mg per kilogram of body weight up to 8 mg per kilogram), plus a sixth group of 19 people who received a placebo (an inactive substance used for comparison). The trial was primarily measuring things related to monitoring and tracking participants' experiences — specifically, how many people had unexpected health events, unusual blood or lab test results, changes in vital signs (like heart rate and blood pressure), or abnormal findings on physical and neurological check-ups. It also measured how much of the drug was present in participants' blood after their first dose. The reported data shows the following counts of participants who had notable findings during the trial. In terms of unexpected health events (called treatment-emergent adverse events), the numbers ranged from 3 people in the 1 mg/kg group up to 16 people in the 8 mg/kg group, with 12 out of 19 in the placebo group also recording such events. For unusual lab test results, between 3 and 13 participants across the groups had these recorded. Abnormal physical examination findings were noted in between 1 and 9 participants per group. Abnormal neurological examination findings were noted in between 1 and 6 participants per group. Regarding the amount of drug measured in the blood after the first dose, the reported data shows it increased with each higher dose — from around 14 micrograms per millilitre at the lowest dose up to around 224 micrograms per millilitre at the highest dose. No drug levels were reported for the placebo group, as expected. It is worth noting that not everyone who started the trial completed it — for example, 5 out of 24 participants in the highest dose group did not complete the study, though the reasons were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01459016 · results posted 13 February 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01459016) enrolled 56 participants, all of whom received what was described as "standard of care." Of those, 41 completed the study and 15 did not finish. The trial was an observational study that used several types of brain scans — including different kinds of MRI and a PET scan — to track changes in the brain over time. The scans measured things like overall brain volume changes, the size of a memory-related brain region called the hippocampus, how different parts of the brain communicate with each other at rest, and how water moves through the brain's white matter (the fibres that connect different brain areas). The reported data shows the following measurements from the brain scans. For overall brain volume loss (called the Brain Boundary Shift Integral), the reported figures were approximately 6.35 and 11.66 millilitres of change from the starting point across two time points; the ventricular spaces (fluid-filled cavities inside the brain) showed changes of around 2.02 and 4.20 millilitres. The hippocampus (a brain region involved in memory) showed average volume reductions of approximately 1.69% and 3.06% from baseline across two time points. Brain connectivity and white matter measurements were also reported across multiple brain regions and time points, with values showing small numerical changes in various directions — the full sets of these figures are available in the ClinicalTrials.gov record. For the PET scan measuring amyloid (a protein that can build up in the brain), the reported data shows a baseline average score of 1.581 on a standardised scale used to compare amyloid levels across brain regions; no follow-up amyloid data was reported in the results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00676143 · results posted 10 June 2016
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called bapineuzumab in people with Alzheimer's disease. A total of 1,099 people were enrolled — 441 in the placebo (dummy treatment) group and 658 in the bapineuzumab group. The trial measured two main things over 78 weeks (about 18 months): changes in thinking and memory abilities using a standard test called the ADAS-Cog/11 (scored 0–70, where higher scores mean more difficulty), and changes in the ability to carry out daily activities using a scale called the DAD (scored 0–100, where higher scores mean better function). A number of additional measures were also tracked, including brain scans looking at amyloid protein build-up, a spinal fluid marker of brain cell damage, and brain shrinkage over time. The reported data shows that on the thinking and memory test (ADAS-Cog/11), both groups worsened by a similar amount over the study period — the placebo group's score increased by 7.31 points and the bapineuzumab group's score increased by 7.32 points (higher scores indicate more difficulty, so both groups showed a similar degree of decline). For daily activities (DAD), both groups also showed a similar decline — the placebo group's score fell by 14.94 points and the bapineuzumab group's score fell by 14.89 points. For the secondary measures, the reported data shows a small difference in brain amyloid levels (a change of +0.03 for placebo versus −0.04 for bapineuzumab), and in the spinal fluid marker of brain cell damage (a change of +0.83 pg/mL for placebo versus −0.55 pg/mL for bapineuzumab). Brain shrinkage rates were reported as 17.64 mL/year for placebo and 17.51 mL/year for bapineuzumab — figures that were very close to each other. It is worth noting that a notable proportion of participants did not complete the trial — 156 in the placebo group and 260 in the bapineuzumab group — though the reasons for this were not detailed in the submitted data. The data for the final secondary outcome (the trend analysis of thinking scores between weeks 39 and 78) was reported across multiple time points, and the figures across both groups appeared broadly similar, though a full breakdown by all dose levels was not clearly separated in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00880555 · results posted 24 March 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 78 people across several groups: 23 people with a non-dementia memory disorder, 40 people in a control group (people without memory problems), 11 people with mild Alzheimer's disease, and smaller numbers in three additional categories (2 people classified as CIND, 1 person classified as intoxicated, and 1 person with a non-Alzheimer's dementia). The trial was measuring financial capacity — that is, people's ability to understand and handle financial tasks and concepts — using a tool called the Financial Capacity Instrument (FCI). This tool gives a score out of 191, where a higher score means a greater ability to manage financial matters. Only the three main groups contributed to the primary outcome results. The reported data shows FCI scores across what appear to be three separate time points or measurement occasions for the three main groups. In the first set of measurements, the control group scored 164.0 out of 191, the non-dementia memory disorder group scored 147.3, and the mild Alzheimer's disease group scored 123.3. In the second set, the control group scored 179.0, the non-dementia memory disorder group scored 150.8, and the mild Alzheimer's disease group recorded a score of 0 (meaning no data was reported for that group at that time point). In the third set, the control group scored 163, the non-dementia memory disorder group scored 93, and again no data was reported for the mild Alzheimer's disease group. It is worth noting that not all participants completed the study — for example, only 13 of the 23 people in the non-dementia memory disorder group and 23 of the 40 control participants finished, and the data does not explain the reasons for non-completion. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00667810 · results posted 8 January 2016
According to the results reported on ClinicalTrials.gov, this trial tested a drug called bapineuzumab in people with Alzheimer's disease. A total of 890 people started the trial across four groups: 269 received a lower dose of bapineuzumab (0.5 mg/kg), 264 received a higher dose (1.0 mg/kg), 346 received a placebo (dummy treatment with no active ingredient), and 11 received a separate 2.0 mg/kg dose. The trial ran for approximately 78 weeks and was mainly measuring changes in thinking and memory abilities, as well as day-to-day functioning. It is worth noting that a large proportion of participants did not complete the trial — for example, around 62% of those in the lower-dose group and around 64% in the placebo group did not finish. The reported data shows that, for the two main things being measured, all groups showed a worsening over time. On the thinking and memory test (scored 0–70, where higher means more difficulty), the lower-dose bapineuzumab group's score increased by about 6.1 points, the higher-dose group's score increased by about 8.1 points, and the placebo group's score increased by about 7.9 points. On the daily activities measure (scored out of 100, where higher means better function), all groups showed a decline: the lower-dose group dropped about 14.6 points, the higher-dose group dropped about 15.1 points, and the placebo group dropped about 16.1 points. The reported data also shows results for several secondary measurements. A brain scan measuring a protein called amyloid showed a small reduction in the lower-dose bapineuzumab group (−0.04 units) and no change in the higher-dose group, while the placebo group showed a slight increase (+0.02 units). A fluid test measuring a marker of brain cell damage called phospho-tau showed reductions in both bapineuzumab groups (around −6.4 to −6.6 pg/mL) compared with a slight increase in the placebo group (+0.70 pg/mL). Brain volume loss, measured by MRI, was reported as approximately 18.6 mL/year in both bapineuzumab groups and 17.5 mL/year in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00498602 · results posted 1 January 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 245 people across seven groups. Each group received a different version or dose of the investigational vaccine being tested — called ACC — either alone, combined with an immune-boosting ingredient called QS-21, or as a comparison substance (QS-21 alone or a saltwater placebo called phosphate buffered saline). The trial was looking at how often participants experienced unwanted medical events (called adverse events) after receiving their assigned treatment, and also measured the body's antibody responses — specifically two types of antibodies known as IgG and IgM — at many different time points over roughly two years. The reported data shows that the primary measure — the percentage of participants who experienced any treatment-emergent adverse event — was very high across all groups. Reported figures ranged from 83.3% in the ACC 30 μg alone group up to 100% in the saltwater placebo group, with most other groups sitting between 90% and 97%. Serious adverse events were also reported in several groups, with figures ranging from around 14% to 42%, though the data as submitted was not fully labelled in a way that allows each serious adverse event figure to be matched to every group with certainty. For the antibody measurements (IgG and IgM), the reported data shows only partial results across the many time points studied. For IgG antibodies, the reported numbers at the time points included were mostly at or near the lowest detectable level (50 U/mL) across groups, with slightly higher readings in some of the combination vaccine groups. For IgM antibodies, some groups showed higher readings at certain time points — for example, one group receiving ACC 30 μg combined with QS-21 had a reported figure of 254.5 U/mL compared to 25 U/mL in the placebo group at one time point. The IgG subtype data was noted as not having been assessed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00998764 · results posted 1 January 2016
According to the results reported on ClinicalTrials.gov, this extension trial (NCT00998764) enrolled 492 people with Alzheimer's disease — 216 who had previously received a placebo in an earlier study and then switched to the experimental drug bapineuzumab, and 276 who had been receiving bapineuzumab throughout. The trial was measuring serious unwanted events (the primary focus), as well as changes in thinking and memory abilities, day-to-day functioning, and behavioural symptoms over time. The reported data shows that 35 out of 216 participants in the placebo-then-bapineuzumab group, and 33 out of 276 in the bapineuzumab-throughout group, reported a serious unwanted event — this was the main thing the trial was set up to count. For thinking and memory (measured on a scale of 0–70, where higher scores mean greater difficulty), both groups showed increasing scores over the 78-week follow-up period, meaning both groups' thinking abilities appeared to decline over time; the numbers reported were similar between the two groups at most time points. For day-to-day functioning (measured on a scale of 0–100, where higher is better), both groups showed declining scores over time, again with similar patterns between groups. For behavioural symptoms (measured on a scale of 0–144, where higher means more disturbance), both groups showed increases over time. Only 2 participants out of 492 completed the study, with the vast majority not completing it; the reasons for non-completion were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00581867 · results posted 14 July 2015
According to the results reported on ClinicalTrials.gov, this trial involved 31 people in total, split into two groups. It was a crossover study, meaning everyone tried both treatments at different times — one group received a placebo (an inactive spray) first and then intranasal insulin (insulin delivered as a nasal spray), while the other group received intranasal insulin first and then the placebo. The trial was measuring brain activity in a region called the hippocampus (an area involved in memory) using a brain scan called an fMRI, as well as overall thinking and memory skills through a series of cognitive tests. The reported data shows that during the fMRI brain scan, the hippocampus showed around 36.4% of its volume as active when participants were using intranasal insulin, compared to about 41.3% when using the placebo. For the cognitive testing, the trial used a combined score (called a z-score, which is simply a way of comparing individual results to an average — a score of zero means exactly average, positive means above average, and negative means below average). The reported data shows a z-score of –0.05 for the intranasal insulin group and –0.02 for the placebo group, both of which are very close to the average. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01524887 · results posted 31 March 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01524887) enrolled 261 people with Alzheimer's disease across three groups: 85 received a higher dose of an intravenous immunoglobulin treatment (IGIV 10% at 0.4 g/kg), 90 received a lower dose (IGIV 10% at 0.2 g/kg), and 86 received a placebo (an inactive infusion). The trial ran for 18 months and was measuring changes in thinking and memory, ability to carry out everyday tasks, overall clinical impression, behavioural symptoms, brain volume on MRI scans, and quality of life. It is worth noting that the data shows zero participants were recorded as having "completed" the study, though the reasons for this are not explained in the submitted results. The reported data shows the following changes over 18 months on the various scales used. For the thinking and memory test (scored 0–70, where higher means more difficulty), scores increased by 4.0 points in the high-dose group, 4.4 in the low-dose group, and 3.1 in the placebo group — meaning all groups showed some decline. For the daily living activities scale (scored 0–78, where lower means more difficulty), scores fell by 8.1 points in the high-dose group, 5.0 in the low-dose group, and 3.8 in the placebo group. On the clinician's overall impression of change (a 1–7 scale where 4 means "no change" and higher numbers mean worsening), all three groups scored between 4.3 and 4.5. For behavioural symptoms (0–144, higher is worse), the reported changes were +2.3, +3.8, and +0.6 for the high-dose, low-dose, and placebo groups respectively. Brain volume changes and quality-of-life scores were also reported, but showed only very small numerical differences across the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
-
NCT01020838 · results posted 25 March 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 218 participants in total, with 216 included in the safety analysis. The trial was testing a brain scanning approach that used a tracer (a substance injected before a PET scan) to detect the presence of beta-amyloid — a protein deposit associated with Alzheimer's disease — in the brain. The key question the trial was designed to answer was how accurately the scan results matched what was later confirmed by examining brain tissue after death (post-mortem). The trial tracked participants over time, with 91 receiving a first repeat injection and 34 receiving a second, and 35 people completing the full study. The reported data shows that, for the primary outcome — comparing scan readings by three independent reviewers against brain tissue analysis — the scan correctly identified regions where beta-amyloid was present (sensitivity) in roughly 58% to 91% of cases depending on the brain region examined. It correctly identified regions where beta-amyloid was absent (specificity — meaning it did not flag a region incorrectly) in roughly 86% to 100% of cases across different brain regions. For the secondary "whole brain" outcomes, where the entire brain was assessed as either showing beta-amyloid or not, the reported sensitivity figures ranged from approximately 96% to 97%, and specificity figures ranged from approximately 85% to 94%, depending on which laboratory method was used to verify the tissue results. Additional measurements of tracer uptake levels (called SUVRs — a numerical score reflecting how much of the tracer was absorbed) were also reported, with figures ranging from approximately 1.18 to 1.71 across different scanning timepoints and groups, though the data was not reported in a way that allows direct comparison between individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00397891 · results posted 4 September 2014
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called bapineuzumab, tested at four different doses (0.15, 0.5, 1.0, and 2.0 milligrams per kilogram of body weight), compared against a placebo (an inactive treatment). A total of 32 people took part — six in each of the four bapineuzumab dose groups and eight in the placebo group. The trial was primarily measuring things related to monitoring and tracking any unwanted medical events or notable changes in participants' bodies, including physical and neurological check-ups, blood tests, heart tracings (ECGs), vital signs like blood pressure and pulse, and any adverse events (unexpected medical occurrences) that happened during the study period. The reported data shows that when it came to adverse events — any unexpected medical occurrence during the study — 5 out of 6 participants in the lowest dose group, 3 out of 6 in the 0.5 mg/kg group, 6 out of 6 in the 1.0 mg/kg group, 3 out of 6 in the 2.0 mg/kg group, and 7 out of 8 in the placebo group experienced at least one such event. No serious adverse events (those involving hospitalisation, life-threatening situations, death, or lasting disability) were reported in any group. The reported data also shows that no participants had clinically notable changes in their physical or neurological examinations. For vital signs, small numbers of participants — ranging from 0 to 2 across the groups — had readings considered potentially clinically important. For heart tracings (ECGs), only 1 participant in the placebo group had a result flagged as potentially notable. For laboratory (blood and urine) tests, the number of participants with potentially notable results ranged from 3 to 6 across all groups, including the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00750282 · results posted 16 July 2014
According to the results reported on ClinicalTrials.gov, this trial looked at a brain scanning technique called florbetaben PET, which uses a special dye to try to detect a protein build-up in the brain associated with Alzheimer's disease. A total of 425 people took part across two main phases (called Part A and Part B): 69 healthy volunteers and 82 people with Alzheimer's disease in Part A, and 126 healthy volunteers and 148 people with Alzheimer's disease in Part B. The trial was measuring how reliably the scan could correctly identify people who had Alzheimer's disease (called "sensitivity" — the percentage of Alzheimer's patients whose scan came back positive) and how reliably it could correctly identify healthy people (called "specificity" — the percentage of healthy volunteers whose scan came back negative). The reported data shows that in Part A, using one scoring method, around 79% of Alzheimer's patients had a positive scan result, and around 91% of healthy volunteers had a negative result. Using a second scoring method in Part A, those figures were approximately 75% and 96% respectively. In Part B — where an independent panel of medical experts set the standard for diagnosis — the reported figures were approximately 67% and 97% using one reading panel, and approximately 79% and 89% using a second reading panel. Secondary measurements looked at scanning at different time points and found broadly similar percentage ranges, and also measured how consistently different readers agreed with each other when scoring the scans, with agreement scores (called kappa values, where 1.0 means perfect agreement) ranging from 0.56 to 0.86 across the different conditions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01626391 · results posted 11 July 2014
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called TRx0237 taken alongside other Alzheimer's medications (an acetylcholinesterase inhibitor and/or memantine — these are types of medicines commonly used for Alzheimer's disease). The trial was very small, with just 9 people taking part in total — 5 in the TRx0237 group and 4 in the placebo (dummy treatment) group. The main thing being measured was how many participants experienced unwanted or unexpected health events (called adverse events) over 8 weeks of treatment. The reported data shows that, out of the 5 people who started in the TRx0237 group, 3 completed the trial and 2 did not. All 4 people in the placebo group completed the trial. When it came to the primary outcome — the number of participants who experienced adverse events — the reported data shows that 4 out of 5 participants in the TRx0237 group and 4 out of 4 participants in the placebo group reported at least one adverse event. No further detail about the nature or severity of those events was included in the submitted results data. It is worth noting that with only 9 participants in total, this was an extremely small trial, and no secondary outcome data was reported in the results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01138111 · results posted 25 June 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 45 adults who had been diagnosed with Mild Cognitive Impairment (MCI) — a condition involving noticeable memory or thinking difficulties that are not yet severe enough to be called dementia. Thirty-six participants completed the study, while nine did not finish. The trial used a brain scanning technique called a PET scan with a tracer called florbetaben, which is designed to detect a protein called beta-amyloid that can build up in the brain. The aim was to see whether the amount of beta-amyloid detected on these scans at the start of the study, and at 12 and 24 months, was different between participants who later went on to be diagnosed with Alzheimer's Disease and those who did not. The reported data shows that participants who eventually progressed to Alzheimer's Disease had higher average beta-amyloid scan readings (called SUVRs — simply a number representing how much of the tracer was detected) than those who did not progress, at all three time points. For those who did not progress to Alzheimer's, the reported average SUVR was around 1.43 at all three scans. For those who did progress, the reported averages were 1.73 at the start, 1.74 at 12 months, and 1.80 at 24 months. Using a cut-off score of 1.4 to label a scan as "abnormal," the reported data shows that the large majority of participants who later progressed to Alzheimer's had abnormal scans, while a sizeable portion of those who did not progress had normal scans. The reported data also shows figures for how well the scan results lined up with eventual Alzheimer's diagnoses. For example, at the 12-month scan, the reported sensitivity (the proportion of people who later developed Alzheimer's who also had an abnormal scan) was 100% at the 45-minute imaging window, and specificity (the proportion of people who did not develop Alzheimer's who had a normal scan) was around 67%. These figures varied depending on the time point and how long after the injection the scan was taken. Some additional detail on predictive values was not broken down further in the reported data beyond what is described above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00476008 · results posted 3 June 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 43 people in total — 22 in the memantine (medication) group and 21 in the placebo (dummy pill) group. The trial was looking at whether people with early memory or thinking difficulties who took memantine were better able to pass a standardised on-road driving test after 12 months compared to those who took a placebo. By the end of the study, 13 people in each group had completed the full trial. The reported data shows that at the 12-month mark, 13 out of 13 participants in the memantine group who completed the study passed the on-road driving test, compared with 9 out of 13 in the placebo group. The trial also measured several thinking and memory tasks as secondary outcomes. On a memory test involving recalling objects (scored 0–30, where higher is better), the memantine group scored around 17.9 at the end compared to 19.1 in the placebo group. On a drawing and visual planning test (scored 0–36, higher is better), the memantine group scored about 27.9 versus 30.0 for placebo. Two timed tests of mental tracking and flexibility showed the memantine group completing the tasks in roughly 38–171 seconds compared to 53–233 seconds for the placebo group — noting that lower times indicate better performance on these tests. A general thinking assessment (scored 0–30) showed the memantine group averaging about 27.2 and the placebo group about 26.0 at the end of the study. It is worth noting that the number of participants who completed the study was quite small, and some measurements appear to have been reported inconsistently in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00814697 · results posted 28 January 2014
According to the results reported on ClinicalTrials.gov, this trial involved 12 participants, all of whom completed the study with no dropouts. The trial was looking at a treatment called rTMS (repetitive transcranial magnetic stimulation — a non-invasive procedure that uses magnetic pulses directed at the brain) and measuring how participants performed on three standard thinking and language tests before, during, and four weeks after the treatment. The three tests used were the Boston Diagnostic Aphasia Examination (BDAE), which measures language ability; the CFL Category Naming test (CFL), which measures word-finding ability; and the Mini-Mental State Examination (MMSE), which measures general thinking and memory. The reported data shows the average scores recorded four weeks after the rTMS treatments were completed. For the BDAE — which has a possible score range of 0 to 15, where higher scores indicate better performance — the average score reported was 13.3. For the CFL — with a possible range of 0 to 62 — the average score was 17.0. For the MMSE — with a possible range of 0 to 30 — the average score was 26.9. The reported data does not include a comparison group or scores from before the treatment period presented in the same structured results section, so direct before-and-after comparisons from this data alone cannot be made here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00996918 · results posted 1 January 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT00996918) was an extension study involving people with Alzheimer's disease who had previously taken part in an earlier trial of a drug called bapineuzumab. A total of 202 participants were enrolled across five groups, depending on what dose they had received previously and what dose they were assigned to in this extension phase. The trial's primary focus was on counting how many participants experienced a serious unwanted medical event (called a serious adverse event). Secondary measures looked at changes in thinking and memory abilities, day-to-day functioning, and behavioural symptoms over time, using standardised rating scales. Notably, the reported data shows that none of the 202 participants completed the study — all were recorded as "not completed." The reported data shows that serious adverse events were recorded in 6 out of 39 participants in the placebo-then-0.5 mg/kg group, 10 out of 66 in the continuous 0.5 mg/kg group, 1 out of 37 in the placebo-then-1.0 mg/kg group, 11 out of 56 in the continuous 1.0 mg/kg group, and 0 out of 4 in the 2.0 mg/kg-then-1.0 mg/kg group. For the secondary measures, the cognitive scale (scored 0–70, where higher means more impairment) showed scores generally increasing over time across all groups, meaning participants' recorded impairment grew over the course of the study. Similarly, the daily functioning scale (scored out of 100, where higher is better) showed declining scores across all groups over time. Behavioural symptom scores also generally increased over time in most groups. The reported data for the smallest group (4 participants in the 2.0 mg/kg-then-1.0 mg/kg group) was not reported for the secondary outcome measures. It is worth noting that because no participants completed the study, the results should be interpreted with that important limitation in mind — the data was not reported in a way that explains why. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01672827 · results posted 19 December 2013
According to the results reported on ClinicalTrials.gov, this trial involved 276 participants and all 276 completed the study with no dropouts. The trial was examining brain scan images taken using a radioactive tracer called [18F]Flutemetamol, which is used in a type of scan called a PET scan. Importantly, no participants were given any new drug or treatment as part of this study — instead, five specialist readers looked at existing PET scan images to see how well they could spot signs of amyloid plaques (protein deposits in the brain that are associated with certain conditions). The trial measured how accurately and consistently those readers could interpret the images. The reported data shows two main things were measured: sensitivity (how often readers correctly identified a scan that truly showed amyloid plaques — called a "true positive") and specificity (how often readers correctly identified a scan that truly did not show amyloid plaques — called a "true negative"). For sensitivity, the five readers' results, along with an overall figure, ranged from 84% to 94%. For specificity, the reported figures ranged from 77% to 96% across the readers. The reported data also shows a secondary measure of how often the readers agreed with each other when looking at the same images; the number of agreements between pairs of readers across 276 images ranged from 223 to 268 out of a possible 276. These figures reflect how the readers performed when interpreting the scans without any additional anatomical (structural) images to help guide them. The reported data shows variation between individual readers in both measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00948766 · results posted 11 February 2013
According to the results reported on ClinicalTrials.gov, this trial looked at two different doses of a rivastigmine skin patch — a higher-dose patch (13.3 mg/24 h) and a lower-dose patch (4.6 mg/24 h) — in people with Alzheimer's disease. The trial had two parts: a core study and an extension study. In the core study, 356 people started on the higher-dose patch and 360 started on the lower-dose patch; around 229 and 234 people respectively completed that part. The extension study then followed 397 participants (all on the higher-dose patch), of whom 306 completed it. The trial measured changes in daily living abilities, thinking and memory, behaviour, and an overall clinical impression of change. The reported data shows the following from the core study after 24 weeks. For daily living abilities (scored 0–54, where higher is better), both groups showed a decline from where they started: the higher-dose group's score fell by an average of 2.6 points, and the lower-dose group's fell by 3.6 points. For thinking and memory (scored 0–100, where higher is better), the higher-dose group's score fell by an average of 1.6 points, while the lower-dose group's fell by 6.4 points. For behaviour (scored 0–144, where lower is better), the higher-dose group's score fell by 0.4 points on average (a small move in the "better" direction on this scale), while the lower-dose group's score rose by 1.2 points. For the clinician's overall impression of change, the reported data shows that in the higher-dose group, about 20% of patients showed minimal improvement, 34% showed no change, and 24% showed minimal worsening, while in the lower-dose group roughly 11% showed minimal improvement, 29% showed no change, and 31% showed minimal worsening. In the extension study (higher-dose patch only), the reported average change from the beginning of the trial was a decline of 4.3 points on daily living abilities and 5.9 points on thinking and memory after a further 24 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00857415 · results posted 7 May 2012
According to the results reported on ClinicalTrials.gov, this trial involved two separate groups of participants. The first group — called the "Autopsy Cohort" — started with 152 people, of whom 37 passed away within one year of having a brain scan using a radioactive tracer called florbetapir (sometimes known as AV-45). Of those, 35 went on to have their brain tissue examined after death. The second group — called the "Specificity Cohort" — included 74 younger, healthy volunteers who were expected not to have the protein deposits (amyloid plaques) that are associated with Alzheimer's disease. The trial was measuring how well the florbetapir brain scan matched what was actually found in brain tissue after death, and whether the scan could correctly identify people who were unlikely to have those deposits. The reported data shows that, for the Autopsy Cohort, the overall match between what the scan suggested and what was found in the brain tissue after death was measured using a statistical tool called a "correlation coefficient" — a number between -1 and +1, where +1 means a perfect match and 0 means no relationship at all. The reported figure was 0.78, indicating a fairly strong positive relationship between the scan results and the physical brain tissue measurements. When six individual brain regions were looked at separately, the reported correlation coefficients ranged from 0.68 to 0.77. For the Specificity Cohort, the reported data shows that 47 out of 74 healthy volunteers received a "negative" scan result — meaning the majority of three independent reviewers judged their scans as showing no significant amyloid deposits. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00593372 · results posted 20 July 2010
According to the results reported on ClinicalTrials.gov, this trial involved 11 people in total — 8 in the Spaced Retrieval Therapy group and 3 in the Continuing Medication Only group. All 11 participants completed the study with no dropouts. The trial was measuring whether a memory training approach called Spaced Retrieval Therapy — where a person practises recalling specific pieces of information over and over at increasing intervals — made a difference to the number of everyday memory tasks participants could consistently remember, such as recalling where they keep their keys. The reported data shows that, over the course of the study, participants in the Spaced Retrieval Therapy group reported an average of 5 successful memory tasks completed, while participants in the Continuing Medication Only group reported an average of 0. For the secondary outcome — a standard short mental assessment tool called the Mini-Mental State Examination, which gives a general snapshot of thinking and memory abilities — the reported data shows that no results were provided for this measure. It is worth noting that this was a very small study with only 11 participants across both groups, which means the numbers above reflect a very limited group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00759863 · results posted 23 February 2010
According to the results reported on ClinicalTrials.gov, this trial involved 242 people in total — 144 in the "Lifezig" group and 98 in the "Usual Care" group. The trial was measuring the wellbeing of people living with dementia, as well as the troubling behaviours those people showed and how much those behaviours bothered their carers, and carer depression. By the end of the study, 124 people in the Lifezig group and 80 in the Usual Care group had completed the trial (20 and 18 people respectively did not finish, though the reasons are not detailed in this data). The reported data shows the following scores at the end of the study. For the main measure — overall wellbeing of people with dementia, rated on a scale where 32 is the best possible score and 144 is the worst — the Lifezig group averaged 69.75 and the Usual Care group averaged 77.99. For the first secondary measure — a checklist of troubling behaviours and how much they bothered carers, where 0 is best and 96 is worst — the Lifezig group averaged 11.39 and the Usual Care group averaged 15.55. For the second secondary measure — a scale measuring depression in carers, where 0 is best and 60 is worst — the Lifezig group averaged 11.00 and the Usual Care group averaged 10.43. It is worth noting that the reported data does not include any statistical analysis of whether these differences between groups are meaningful, so it is not possible from this summary alone to draw conclusions about what the numbers signify. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00469456 · results posted 7 December 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 264 people in total — 129 in the placebo group and 135 in the memantine group. The trial was looking at whether memantine, a medicine used in Alzheimer's disease, had any effect on communication abilities in people with moderate-to-severe Alzheimer's. Two communication assessment tools were used: one called the FLCI (Functional Linguistic Communication Inventory), which was the main measure, and one called the ASHA FACS, which was a secondary measure. Most participants completed the study — 120 in the placebo group and 131 in the memantine group. The reported data shows that, after 12 weeks, scores on the FLCI (which runs from 0 to 87, where a higher number means better communication) changed by an average of −0.6 points in the placebo group and +0.7 points in the memantine group from where they started. In other words, the placebo group's average score went down slightly, while the memantine group's average score went up slightly. For the secondary measure, the ASHA FACS (where a higher score also means better communication, with a possible range of 0 to 196), the reported data shows the placebo group's average score changed by −5.3 points and the memantine group's average score changed by +0.5 points from the start of the study. The trial report does not include additional detail beyond these average score changes, and no further breakdown of the results was provided in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00911807 · results posted 2 June 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 217 people in total across three groups: 72 received a combination of Cerebrolysin and Donepezil, 70 received Cerebrolysin alone, and 75 received Donepezil alone. The trial was measuring changes in thinking and memory abilities in people with Alzheimer's disease over 28 weeks, using a recognised assessment tool called the ADAS-COG+ (a scored test where higher numbers indicate greater difficulty, out of a maximum of 85 points). Not everyone who started the trial finished it — 55, 52, and 52 participants completed the study in each group respectively. The reported data shows that all three groups had lower scores at week 28 compared to where they started, meaning their test scores moved in a direction suggesting less difficulty on the assessment. The combination group's average score changed by minus 2.348 points, the Cerebrolysin-only group's by minus 1.711 points, and the Donepezil-only group's by minus 1.246 points. It is important to note that these are average changes across all participants in each group, and a change of a few points on an 85-point scale gives an idea of the size of the shift recorded. For the second primary measure — a clinician's overall impression of change (known as CIBIC+) — and for all of the secondary outcome measures, no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
See the full Alzheimer's Disease page · What changed recently
Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.