Trial 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
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.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Alzheimer's Disease Trial, Terminated
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility 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
Who may be able to join
- People aged 50 to 89 years old at the time of screening
- People who are able to give written agreement to take part, or who have a legally authorised representative who can do so on their behalf
- People who have a capable and willing caregiver who agrees in writing to support their participation and follow the study requirements
- People who have been diagnosed with probable Alzheimer's disease using a specific set of recognised medical guidelines (the NINCDS-ADRDA 1984 criteria)
- People whose Alzheimer's disease is at a mild to moderate stage, based on a standard memory and thinking test score (MMSE) of between 16 and 26
- People who have had a brain scan (CT or MRI) after their symptoms began, with results that fit the Alzheimer's disease diagnosis
- People who are willing and able to follow the study schedule, attend regular infusions, and complete testing, including having adequate vision and hearing
- People who have been on stable, locally approved Alzheimer's medication(s) for at least 12 weeks before screening (but not taking two acetylcholinesterase inhibitor medications at the same time)
- People who have suitable veins for repeated blood draws and infusions
- People taking certain medications that affect mood, behaviour, or brain activity (such as some antidepressants, antipsychotics, or anti-seizure medications) who have been on a stable dose for at least 6 weeks before screening
- Women who could become pregnant must have a negative pregnancy test at screening and must agree to use reliable contraception throughout the study
- People who have a coronary artery stent must have written clearance from an interventional heart specialist confirming they are not at increased risk from immunoglobulin treatment
- People who have a blood vessel stent elsewhere in the body must have written clearance from a vascular surgeon confirming they are not at increased risk from immunoglobulin treatment
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People whose diagnosis is considered "possible" Alzheimer's disease (rather than "probable"), or who have a different type of dementia such as vascular dementia, Lewy body dementia, or frontotemporal dementia
- People who are currently living full-time in a skilled nursing facility
- People who cannot have an MRI scan — for example, due to certain pacemakers (MRI-compatible pacemakers may be acceptable — confirm with trial site), severe claustrophobia, or metal implants in the body
- People with significant heart failure (confirm with trial site for specific severity levels)
- People with current irregular heart rhythm (atrial fibrillation), unstable chest pain at rest, or who have had a heart attack within the 12 months before screening
- People with poorly controlled high blood pressure (above 160/100 mmHg confirmed on repeated checks)
- People who have had a blood clot or clot-related event in the 12 months before screening
- People with a known inherited or existing blood clotting disorder (such as factor V Leiden or antiphospholipid syndrome)
- People who have had bleeding inside the brain within the 5 years before screening
- People whose MRI scan shows certain concerning findings, such as more than 4 small bleeds in the brain, signs of surface bleeding, fluid build-up, a larger bleed, a major stroke, significant white matter disease, or multiple small brain lesions (confirm with trial site for exact definitions)
- People who have had a head injury with loss of consciousness, bruising of the brain, or an open head wound within the 12 months before screening
- People with a seizure disorder that is not well controlled, meaning two or more unexpected seizures per year despite treatment
- People with a score above 4 on a specific scale used to assess blood vessel-related memory problems (Modified Hachinski score — confirm with trial site)
- People with an active cancer, or a history of cancer within the 5 years before screening (some skin cancers, cervical carcinoma in situ, and stable prostate cancer not requiring treatment may be exceptions — confirm with trial site)
- People with an active autoimmune or immune-related neurological condition
- People with uncontrolled severe depression, psychosis, or other major mental health conditions
- People with poorly controlled diabetes, defined by a specific blood sugar level marker (HbA1c of 6.5% or higher)
- People with significantly reduced kidney function based on a standard calculation adjusted for age and sex
- People with a known history of untreated vitamin B12 deficiency within 6 months before screening, or a clinically significant low vitamin B12 level at the time of screening
- People with certain abnormal blood test results, including liver enzyme levels more than 2.5 times the upper limit of normal, significant anaemia or haemoglobin below 10.0 g/dL, very low white blood cell counts, low platelet counts, very high total protein levels, or clotting problems
- People who test positive at screening for hepatitis B, hepatitis C, or HIV
- People with a known deficiency of a specific protein called IgA (below 8 mg/dL)
- People with a known history of allergic or serious reactions to human blood products, such as immunoglobulins or human albumin
- People who have received certain immune-modifying treatments recently, including anti-CD20 therapy within 12 months or other immunotherapy within 12 weeks before screening (some low-dose or non-systemic steroid use may be allowed — confirm with trial site)
- People who have received intravenous or under-skin immunoglobulin treatment within the 2 years before screening, or who took part in a specific previous Baxter study
- People who have ever received a vaccine or active treatment specifically designed to slow or stop Alzheimer's disease progression
- People who have received an experimental drug, device, or passive immunotherapy aimed at Alzheimer's disease within the 12 months before screening
- People who have taken part in any other clinical trial involving an experimental treatment or device within 12 weeks before screening, or who plan to do so during this study
- People who are a family member or employee of the study investigator
- People who are currently breastfeeding or plan to breastfeed during the study
- People with any other condition, disease, or abnormal test result that, in medical judgment, could interfere with participation, increase risk, or affect study results
- People who are currently taking blood-thinning or anti-clotting medications other than aspirin
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Trial contact details on record
Principal Investigator: Study Director, Takeda
Australian sites
This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 1 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Change From Baseline to Month 18 in Cognitive Subscale of the Alzheimer´s Disease Assessment Scale (ADAS-Cog); Change From Baseline to Month 18 in Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) Inventory
Other options
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.