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 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.
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, Completed
Who may 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 might be able to join this trial:
- You are between 50 and 85 years old
- You have been diagnosed with early-stage (prodromal) Alzheimer's disease and are not currently taking medications called memantine or cholinesterase inhibitors
- You have a family member, friend, or carer who sees you regularly and can accurately report on how your memory and daily abilities are doing, and who is willing to attend clinic visits to provide this information
- You have had enough education or work experience to rule out intellectual disability
- Someone close to you has noticed your memory has been gradually getting worse over the last 12 months (you may or may not have noticed this yourself)
- Your score on a standard memory and thinking test (called the MMSE) is 24 or higher out of 30
For an optional part of the study involving brain scans (PET sub-study):
- You are able and willing to travel to a PET imaging centre and complete the planned brain scans
- Your past and planned exposure to radiation from medical or research procedures is within safe limits
Who may not be able to join:
- You have another neurological or medical condition that affects, or could affect, your thinking or mental health during the study
- You have had a stroke in the past
- You have had a mini-stroke (transient ischemic attack) within the last 12 months
- You have a history of schizophrenia, schizoaffective disorder, or bipolar disorder
- You currently have major depression
- You have had a significant heart problem, such as a heart attack or chest pain (angina), in the last 2 years
For the optional PET brain scan part of the study:
- You have taken part in a study or medical procedure involving PET scan tracers or other radioactive substances within the last 12 months
- You are currently or planning to take part in another study involving PET scan tracers or radioactive substances (other than this trial)
- You have had or are planning to have radiation exposure that, when combined with the scan in this study, would exceed the recommended safe limits for radiation (confirm with trial site)
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 104 (Double-Blind Treatment Phase); Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (OLE Phase)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.