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 (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.
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
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 must have confirmed evidence of amyloid beta (an Alzheimer's-related protein) in your brain, shown through a spinal fluid test or a special brain scan called an amyloid PET scan.
- You must have noticed your memory getting worse gradually over at least the 6 months before the study screening, and someone who knows you well must be able to confirm this.
- You must have a family member, friend, or carer who spends at least 10 hours per week with you (in person or by phone) and can give accurate updates about how your memory and daily functioning are changing over time.
- You must meet the medical criteria for mild cognitive impairment (MCI) or mild Alzheimer's disease, which includes scoring between 22 and 30 on a standard memory test (MMSE), showing certain results on other memory and thinking assessments, and meeting specific rating scale scores set by a recognised Alzheimer's organisation (confirm with trial site).
- Apart from early Alzheimer's disease, you must be generally in good health based on your medical history and screening tests.
- You must agree to a genetic test that looks at a gene called ApoE — you do not need to have a specific version of this gene to participate.
Who may not be able to join:
- You may not be eligible if you have another uncontrolled medical or neurological condition (besides Alzheimer's disease) that could be causing your memory or thinking problems.
- You may not be eligible if you have had significant or unstable mental health issues in the 6 months before screening.
- You may not be eligible if you have had a mini-stroke, stroke, or unexplained loss of consciousness in the past year.
- You may not be eligible if you have a history of severe allergic reactions, including anaphylaxis, or are known to be sensitive to any inactive ingredients in the study drug.
- You may not be eligible if you have taken part in another Alzheimer's disease-modifying treatment study within the past 12 months, unless you can prove you received a placebo (inactive treatment) in that study.
- You may not be eligible if you are currently taking or have previously taken any medication outside of a clinical study that is intended to slow or change the course of Alzheimer's disease.
- You may not be eligible if you are taking any medications that the study doctor believes could affect your thinking, increase your health risks, or interfere with study tests and procedures.
- You may not be eligible if you are currently taking any other experimental (investigational) drug.
- You may not be eligible if you have previously received a drug called aducanumab, either through a clinical trial or commercially — however, if you were in a previous aducanumab study but only received the placebo, you may still be eligible.
- You may not be eligible if you had a negative amyloid brain scan result within the 12 months before screening.
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.
Contact this trial
Principal Investigator: Medical Director, Biogen
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
8 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78
Can't join this trial?
Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.