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 (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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 42273802) ↗
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, Active, Not Recruiting
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 (or someone who knows you well) have noticed your memory has been slowly and gradually getting worse over at least 6 months
- You scored between 20 and 28 (inclusive) on a standard memory and thinking test called the MMSE, taken at the start of the study
- Your results from a specific brain scan (called an 18F flortaucipir PET scan, reviewed by a central team) meet the study's requirements — note: this does not apply to one particular safety group in the trial (confirm with trial site)
- Your results from another specific brain scan (called an 18F florbetapir PET scan, reviewed by a central team) meet the study's requirements
- You have a "study partner" (such as a family member or close friend) who is willing to be involved in the study and sign a consent form
Who may not be able to join:
- You have a medical reason why you cannot have an MRI or PET scan (for example, a pacemaker or severe claustrophobia)
- You are currently receiving a type of treatment called immunoglobulin G (IgG) therapy (confirm with trial site if you are unsure whether this applies to you)
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: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
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
9 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population); Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)
Can't join this trial?
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.