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Donanemab for Alzheimer's Disease (Extension Study)

This study is for people with Alzheimer's disease and amyloid plaques (abnormal protein clumps in the brain) who have already completed a previous study (AACM Addendum 7) involving the drug donanemab. Researchers want to see if continuing to receive donanemab annually provides ongoing benefits. You would receive donanemab or a placebo (an inactive substance) through an IV (into a vein). The main way success will be measured is by looking at changes in your thinking and daily function using a tool called the Clinical Dementia Rating - Sum of Boxes (CDR-SB) over about 2.5 years. This study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 550 participants. It is an extension of a previous study.
What's involved
You would participate in this study for up to 2.5 years, which includes 6 visits.
Compensation
Not stated in the trial record.
Follow-up
Your cognitive and functional changes will be measured from the start of the study through Week 130 (about 2.5 years).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07602582

A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).

Recruiting
PHASE3Ages 55+InterventionalTreatment
Eli Lilly and Company
~550 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:DonanemabPlacebo

At a glance

Recruiting sites
42 of 59 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Measured over Baseline through Week 130

Conditions

Alzheimer Disease
Dementia
Plaque, Amyloid

Explore related trials

Alzheimer's Disease

Where it's being run

59 sites across 20 states
Florida19
California9
Japan6
Texas4
Georgia2
Indiana2
Massachusetts2
Ohio2

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Have completed study AACM Addendum 7.
Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
Are individuals assigned female at birth who are not of childbearing potential, or are individuals assigned male at birth.
Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion

Current serious or unstable illnesses that, in the investigator's opinion, could interfere with participation in this study.
Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
Have any intracranial abnormality or lesion, including but not limited to macrohemorrhage, inflammation, or structural findings that, in the opinion of the investigator, may pose an unacceptable safety risk to the participant. Screening MRI finding of amyloid-related imaging abnormalities with edema (ARIA-E) may be monitored for resolution.
Contraindication to florbetapir F 18 PET.
Have had history of amyloid-targeting therapy treatment outside donanemab trials.
Have participated, within the last 30 days, in a clinical trial involving a study intervention judged not to be scientifically or medically compatible with this study.

What this trial measures

  • Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB)Baseline through Week 130