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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Alzheimer Disease, Dementia, Plaque, Amyloid

In brief

The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.

Key facts

Study ID

NCT07602582

Run by

Eli Lilly and Company

People needed

550

Starts

2026-05-22

Expected to finish

2029-09-01

Last updated by the study team

2026-07-07

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Care Access - Huntington Beach — Huntington Beach, California, United States (enrolling)
• Care Access - Tampa — Tampa, Florida, United States (enrolling)
• Healthy Brain Clinic — Long Beach, California, United States (enrolling)
• Artemis Institute for Clinical Research — Riverside, California, United States (enrolling)
• Clinical Trials Research — Sacramento, California, United States (enrolling)
• Irvine Clinical Research — Irvine, California, United States (enrolling)
• Syrentis Clinical Research — Santa Ana, California, United States (enrolling)
• Providence Medical Foundation — Santa Rosa, California, United States (enrolling)
• Infectious Disease Doctors Medical Group, APC — Walnut Creek, California, United States (enrolling)
• VIN - Aventura — Aventura, Florida, United States (enrolling)
• Bradenton Research Center, Inc. — Bradenton, Florida, United States (enrolling)
• Finlay Medical Research — Greenacres City, Florida, United States (enrolling)
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (enrolling)
• K2 Medical Research ORLANDO — Maitland, Florida, United States (enrolling)
• Merritt Island Medical Research, LLC — Merritt Island, Florida, United States (enrolling)
• Finlay Medical Research — Miami, Florida, United States (enrolling)
• VIN-Andrew Lerman — Miami, Florida, United States (enrolling)
• Indago Research & Health Center, Inc — Miami Lakes, Florida, United States (enrolling)
• Adult Medicine of Lake County, Inc. — Mt. Dora, Florida, United States (enrolling)
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States (enrolling)
• Charter Research - Orlando — Orlando, Florida, United States (enrolling)
• Headlands Research Orlando — Orlando, Florida, United States (enrolling)
• Emerald Coast Neurology - Airport Boulevard — Pensacola, Florida, United States (enrolling)
• Progressive Medical Research — Port Orange, Florida, United States (enrolling)
• Charter Research - The Villages — The Villages, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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