NCT07602582RecruitingPhase 3
A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).
An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 550 (estimated)
- First submitted
- 15 May 2026
- Start date
- 22 May 2026
- Primary completion date
- Sept 2029
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Alzheimer disease
- NCT number
- NCT07602582
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 550
- From 22 May 2026 to the primary completion date, Sept 2029
- 62 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 had history of amyloid-targeting therapy treatment outside donanemab trials.
Other
- 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 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.
Who the study is looking for
- 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.
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (62)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tokyo-Eki Center-building Clinic Coordinator of this site? Confirm its status | Chūōku | Japan | Recruiting |
| P-One Clinic Coordinator of this site? Confirm its status | Hachiōji | Japan | Recruiting |
| National Center for Geriatrics and Gerontology Coordinator of this site? Confirm its status | Ōbu | Japan | Not yet recruiting |
| Samoncho Clinic Coordinator of this site? Confirm its status | Shinjuku | Japan | Not yet recruiting |
| Yotsuya Internal Medicine Clinic Coordinator of this site? Confirm its status | Shinjyuku | Japan | Recruiting |
| Tokyo Metropolitan Institute for Geriatrics and Gerontology Coordinator of this site? Confirm its status | tabashi City | Japan | Recruiting |
| SCB Research Center Coordinator of this site? Confirm its status | Bayamón | Puerto Rico | Recruiting |
| Senior Adults Specialty Research Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| VIN - Aventura Coordinator of this site? Confirm its status | Aventura | United States | Recruiting |
| Gadolin Research Coordinator of this site? Confirm its status | Beaumont | United States | Recruiting |
| Northwest Clinical Research Center Coordinator of this site? Confirm its status | Bellevue | United States | Recruiting |
| Northwest Clinical Trials Coordinator of this site? Confirm its status | Boise | United States | Recruiting |
| Citizens Memorial Hospital District Coordinator of this site? Confirm its status | Bolivar | United States | Recruiting |
| Bradenton Research Center, Inc. Coordinator of this site? Confirm its status | Bradenton | United States | Recruiting |
| Great Lakes Clinical Trials - Andersonville Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| K2 Medical Research WINTER GARDEN Coordinator of this site? Confirm its status | Clermont | United States | Recruiting |
| NDx Clinical Research Inc. Coordinator of this site? Confirm its status | Dayton | United States | Recruiting |
| K2 Medical Research - Daytona Beach Coordinator of this site? Confirm its status | Daytona Beach | United States | Recruiting |
| Center for Advanced Research & Education Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Finlay Medical Research Coordinator of this site? Confirm its status | Greenacres City | United States | Recruiting |
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Care Access - Huntington Beach Coordinator of this site? Confirm its status | Huntington Beach | United States | Recruiting |
| Care Access - South Indianapolis Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Josephson Wallack Munshower Neurology, PC Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Irvine Clinical Research Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Jacksonville Center for Clinical Research Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| K2 MEDICAL Research THE VILLAGES Coordinator of this site? Confirm its status | Lady Lake | United States | Recruiting |
| Care Access - Lake Charles (Bayou Pines) Coordinator of this site? Confirm its status | Lake Charles | United States | Recruiting |
| Vector Clinical Trials Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Care Access - Lima Coordinator of this site? Confirm its status | Lima | United States | Recruiting |
| Healthy Brain Clinic Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| K2 Medical Research ORLANDO Coordinator of this site? Confirm its status | Maitland | United States | Recruiting |
| Merritt Island Medical Research, LLC Coordinator of this site? Confirm its status | Merritt Island | United States | Recruiting |
| VIN-Andrew Lerman Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Finlay Medical Research Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Indago Research & Health Center, Inc Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| Monroe Biomedical Research Coordinator of this site? Confirm its status | Monroe | United States | Recruiting |
| Adult Medicine of Lake County, Inc. Coordinator of this site? Confirm its status | Mt. Dora | United States | Recruiting |
| Suncoast Clinical Research, Inc. Coordinator of this site? Confirm its status | New Port Richey | United States | Recruiting |
| Boston Center for Memory Coordinator of this site? Confirm its status | Newton | United States | Recruiting |
| Charter Research - Orlando Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Headlands Research Orlando Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Emerald Coast Neurology - Airport Boulevard Coordinator of this site? Confirm its status | Pensacola | United States | Recruiting |
| Banner Alzheimer's Institute Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Progressive Medical Research Coordinator of this site? Confirm its status | Port Orange | United States | Recruiting |
| Artemis Institute for Clinical Research Coordinator of this site? Confirm its status | Riverside | United States | Recruiting |
| Headlands Research- Sacramento Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Artemis Institute for Clinical Research Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Syrentis Clinical Research Coordinator of this site? Confirm its status | Santa Ana | United States | Recruiting |
| Providence Medical Foundation Coordinator of this site? Confirm its status | Santa Rosa | United States | Recruiting |
| Consano Clinical Research, LLC Coordinator of this site? Confirm its status | Shavano Park | United States | Recruiting |
| Revival Research Institute, LLC Coordinator of this site? Confirm its status | Southfield | United States | Recruiting |
| The Cognitive and Research Center of New Jersey Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Universal Research Group Coordinator of this site? Confirm its status | Tacoma | United States | Recruiting |
| K2 Medical Research - Tampa Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Care Access - Tampa Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Charter Research The Villages Coordinator of this site? Confirm its status | The Villages | United States | Recruiting |
| Infectious Disease Doctors Medical Group, APC Coordinator of this site? Confirm its status | Walnut Creek | United States | Recruiting |
| MedVadis Research Corporation Coordinator of this site? Confirm its status | Waltham | United States | Recruiting |
| Covenant Medical Center Coordinator of this site? Confirm its status | Waterloo | United States | Recruiting |
| Conquest Research Coordinator of this site? Confirm its status | Winter Park | United States | Recruiting |
| North Georgia Clinical Research Coordinator of this site? Confirm its status | Woodstock | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.