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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
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

Full criteria on ClinicalTrials.gov

Sites (62)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tokyo-Eki Center-building Clinic
Coordinator of this site? Confirm its status
ChūōkuJapanRecruiting
P-One Clinic
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HachiōjiJapanRecruiting
National Center for Geriatrics and Gerontology
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ŌbuJapanNot yet recruiting
Samoncho Clinic
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ShinjukuJapanNot yet recruiting
Yotsuya Internal Medicine Clinic
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ShinjyukuJapanRecruiting
Tokyo Metropolitan Institute for Geriatrics and Gerontology
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tabashi CityJapanRecruiting
SCB Research Center
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BayamónPuerto RicoRecruiting
Senior Adults Specialty Research
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AustinUnited StatesRecruiting
VIN - Aventura
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AventuraUnited StatesRecruiting
Gadolin Research
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BeaumontUnited StatesRecruiting
Northwest Clinical Research Center
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BellevueUnited StatesRecruiting
Northwest Clinical Trials
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BoiseUnited StatesRecruiting
Citizens Memorial Hospital District
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BolivarUnited StatesRecruiting
Bradenton Research Center, Inc.
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BradentonUnited StatesRecruiting
Great Lakes Clinical Trials - Andersonville
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ChicagoUnited StatesRecruiting
K2 Medical Research WINTER GARDEN
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ClermontUnited StatesRecruiting
NDx Clinical Research Inc.
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DaytonUnited StatesRecruiting
K2 Medical Research - Daytona Beach
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Daytona BeachUnited StatesRecruiting
Center for Advanced Research & Education
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GainesvilleUnited StatesRecruiting
Finlay Medical Research
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Greenacres CityUnited StatesRecruiting
The University of Texas Health Science Center at Houston
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HoustonUnited StatesRecruiting
Care Access - Huntington Beach
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Huntington BeachUnited StatesRecruiting
Care Access - South Indianapolis
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IndianapolisUnited StatesRecruiting
Josephson Wallack Munshower Neurology, PC
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IndianapolisUnited StatesRecruiting
Irvine Clinical Research
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IrvineUnited StatesRecruiting
Jacksonville Center for Clinical Research
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JacksonvilleUnited StatesRecruiting
K2 MEDICAL Research THE VILLAGES
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Lady LakeUnited StatesRecruiting
Care Access - Lake Charles (Bayou Pines)
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Lake CharlesUnited StatesRecruiting
Vector Clinical Trials
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Las VegasUnited StatesRecruiting
Care Access - Lima
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LimaUnited StatesRecruiting
Healthy Brain Clinic
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Long BeachUnited StatesRecruiting
K2 Medical Research ORLANDO
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MaitlandUnited StatesRecruiting
Merritt Island Medical Research, LLC
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Merritt IslandUnited StatesRecruiting
VIN-Andrew Lerman
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MiamiUnited StatesRecruiting
Finlay Medical Research
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MiamiUnited StatesRecruiting
Indago Research & Health Center, Inc
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Miami LakesUnited StatesRecruiting
Monroe Biomedical Research
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MonroeUnited StatesRecruiting
Adult Medicine of Lake County, Inc.
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Mt. DoraUnited StatesRecruiting
Suncoast Clinical Research, Inc.
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New Port RicheyUnited StatesRecruiting
Boston Center for Memory
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NewtonUnited StatesRecruiting
Charter Research - Orlando
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OrlandoUnited StatesRecruiting
Headlands Research Orlando
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OrlandoUnited StatesRecruiting
Emerald Coast Neurology - Airport Boulevard
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PensacolaUnited StatesRecruiting
Banner Alzheimer's Institute
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PhoenixUnited StatesRecruiting
Progressive Medical Research
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Port OrangeUnited StatesRecruiting
Artemis Institute for Clinical Research
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RiversideUnited StatesRecruiting
Headlands Research- Sacramento
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SacramentoUnited StatesRecruiting
Artemis Institute for Clinical Research
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San DiegoUnited StatesRecruiting
Syrentis Clinical Research
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Santa AnaUnited StatesRecruiting
Providence Medical Foundation
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Santa RosaUnited StatesRecruiting
Consano Clinical Research, LLC
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Shavano ParkUnited StatesRecruiting
Revival Research Institute, LLC
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SouthfieldUnited StatesRecruiting
The Cognitive and Research Center of New Jersey
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SpringfieldUnited StatesRecruiting
Universal Research Group
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TacomaUnited StatesRecruiting
K2 Medical Research - Tampa
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TampaUnited StatesRecruiting
Care Access - Tampa
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TampaUnited StatesRecruiting
Charter Research The Villages
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The VillagesUnited StatesRecruiting
Infectious Disease Doctors Medical Group, APC
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Walnut CreekUnited StatesRecruiting
MedVadis Research Corporation
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WalthamUnited StatesRecruiting
Covenant Medical Center
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WaterlooUnited StatesRecruiting
Conquest Research
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Winter ParkUnited StatesRecruiting
North Georgia Clinical Research
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WoodstockUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.