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NCT07602582PHASE3Recruiting

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

Eli Lilly and Company

Start Date

5/22/2026

Completion Date

9/1/2029

Summary

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.

Eligibility Criteria

Age Range: 55 years to No maximum

Inclusion Criteria: * 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 Criteria: * 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.

Interventions

DRUG

Donanemab

DRUG

Placebo

Interested in This Trial?

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Conditions

Alzheimer DiseaseDementiaPlaque, Amyloid

Locations

Banner Alzheimer's Institute

Phoenix, Arizona 85006

United States

Care Access - Huntington Beach

Huntington Beach, California 92648

United States

Irvine Clinical Research

Irvine, California 92614

United States

Healthy Brain Clinic

Long Beach, California 90804

United States

Artemis Institute for Clinical Research

Riverside, California 92503

United States

Clinical Trials Research

Sacramento, California 95821

United States

Artemis Institute for Clinical Research

San Diego, California 92123

United States

Syrentis Clinical Research

Santa Ana, California 92705

United States

Providence Medical Foundation

Santa Rosa, California 95403

United States

Infectious Disease Doctors Medical Group, APC

Walnut Creek, California 94598

United States

VIN - Aventura

Aventura, Florida 33180

United States

Bradenton Research Center, Inc.

Bradenton, Florida 34205

United States

Finlay Medical Research

Greenacres City, Florida 33467

United States

Jacksonville Center for Clinical Research

Jacksonville, Florida 32216

United States

K2 Medical Research ORLANDO

Maitland, Florida 32751

United States

Merritt Island Medical Research, LLC

Merritt Island, Florida 32952

United States

Finlay Medical Research

Miami, Florida 33126

United States

VIN-Andrew Lerman

Miami, Florida 33133

United States

Indago Research & Health Center, Inc

Miami Lakes, Florida 33016

United States

Adult Medicine of Lake County, Inc.

Mt. Dora, Florida 32757

United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida 34652

United States

Charter Research - Orlando

Orlando, Florida 32803

United States

Headlands Research Orlando

Orlando, Florida 32803

United States

Emerald Coast Neurology - Airport Boulevard

Pensacola, Florida 32504

United States

Progressive Medical Research

Port Orange, Florida 32127

United States

Care Access - Tampa

Tampa, Florida 33625

United States

K2 Medical Research - Tampa

Tampa, Florida 33634

United States

Charter Research - The Villages

The Villages, Florida 32162

United States

Conquest Research

Winter Park, Florida 32789

United States

Center for Advanced Research & Education

Gainesville, Georgia 30501

United States

North Georgia Clinical Research

Woodstock, Georgia 30189

United States

Northwest Clinical Trials

Boise, Idaho 83704

United States

Great Lakes Clinical Trials - Andersonville

Chicago, Illinois 60640

United States

Care Access - South Indianapolis

Indianapolis, Indiana 46254

United States

Josephson Wallack Munshower Neurology, PC

Indianapolis, Indiana 46256

United States

Covenant Medical Center

Waterloo, Iowa 50702

United States

Care Access - Lake Charles (Bayou Pines)

Lake Charles, Louisiana 70601

United States

Boston Center for Memory

Newton, Massachusetts 02459

United States

MedVadis Research Corporation

Waltham, Massachusetts 02451

United States

Revival Research Institute, LLC

Southfield, Michigan 48075

United States

Citizens Memorial Hospital District

Bolivar, Missouri 65613

United States

Vector Clinical Trials

Las Vegas, Nevada 89128

United States

The Cognitive and Research Center of New Jersey

Springfield, New Jersey 07081

United States

Monroe Biomedical Research

Monroe, North Carolina 28112

United States

NDx Clinical Research, Inc.

Dayton, Ohio 45459

United States

Care Access - Lima

Lima, Ohio 45805

United States

Senior Adults Specialty Research

Austin, Texas 78757

United States

Gadolin Research

Beaumont, Texas 77702

United States

The University of Texas Health Science Center at Houston

Houston, Texas 77054

United States

Consano Clinical Research, LLC

Shavano Park, Texas 78231

United States

Northwest Clinical Research Center

Bellevue, Washington 98007

United States

Universal Research Group

Tacoma, Washington 98405

United States

Tokyo-Eki Center-building Clinic

Chūōku, 103-0027

Japan

P-One Clinic

Hachiōji, 192-0071

Japan

National Center for Geriatrics and Gerontology

Ōbu, 474-8511

Japan

Samoncho Clinic

Shinjuku, 160-0017

Japan

Yotsuya Internal Medicine Clinic

Shinjyuku, 160-0017

Japan

Tokyo Metropolitan Institute for Geriatrics and Gerontology

tabashi City, 173-0015

Japan

SCB Research Center

Bayamón, 00961

Puerto Rico