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RecruitingPhase 3

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

Eli Lilly and Company · NCT07602582

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
550
US sites recruiting
42
Study start
May 22, 2026
Record last updated
July 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Donanemab; Placebo

Conditions: Alzheimer Disease; Dementia; Plaque, Amyloid

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Care Access - Huntington Beach

    Huntington Beach, CA 92648

    Site contact: 714-378-2440

  • Irvine Clinical Research

    Irvine, CA 92614

    Site contact: 949-753-1663

  • Healthy Brain Clinic

    Long Beach, CA 90804

    Site contact: 562-606-5999

  • Artemis Institute for Clinical Research

    Riverside, CA 92503

    Site contact: 951-374-1190

  • Clinical Trials Research

    Sacramento, CA 95821

    Site contact: 916-434-8230

  • Syrentis Clinical Research

    Santa Ana, CA 92705

    Site contact: 714-542-3008

  • Providence Medical Foundation

    Santa Rosa, CA 95403

    Site contact: 707-521-3830

  • Infectious Disease Doctors Medical Group, APC

    Walnut Creek, CA 94598

    Site contact: 925-947-2334

  • VIN - Aventura

    Aventura, FL 33180

    Site contact: 305-933-5993

  • Bradenton Research Center, Inc.

    Bradenton, FL 34205

    Site contact: 941-708-0005

  • Finlay Medical Research

    Greenacres City, FL 33467

    Site contact: 561-766-2181

  • Jacksonville Center for Clinical Research

    Jacksonville, FL 32216

    Site contact: 904-730-0101

  • K2 Medical Research ORLANDO

    Maitland, FL 32751

    Site contact: 407-500-5252

  • Merritt Island Medical Research, LLC

    Merritt Island, FL 32952

    Site contact: David Kirk

  • Finlay Medical Research

    Miami, FL 33126

    Site contact: Lilia Rodriguez Ables

  • VIN-Andrew Lerman

    Miami, FL 33133

    Site contact: 786-655-8010

  • Indago Research & Health Center, Inc

    Miami Lakes, FL 33016

    Site contact: 305-825-6588

  • Adult Medicine of Lake County, Inc.

    Mt. Dora, FL 32757

    Site contact: 352-383-8222

  • Suncoast Clinical Research, Inc.

    New Port Richey, FL 34652

    Site contact: 727-849-4131

  • Charter Research - Orlando

    Orlando, FL 32803

    Site contact: 407-337-3000

  • Headlands Research Orlando

    Orlando, FL 32803

    Site contact: 407-705-3471

  • Emerald Coast Neurology - Airport Boulevard

    Pensacola, FL 32504

    Site contact: 850-438-1136

  • Progressive Medical Research

    Port Orange, FL 32127

    Site contact: 386-304-7070

  • Care Access - Tampa

    Tampa, FL 33625

    Site contact: 877-791-0656

  • Charter Research - The Villages

    The Villages, FL 32162

    Site contact: 352-441-2000

  • Conquest Research

    Winter Park, FL 32789

    Site contact: 407-916-0060

  • Center for Advanced Research & Education

    Gainesville, GA 30501

    Site contact: 770-534-5154

  • North Georgia Clinical Research

    Woodstock, GA 30189

    Site contact: 678-494-5735

  • Northwest Clinical Trials

    Boise, ID 83704

    Site contact: 208-685-0600

  • Great Lakes Clinical Trials - Andersonville

    Chicago, IL 60640

    Site contact: 773-275-3500

  • Care Access - South Indianapolis

    Indianapolis, IN 46254

    Site contact: 877-791-0656

  • Josephson Wallack Munshower Neurology, PC

    Indianapolis, IN 46256

    Site contact: 317-537-6099

  • Care Access - Lake Charles (Bayou Pines)

    Lake Charles, LA 70601

    Site contact: 337-602-6642

  • Boston Center for Memory

    Newton, MA 02459

    Site contact: 617-699-6927

  • Citizens Memorial Hospital District

    Bolivar, MO 65613

    Site contact: 417-328-7781

  • Vector Clinical Trials

    Las Vegas, NV 89128

    Site contact: 702-750-000

  • The Cognitive and Research Center of New Jersey

    Springfield, NJ 07081

    Site contact: Raminder Parihar

  • Care Access - Lima

    Lima, OH 45805

    Site contact: 877-791-0656

  • Gadolin Research

    Beaumont, TX 77702

    Site contact: 409-331-6040

  • The University of Texas Health Science Center at Houston

    Houston, TX 77054

    Site contact: 713-486-0536

  • Northwest Clinical Research Center

    Bellevue, WA 98007

    Site contact: Jeena Vaid

  • Universal Research Group

    Tacoma, WA 98405

    Site contact: 253-882-1070

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
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A Study of Donanemab (LY3002813) in Participants Who Completed… (NCT07602582) | Bored Studies