Recruiting

Phase 3

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

Sponsor:

Eli Lilly and Company

Code:

NCT07602582

Conditions

Alzheimer Disease

Dementia

Plaque, Amyloid

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Donanemab

Placebo

Study Details

Brief 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.

Conditions

Alzheimer Disease

Dementia

Plaque, Amyloid

Study ID

NCT07602582

Start date

May 22, 2026

Status verified date

Jul, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Donanemab

Donanemab administered intravenously (IV)

placebo comparator: Placebo

Placebo IV

Interventions

Donanemab

Administered IV

Placebo

Administered IV

Primary outcome measure

Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Baseline through Week 130 ]

Central Contacts and Locations

Central contacts

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

Locations

Care Access - Huntington Beach

Recruiting

Huntington Beach, California, United States, 92648

Contacts

714-378-2440

Principal Investigator:

Christine Thai

Irvine Clinical Research

Recruiting

Irvine, California, United States, 92614

Contacts

949-753-1663

Principal Investigator:

Elly Lee

Healthy Brain Clinic

Recruiting

Long Beach, California, United States, 90804

Contacts

562-606-5999

Principal Investigator:

Dung Trinh

Artemis Institute for Clinical Research

Recruiting

Riverside, California, United States, 92503

Contacts

951-374-1190

Principal Investigator:

Jack Vu

Clinical Trials Research

Recruiting

Sacramento, California, United States, 95821

Contacts

916-434-8230

Principal Investigator:

Jeffrey Wayne

Syrentis Clinical Research

Recruiting

Santa Ana, California, United States, 92705

Contacts

714-542-3008

Principal Investigator:

John Duffy

Providence Medical Foundation

Recruiting

Santa Rosa, California, United States, 95403

Contacts

707-521-3830

Principal Investigator:

Allan Bernstein

Infectious Disease Doctors Medical Group, APC

Recruiting

Walnut Creek, California, United States, 94598

Contacts

925-947-2334

Principal Investigator:

Bhavna Malik

VIN - Aventura

Recruiting

Aventura, Florida, United States, 33180

Contacts

305-933-5993

Principal Investigator:

Jonathan Cross

Bradenton Research Center, Inc.

Recruiting

Bradenton, Florida, United States, 34205

Contacts

941-708-0005

Principal Investigator:

Eric Folkens

Finlay Medical Research

Recruiting

Greenacres City, Florida, United States, 33467

Contacts

561-766-2181

Principal Investigator:

Jorge Calle Medina

Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

904-730-0101

Principal Investigator:

Steven Toenjes

K2 Medical Research ORLANDO

Recruiting

Maitland, Florida, United States, 32751

Contacts

407-500-5252

Principal Investigator:

Brandon Lenox

Merritt Island Medical Research, LLC

Recruiting

Merritt Island, Florida, United States, 32952

Principal Investigator:

David Kirk

Finlay Medical Research

Recruiting

Miami, Florida, United States, 33126

Principal Investigator:

Lilia Rodriguez Ables

VIN-Andrew Lerman

Recruiting

Miami, Florida, United States, 33133

Contacts

786-655-8010

Principal Investigator:

Andrew Lerman

Indago Research & Health Center, Inc

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

305-825-6588

Principal Investigator:

Jose Cardona

Adult Medicine of Lake County, Inc.

Recruiting

Mt. Dora, Florida, United States, 32757

Contacts

352-383-8222

Principal Investigator:

Shirley Nagel

Suncoast Clinical Research, Inc.

Recruiting

New Port Richey, Florida, United States, 34652

Contacts

727-849-4131

Principal Investigator:

Cathy Barnes

Charter Research - Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

407-337-3000

Principal Investigator:

Edgardo Rivera-Rivera

Headlands Research Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

407-705-3471

Principal Investigator:

Uzma Khan

Emerald Coast Neurology - Airport Boulevard

Recruiting

Pensacola, Florida, United States, 32504

Contacts

850-438-1136

Principal Investigator:

David Bear

Progressive Medical Research

Recruiting

Port Orange, Florida, United States, 32127

Contacts

386-304-7070

Principal Investigator:

Alexander White

Care Access - Tampa

Recruiting

Tampa, Florida, United States, 33625

Contacts

877-791-0656

Principal Investigator:

Brad Lipson

Charter Research - The Villages

Recruiting

The Villages, Florida, United States, 32162

Contacts

352-441-2000

Principal Investigator:

Jeffrey Norton

Conquest Research

Recruiting

Winter Park, Florida, United States, 32789

Contacts

407-916-0060

Principal Investigator:

Rekha Gandhi

Center for Advanced Research & Education

Recruiting

Gainesville, Georgia, United States, 30501

Contacts

770-534-5154

Principal Investigator:

Angela Ritter

North Georgia Clinical Research

Recruiting

Woodstock, Georgia, United States, 30189

Contacts

678-494-5735

Principal Investigator:

Bram Wieskopf

Northwest Clinical Trials

Recruiting

Boise, Idaho, United States, 83704

Contacts

208-685-0600

Principal Investigator:

Brock McConnehey

Great Lakes Clinical Trials - Andersonville

Recruiting

Chicago, Illinois, United States, 60640

Contacts

773-275-3500

Principal Investigator:

Jeffrey Ross

Care Access - South Indianapolis

Recruiting

Indianapolis, Indiana, United States, 46254

Contacts

877-791-0656

Principal Investigator:

Gigi Lefebvre

Josephson Wallack Munshower Neurology, PC

Recruiting

Indianapolis, Indiana, United States, 46256

Contacts

317-537-6099

Principal Investigator:

Kristi George

Care Access - Lake Charles (Bayou Pines)

Recruiting

Lake Charles, Louisiana, United States, 70601

Contacts

337-602-6642

Principal Investigator:

Jason Morris

Boston Center for Memory

Recruiting

Newton, Massachusetts, United States, 02459

Contacts

617-699-6927

Principal Investigator:

Paul Solomon

Citizens Memorial Hospital District

Recruiting

Bolivar, Missouri, United States, 65613

Contacts

417-328-7781

Principal Investigator:

Curtis Schreiber

Vector Clinical Trials

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

702-750-000

Principal Investigator:

Bharat Mocherla

The Cognitive and Research Center of New Jersey

Recruiting

Springfield, New Jersey, United States, 07081

Principal Investigator:

Raminder Parihar

Care Access - Lima

Recruiting

Lima, Ohio, United States, 45805

Contacts

877-791-0656

Principal Investigator:

Gigi Lefebvre

Gadolin Research

Recruiting

Beaumont, Texas, United States, 77702

Contacts

409-331-6040

Principal Investigator:

Joseph Oommen

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

713-486-0536

Principal Investigator:

David Hunter

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Principal Investigator:

Jeena Vaid

Universal Research Group

Recruiting

Tacoma, Washington, United States, 98405

Contacts

253-882-1070

Principal Investigator:

Sabrina Benjamin

More Information

Sponsor

Eli Lilly and Company

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

Donanemab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-07-07.