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NCT07589595PHASE2Recruiting

A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

Eli Lilly and Company

Start Date

5/20/2026

Completion Date

8/1/2028

Summary

The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.

Eligibility Criteria

Age Range: 55 years to 85 years

Inclusion Criteria: * Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months. * Have least 1 core clinical feature of dementia with Lewy bodies (DLB). * Have a score ≥20 on Montreal Cognitive Assessment (MoCA). * Meet plasma P-tau217 criteria. * Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology. * Have a CSF result consistent with the presence of alpha-synuclein pathology. * Have at least 1 reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant, and is familiar with overall function and behavior, such as day-to-day activities and cognitive abilities. Exclusion Criteria: * Have a disease or condition that could interfere with this study or is a current serious or unstable illness. * Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study. * Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study. * Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions. * Have previously received amyloid-targeting therapy. * Active immunization against amyloid-beta. * Have a centrally read MRI that does not meet study entry criteria. * Have contraindication to MRI or PET scans. * Have any contraindication to lumbar puncture.

Interventions

DRUG

Donanemab

DRUG

Placebo

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Conditions

Cognitive DysfunctionLewy Body DiseaseSynucleinopathiesAmyloid

Locations

TrialSphere Corp

Chandler, Arizona 85286

United States

HonorHealth Research Institute

Scottsdale, Arizona 85251

United States

Profound Research LLC

Carlsbad, California 92011

United States

Irvine Clinical Research

Irvine, California 92614

United States

UCSD - Altman Clinical and Translational Research Institute (ACTRI)

La Jolla, California 92037

United States

Stanford Neuroscience Health Center

Palo Alto, California 94304

United States

CenExel Rocky Mountain Clinical Research

Englewood, Colorado 80113

United States

Ki Health Partners, LLc, dba New England Institute for Clinical Research

Stamford, Connecticut 06905

United States

JEM Research Institute

Atlantis, Florida 33462

United States

VIN - Aventura

Aventura, Florida 33180

United States

Brain Matters Research

Delray Beach, Florida 33445

United States

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida 33912

United States

Norman Fixel Institute for Neurological Diseases (FIND)

Gainesville, Florida 32608

United States

Mayo Clinic in Florida

Jacksonville, Florida 32224

United States

K2 Medical Research ORLANDO

Maitland, Florida 32751

United States

BRP-Kendal Lakes

Miami, Florida 33175

United States

Renstar Medical Research

Ocala, Florida 34471

United States

Charter Research - Orlando

Orlando, Florida 32803

United States

Axiom Brain Health LLC

Tampa, Florida 33609

United States

Palm Beach Neurology

West Palm Beach, Florida 33407

United States

Conquest Research

Winter Park, Florida 32789

United States

Indiana University Health Neuroscience Center

Indianapolis, Indiana 46202

United States

The University of Kansas - Clinical Research Center

Fairway, Kansas 66205

United States

Massachusetts General Hospital - Charlestown

Charlestown, Massachusetts 02129

United States

K2 Medical Research - Foxborough

Foxborough, Massachusetts 02035

United States

Neurology Center of New England

Foxborough, Massachusetts 02035

United States

Headlands Eastern MA LLC

Plymouth, Massachusetts 02360

United States

QUEST Research Institute

Farmington Hills, Michigan 48334

United States

Struthers Parkinson's Center

Golden Valley, Minnesota 55427

United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota 55905

United States

Citizens Memorial Hospital District

Bolivar, Missouri 65613

United States

Summit Headlands

Portland, Oregon 97210

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Pennsylvania Hospital

Philadelphia, Pennsylvania 19107

United States

Gadolin Research

Beaumont, Texas 77702

United States

Kerwin Medical Center

Dallas, Texas 75231

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

The University of Texas Health Science Center at Houston

Houston, Texas 77054

United States

Central Texas Neurology Consultants

Round Rock, Texas 78681

United States

The University of Texas Health Science Center

San Antonio, Texas 78229

United States

Re:Cognition Health

Fairfax, Virginia 22031

United States

EvergreenHealth

Kirkland, Washington 98034

United States

Memory Clinic Ochanomizu

Bunkyō City, 113-0034

Japan

Shonan Keiiku Hospital

Fujisawa, 252-0816

Japan

Hyogo Prefectural Harima-Himeji General Medical Center

Himeji, 670-8560

Japan

Inage Neurology and Memory Clinic

Inage, 263-0043

Japan

Nippon Medical School Musashi Kosugi Hospital

Kawasaki, 211-8533

Japan

St. Marianna University Hospital

Kawasaki, 216-8511

Japan

Kobe University Hospital

Kobe, 650-0017

Japan

Juntendo Tokyo Koto Geriatric Medical Center

Kōtoku, 136-0075

Japan

Katayama Medical Clinic

Kurashiki, 710-0813

Japan

Nagoya Ekisaikai Hospital

Nagoya, 454-8502

Japan

Nagoya University Hospital

Nagoya, 466-8560

Japan

National Center for Geriatrics and Gerontology

Ōbu, 474-8511

Japan

The University of Osaka Hospital

Suita, 565-0871

Japan

Tokyo Metropolitan Institute for Geriatrics and Gerontology

tabashi City, 173-0015

Japan

Tachikawa Hospital

Tachikawa, 190-8531

Japan

Memory Clinic Toride

Toride, 302-0004

Japan

Yokohama Minami Kyosai Hospital

Yokohama, 236-0037

Japan

Oita University Hospital

Yufu, 879-5593

Japan

Gangnam Severance Hospital, Yonsei University Health System

Gangnam-gu, 06273

South Korea

Inha University Hospital

Incheon, 22332

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Hanyang University Seoul Hospital

Seoul, 04763

South Korea

Konkuk University Medical Center

Seoul, 05030

South Korea

Ewha Womans University Mokdong Hospital

Seoul, 07985

South Korea

Taipei Medical University Shuang Ho Hospital

New Taipei City, 235

Taiwan

New Taipei Municipal TuCheng Hospital

New Taipei City, 236

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan