RecruitingPhase 2NCT07589595

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

A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology

Sponsor

Eli Lilly and Company

Enrollment

350 participants

Start Date

May 20, 2026

Study Type

INTERVENTIONAL

Conditions

Cognitive Dysfunction Lewy Body Disease Amyloid Synucleinopathies

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

Min Age: 55 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Donanemab and a drug called Placebo for people with amyloid, cognitive dysfunction, and other related conditions. The study is currently recruiting participants at 72 locations. People eligible for this study include aged 55 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDonanemab

Donanemab administered IV

DRUGPlacebo

Placebo administered IV

Locations(72)

TrialSphere Corp

Chandler, Arizona, United States

HonorHealth Research Institute

Scottsdale, Arizona, United States

Profound Research LLC

Carlsbad, California, United States

Irvine Clinical Research

Irvine, California, United States

UCSD - Altman Clinical and Translational Research Institute (ACTRI)

La Jolla, California, United States

Stanford Neuroscience Health Center

Palo Alto, California, United States

CenExel Rocky Mountain Clinical Research

Englewood, Colorado, United States

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

Stamford, Connecticut, United States

JEM Research Institute

Atlantis, Florida, United States

VIN - Aventura

Aventura, Florida, United States

Brain Matters Research

Delray Beach, Florida, United States

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, United States

Norman Fixel Institute for Neurological Diseases (FIND)

Gainesville, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

K2 Medical Research ORLANDO

Maitland, Florida, United States

BRP-Kendal Lakes

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Charter Research - Orlando

Orlando, Florida, United States

Axiom Brain Health LLC

Tampa, Florida, United States

Palm Beach Neurology

West Palm Beach, Florida, United States

Conquest Research

Winter Park, Florida, United States

Indiana University Health Neuroscience Center

Indianapolis, Indiana, United States

The University of Kansas - Clinical Research Center

Fairway, Kansas, United States

Massachusetts General Hospital - Charlestown

Charlestown, Massachusetts, United States

K2 Medical Research - Foxborough

Foxborough, Massachusetts, United States

Neurology Center of New England

Foxborough, Massachusetts, United States

Headlands Eastern MA LLC

Plymouth, Massachusetts, United States

QUEST Research Institute

Farmington Hills, Michigan, United States

Struthers Parkinson's Center

Golden Valley, Minnesota, United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

Citizens Memorial Hospital District

Bolivar, Missouri, United States

Summit Headlands

Portland, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Gadolin Research

Beaumont, Texas, United States

Kerwin Medical Center

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Central Texas Neurology Consultants

Round Rock, Texas, United States

The University of Texas Health Science Center

San Antonio, Texas, United States

Re:Cognition Health

Fairfax, Virginia, United States

EvergreenHealth

Kirkland, Washington, United States

Memory Clinic Ochanomizu

Bunkyō City, Japan

Shonan Keiiku Hospital

Fujisawa, Japan

Hyogo Prefectural Harima-Himeji General Medical Center

Himeji, Japan

Inage Neurology and Memory Clinic

Inage, Japan

Nippon Medical School Musashi Kosugi Hospital

Kawasaki, Japan

St. Marianna University Hospital

Kawasaki, Japan

Kobe University Hospital

Kobe, Japan

Juntendo Tokyo Koto Geriatric Medical Center

Kōtoku, Japan

Katayama Medical Clinic

Kurashiki, Japan

Nagoya Ekisaikai Hospital

Nagoya, Japan

Nagoya University Hospital

Nagoya, Japan

National Center for Geriatrics and Gerontology

Ōbu, Japan

The University of Osaka Hospital

Suita, Japan

Tokyo Metropolitan Institute for Geriatrics and Gerontology

tabashi City, Japan

Tachikawa Hospital

Tachikawa, Japan

Memory Clinic Toride

Toride, Japan

Yokohama Minami Kyosai Hospital

Yokohama, Japan

Oita University Hospital

Yufu, Japan

Gangnam Severance Hospital, Yonsei University Health System

Gangnam-gu, South Korea

Inha University Hospital

Incheon, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Hanyang University Seoul Hospital

Seoul, South Korea

Konkuk University Medical Center

Seoul, South Korea

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

New Taipei Municipal TuCheng Hospital

New Taipei City, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07589595

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

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(72)

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