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ACTIVE NOT RECRUITING
NCT05026866
PHASE3

A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD) over up to 332 weeks. Approximately 800 additional participants will be enrolled in the 12-month Addendum 7 to assess safety of a different titration regimen.

Official title: A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease

Key Details

Gender

All

Age Range

55 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

2996

Start Date

2021-08-27

Completion Date

2027-11

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

DRUG

Donanemab

Administered intravenously

DRUG

Placebo

Administered intravenously

Locations (216)

Parkway Medical Center

Birmingham, Alabama, United States

Alabama Psychiatry - Birmingham - Brookwood Medical Center Drive

Homewood, Alabama, United States

Rehabilitation & Neurological Services

Huntsville, Alabama, United States

Care Access - 801 South Power Road, Mesa

Mesa, Arizona, United States

Banner Alzheimer's Institute

Phoenix, Arizona, United States

Banner Alzheimer's Institute Tucson

Tucson, Arizona, United States

Center for Neurosciences

Tucson, Arizona, United States

Care Access - Berkeley

Berkeley, California, United States

Care Access - Beverly Hills

Beverly Hills, California, United States

Velocity Clinical Research, Chula Vista

Chula Vista, California, United States

Valley Clinical Trials, Inc.

Covina, California, United States

Neurology Center of North Orange County

Fullerton, California, United States

Care Access - Gilroy

Gilroy, California, United States

Marvel Clinical Research

Huntington Beach, California, United States

Care Access Research - Huntington Beach

Huntington Beach, California, United States

Irvine Clinical Research

Irvine, California, United States

Option Care - Irvine

Irvine, California, United States

Kaizen Brain Center

La Jolla, California, United States

Velocity Clinical Research, San Diego

La Mesa, California, United States

Pacific Research Network

Lemon Grove, California, United States

Healthy Brain Clinic

Long Beach, California, United States

Neurovations

Napa, California, United States

Care Access - Newport Beach

Newport Beach, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

Inland Psychiatric Medical Group

Redlands, California, United States

Anderson Clinical Research

Redlands, California, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Option Care - Riverside

Riverside, California, United States

Clinical Trials Research

Sacramento, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Ray Dolby Brain Health Center

San Francisco, California, United States

Care Access - Los Gatos

San Jose, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

Care Access - Santa Clarita

Santa Clarita, California, United States

Option Care - Los Angeles South

Santa Fe Springs, California, United States

Providence Medical Foundation

Santa Rosa, California, United States

Mazur, Statner, Dutta, Nathan, PC

Thousand Oaks, California, United States

Tilda Research

Tustin, California, United States

Velocity Clinical Research, Panorama City

Van Nuys, California, United States

Infectious Disease Doctors Medical Group, APC

Walnut Creek, California, United States

Care Access - Aurora

Aurora, Colorado, United States

Mountain Neurological Research Center

Basalt, Colorado, United States

Denver Neurological Research

Denver, Colorado, United States

Invicro

New Haven, Connecticut, United States

JEM Research Institute

Atlantis, Florida, United States

VIN-Julie Schwartzbard

Aventura, Florida, United States

Neurology Offices of South Florida

Boca Raton, Florida, United States

Excel Medical Clinical Trials

Boca Raton, Florida, United States

SFM Clinical Research

Boca Raton, Florida, United States

Bradenton Research Center, Inc.

Bradenton, Florida, United States

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida, United States

Care Access - Daytona Beach

Daytona Beach, Florida, United States

Care Access - Delray Beach

Delray Beach, Florida, United States

Finlay Medical Research

Greenacres City, Florida, United States

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Infinity Clinical Research, LLC

Hollywood, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Care Access - Guava Street

Lady Lake, Florida, United States

Accel Research Sites - St. Pete-Largo Clinical Research Unit

Largo, Florida, United States

ClinCloud - Maitland

Maitland, Florida, United States

K2 Medical Research

Maitland, Florida, United States

ClinCloud - Viera

Melbourne, Florida, United States

Merritt Island Medical Research, LLC

Merritt Island, Florida, United States

Optimus U Corporation

Miami, Florida, United States

Finlay Medical Research

Miami, Florida, United States

VIN-Andrew Lerman

Miami, Florida, United States

South Florida Research Phase I-IV

Miami, Florida, United States

Brainstorm Research Group

Miami, Florida, United States

IMIC, Inc.

Miami, Florida, United States

VIN-Victor Faradji

Miami, Florida, United States

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, United States

Adult Medicine of Lake County

Mt. Dora, Florida, United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Charter Research - Winter Park

Orlando, Florida, United States

Headlands Research Orlando

Orlando, Florida, United States

Pines Care Research Center, LLC

Pembroke Pines, Florida, United States

VIN- Margarita Almeida El-Ramey

Pembroke Pines, Florida, United States

Emerald Coast Neurology - Airport Boulevard

Pensacola, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Care Access - Tamarac

Tamarac, Florida, United States

Clinical Research of West Florida

Tampa, Florida, United States

Stedman Clinical Trials

Tampa, Florida, United States

Vicis Clinical Research

Tampa, Florida, United States

Care Access - Tampa

Tampa, Florida, United States

Coram CVS/Specialty Infusion Services - Tampa

Tampa, Florida, United States

K2 Medical Research - Tampa

Tampa, Florida, United States

Charter Research - Lady Lake

The Villages, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Conquest Research

Winter Park, Florida, United States

Masters of Clinical Research

Augusta, Georgia, United States

iResearch Atlanta

Decatur, Georgia, United States

Center for Advanced Research & Education

Gainesville, Georgia, United States

Meridian Clinical Research, LLC

Savannah, Georgia, United States

SKY Clinical Research Network Group-Blake

Union City, Georgia, United States

North Georgia Clinical Research

Woodstock, Georgia, United States

Northwest Clinical Trials

Boise, Idaho, United States

IMA Clinical Research Chicago

Chicago, Illinois, United States

Great Lakes Clinical Trials - Andersonville

Chicago, Illinois, United States

Uptown Research Institute

Chicago, Illinois, United States

AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research

Elk Grove Village, Illinois, United States

Care Access - Fairview Heights

Fairview Heights, Illinois, United States

Great Lakes Clinical Trials - Gurnee

Gurnee, Illinois, United States

Accellacare - DuPage

Lombard, Illinois, United States

Coram CVS/Specialty Infusion Services - Fort Wayne

Fort Wayne, Indiana, United States

Care Access - South Indianapolis

Indianapolis, Indiana, United States

Josephson Wallack Munshower Neurology, PC

Indianapolis, Indiana, United States

Covenant Medical Center

Waterloo, Iowa, United States

College Park Specialty Center

Overland Park, Kansas, United States

Norton Brownsboro Hospital

Louisville, Kentucky, United States

Optum Infusion - Baton Rouge

Baton Rouge, Louisiana, United States

Care Access - Lake Charles

Lake Charles, Louisiana, United States

MD Medical Research

Oxon Hill, Maryland, United States

ActivMed Practices and Research

Methuen, Massachusetts, United States

Boston Center for Memory

Newton, Massachusetts, United States

Care Access - Quincy

Quincy, Massachusetts, United States

MedVadis Research Corporation

Waltham, Massachusetts, United States

Revival Research Institute

Southfield, Michigan, United States

Minneapolis Clinic of Neurology - Burnsville Office

Burnsville, Minnesota, United States

Coram CVS/Specialty Infusion Services - Mendota Heights

Mendota Heights, Minnesota, United States

SKY Clinical Research Network Group - Hall

Fayette, Mississippi, United States

SKY Clinical Research Network Group-Quinn

Ridgeland, Mississippi, United States

Citizens Memorial Hospital District

Bolivar, Missouri, United States

Clinical Research Professionals

Chesterfield, Missouri, United States

IMA Clinical Research - St. Louis

St Louis, Missouri, United States

Coram CVS/Specialty Infusion Services - Henderson

Henderson, Nevada, United States

Option Care - Las Vegas

Las Vegas, Nevada, United States

Las Vegas Medical Research

Las Vegas, Nevada, United States

IMA Clinical Research Hoboken

Hoboken, New Jersey, United States

The Cognitive and Research Center of New Jersey

Springfield, New Jersey, United States

IMA Clinical Research Warren

Warren Township, New Jersey, United States

Albuquerque Neuroscience Inc.

Albuquerque, New Mexico, United States

IMA Clinical Research Albany

Albany, New York, United States

Neurological Associates Albany

Albany, New York, United States

Velocity Clinical Research, Syracuse

East Syracuse, New York, United States

IMA Clinical Research Westchester

Hartsdale, New York, United States

IMA Clinical Research

New York, New York, United States

South Shore Neurologic Associates

Patchogue, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Prime Global Research

The Bronx, New York, United States

Asheville Neurology Specialists

Asheville, North Carolina, United States

Care Access - Charlotte

Charlotte, North Carolina, United States

Care Access - Fayetteville

Fayetteville, North Carolina, United States

Care Access - Greensboro

Greensboro, North Carolina, United States

Medication Management

Greensboro, North Carolina, United States

Care Access - Kinston

Kinston, North Carolina, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Carteret Medical Group

Morehead City, North Carolina, United States

Care Access - Raleigh

Raleigh, North Carolina, United States

Accellacare - Winston-Salem

Winston-Salem, North Carolina, United States

NeuroScience Research Center

Canton, Ohio, United States

Hometown Urgent Care and Research - Cincinnati

Dayton, Ohio, United States

Neurology Diagnostics, Inc.

Dayton, Ohio, United States

Care Access - Lima

Lima, Ohio, United States

North Star Medical Research

Middleburg Heights, Ohio, United States

Care Access - Youngstown

Poland, Ohio, United States

Central States Research

Tulsa, Oklahoma, United States

Optum Infusion - Bend

Bend, Oregon, United States

Velocity Clinical Research, Medford

Medford, Oregon, United States

Center for Cognitive Health

Portland, Oregon, United States

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, United States

Care Access - Pottsville

Pottsville, Pennsylvania, United States

Care Access Research - Warwick

Warwick, Rhode Island, United States

Care Access - Anderson

Anderson, South Carolina, United States

Velocity Clinical Research, Anderson

Anderson, South Carolina, United States

VitaLink Research - Columbia

Columbia, South Carolina, United States

Velocity Clinical Research, Gaffney

Gaffney, South Carolina, United States

VitaLink Research - Greenville

Greenville, South Carolina, United States

Care Access - Mauldin

Mauldin, South Carolina, United States

VitaLink Research - Spartanburg

Spartanburg, South Carolina, United States

VitaLink Research - Union

Union, South Carolina, United States

Health Concepts

Rapid City, South Dakota, United States

Neurology Clinic

Cordova, Tennessee, United States

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Memphis, Tennessee, United States

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, United States

Senior Adults Specialty Research

Austin, Texas, United States

Gadolin Research

Beaumont, Texas, United States

Headlands Research - Brownsville

Brownsville, Texas, United States

Conroe Willis Medical Research

Conroe, Texas, United States

Advanced Neuro Research Center - ANRC

El Paso, Texas, United States

Care Access - Georgetown

Georgetown, Texas, United States

Optum Infusion - Houston

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Next Level Urgent Care

Houston, Texas, United States

Family Practice Center

McAllen, Texas, United States

El Faro Health and Therapeutics

Rio Grande City, Texas, United States

Benchmark Research - Knickerbocker

San Angelo, Texas, United States

Diagnostics Research Group

San Antonio, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Texas Valley Clinical Research

Weslaco, Texas, United States

The Memory Clinic

Bennington, Vermont, United States

Care Access - Arlington

Arlington, Virginia, United States

Option Care - Chantilly

Chantilly, Virginia, United States

Dominion Medical Associates, Inc.

Richmond, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Universal Research Group

Tacoma, Washington, United States

Optum Infusion - Woodinville

Woodinville, Washington, United States

Exemplar Research

Morgantown, West Virginia, United States

The University of Tokyo Hospital

Bunkyō City, Japan

Tokyo-Eki Center-building Clinic

Chūōku, Japan

Fukuwa Clinic

Chūōku, Japan

Tokyo Asbo Clinic

Chūōku, Japan

P-One Clinic

Hachiōji, Japan

AMC Nishiumeda Clinic

Osaka, Japan

National Center for Geriatrics and Gerontology

Ōbu, Japan

Samoncho Clinic

Shinjuku, Japan

Heishinkai Medical Group ToCROM Clinic

Shinjuku-ku, Japan

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Japan

Tokyo Metropolitan Geriatric Hospital

tabashi City, Japan

Oita University Hospital

Yufu, Japan

SCB Research Center

Bayamón, Puerto Rico

Dr. Samuel Sanchez PSC

Caguas, Puerto Rico

INSPIRA Clinical Research

San Juan, Puerto Rico

Instituto De Neurologia Dra. Ivonne Fraga

San Juan, Puerto Rico

Mindful Medical Research

San Juan, Puerto Rico

University of Puerto Rico - Medical Sciences Campus_Do not use - Duplicate facility

San Juan, Puerto Rico