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ACTIVE NOT RECRUITING
NCT04437511
PHASE3

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab. Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up.

Official title: Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

Key Details

Gender

All

Age Range

60 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

1736

Start Date

2020-06-19

Completion Date

2028-11

Last Updated

2025-08-29

Healthy Volunteers

No

Interventions

DRUG

Donanemab

Given IV

DRUG

Placebo

Given IV

Locations (274)

Gilbert Neurology

Gilbert, Arizona, United States

Xenoscience

Phoenix, Arizona, United States

Banner Alzheimer's Institute

Phoenix, Arizona, United States

Perseverance Research Center

Scottsdale, Arizona, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

Banner Alzheimer's Institute Tucson

Tucson, Arizona, United States

Center for Neurosciences

Tucson, Arizona, United States

Health Initiatives Research

Fayetteville, Arkansas, United States

North County Neurology Associates

Carlsbad, California, United States

Wr- Pri, Llc

Encino, California, United States

Neuro-Pain Medical Center

Fresno, California, United States

Neurology Center of North Orange County

Fullerton, California, United States

Irvine Clinical Research

Irvine, California, United States

Kaizen Brain Center

La Jolla, California, United States

Senior Clinical Trials, Inc.

Laguna Hills, California, United States

Collaborative Neuroscience Research, LLC

Los Alamitos, California, United States

USC Keck School of Medicine

Los Angeles, California, United States

Clinical Research Institute

Los Angeles, California, United States

Neurovations

Napa, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Stanford Neuroscience Health Center

Palo Alto, California, United States

SC3 Research - Pasadena

Pasadena, California, United States

PCND Neurology

Poway, California, United States

Anderson Clinical Research

Redlands, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Pacific Research Network

San Diego, California, United States

Sharp Neurocognitive Research Center

San Diego, California, United States

UCSF Memory and Aging Center

San Francisco, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

California Neuroscience Research Medical Group, Inc.

Sherman Oaks, California, United States

Tilda Research

Tustin, California, United States

Mountain Neurological Research Center

Basalt, Colorado, United States

Alpine Clinical Research Center

Boulder, Colorado, United States

Colorado Springs Neurological Associates

Colorado Springs, Colorado, United States

Colorado Neurological Research Center, PC

Denver, Colorado, United States

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Yale University, Alzheimer's Disease Research Unit

New Haven, Connecticut, United States

Research Center for Clinical Studies

Norwalk, Connecticut, United States

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

Stamford, Connecticut, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, 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

SFM Clinical Research

Boca Raton, Florida, United States

Brain Matters Research

Delray Beach, Florida, United States

Cohen Medical Associates

Delray Beach, Florida, United States

Integrity Clinical Research

Doral, Florida, United States

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, United States

Finlay Medical Research

Greenacres City, Florida, United States

MD Clinical

Hallandale, Florida, United States

AGA Clinical Trials

Hialeah, Florida, United States

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Infinity Clinical Research, LLC

Hollywood, Florida, United States

Encore Research Group- Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Accel Research Sites - Lakeland Clinical Research Unit

Lakeland, Florida, United States

ClinCloud - Maitland

Maitland, Florida, United States

Merritt Island Medical Research, LLC

Merritt Island, Florida, United States

Homestead Associates in Research

Miami, Florida, United States

Finlay Medical Research

Miami, Florida, United States

Optimus U Corporation

Miami, Florida, United States

Miami Jewish health

Miami, Florida, United States

Future Care Solution

Miami, Florida, United States

Allied Biomedical Research Institute

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Florida International Research Center

Miami, Florida, United States

Ezy Medical Research

Miami, Florida, United States

Miami Dade Medical Research Institute, LLC

Miami, Florida, United States

The Neurology Research Group

Miami, Florida, United States

VIN-Victor Faradji

Miami, Florida, United States

Mount Sinai Cancer Center

Miami Beach, Florida, United States

Goji Group - Research Trials Group

Miami Lakes, Florida, United States

Collier Neurologic Specialists

Naples, Florida, United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Sensible Healthcare, LLC

Ocoee, Florida, United States

Medical Research Group of Central Florida

Orange City, Florida, United States

Synexus Clinical Research US, Inc.

Orlando, Florida, United States

Headlands Research Orlando

Orlando, Florida, United States

IMIC, Inc.

Palmetto Bay, Florida, United States

Emerald Coast Neurology - Airport Boulevard

Pensacola, Florida, United States

Quantum Laboratories Clinical Research

Pompano Beach, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Intercoastal Medical Group

Sarasota, Florida, United States

Roskamp Institute Clinical Trials Division

Sarasota, Florida, United States

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, United States

Alzheimer's Research and Treatment Center

Stuart, Florida, United States

Brain Matters Research

Stuart, Florida, United States

Tallahassee Neurological Clinic

Tallahassee, Florida, United States

Axiom Clinical Research of Florida

Tampa, Florida, United States

Stedman Clinical Trials

Tampa, Florida, United States

USF Health Byrd Alzheimer's Institute

Tampa, Florida, United States

Charter Research - Lady Lake

The Villages, Florida, United States

Synexus Clinical Research US, Inc.

The Villages, Florida, United States

Alzheimer's Research and Treatment Center

Wellington, Florida, United States

Palm Beach Neurology

West Palm Beach, Florida, United States

Conquest Research

Winter Park, Florida, United States

Charter Research - Winter Park

Winter Park, Florida, United States

Gwinnett Research Institute

Buford, Georgia, United States

Columbus Memory Center, LLC

Columbus, Georgia, United States

NeuroStudies

Decatur, Georgia, United States

Center for Advanced Research & Education

Gainesville, Georgia, United States

Northwest Clinical Trials

Boise, Idaho, United States

Great Lakes Clinical Trials - Andersonville

Chicago, Illinois, United States

AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research

Elk Grove Village, Illinois, United States

Advocate Medical Group

Park Ridge, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Josephson Wallack Munshower Neurology, PC

Indianapolis, Indiana, United States

McFarland Clinic, PC

Ames, Iowa, United States

Covenant Medical Center

Waterloo, Iowa, United States

The University of Kansas - Clinical Research Center

Fairway, Kansas, United States

College Park Family Care Center/Multi Specialty Clinical Res

Overland Park, Kansas, United States

Cotton O'Neil Clinical Research Center - Central Office

Topeka, Kansas, United States

Ascension Via Christi Research

Wichita, Kansas, United States

Maine Medical Center-Maine Medical Partners Neurology

Scarborough, Maine, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Boston Clinical Trials

Boston, Massachusetts, United States

NECCR PrimaCare Research

Fall River, Massachusetts, United States

BTC Network

New Bedford, Massachusetts, United States

Boston Center for Memory

Newton, Massachusetts, United States

Donald S. Marks M.D., P.C.

Plymouth, Massachusetts, United States

Alzheimers Disease Center

Quincy, Massachusetts, United States

MedVadis Research Corporation

Waltham, Massachusetts, United States

Adams Clinical

Watertown, Massachusetts, United States

QUEST Research Institute

Farmington Hills, Michigan, United States

Precise Research Centers

Flowood, Mississippi, United States

Citizens Memorial Hospital District

Bolivar, Missouri, United States

Clinical Research Professionals

Chesterfield, Missouri, United States

North Kansas City Hospital

North Kansas City, Missouri, United States

Sharlin Health and Neurology

Ozark, Missouri, United States

Arch Clinical Trials

St Louis, Missouri, United States

Las Vegas Medical Research

Las Vegas, Nevada, United States

The Cognitive and Research Center of New Jersey

Springfield, New Jersey, United States

Advanced Memory Research Institute of New Jersey

Toms River, New Jersey, United States

Bio Behavioral Health

Toms River, New Jersey, United States

Albany Medical College

Albany, New York, United States

Neurological Associates Albany

Albany, New York, United States

Dent Neurologic Institute

Amherst, New York, United States

University at Buffalo - UBMD Neurology

Buffalo, New York, United States

Clarity Clinical Research

East Syracuse, New York, United States

NYU Langone Health

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

CHS-Behavioral Health Research

Charlotte, North Carolina, United States

Guilford Neurologic Associates, Inc

Greensboro, North Carolina, United States

AMC Research

Matthews, North Carolina, United States

Carteret Medical Group

Morehead City, North Carolina, United States

Accellacare - Winston-Salem

Winston-Salem, North Carolina, United States

NeuroScience Research Center

Canton, Ohio, United States

Valley Medical Research

Centerville, Ohio, United States

Rapid Medical Research

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

University of Cincinnati Physicians Company, LLC

Dayton, Ohio, United States

Neurology Diagnostics, Inc.

Dayton, Ohio, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Central States Research

Tulsa, Oklahoma, United States

Summit Headlands

Portland, Oregon, United States

Center for Cognitive Health

Portland, Oregon, United States

Abington Neurological Associates, Ltd.

Abington, Pennsylvania, United States

Penn Medicine: University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Keystone Clinical Studies

Plymouth Meeting, Pennsylvania, United States

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, United States

Prism Health Richland Department of Neurology Research

Columbia, South Carolina, United States

Neurology Clinic, P.C.

Cordova, Tennessee, United States

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Memphis, Tennessee, United States

Senior Adults Specialty Research

Austin, Texas, United States

Gadolin Research

Beaumont, Texas, United States

Kerwin Medical Center

Dallas, Texas, United States

Neurology Consultants of Dallas, PA

Dallas, Texas, United States

InSite Clinical Research

DeSoto, 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

Glenn Biggs Institute for Alzheimers & Neurodegenerative Diseases

San Antonio, Texas, United States

The Memory Clinic

Bennington, Vermont, United States

Integrated Neurology Services - Falls Church

Arlington, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

National Clinical Research, Inc

Richmond, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

EvergreenHealth Medical Center

Kirkland, Washington, United States

University of Washington - Harborview Medical Center

Seattle, Washington, United States

Kingfisher Cooperative

Spokane, Washington, United States

Universal Research Group

Tacoma, Washington, United States

Central Coast Neurosciences Research

Erina, New South Wales, Australia

St Vincent's Hospital

Sydney, New South Wales, Australia

HammondCare Greenwich Hospital

Sydney, New South Wales, Australia

KARA Institute for Neurological Diseases

Sydney, New South Wales, Australia

NeuroCentrix

Carlton, Victoria, Australia

Delmont Private Hospital

Glen Iris, Victoria, Australia

HammondCare

Malvern, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

The Royal Melbourne Hospital

Parkville, Victoria, Australia

OCT Research ULC

Kelowna, British Columbia, Canada

True North Clinical Research

Halifax, Nova Scotia, Canada

True North Clinical Research

New Minas, Nova Scotia, Canada

SKDS Research Inc.

Newmarket, Ontario, Canada

Ottawa Memory Clinic

Ottawa, Ontario, Canada

Bruyère Research Institute

Ottawa, Ontario, Canada

Kawartha Centre - Redefining Healthy Aging

Peterborough, Ontario, Canada

Bluewater Clinical Research Group Inc.

Sarnia, Ontario, Canada

Toronto Memory Program

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Baycrest Health Sciences

Toronto, Ontario, Canada

Clinique de la Mémoire de l'Outaouais

Gatineau, Quebec, Canada

MoCA Research and Innovation Inc.

Greenfield Park, Quebec, Canada

Q&T Research Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Alpha Recherche Clinique

Québec, Canada

ALPHA Recherche Clinique

Québec, Canada

Clinline Services

Hostivice, Central Bohemia, Czechia

Brain-Soul Therapy

Kladno, Central Bohemia, Czechia

A-Shine

Pilsen, Plzeň-město, Czechia

Clintrial s.r.o.

Prague, Praha 10, Czechia

Neurologická Ambulance - Forbeli

Prague, Praha 6, Czechia

Neuropsychiatrie

Prague, Praha 6, Czechia

Nagoya Ekisaikai Hospital

Nagoya, Aichi-ken, Japan

Chubu Rosai Hospital

Nagoya, Aichi-ken, Japan

Kojunkai Daido Clinic

Nagoya, Aichi-ken, Japan

National Center for Geriatrics and Gerontology

Ōbu, Aichi-ken, Japan

Inage Neurology and Memory Clinic

Inage, Chiba, Japan

Matsui e-clinic

Akashi, Hyōgo, Japan

Himeji Central Hospital Affiliated Clinic

Himeji, Hyōgo, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Kakigi Dementia Happiness Clinic

Kobe, Hyōgo, Japan

Tokyo Medical University Ibaraki Medical Center

Inashiki, Ibaraki, Japan

Memory Clinic Toride

Toride, Ibaraki, Japan

Yokohama City Minato Red Cross Hospital

Yokohama, Kanagawa, Japan

Oita University Hospital

Yufu, Oita Prefecture, Japan

Katayama Medical Clinic

Kurashiki, Okayama-ken, Japan

Honmachi Clinic

Ikeda, Osaka, Japan

Takatsuki General Hospital

Takatsuki, Osaka, Japan

Medical Corporation Chiseikai Tokyo Center Clinic

Chuo-ku, Tokyo, Japan

Moriyama Neuro Center Hospital

Edogawa-ku, Tokyo, Japan

P-One Clinic

Hachiōji, Tokyo, Japan

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, Japan

Tokyo Metro Bokutoh Hospital

Sumida-ku, Tokyo, Japan

Hiroshima Neurology Clinic

Hiroshima, Japan

Koseikai Takeda Hospital

Kyoto, Japan

Ishikawa Clinic

Kyoto, Japan

National hospital Organization Utano National Hospital

Kyoto, Japan

Oita Prefectural Hospital

Ōita, Japan

Itsuki Hospital

Tokushima, Japan

Tokyo Asbo Clinic

Tokyo, Japan

Nippon Medical School Hospital

Tokyo, Japan

Makita General Hospital

Tokyo, Japan

Brain Research Center Den Bosch B.V.

's-Hertogenbosch, North Brabant, Netherlands

Brain Research Center

Amsterdam, North Holland, Netherlands

Brain Research Center Zwolle

Zwolle, Overijssel, Netherlands

QPS Netherlands B.V

Leeuwarden, Provincie Friesland, Netherlands

Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

Poznan, Greater Poland Voivodeship, Poland

Centrum Medyczne NEUROMED

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Diamond Clinic

Krakow, Lesser Poland Voivodeship, Poland

Ośrodek Badawczo Naukowo Dydaktyczny Chorób Otępiennych Im Księdza Henryka Kardynała Gulbinowicza Uniwersy -T

Ścinawa, Lower Silesian Voivodeship, Poland

Wroclawskie Centrum Alzheimerowskie

Wroclaw, Lower Silesian Voivodeship, Poland

Private Practice - Dr. Urszula Chyrchel- Paszkiewicz

Lublin, Lublin Voivodeship, Poland

FutureMeds Warszawa Centrum

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne NeuroProtect

Warsawawa, Masovian Voivodeship, Poland

KLIMED Marek Klimkiewicz

Bialystok, Podlaskie Voivodeship, Poland

Podlaskie Centrum Psychogeriatrii

Bialystok, Podlaskie Voivodeship, Poland

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, Poland

Centrum Medyczne SENIOR

Sopot, Pomeranian Voivodeship, Poland

Klinika Neuro-Care

Katowice, Silesian Voivodeship, Poland

Centrum Medyczne Euromedis

Szczecin, West Pomeranian Voivodeship, Poland

SCB Research Center

Bayamón, Puerto Rico

INSPIRA Clinical Research

San Juan, Puerto Rico

Instituto De Neurologia Dra. Ivonne Fraga

San Juan, Puerto Rico

Barbara Diaz-Hernandez MD Research, Inc.

San Juan, Puerto Rico

Glasgow Memory Clinic

Motherwell, Great Britain, United Kingdom

Re:Cognition Health - London

London, London, City of, United Kingdom

Re:Cognition Health Guildford

Guildford, Surrey, United Kingdom

Re:Cognition Health - Birmingham

Birmingham, United Kingdom