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A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
Sponsor: Eli Lilly and Company
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
Conditions
Interventions
Donanemab
Given IV
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