Can a new antibody slow Alzheimer's decline?

NCT ID NCT04437511

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial tests whether an experimental drug called donanemab can slow the mental and functional decline seen in early Alzheimer's disease. Participants with mild symptoms receive either donanemab or a placebo via IV infusion, and researchers track changes in cognition and daily living skills over time. The study also includes a safety cohort and a long-term follow-up to monitor effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: donanemab (an experimental antibody given by IV infusion)
What this could lead to: If successful, donanemab could become a treatment that slows the progression of early Alzheimer's disease, helping people maintain their memory and daily function for longer.
What could go wrong: This is a large phase 3 trial, but the drug is still experimental. It may not prove effective or safe in the long term, and there are risks such as brain swelling or bleeding, which the trial monitors closely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,736 people

The number who actually took part.

Started

Jun 2020

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months * MMSE score of 20 to 28 (inclusive) at baseline * Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort * Meet 18F florbetapir PET scan (central read) criteria * Have a study partner who will provide written informed consent to participate Exclusion Criteria: * Contraindication to MRI or PET scans * Current treatment with immunoglobulin G (IgG) therapy

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction dementia Plaque, Amyloid

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease

Contacts and locations

Locations

A-Shine

Pilsen, Plzeň-město, 30100, Czechia
AGA Clinical Trials

Hialeah, Florida, 33012, United States
ALPHA Recherche Clinique

Québec, G3K 2P8, Canada
AMC Research

Matthews, North Carolina, 28105, United States
AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research

Elk Grove Village, Illinois, 60007, United States
Abington Neurological Associates, Ltd.

Abington, Pennsylvania, 19001, United States
Accel Research Sites - Lakeland Clinical Research Unit

Lakeland, Florida, 33803, United States
Accellacare - Winston-Salem

Winston-Salem, North Carolina, 27103, United States
Adams Clinical

Watertown, Massachusetts, 02472, United States
Advanced Memory Research Institute of New Jersey

Toms River, New Jersey, 08755, United States
Advocate Medical Group

Park Ridge, Illinois, 60068, United States
Albany Medical College

Albany, New York, 12208, United States
Allied Biomedical Research Institute

Miami, Florida, 33155, United States
Alpha Recherche Clinique

Québec, G2J 0C4, Canada
Alpine Clinical Research Center

Boulder, Colorado, 80301, United States
Alzheimer's Research and Treatment Center

Stuart, Florida, 34997, United States
Alzheimer's Research and Treatment Center

Wellington, Florida, 33414, United States
Alzheimers Disease Center

Quincy, Massachusetts, 02169, United States
Anderson Clinical Research

Redlands, California, 92374, United States
Arch Clinical Trials

St Louis, Missouri, 63141, United States
Artemis Institute for Clinical Research

San Diego, California, 92103, United States
Ascension Via Christi Research

Wichita, Kansas, 67214, United States
Axiom Clinical Research of Florida

Tampa, Florida, 33609, United States
BTC Network

New Bedford, Massachusetts, 02740, United States
Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States
Banner Alzheimer's Institute Tucson

Tucson, Arizona, 85718, United States
Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States
Barbara Diaz-Hernandez MD Research, Inc.

San Juan, 00926, Puerto Rico
Baycrest Health Sciences

Toronto, Ontario, M6A 2E1, Canada
Bio Behavioral Health

Toms River, New Jersey, 08755, United States
Bluewater Clinical Research Group Inc.

Sarnia, Ontario, N7T 4X3, Canada
Boston Center for Memory

Newton, Massachusetts, 02459, United States
Boston Clinical Trials

Boston, Massachusetts, 02131, United States
Brain Matters Research

Delray Beach, Florida, 33445, United States
Brain Matters Research

Stuart, Florida, 34997, United States
Brain Research Center

Amsterdam, North Holland, 1081 GN, Netherlands
Brain Research Center Den Bosch B.V.

's-Hertogenbosch, North Brabant, 5223 LA, Netherlands
Brain Research Center Zwolle

Zwolle, Overijssel, 8025 AZ, Netherlands
Brain-Soul Therapy

Kladno, Central Bohemia, 272 01, Czechia
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
Bruyère Research Institute

Ottawa, Ontario, Canada
CHS-Behavioral Health Research

Charlotte, North Carolina, 28211, United States
California Neuroscience Research Medical Group, Inc.

Sherman Oaks, California, 91403, United States
Carteret Medical Group

Morehead City, North Carolina, 28557, United States
Center for Advanced Research & Education

Gainesville, Georgia, 30501, United States
Center for Cognitive Health

Portland, Oregon, 97225, United States
Center for Neurosciences

Tucson, Arizona, 85718, United States
Central Coast Neurosciences Research

Erina, New South Wales, 2250, Australia
Central States Research

Tulsa, Oklahoma, 74136, United States
Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States
Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, 80-546, Poland
Centrum Medyczne Euromedis

Szczecin, West Pomeranian Voivodeship, 70-111, Poland
Centrum Medyczne NEUROMED

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163, Poland
Centrum Medyczne NeuroProtect

Warsawawa, Masovian Voivodeship, 01-684, Poland
Centrum Medyczne SENIOR

Sopot, Pomeranian Voivodeship, 81-855, Poland
Charter Research - Lady Lake

The Villages, Florida, 32162, United States
Charter Research - Winter Park

Winter Park, Florida, 32803, United States
Chubu Rosai Hospital

Nagoya, Aichi-ken, 455-8530, Japan
Citizens Memorial Hospital District

Bolivar, Missouri, 65613, United States
Clarity Clinical Research

East Syracuse, New York, 13057, United States
ClinCloud - Maitland

Maitland, Florida, 32751, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Memphis, Tennessee, 38119, United States
Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, 162-0053, Japan
Clinical Research Institute

Los Angeles, California, 90048, United States
Clinical Research Professionals

Chesterfield, Missouri, 63005, United States
Clinique de la Mémoire de l'Outaouais

Gatineau, Quebec, K1Z 1G3, Canada
Clinline Services

Hostivice, Central Bohemia, 253 01, Czechia
Clintrial s.r.o.

Prague, Praha 10, 100 00, Czechia
Cohen Medical Associates

Delray Beach, Florida, 33446, United States
Collaborative Neuroscience Research, LLC

Los Alamitos, California, 90720, United States
College Park Family Care Center/Multi Specialty Clinical Res

Overland Park, Kansas, 66212, United States
Collier Neurologic Specialists

Naples, Florida, 34105, United States
Colorado Neurological Research Center, PC

Denver, Colorado, 80210, United States
Colorado Springs Neurological Associates

Colorado Springs, Colorado, 80907, United States
Columbus Memory Center, LLC

Columbus, Georgia, 31909, United States
Conquest Research

Winter Park, Florida, 32789, United States
Cotton O'Neil Clinical Research Center - Central Office

Topeka, Kansas, 66606, United States
Covenant Medical Center

Waterloo, Iowa, 50702, United States
Delmont Private Hospital

Glen Iris, Victoria, 3146, Australia
Dent Neurologic Institute

Amherst, New York, 14226, United States
Diamond Clinic

Krakow, Lesser Poland Voivodeship, 31-559, Poland
Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8, Canada
Donald S. Marks M.D., P.C.

Plymouth, Massachusetts, 02360, United States
Emerald Coast Neurology - Airport Boulevard

Pensacola, Florida, 32504, United States
Encore Research Group- Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States
EvergreenHealth Medical Center

Kirkland, Washington, 98034, United States
Ezy Medical Research

Miami, Florida, 33175, United States
Finlay Medical Research

Greenacres City, Florida, 33467, United States
Finlay Medical Research

Miami, Florida, 33126, United States
Florida International Research Center

Miami, Florida, 33173, United States
Future Care Solution

Miami, Florida, 33142, United States
FutureMeds Warszawa Centrum

Warsaw, Masovian Voivodeship, 00-215, Poland
Gadolin Research

Beaumont, Texas, 77702, United States
Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States
Gilbert Neurology

Gilbert, Arizona, 85297, United States
Glasgow Memory Clinic

Motherwell, Great Britain, ML1 4UF, United Kingdom
Glenn Biggs Institute for Alzheimers & Neurodegenerative Diseases

San Antonio, Texas, 78229-3900, United States
Goji Group - Research Trials Group

Miami Lakes, Florida, 33016, United States
Great Lakes Clinical Trials - Andersonville

Chicago, Illinois, 60640, United States
Guilford Neurologic Associates, Inc

Greensboro, North Carolina, 27405, United States
Gwinnett Research Institute

Buford, Georgia, 30519, United States
HammondCare

Malvern, Victoria, 3144, Australia
HammondCare Greenwich Hospital

Sydney, New South Wales, 2065, Australia
Headlands Research Orlando

Orlando, Florida, 32819, United States
Health Initiatives Research

Fayetteville, Arkansas, 72703, United States
Himeji Central Hospital Affiliated Clinic

Himeji, Hyōgo, 672-8043, Japan
Hiroshima Neurology Clinic

Hiroshima, 732-0822, Japan
Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States
Homestead Associates in Research

Miami, Florida, 33032, United States
Honmachi Clinic

Ikeda, Osaka, 563-0058, Japan
Houston Methodist Hospital

Houston, Texas, 77030, United States
IMIC, Inc.

Palmetto Bay, Florida, 33157, United States
INSPIRA Clinical Research

San Juan, 00918, Puerto Rico
IPS Research Company

Oklahoma City, Oklahoma, 73106, United States
InSite Clinical Research

DeSoto, Texas, 75115, United States
Inage Neurology and Memory Clinic

Inage, Chiba, 263-0043, Japan
Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States
Indiana University

Indianapolis, Indiana, 46202, United States
Infinity Clinical Research, LLC

Hollywood, Florida, 33024, United States
Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States
Instituto De Neurologia Dra. Ivonne Fraga

San Juan, 00918, Puerto Rico
Integrated Neurology Services - Falls Church

Arlington, Virginia, 22207, United States
Integrity Clinical Research

Doral, Florida, 33166, United States
Intercoastal Medical Group

Sarasota, Florida, 34239, United States
Irvine Clinical Research

Irvine, California, 92614, United States
Ishikawa Clinic

Kyoto, 606-0851, Japan
Itsuki Hospital

Tokushima, 770-0852, Japan
JEM Research Institute

Atlantis, Florida, 33462, United States
Josephson Wallack Munshower Neurology, PC

Indianapolis, Indiana, 46256, United States
KARA Institute for Neurological Diseases

Sydney, New South Wales, 2113, Australia
KLIMED Marek Klimkiewicz

Bialystok, Podlaskie Voivodeship, 15-704, Poland
Kaizen Brain Center

La Jolla, California, 92037, United States
Kakigi Dementia Happiness Clinic

Kobe, Hyōgo, 657-0825, Japan
Katayama Medical Clinic

Kurashiki, Okayama-ken, 710-0813, Japan
Kawartha Centre - Redefining Healthy Aging

Peterborough, Ontario, K9H 2P4, Canada
Kerwin Medical Center

Dallas, Texas, 75231, United States
Keystone Clinical Studies

Plymouth Meeting, Pennsylvania, 19462, United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States
Kingfisher Cooperative

Spokane, Washington, 99201, United States
Klinika Neuro-Care

Katowice, Silesian Voivodeship, 40-749, Poland
Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan
Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan
Kojunkai Daido Clinic

Nagoya, Aichi-ken, 4570818, Japan
Koseikai Takeda Hospital

Kyoto, 600-8558, Japan
Las Vegas Medical Research

Las Vegas, Nevada, 89128, United States
Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States
MD Clinical

Hallandale, Florida, 33009, United States
Maine Medical Center-Maine Medical Partners Neurology

Scarborough, Maine, 04074, United States
Makita General Hospital

Tokyo, 143-0016, Japan
Matsui e-clinic

Akashi, Hyōgo, 673-0891, Japan
McFarland Clinic, PC

Ames, Iowa, 50010, United States
MedVadis Research Corporation

Waltham, Massachusetts, 02451, United States
Medical Corporation Chiseikai Tokyo Center Clinic

Chuo-ku, Tokyo, 103-0028, Japan
Medical Research Group of Central Florida

Orange City, Florida, 32763, United States
Memory Clinic Toride

Toride, Ibaraki, 302-0004, Japan
Merritt Island Medical Research, LLC

Merritt Island, Florida, 32952, United States
Miami Dade Medical Research Institute, LLC

Miami, Florida, 33176, United States
Miami Jewish health

Miami, Florida, 33137, United States
MoCA Research and Innovation Inc.

Greenfield Park, Quebec, J4V 2J2, Canada
Moriyama Neuro Center Hospital

Edogawa-ku, Tokyo, 134-0088, Japan
Mount Sinai Cancer Center

Miami Beach, Florida, 33140, United States
Mountain Neurological Research Center

Basalt, Colorado, 81621, United States
NECCR PrimaCare Research

Fall River, Massachusetts, 02721, United States
NYU Langone Health

New York, New York, 10016, United States
Nagoya Ekisaikai Hospital

Nagoya, Aichi-ken, 454-8502, Japan
National Center for Geriatrics and Gerontology

Ōbu, Aichi-ken, 474-8511, Japan
National Clinical Research, Inc

Richmond, Virginia, 23294, United States
National hospital Organization Utano National Hospital

Kyoto, 616-8255, Japan
Neuro-Pain Medical Center

Fresno, California, 93710, United States
NeuroCentrix

Carlton, Victoria, 3053, Australia
NeuroScience Research Center

Canton, Ohio, 44718, United States
NeuroStudies

Decatur, Georgia, 30030, United States
Neurological Associates Albany

Albany, New York, 12208, United States
Neurologická Ambulance - Forbeli

Prague, Praha 6, 160 00, Czechia
Neurology Center of North Orange County

Fullerton, California, 92835, United States
Neurology Clinic, P.C.

Cordova, Tennessee, 38018, United States
Neurology Consultants of Dallas, PA

Dallas, Texas, 75243, United States
Neurology Diagnostics, Inc.

Dayton, Ohio, 45459, United States
Neurology Offices of South Florida

Boca Raton, Florida, 33428, United States
Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, 33912, United States
Neuropsychiatrie

Prague, Praha 6, 160 00, Czechia
Neurovations

Napa, California, 94558, United States
New Horizon Research Center

Miami, Florida, 33165, United States
Nippon Medical School Hospital

Tokyo, 113-8603, Japan
North County Neurology Associates

Carlsbad, California, 92011, United States
North Kansas City Hospital

North Kansas City, Missouri, 64116, United States
Northwest Clinical Research Center

Bellevue, Washington, 98007, United States
Northwest Clinical Trials

Boise, Idaho, 83704, United States
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

Poznan, Greater Poland Voivodeship, 61-853, Poland
OCT Research ULC

Kelowna, British Columbia, V1Y 1Z9, Canada
Ohio State University

Columbus, Ohio, 43210, United States
Oita Prefectural Hospital

Ōita, 870-0855, Japan
Oita University Hospital

Yufu, Oita Prefecture, 879-5593, Japan
Optimus U Corporation

Miami, Florida, 33135, United States
Ottawa Memory Clinic

Ottawa, Ontario, K1Z 1G3, Canada
Ośrodek Badawczo Naukowo Dydaktyczny Chorób Otępiennych Im Księdza Henryka Kardynała Gulbinowicza Uniwersy -T

Ścinawa, Lower Silesian Voivodeship, 59-330, Poland
P-One Clinic

Hachiōji, Tokyo, 192-0071, Japan
PCND Neurology

Poway, California, 92064, United States
Pacific Research Network

San Diego, California, 92103, United States
Palm Beach Neurology

West Palm Beach, Florida, 33407, United States
Penn Medicine: University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States
Perseverance Research Center

Scottsdale, Arizona, 85254, United States
Podlaskie Centrum Psychogeriatrii

Bialystok, Podlaskie Voivodeship, 15-756, Poland
Precise Research Centers

Flowood, Mississippi, 39232, United States
Prism Health Richland Department of Neurology Research

Columbia, South Carolina, 29203, United States
Private Practice - Dr. Urszula Chyrchel- Paszkiewicz

Lublin, Lublin Voivodeship, 20-093, Poland
Progressive Medical Research

Port Orange, Florida, 32127, United States
Q&T Research Sherbrooke Inc.

Sherbrooke, Quebec, J1J 2G2, Canada
QPS Netherlands B.V

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands
QUEST Research Institute

Farmington Hills, Michigan, 48334, United States
Quantum Laboratories Clinical Research

Pompano Beach, Florida, 33064, United States
Rapid Medical Research

Cleveland, Ohio, 44122, United States
Re:Cognition Health - Birmingham

Birmingham, B16 8LT, United Kingdom
Re:Cognition Health - London

London, London, City of, W1G 9JF, United Kingdom
Re:Cognition Health Guildford

Guildford, Surrey, GU2 7YD, United Kingdom
Renstar Medical Research

Ocala, Florida, 34470, United States
Research Center for Clinical Studies

Norwalk, Connecticut, 06851, United States
Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, 02914, United States
Richmond Behavioral Associates

Staten Island, New York, 10312, United States
Roskamp Institute Clinical Trials Division

Sarasota, Florida, 34243, United States
SC3 Research - Pasadena

Pasadena, California, 91105, United States
SCB Research Center

Bayamón, 00961, Puerto Rico
SFM Clinical Research

Boca Raton, Florida, 33487, United States
SKDS Research Inc.

Newmarket, Ontario, L3Y 5G8, Canada
SUNY Upstate Medical University

Syracuse, New York, 13210, United States
Senior Adults Specialty Research

Austin, Texas, 78757, United States
Senior Clinical Trials, Inc.

Laguna Hills, California, 92653, United States
Sensible Healthcare, LLC

Ocoee, Florida, 34761, United States
Sentara Norfolk General Hospital

Norfolk, Virginia, 23510, United States
Sharlin Health and Neurology

Ozark, Missouri, 65721, United States
Sharp Neurocognitive Research Center

San Diego, California, 92123, United States
Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States
St Vincent's Hospital

Sydney, New South Wales, 2010, Australia
Stanford Neuroscience Health Center

Palo Alto, California, 94304, United States
Stedman Clinical Trials

Tampa, Florida, 33613, United States
Summit Headlands

Portland, Oregon, 97210, United States
Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States
Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, 33713, United States
Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada
Synexus Clinical Research US, Inc.

Orlando, Florida, 32806, United States
Synexus Clinical Research US, Inc.

The Villages, Florida, 32162, United States
Syrentis Clinical Research

Santa Ana, California, 92705, United States
Takatsuki General Hospital

Takatsuki, Osaka, 569-1192, Japan
Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States
The Alfred Hospital

Melbourne, Victoria, 3004, Australia
The Cognitive and Research Center of New Jersey

Springfield, New Jersey, 07081, United States
The Memory Clinic

Bennington, Vermont, 05201-9810, United States
The Neurology Research Group

Miami, Florida, 33176, United States
The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia
The University of Kansas - Clinical Research Center

Fairway, Kansas, 66205, United States
The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States
Tilda Research

Tustin, California, 92780, United States
Tokyo Asbo Clinic

Tokyo, 104-0031, Japan
Tokyo Medical University Ibaraki Medical Center

Inashiki, Ibaraki, 300-0332, Japan
Tokyo Metro Bokutoh Hospital

Sumida-ku, Tokyo, 130-0022, Japan
Toronto Memory Program

Toronto, Ontario, M3B 2S7, Canada
True North Clinical Research

Halifax, Nova Scotia, B3S 1N2, Canada
True North Clinical Research

New Minas, Nova Scotia, B4N 3R7, Canada
UCSF Memory and Aging Center

San Francisco, California, 94158, United States
USC Keck School of Medicine

Los Angeles, California, 90033, United States
USF Health Byrd Alzheimer's Institute

Tampa, Florida, 33613, United States
Universal Research Group

Tacoma, Washington, 98405, United States
University at Buffalo - UBMD Neurology

Buffalo, New York, 14203, United States
University of Cincinnati Physicians Company, LLC

Dayton, Ohio, 45417, United States
University of Rochester Medical Center

Rochester, New York, 14642, United States
University of Washington - Harborview Medical Center

Seattle, Washington, 98104, United States
VIN-Julie Schwartzbard

Aventura, Florida, 33180, United States
VIN-Victor Faradji

Miami, Florida, 33176, United States
Valley Medical Research

Centerville, Ohio, 45459, United States
Wr- Pri, Llc

Encino, California, 91316, United States
Wroclawskie Centrum Alzheimerowskie

Wroclaw, Lower Silesian Voivodeship, 53-659, Poland
Xenoscience

Phoenix, Arizona, 85004, United States
Yale University, Alzheimer's Disease Research Unit

New Haven, Connecticut, 06510, United States
Yokohama City Minato Red Cross Hospital

Yokohama, Kanagawa, 231-0801, Japan

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