AzTrials
AzTrials

Alzheimer DiseasePhase 3NCT04437511

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

A Phase 3 study testing Donanemab in people with Alzheimer Disease, run by Eli Lilly and Company at 274 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Donanemab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,736 participants
Where
274 sitesin 9 countries
Study dates
19 Jun 2020to Nov 2028
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Contraindication to MRI or PET scans
  • Current treatment with immunoglobulin G (IgG) therapy

Trial locations and contacts

274 sites in 9 countries.

274 sites in 9 countries

United States185 sites

  • Abington Neurological Associates, Ltd.

    Abington, Pennsylvania, 19001

  • Albany Medical College

    Albany, New York, 12208

  • Neurological Associates Albany

    Albany, New York, 12208

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • Integrated Neurology Services - Falls Church

    Arlington, Virginia, 22207

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Senior Adults Specialty Research

    Austin, Texas, 78757

  • VIN-Julie Schwartzbard

    Aventura, Florida, 33180

  • Mountain Neurological Research Center

    Basalt, Colorado, 81621

  • Gadolin Research

    Beaumont, Texas, 77702

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • The Memory Clinic

    Bennington, Vermont, 05201-9810

  • Neurology Offices of South Florida

    Boca Raton, Florida, 33428

  • SFM Clinical Research

    Boca Raton, Florida, 33487

  • Northwest Clinical Trials

    Boise, Idaho, 83704

  • Citizens Memorial Hospital District

    Bolivar, Missouri, 65613

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Alpine Clinical Research Center

    Boulder, Colorado, 80301

  • University at Buffalo - UBMD Neurology

    Buffalo, New York, 14203

  • Gwinnett Research Institute

    Buford, Georgia, 30519

  • NeuroScience Research Center

    Canton, Ohio, 44718

  • North County Neurology Associates

    Carlsbad, California, 92011

  • Valley Medical Research

    Centerville, Ohio, 45459

  • CHS-Behavioral Health Research

    Charlotte, North Carolina, 28211

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Great Lakes Clinical Trials - Andersonville

    Chicago, Illinois, 60640

  • Rapid Medical Research

    Cleveland, Ohio, 44122

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, 80907

  • Prism Health Richland Department of Neurology Research

    Columbia, South Carolina, 29203

  • Columbus Memory Center, LLC

    Columbus, Georgia, 31909

  • Ohio State University

    Columbus, Ohio, 43210

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018

  • Kerwin Medical Center

    Dallas, Texas, 75231

  • Neurology Consultants of Dallas, PA

    Dallas, Texas, 75243

  • University of Cincinnati Physicians Company, LLC

    Dayton, Ohio, 45417

  • Neurology Diagnostics, Inc.

    Dayton, Ohio, 45459

  • NeuroStudies

    Decatur, Georgia, 30030

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Cohen Medical Associates

    Delray Beach, Florida, 33446

  • Colorado Neurological Research Center, PC

    Denver, Colorado, 80210

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • Integrity Clinical Research

    Doral, Florida, 33166

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • Clarity Clinical Research

    East Syracuse, New York, 13057

  • AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research

    Elk Grove Village, Illinois, 60007

  • Wr- Pri, Llc

    Encino, California, 91316

  • The University of Kansas - Clinical Research Center

    Fairway, Kansas, 66205

  • NECCR PrimaCare Research

    Fall River, Massachusetts, 02721

  • QUEST Research Institute

    Farmington Hills, Michigan, 48334

  • Health Initiatives Research

    Fayetteville, Arkansas, 72703

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Center for Advanced Research & Education

    Gainesville, Georgia, 30501

  • Gilbert Neurology

    Gilbert, Arizona, 85297

  • Finlay Medical Research

    Greenacres City, Florida, 33467

  • Guilford Neurologic Associates, Inc

    Greensboro, North Carolina, 27405

  • MD Clinical

    Hallandale, Florida, 33009

  • AGA Clinical Trials

    Hialeah, Florida, 33012

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33024

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • Josephson Wallack Munshower Neurology, PC

    Indianapolis, Indiana, 46256

  • Irvine Clinical Research

    Irvine, California, 92614

  • Encore Research Group- Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • EvergreenHealth Medical Center

    Kirkland, Washington, 98034

  • Kaizen Brain Center

    La Jolla, California, 92037

  • Senior Clinical Trials, Inc.

    Laguna Hills, California, 92653

  • Accel Research Sites - Lakeland Clinical Research Unit

    Lakeland, Florida, 33803

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89128

  • Collaborative Neuroscience Research, LLC

    Los Alamitos, California, 90720

  • USC Keck School of Medicine

    Los Angeles, California, 90033

  • Clinical Research Institute

    Los Angeles, California, 90048

  • ClinCloud - Maitland

    Maitland, Florida, 32751

  • AMC Research

    Matthews, North Carolina, 28105

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Memphis, Tennessee, 38119

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida, 32952

  • Homestead Associates in Research

    Miami, Florida, 33032

  • Finlay Medical Research

    Miami, Florida, 33126

  • Optimus U Corporation

    Miami, Florida, 33135

  • Miami Jewish health

    Miami, Florida, 33137

  • Future Care Solution

    Miami, Florida, 33142

  • Allied Biomedical Research Institute

    Miami, Florida, 33155

  • New Horizon Research Center

    Miami, Florida, 33165

  • Florida International Research Center

    Miami, Florida, 33173

  • Ezy Medical Research

    Miami, Florida, 33175

  • Miami Dade Medical Research Institute, LLC

    Miami, Florida, 33176

  • The Neurology Research Group

    Miami, Florida, 33176

  • VIN-Victor Faradji

    Miami, Florida, 33176

  • Mount Sinai Cancer Center

    Miami Beach, Florida, 33140

  • Goji Group - Research Trials Group

    Miami Lakes, Florida, 33016

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Neurovations

    Napa, California, 94558

  • Collier Neurologic Specialists

    Naples, Florida, 34105

  • BTC Network

    New Bedford, Massachusetts, 02740

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

  • Yale University, Alzheimer's Disease Research Unit

    New Haven, Connecticut, 06510

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • NYU Langone Health

    New York, New York, 10016

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23510

  • North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • Research Center for Clinical Studies

    Norwalk, Connecticut, 06851

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Sensible Healthcare, LLC

    Ocoee, Florida, 34761

  • IPS Research Company

    Oklahoma City, Oklahoma, 73106

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763

  • Synexus Clinical Research US, Inc.

    Orlando, Florida, 32806

  • Headlands Research Orlando

    Orlando, Florida, 32819

  • College Park Family Care Center/Multi Specialty Clinical Res

    Overland Park, Kansas, 66212

  • Sharlin Health and Neurology

    Ozark, Missouri, 65721

  • IMIC, Inc.

    Palmetto Bay, Florida, 33157

  • Stanford Neuroscience Health Center

    Palo Alto, California, 94304

  • Advocate Medical Group

    Park Ridge, Illinois, 60068

  • SC3 Research - Pasadena

    Pasadena, California, 91105

  • Emerald Coast Neurology - Airport Boulevard

    Pensacola, Florida, 32504

  • Penn Medicine: University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • Xenoscience

    Phoenix, Arizona, 85004

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Donald S. Marks M.D., P.C.

    Plymouth, Massachusetts, 02360

  • Keystone Clinical Studies

    Plymouth Meeting, Pennsylvania, 19462

  • Quantum Laboratories Clinical Research

    Pompano Beach, Florida, 33064

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Summit Headlands

    Portland, Oregon, 97210

  • Center for Cognitive Health

    Portland, Oregon, 97225

  • PCND Neurology

    Poway, California, 92064

  • Alzheimers Disease Center

    Quincy, Massachusetts, 02169

  • Anderson Clinical Research

    Redlands, California, 92374

  • National Clinical Research, Inc

    Richmond, Virginia, 23294

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

  • Glenn Biggs Institute for Alzheimers & Neurodegenerative Diseases

    San Antonio, Texas, 78229-3900

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Pacific Research Network

    San Diego, California, 92103

  • Sharp Neurocognitive Research Center

    San Diego, California, 92123

  • UCSF Memory and Aging Center

    San Francisco, California, 94158

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Intercoastal Medical Group

    Sarasota, Florida, 34239

  • Roskamp Institute Clinical Trials Division

    Sarasota, Florida, 34243

  • Maine Medical Center-Maine Medical Partners Neurology

    Scarborough, Maine, 04074

  • Perseverance Research Center

    Scottsdale, Arizona, 85254

  • University of Washington - Harborview Medical Center

    Seattle, Washington, 98104

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California, 91403

  • Kingfisher Cooperative

    Spokane, Washington, 99201

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey, 07081

  • Arch Clinical Trials

    St Louis, Missouri, 63141

  • Suncoast Neuroscience Associates, Inc.

    St. Petersburg, Florida, 33713

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

    Stamford, Connecticut, 06905

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Alzheimer's Research and Treatment Center

    Stuart, Florida, 34997

  • Brain Matters Research

    Stuart, Florida, 34997

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Universal Research Group

    Tacoma, Washington, 98405

  • Tallahassee Neurological Clinic

    Tallahassee, Florida, 32308

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • USF Health Byrd Alzheimer's Institute

    Tampa, Florida, 33613

  • Charter Research - Lady Lake

    The Villages, Florida, 32162

  • Synexus Clinical Research US, Inc.

    The Villages, Florida, 32162

  • Advanced Memory Research Institute of New Jersey

    Toms River, New Jersey, 08755

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Cotton O'Neil Clinical Research Center - Central Office

    Topeka, Kansas, 66606

  • Banner Alzheimer's Institute Tucson

    Tucson, Arizona, 85718

  • Center for Neurosciences

    Tucson, Arizona, 85718

  • Central States Research

    Tulsa, Oklahoma, 74136

  • Tilda Research

    Tustin, California, 92780

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Covenant Medical Center

    Waterloo, Iowa, 50702

  • Adams Clinical

    Watertown, Massachusetts, 02472

  • Alzheimer's Research and Treatment Center

    Wellington, Florida, 33414

  • Palm Beach Neurology

    West Palm Beach, Florida, 33407

  • Ascension Via Christi Research

    Wichita, Kansas, 67214

  • Accellacare - Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Conquest Research

    Winter Park, Florida, 32789

  • Charter Research - Winter Park

    Winter Park, Florida, 32803

Other trials in United States

Japan31 sites

  • Matsui e-clinic

    Akashi, Hyōgo, 673-0891

  • Medical Corporation Chiseikai Tokyo Center Clinic

    Chuo-ku, Tokyo, 103-0028

  • Moriyama Neuro Center Hospital

    Edogawa-ku, Tokyo, 134-0088

  • P-One Clinic

    Hachiōji, Tokyo, 192-0071

  • Himeji Central Hospital Affiliated Clinic

    Himeji, Hyōgo, 672-8043

  • Hiroshima Neurology Clinic

    Hiroshima, 732-0822

  • Honmachi Clinic

    Ikeda, Osaka, 563-0058

  • Inage Neurology and Memory Clinic

    Inage, Chiba, 263-0043

  • Tokyo Medical University Ibaraki Medical Center

    Inashiki, Ibaraki, 300-0332

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Kakigi Dementia Happiness Clinic

    Kobe, Hyōgo, 657-0825

  • Katayama Medical Clinic

    Kurashiki, Okayama-ken, 710-0813

  • Koseikai Takeda Hospital

    Kyoto, 600-8558

  • Ishikawa Clinic

    Kyoto, 606-0851

  • National hospital Organization Utano National Hospital

    Kyoto, 616-8255

  • Nagoya Ekisaikai Hospital

    Nagoya, Aichi-ken, 454-8502

  • Chubu Rosai Hospital

    Nagoya, Aichi-ken, 455-8530

  • Kojunkai Daido Clinic

    Nagoya, Aichi-ken, 4570818

  • National Center for Geriatrics and Gerontology

    Ōbu, Aichi-ken, 474-8511

  • Oita Prefectural Hospital

    Ōita, 870-0855

  • Clinical Research Hospital Tokyo

    Shinjuku-ku, Tokyo, 162-0053

  • Tokyo Metro Bokutoh Hospital

    Sumida-ku, Tokyo, 130-0022

  • Takatsuki General Hospital

    Takatsuki, Osaka, 569-1192

  • Itsuki Hospital

    Tokushima, 770-0852

  • Tokyo Asbo Clinic

    Tokyo, 104-0031

  • Nippon Medical School Hospital

    Tokyo, 113-8603

  • Makita General Hospital

    Tokyo, 143-0016

  • Memory Clinic Toride

    Toride, Ibaraki, 302-0004

  • Yokohama City Minato Red Cross Hospital

    Yokohama, Kanagawa, 231-0801

  • Oita University Hospital

    Yufu, Oita Prefecture, 879-5593

Other trials in Japan

Canada17 sites

  • Clinique de la Mémoire de l'Outaouais

    Gatineau, Quebec, K1Z 1G3

  • MoCA Research and Innovation Inc.

    Greenfield Park, Quebec, J4V 2J2

  • True North Clinical Research

    Halifax, Nova Scotia, B3S 1N2

  • OCT Research ULC

    Kelowna, British Columbia, V1Y 1Z9

  • True North Clinical Research

    New Minas, Nova Scotia, B4N 3R7

  • SKDS Research Inc.

    Newmarket, Ontario, L3Y 5G8

  • Ottawa Memory Clinic

    Ottawa, Ontario, K1Z 1G3

  • Bruyère Research Institute

    Ottawa, Ontario

  • Kawartha Centre - Redefining Healthy Aging

    Peterborough, Ontario, K9H 2P4

  • Alpha Recherche Clinique

    Québec, G2J 0C4

  • ALPHA Recherche Clinique

    Québec, G3K 2P8

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario, N7T 4X3

  • Q&T Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1J 2G2

  • Diex Recherche Sherbrooke Inc.

    Sherbrooke, Quebec, J1L 0H8

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Baycrest Health Sciences

    Toronto, Ontario, M6A 2E1

Other trials in Canada

Poland14 sites

  • KLIMED Marek Klimkiewicz

    Bialystok, Podlaskie Voivodeship, 15-704

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, Podlaskie Voivodeship, 15-756

  • Centrum Medyczne NEUROMED

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163

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

    Gdansk, Pomeranian Voivodeship, 80-546

  • Klinika Neuro-Care

    Katowice, Silesian Voivodeship, 40-749

  • Diamond Clinic

    Krakow, Lesser Poland Voivodeship, 31-559

  • Private Practice - Dr. Urszula Chyrchel- Paszkiewicz

    Lublin, Lublin Voivodeship, 20-093

  • Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

    Poznan, Greater Poland Voivodeship, 61-853

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

    Ścinawa, Lower Silesian Voivodeship, 59-330

  • Centrum Medyczne SENIOR

    Sopot, Pomeranian Voivodeship, 81-855

  • Centrum Medyczne Euromedis

    Szczecin, West Pomeranian Voivodeship, 70-111

  • FutureMeds Warszawa Centrum

    Warsaw, Masovian Voivodeship, 00-215

  • Centrum Medyczne NeuroProtect

    Warsawawa, Masovian Voivodeship, 01-684

  • Wroclawskie Centrum Alzheimerowskie

    Wroclaw, Lower Silesian Voivodeship, 53-659

Other trials in Poland

Australia9 sites

  • NeuroCentrix

    Carlton, Victoria, 3053

  • Central Coast Neurosciences Research

    Erina, New South Wales, 2250

  • Delmont Private Hospital

    Glen Iris, Victoria, 3146

  • HammondCare

    Malvern, Victoria, 3144

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • St Vincent's Hospital

    Sydney, New South Wales, 2010

  • HammondCare Greenwich Hospital

    Sydney, New South Wales, 2065

  • KARA Institute for Neurological Diseases

    Sydney, New South Wales, 2113

Other trials in Australia

Czechia6 sites

  • Clinline Services

    Hostivice, Central Bohemia, 253 01

  • Brain-Soul Therapy

    Kladno, Central Bohemia, 272 01

  • A-Shine

    Pilsen, Plzeň-město, 30100

  • Clintrial s.r.o.

    Prague, Praha 10, 100 00

  • Neurologická Ambulance - Forbeli

    Prague, Praha 6, 160 00

  • Neuropsychiatrie

    Prague, Praha 6, 160 00

Other trials in Czechia

Netherlands4 sites

  • Brain Research Center Den Bosch B.V.

    's-Hertogenbosch, North Brabant, 5223 LA

  • Brain Research Center

    Amsterdam, North Holland, 1081 GN

  • QPS Netherlands B.V

    Leeuwarden, Provincie Friesland, 8934 AD

  • Brain Research Center Zwolle

    Zwolle, Overijssel, 8025 AZ

Other trials in Netherlands

Puerto Rico4 sites

  • SCB Research Center

    Bayamón, 00961

  • INSPIRA Clinical Research

    San Juan, 00918

  • Instituto De Neurologia Dra. Ivonne Fraga

    San Juan, 00918

  • Barbara Diaz-Hernandez MD Research, Inc.

    San Juan, 00926

Other trials in Puerto Rico

United Kingdom4 sites

  • Re:Cognition Health - Birmingham

    Birmingham, B16 8LT

  • Re:Cognition Health Guildford

    Guildford, Surrey, GU2 7YD

  • Re:Cognition Health - London

    London, London, City of, W1G 9JF

  • Glasgow Memory Clinic

    Motherwell, Great Britain, ML1 4UF

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

TRAILBLAZER-ALZ 2 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of N3pG antibody (donanemab) in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain amyloid and tau pathology.

Following the double-blind 76-week main study period, a double-blind 78-week long-term extension period is added to further evaluate donanemab efficacy and safety over time. Participants from the addendum safety cohort are not eligible for the extension period.

Participants previously dosed with donanemab in the main study will be monitored to track re-accumulation of amyloid plaque for 3 years.

Being tested
Donanemab, Placebo
Keywords
Alzheimer's, Dementia, Cognitive Impairment, Amyloid Plaque
Medical subject headings
Alzheimer Disease, Dementia, Cognitive Dysfunction, Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DonanemabDrug

    Also called LY3002813

    Given IV

  • PlaceboDrug

    Given IV

Study groups in NCT04437511
Study groupRoleWhat they receive
DonanemabExperimentalParticipants received 700 milligram (mg) Donanemab every 4 weeks (Q4W) x 3 doses, then 1400 mg Q4W given intravenously (IV) for up to 72 weeks
Receives: Drug: Donanemab
PlaceboPlacebo comparatorParticipants received placebo given IV.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population)

    Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the clinical decline associated with AD compared with placebo. iADRS is an integrated assessment of cognition and daily function comprised of items from the ADAS-Cog13 and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance. Least Squares (LS) Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline acetylcholinesterase inhibitor (AchI)/Memantine use.

    Measured: Baseline, Week 76

  2. Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)

    Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the clinical decline associated with AD compared with placebo. iADRS is an integrated assessment of cognition and daily function comprised of items from the Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.

    Measured: Baseline, Week 76

Secondary outcomes (13)

  1. Change From Baseline on the Mini Mental State Examination (MMSE) Score (Overall Population)

    MMSE is an instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline AchI/Memantine use.

    Measured: Baseline, Week 76

  2. Change From Baseline on the Mini Mental State Examination (MMSE) Score (Intermediate (Low-medium) Tau Population)

    MMSE is an instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.

    Measured: Baseline, Week 76

  3. Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population)

    The ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline AchI/Memantine use.

    Measured: Baseline, Week 76

  4. Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population)

    The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-cog consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.

    Measured: Baseline, Week 76

  5. Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Overall Population)

    CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline score-by-visit interaction, age at baseline, baseline tau category, pooled investigator, and baseline AchI/Memantine use.

    Measured: Baseline, Week 76

  6. Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Intermediate (Low-medium) Tau Population)

    CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline score-by-visit interaction, age at baseline, pooled investigator, and baseline AchI/Memantine use.

    Measured: Baseline, Week 76

  7. Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Overall Population)

    The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities (instrumental activity items 6a, 7-23) of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline AchI/Memantine use.

    Measured: Baseline, Week 76

  8. Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Intermediate (Low-medium) Tau Population)

    The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities (instrumental activity items 6a, 7-23) of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.

    Measured: Baseline, Week 76

  9. Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Amyloid Positron Emission Tomography (PET) Scan

    Amyloid PET scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in amyloid plaques. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical brain regions relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline score-by-visit interaction, baseline tau category, and age at baseline.

    Measured: Baseline, Week 76

  10. Change From Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan

    Flortaucipir PET imaging was used as a quantitative tau biomarker. Tau PET scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in aggregated tau neurofibrillary tangles (NFTs). Quantitative tau burden was formalized using Standardized Uptake Value Ratio (SUVR) in frontal lobe relative to the cerebellum gray as a reference region. Larger SUVR reflects larger tau burden in the frontal lobe relative to cerebellum gray. LS Mean value was adjusted for baseline score, screening tau category, age and treatment (Type III sum of squares).

    Measured: Baseline, Week 76

  11. Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)

    MRI scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in brain volume. Volumetric MRI parameters were measured in bilateral hippocampus, bilateral whole brain, and bilateral ventricles. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline tau category, and age at baseline.

    Measured: Baseline, Week 76

  12. Pharmacokinetics (PK): Average Serum Concentration at Steady State of Donanemab

    The average serum concentration at steady state, calculated as Cav = AUCtau/tau, where tau is the dosing interval (4 weeks). AUCtau/tau was assessed at week 12, 16, 24, 36, 52, 64 and Cav for the dosing interval from week 16 to week 20 is reported.

    Measured: Week 16 to week 20

  13. Number or Participants With Anti-Donanemab Antibodies

    Number of participants with treatment-emergent positive Anti-Donanemab antibodies was summarized by treatment group.

    Measured: Baseline through Week 76

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2020
  2. Study start19 Jun 2020
  3. Primary completion14 Apr 2023
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,736 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04437511
Sponsor's protocol ID
17737
Other IDs
I5T-MC-AACI, 2020-000077-25
Status last verified
Aug 2026
First submitted
17 Jun 2020
Last updated
26 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Brookfield N, Hauck PM, Doty EG, Zimmer JA, Yang F, Chen YF, Ardayfio P, Khanna R, Ye W, Tockhorn-Heidenreich A, Patel N. Donanemab for early symptomatic AD in the UK-indicated population: safety and efficacy in those who are non-carriers or heterozygous for APOE epsilon4. Neurodegener Dis Manag. 2026 Aug 26:1-11. doi: 10.1080/17582024.2026.2723524. Online ahead of print.

    PubMed 42644303

  • Boustani M, Klein EG, Zimmer JA, Wang H, Engle SE, Phipps A, Japha M, Schilling T, Hartry A; Alzheimer's Disease Neuroimaging Initiative. Further data to address the Alzheimer's coverage with evidence development questions. Alzheimers Dement. 2026 Aug;22(8):e71724. doi: 10.1002/alz.71724.

    PubMed 42552749

  • Raket LL, Lu M, Evans CD, Zimmer JA, Sparks J, Collins EC, Shcherbinin S, Wang H, Nery ESM, Epelbaum S, Dell'Agnello G, Brooks DA, Sims JR, Mintun MA. Donanemab treatment effect by baseline tau burden and disease severity: Observations from the TRAILBLAZER-ALZ 2 trial. Alzheimers Dement. 2026 Jun;22(6):e71577. doi: 10.1002/alz.71577.

    PubMed 42273802

  • Atri A, Apostolova LG, Iwata A, Wessels AM, Atkins A, Lu M, Ye W, Ryan S, Doty EG. Clinical Meaningfulness of Donanemab in Early Symptomatic Alzheimer Disease: Data From the Randomized Phase 3 TRAILBLAZER-ALZ 2 Trial. Neurol Clin Pract. 2026 Jun;16(3):e200621. doi: 10.1212/CPJ.0000000000200621. Epub 2026 May 13.

    PubMed 42128444

  • Ardayfio P, Mullins GR, Khanna R, Zimmer JA, Wang H, Nery ESM, Evans CD, Piela P, Battioui C, Lauzon S, Anglin G, Ng HW, Jayaraman AR, Agada N, Natalie CR, Brooks DA, Sims JR. Infusion-related reactions in donanemab-treated participants with early symptomatic Alzheimer's disease. Alzheimers Dement (N Y). 2026 Mar 8;12(1):e70229. doi: 10.1002/trc2.70229. eCollection 2026 Jan-Mar.

    PubMed 41804324

  • Zimmer JA, Sims JR, Evans CD, Nery ESM, Wang H, Wessels AM, Tronchin G, Sato S, Raket LL, Andersen SW, Sapin C, Paget MA, Gueorguieva I, Ardayfio P, Khanna R, Brooks DA, Matthews BR, Mintun MA; Alzheimer's Disease Neuroimaging Initiative. Donanemab in early symptomatic Alzheimer's disease: results from the TRAILBLAZER-ALZ 2 long-term extension. J Prev Alzheimers Dis. 2026 Feb;13(2):100446. doi: 10.1016/j.tjpad.2025.100446. Epub 2025 Dec 1.

    PubMed 41330788

  • Lu M, Kim MJ, Collins EC, Shcherbinin S, Ellinwood AK, Yokoi Y, Brooks DA, Hansson O, Knopman DS, Sims JR, Mintun MA. Posttreatment Amyloid Levels and Clinical Outcomes Following Donanemab for Early Symptomatic Alzheimer Disease: A Secondary Analysis of the TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA Neurol. 2025 Dec 1;82(12):1251-1256. doi: 10.1001/jamaneurol.2025.3869.

    PubMed 41082199

  • Gueorguieva I, Chow K, Chua L, Shcherbinin S, Zimmer JA, Evans CD, Wang H, Nery ESM, Brooks DA, Sims JR. Donanemab exposure-response in early symptomatic Alzheimer's disease. Alzheimers Dement. 2025 Jul;21(7):e70491. doi: 10.1002/alz.70491.

    PubMed 40667684

  • Chandler JM, Lansdall CJ, Ye W, McDougall F, Belger M, Toth B, Mi X, Sink KM, Atkins AS. The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity. J Prev Alzheimers Dis. 2025 Sep;12(8):100261. doi: 10.1016/j.tjpad.2025.100261. Epub 2025 Jul 1.

    PubMed 40603145

  • Zimmer JA, Ardayfio P, Wang H, Khanna R, Evans CD, Lu M, Sparks J, Andersen S, Lauzon S, Nery ESM, Battioui C, Engle SE, Biffi A, Svaldi D, Salloway S, Greenberg SM, Sperling RA, Mintun M, Brooks DA, Sims JR. Amyloid-Related Imaging Abnormalities With Donanemab in Early Symptomatic Alzheimer Disease: Secondary Analysis of the TRAILBLAZER-ALZ and ALZ 2 Randomized Clinical Trials. JAMA Neurol. 2025 May 1;82(5):461-469. doi: 10.1001/jamaneurol.2025.0065.

    PubMed 40063015

  • Boustani M, Doty EG, Garrison LP Jr, Smolen LJ, Klein TM, Murphy DR, Spargo AW, Belger M, Johnston JA. Estimating the Economically Justifiable Price of Limited-Duration Treatment with Donanemab for Early Symptomatic Alzheimer's Disease in the United States. Neurol Ther. 2024 Dec;13(6):1641-1659. doi: 10.1007/s40120-024-00649-y. Epub 2024 Sep 18.

    PubMed 39292433

  • Sato S, Hatakeyama N, Fujikoshi S, Katayama S, Katagiri H, Sims JR. Donanemab in Japanese Patients with Early Alzheimer's Disease: Subpopulation Analysis of the TRAILBLAZER-ALZ 2 Randomized Trial. Neurol Ther. 2024 Jun;13(3):677-695. doi: 10.1007/s40120-024-00604-x. Epub 2024 Apr 6.

    PubMed 38581616

  • Klein EG, Schroeder K, Wessels AM, Phipps A, Japha M, Schilling T, Zimmer JA. How donanemab data address the coverage with evidence development questions. Alzheimers Dement. 2024 Apr;20(4):3127-3140. doi: 10.1002/alz.13700. Epub 2024 Feb 7.

    PubMed 38323738

  • Sims JR, Zimmer JA, Evans CD, Lu M, Ardayfio P, Sparks J, Wessels AM, Shcherbinin S, Wang H, Monkul Nery ES, Collins EC, Solomon P, Salloway S, Apostolova LG, Hansson O, Ritchie C, Brooks DA, Mintun M, Skovronsky DM; TRAILBLAZER-ALZ 2 Investigators. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023 Aug 8;330(6):512-527. doi: 10.1001/jama.2023.13239.

    PubMed 37459141

  • Brodtmann A, Darby D, Oboudiyat C, Mahoney CJ, Le Heron C, Panegyres PK, Brew B. Assessing preparedness for Alzheimer disease-modifying therapies in Australasian health care systems. Med J Aust. 2023 Apr 3;218(6):247-249. doi: 10.5694/mja2.51880. Epub 2023 Mar 19. No abstract available.

    PubMed 36934371

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Donanemab in people with Alzheimer Disease, run by Eli Lilly and Company at 274 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 274 sites in United States, Japan, Canada, Poland, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population) (time frame: Baseline, Week 76). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04437511, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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