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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: Donanemab; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 1736
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Erina, New South Wales, Australia, 2250
      • Central Coast Neurosciences Research
    • Sydney, New South Wales, Australia, 2113
      • KARA Institute for Neurological Diseases
    • Sydney, New South Wales, Australia, 2010
      • St Vincent's Hospital
    • Sydney, New South Wales, Australia, 2065
      • HammondCare Greenwich Hospital
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • NeuroCentrix
    • Glen Iris, Victoria, Australia, 3146
      • Delmont Private Hospital
    • Malvern, Victoria, Australia, 3144
      • HammondCare
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital
• Canada
  • Québec, Canada, G3K 2P8
    • ALPHA Recherche Clinique
  • Québec, Canada, G2J 0C4
    • ALPHA Recherche Clinique
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1Z9
      • OCT Research ULC
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3S 1N2
      • True North Clinical Research
    • New Minas, Nova Scotia, Canada, B4N 3R7
      • True North Clinical Research
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 5G8
      • SKDS Research Inc.
    • Ottawa, Ontario, Canada
      • Bruyere Research Institute
    • Ottawa, Ontario, Canada, K1Z 1G3
      • Ottawa Memory Clinic
    • Peterborough, Ontario, Canada, K9H 2P4
      • Kawartha Centre - Redefining Healthy Aging
    • Sarnia, Ontario, Canada, N7T 4X3
      • Bluewater Clinical Research Group Inc.
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M3B 2S7
      • Toronto Memory Program
    • Toronto, Ontario, Canada, M6A 2E1
      • Baycrest Health Sciences
  • Quebec
    • Gatineau, Quebec, Canada, K1Z 1G3
      • Clinique de la Memoire de l'Outaouais
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • MoCA Research and Innovation Inc.
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • DIEX Recherche Sherbrooke Inc.
    • Sherbrooke, Quebec, Canada, J1J 2G2
      • Q&T Research Sherbrooke Inc.
• Czechia
  • Central Bohemia
    • Hostivice, Central Bohemia, Czechia, 253 01
      • Clinline Services
    • Kladno, Central Bohemia, Czechia, 272 01
      • Brain-Soul Therapy
  • Plzeň-město
    • Pilsen, Plzeň-město, Czechia, 30100
      • A-Shine
  • Praha 10
    • Prague, Praha 10, Czechia, 100 00
      • CLINTRIAL s.r.o.
  • Praha 6
    • Prague, Praha 6, Czechia, 160 00
      • Neuropsychiatrie
    • Prague, Praha 6, Czechia, 160 00
      • Neurologická Ambulance - Forbeli
• Japan
  • Hiroshima, Japan, 732-0822
    • Hiroshima Neurology Clinic
  • Kyoto, Japan, 606-0851
    • Ishikawa Clinic
  • Kyoto, Japan, 616-8255
    • National Hospital Organization Utano National Hospital
  • Kyoto, Japan, 600-8558
    • Koseikai Takeda Hospital
  • Tokushima, Japan, 770-0852
    • Itsuki Hospital
  • Tokyo, Japan, 113-8603
    • Nippon Medical School Hospital
  • Tokyo, Japan, 104-0031
    • Tokyo Asbo Clinic
  • Tokyo, Japan, 143-0016
    • Makita General Hospital
  • Ōita, Japan, 870-0855
    • Oita Prefectural Hospital
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 454-8502
      • Nagoya Ekisaikai Hospital
    • Nagoya, Aichi-ken, Japan, 455-8530
      • Chubu Rosai Hospital
    • Nagoya, Aichi-ken, Japan, 4570818
      • Kojunkai Daido Clinic
    • Ōbu, Aichi-ken, Japan, 474-8511
      • National Center for Geriatrics and Gerontology
  • Chiba
    • Inage, Chiba, Japan, 263-0043
      • Inage Neurology and Memory Clinic
  • Hyōgo
    • Akashi, Hyōgo, Japan, 673-0891
      • Matsui e-clinic
    • Himeji, Hyōgo, Japan, 672-8043
      • Himeji Central Hospital Affiliated Clinic
    • Kobe, Hyōgo, Japan, 650-0017
      • Kobe University Hospital
    • Kobe, Hyōgo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
    • Kobe, Hyōgo, Japan, 657-0825
      • Kakigi Dementia Happiness Clinic
  • Ibaraki
    • Inashiki, Ibaraki, Japan, 300-0332
      • Tokyo Medical University Ibaraki Medical Center
    • Toride, Ibaraki, Japan, 302-0004
      • Memory Clinic Toride
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 231-0801
      • Yokohama City Minato Red Cross Hospital
  • Oita Prefecture
    • Yufu, Oita Prefecture, Japan, 879-5593
      • Oita University Hospital
  • Okayama-ken
    • Kurashiki, Okayama-ken, Japan, 710-0813
      • Katayama Medical Clinic
  • Osaka
    • Ikeda, Osaka, Japan, 563-0058
      • Honmachi Clinic
    • Takatsuki, Osaka, Japan, 569-1192
      • Takatsuki General Hospital
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 103-0028
      • Medical Corporation Chiseikai Tokyo Center Clinic
    • Edogawa-ku, Tokyo, Japan, 134-0088
      • Moriyama Neuro Center Hospital
    • Hachiōji, Tokyo, Japan, 192-0071
      • P-One Clinic
    • Shinjuku-ku, Tokyo, Japan, 162-0053
      • Clinical Research Hospital Tokyo
    • Sumida-ku, Tokyo, Japan, 130-0022
      • Tokyo Metro Bokutoh Hospital
• Netherlands
  • North Brabant
    • 's-Hertogenbosch, North Brabant, Netherlands, 5223 LA
      • Brain Research Center Den Bosch B.V.
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1081 GN
      • Brain Research Center
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025 AZ
      • Brain Research Center Zwolle
  • Provincie Friesland
    • Leeuwarden, Provincie Friesland, Netherlands, 8934 AD
      • QPS Netherlands B.V
• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 61-853
      • Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-163
      • Centrum Medyczne Neuromed
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 31-559
      • Diamond Clinic
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 53-659
      • Wroclawskie Centrum Alzheimerowskie
    • Ścinawa, Lower Silesian Voivodeship, Poland, 59-330
      • Ośrodek Badawczo Naukowo Dydaktyczny Chorób Otępiennych Im Księdza Henryka Kardynała Gulbinowicza Uniwersy -T
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-093
      • Private Practice - Dr. Urszula Chyrchel- Paszkiewicz
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 00-215
      • FutureMeds Warszawa Centrum
    • Warsawawa, Masovian Voivodeship, Poland, 01-684
      • Centrum Medyczne NeuroProtect
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-704
      • KLIMED Marek Klimkiewicz
    • Bialystok, Podlaskie Voivodeship, Poland, 15-756
      • Podlaskie Centrum Psychogeriatrii
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-546
      • Centrum Badan Klinicznych PI-House sp. z o.o.
    • Sopot, Pomeranian Voivodeship, Poland, 81-855
      • Centrum Medyczne SENIOR
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-749
      • Klinika Neuro-Care
  • West Pomeranian Voivodeship
    • Szczecin, West Pomeranian Voivodeship, Poland, 70-111
      • Centrum Medyczne Euromedis
• Puerto Rico
  • Bayamón, Puerto Rico, 00961
    • SCB Research Center
  • San Juan, Puerto Rico, 00918
    • Instituto De Neurologia Dra. Ivonne Fraga
  • San Juan, Puerto Rico, 00918
    • INSPIRA Clinical Research
  • San Juan, Puerto Rico, 00926
    • Barbara Diaz-Hernandez MD Research, Inc.
• United Kingdom
  • Birmingham, United Kingdom, B16 8LT
    • Re:Cognition Health - Birmingham
  • Great Britain
    • Motherwell, Great Britain, United Kingdom, ML1 4UF
      • Glasgow Memory Clinic
  • London, City of
    • London, London, City of, United Kingdom, W1G 9JF
      • Re:Cognition Health - London
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7YD
      • Re:Cognition Health Guildford
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Gilbert Neurology
    • Phoenix, Arizona, United States, 85006
      • Banner Alzheimer's Institute
    • Phoenix, Arizona, United States, 85004
      • Xenoscience
    • Scottsdale, Arizona, United States, 85254
      • Perseverance Research Center
    • Sun City, Arizona, United States, 85351
      • Banner Sun Health Research Institute
    • Tucson, Arizona, United States, 85718
      • Center for Neurosciences
    • Tucson, Arizona, United States, 85718
      • Banner Alzheimer's Institute Tucson
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Health Initiatives Research
  • California
    • Carlsbad, California, United States, 92011
      • North County Neurology Associates
    • Encino, California, United States, 91316
      • Wr- Pri, Llc
    • Fresno, California, United States, 93710
      • Neuro-Pain Medical Center
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • Irvine, California, United States, 92614
      • Irvine Clinical Research
    • La Jolla, California, United States, 92037
      • Kaizen Brain Center
    • Laguna Hills, California, United States, 92653
      • Senior Clinical Trials, Inc.
    • Los Alamitos, California, United States, 90720
      • Collaborative Neuroscience Research, LLC
    • Los Angeles, California, United States, 90048
      • Clinical Research Institute
    • Los Angeles, California, United States, 90033
      • USC Keck School of Medicine
    • Napa, California, United States, 94558
      • Neurovations
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian
    • Palo Alto, California, United States, 94304
      • Stanford Neuroscience Health Center
    • Pasadena, California, United States, 91105
      • SC3 Research - Pasadena
    • Poway, California, United States, 92064
      • PCND Neurology
    • Redlands, California, United States, 92374
      • Anderson Clinical Research
    • San Diego, California, United States, 92103
      • Pacific Research Network
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • San Diego, California, United States, 92123
      • Sharp Neurocognitive Research Center
    • San Francisco, California, United States, 94158
      • UCSF Memory and Aging Center
    • Santa Ana, California, United States, 92705
      • Syrentis Clinical Research
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research Medical Group, Inc.
    • Tustin, California, United States, 92780
      • Tilda Research
  • Colorado
    • Basalt, Colorado, United States, 81621
      • Mountain Neurological Research Center
    • Boulder, Colorado, United States, 80301
      • Alpine Clinical Research Center
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs Neurological Associates
    • Denver, Colorado, United States, 80210
      • Colorado Neurological Research Center, PC
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Institute for Neurodegenerative Disorders
    • New Haven, Connecticut, United States, 06510
      • Yale University, Alzheimer's Disease Research Unit
    • Norwalk, Connecticut, United States, 06851
      • Research Center for Clinical Studies
    • Stamford, Connecticut, United States, 06905
      • Ki Health Partners, LLc, dba New England Institute for Clinical Research
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute
    • Aventura, Florida, United States, 33180
      • VIN-Julie Schwartzbard
    • Boca Raton, Florida, United States, 33428
      • Neurology Offices of South Florida
    • Boca Raton, Florida, United States, 33487
      • SFM Clinical Research
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research
    • Delray Beach, Florida, United States, 33446
      • Cohen Medical Associates
    • Doral, Florida, United States, 33166
      • Integrity Clinical Research
    • Fort Myers, Florida, United States, 33912
      • Neuropsychiatric Research Center of Southwest Florida
    • Greenacres City, Florida, United States, 33467
      • Finlay Medical Research
    • Hallandale, Florida, United States, 33009
      • MD Clinical
    • Hialeah, Florida, United States, 33012
      • AGA Clinical Trials
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc
    • Hollywood, Florida, United States, 33024
      • Infinity Clinical Research, LLC
    • Jacksonville, Florida, United States, 32216
      • Encore Research Group- Jacksonville Center for Clinical Research
    • Lakeland, Florida, United States, 33803
      • Accel Research Sites - Lakeland Clinical Research Unit
    • Maitland, Florida, United States, 32751
      • ClinCloud - Maitland
    • Merritt Island, Florida, United States, 32952
      • Merritt Island Medical Research, LLC
    • Miami, Florida, United States, 33032
      • Homestead Associates in Research
    • Miami, Florida, United States, 33176
      • VIN-Victor Faradji
    • Miami, Florida, United States, 33126
      • Finlay Medical Research
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • Miami, Florida, United States, 33155
      • Allied Biomedical Research Institute
    • Miami, Florida, United States, 33173
      • Florida International Research Center
    • Miami, Florida, United States, 33176
      • Miami Dade Medical Research Institute, LLC
    • Miami, Florida, United States, 33137
      • Miami Jewish Health
    • Miami, Florida, United States, 33176
      • The Neurology Research Group
    • Miami, Florida, United States, 33175
      • Ezy Medical Research
    • Miami, Florida, United States, 33135
      • Optimus U Corporation
    • Miami, Florida, United States, 33142
      • Future Care Solution
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Cancer Center
    • Miami Lakes, Florida, United States, 33016
      • Goji Group - Research Trials Group
    • Naples, Florida, United States, 34105
      • Collier Neurologic Specialists
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc.
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Ocoee, Florida, United States, 34761
      • Sensible HealthCare, LLC
    • Orange City, Florida, United States, 32763
      • Medical Research Group of Central Florida
    • Orlando, Florida, United States, 32819
      • Headlands Research Orlando
    • Orlando, Florida, United States, 32806
      • Synexus Clinical Research US, Inc.
    • Palmetto Bay, Florida, United States, 33157
      • IMIC, Inc.
    • Pensacola, Florida, United States, 32504
      • Emerald Coast Neurology - Airport Boulevard
    • Pompano Beach, Florida, United States, 33064
      • Quantum Laboratories Clinical Research
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Sarasota, Florida, United States, 34239
      • Intercoastal Medical Group
    • Sarasota, Florida, United States, 34243
      • Roskamp Institute Clinical Trials Division
    • St. Petersburg, Florida, United States, 33713
      • Suncoast Neuroscience Associates, Inc.
    • Stuart, Florida, United States, 34997
      • Brain Matters Research
    • Stuart, Florida, United States, 34997
      • Alzheimer's Research and Treatment Center
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Neurological Clinic
    • Tampa, Florida, United States, 33613
      • USF Health Byrd Alzheimer's Institute
    • Tampa, Florida, United States, 33609
      • Axiom Clinical Research of Florida
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
    • The Villages, Florida, United States, 32162
      • Synexus Clinical Research US, Inc.
    • The Villages, Florida, United States, 32162
      • Charter Research - Lady Lake
    • Wellington, Florida, United States, 33414
      • Alzheimer's Research and Treatment Center
    • West Palm Beach, Florida, United States, 33407
      • Palm Beach Neurology
    • Winter Park, Florida, United States, 32789
      • Conquest Research
    • Winter Park, Florida, United States, 32803
      • Charter Research - Winter Park
  • Georgia
    • Buford, Georgia, United States, 30519
      • Gwinnett Research Institute
    • Columbus, Georgia, United States, 31909
      • Columbus Memory Center, LLC
    • Decatur, Georgia, United States, 30030
      • NeuroStudies
    • Gainesville, Georgia, United States, 30501
      • Center for Advanced Research & Education
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trials
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials - Andersonville
    • Elk Grove Village, Illinois, United States, 60007
      • AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
    • Park Ridge, Illinois, United States, 60068
      • Advocate Medical Group
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University School of Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
    • Indianapolis, Indiana, United States, 46256
      • Josephson Wallack Munshower Neurology, PC
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic, PC
    • Waterloo, Iowa, United States, 50702
      • Covenant Medical Center
  • Kansas
    • Fairway, Kansas, United States, 66205
      • The University of Kansas - Clinical Research Center
    • Overland Park, Kansas, United States, 66212
      • College Park Family Care Center/Multi Specialty Clinical Res
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinical Research Center - Central Office
    • Wichita, Kansas, United States, 67214
      • Ascension via Christi Research
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Medical Center-Maine Medical Partners Neurology
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Fall River, Massachusetts, United States, 02721
      • NECCR PrimaCare Research
    • New Bedford, Massachusetts, United States, 02740
      • BTC Network
    • Newton, Massachusetts, United States, 02459
      • Boston Center for Memory
    • Plymouth, Massachusetts, United States, 02360
      • Donald S. Marks M.D., P.C.
    • Quincy, Massachusetts, United States, 02169
      • Alzheimers Disease Center
    • Waltham, Massachusetts, United States, 02451
      • MedVadis Research Corporation
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Missouri
    • Bolivar, Missouri, United States, 65613
      • Citizens Memorial Hospital District
    • Chesterfield, Missouri, United States, 63005
      • Clinical Research Professionals
    • North Kansas City, Missouri, United States, 64116
      • North Kansas City Hospital
    • Ozark, Missouri, United States, 65721
      • Sharlin Health and Neurology
    • St Louis, Missouri, United States, 63141
      • Arch Clinical Trials
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Las Vegas Medical Research
  • New Jersey
    • Springfield, New Jersey, United States, 07081
      • The Cognitive and Research Center of New Jersey
    • Toms River, New Jersey, United States, 08755
      • Advanced Memory Research Institute of New Jersey
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • Albany, New York, United States, 12208
      • Neurological Associates Albany
    • Amherst, New York, United States, 14226
      • Dent Neurologic Institute
    • Buffalo, New York, United States, 14203
      • University at Buffalo - UBMD Neurology
    • East Syracuse, New York, United States, 13057
      • Clarity Clinical Research
    • New York, New York, United States, 10016
      • NYU Langone Health
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
    • Staten Island, New York, United States, 10312
      • Richmond Behavioral Associates
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • CHS-Behavioral Health Research
    • Greensboro, North Carolina, United States, 27405
      • Guilford Neurologic Associates, Inc
    • Matthews, North Carolina, United States, 28105
      • AMC Research
    • Morehead City, North Carolina, United States, 28557
      • Carteret Medical Group
    • Winston-Salem, North Carolina, United States, 27103
      • Accellacare - Winston-Salem
  • Ohio
    • Canton, Ohio, United States, 44718
      • NeuroScience Research Center
    • Centerville, Ohio, United States, 45459
      • Valley Medical Research
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research
    • Columbus, Ohio, United States, 43210
      • Ohio State University
    • Dayton, Ohio, United States, 45459
      • Neurology Diagnostics, Inc.
    • Dayton, Ohio, United States, 45417
      • University of Cincinnati Physicians Company, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73106
      • IPS Research Company
    • Tulsa, Oklahoma, United States, 74136
      • Central States Research
  • Oregon
    • Portland, Oregon, United States, 97225
      • Center for Cognitive Health
    • Portland, Oregon, United States, 97210
      • Summit Headlands
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Neurological Associates, Ltd.
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Medicine: University of Pennsylvania Health System
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Keystone Clinical Studies
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Rhode Island Mood & Memory Research Institute
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Prism Health Richland Department of Neurology Research
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Neurology Clinic, P.C.
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
  • Texas
    • Austin, Texas, United States, 78757
      • Senior Adults Specialty Research
    • Beaumont, Texas, United States, 77702
      • Gadolin Research
    • Dallas, Texas, United States, 75231
      • Kerwin Medical Center
    • Dallas, Texas, United States, 75243
      • Neurology Consultants of Dallas, PA
    • DeSoto, Texas, United States, 75115
      • InSite Clinical Research
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology Consultants
    • San Antonio, Texas, United States, 78229-3900
      • Glenn Biggs Institute for Alzheimers & Neurodegenerative Diseases
  • Vermont
    • Bennington, Vermont, United States, 05201-9810
      • The Memory Clinic
  • Virginia
    • Arlington, Virginia, United States, 22207
      • Integrated Neurology Services - Falls Church
    • Norfolk, Virginia, United States, 23510
      • Sentara Norfolk General Hospital
    • Richmond, Virginia, United States, 23294
      • National Clinical Research, Inc
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Kirkland, Washington, United States, 98034
      • EvergreenHealth Medical Center
    • Seattle, Washington, United States, 98104
      • University of Washington - Harborview Medical Center
    • Spokane, Washington, United States, 99201
      • Kingfisher Cooperative
    • Tacoma, Washington, United States, 98405
      • Universal Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Donanemab; Participants received 700 milligram (mg) Donanemab every 4 weeks (Q4W) x 3 doses, then 1400 mg Q4W given intravenously (IV) for up to 72 weeks	Drug: Donanemab; Given IV; Other Names: LY3002813
Placebo Comparator: Placebo; Participants received placebo given IV.	Drug: Placebo; Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 76
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.	Baseline, Week 76

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 76
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.	Baseline, Week 76
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.	Baseline, Week 76
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.	Baseline, Week 76
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.	Baseline, Week 76
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.	Baseline, Week 76
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.	Baseline, Week 76
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.	Baseline, Week 76
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.	Baseline, Week 76
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).	Baseline, Week 76
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.	Baseline, Week 76
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.	Week 16 to week 20
Number or Participants With Anti-Donanemab Antibodies	Number of participants with treatment-emergent positive Anti-Donanemab antibodies was summarized by treatment group.	Baseline through Week 76

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2020
• Primary Completion (Actual): April 14, 2023
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cognitive Impairment; Dementia; Amyloid Plaque; Alzheimer's
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Pathological Conditions, Anatomical; Neurocognitive Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Alzheimer Disease; Dementia; Plaque, Amyloid; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs; donanemab
• Other Study ID Numbers: 17737; I5T-MC-AACI (Other Identifier: Eli Lilly and Company); 2020-000077-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No