A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)

A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease

The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD) over up to 332 weeks. Approximately 800 additional participants will be enrolled in the 12-month Addendum 7 to assess safety of a different titration regimen.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 2996
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Bunkyō City, Japan, 113-8654
    • The University of Tokyo Hospital
  • Chūōku, Japan, 103-0027
    • Tokyo-Eki Center-building Clinic
  • Chūōku, Japan, 104-0031
    • Fukuwa Clinic
  • Chūōku, Japan, 104-0031
    • Tokyo Asbo Clinic
  • Hachiōji, Japan, 192-0071
    • P-One Clinic
  • Osaka, Japan, 530-0001
    • AMC Nishiumeda Clinic
  • Shinjuku, Japan, 160-0017
    • Samoncho Clinic
  • Shinjuku-ku, Japan, 160-0008
    • Heishinkai Medical Group ToCROM Clinic
  • Suita-shi, Japan, 565-0853
    • Medical Corporation Heishinkai OCROM Clinic
  • Yufu, Japan, 879-5593
    • Oita University Hospital
  • tabashi City, Japan, 173-0015
    • Tokyo Metropolitan Geriatric Hospital
  • Ōbu, Japan, 474-8511
    • National Center for Geriatrics and Gerontology
• Puerto Rico
  • Bayamón, Puerto Rico, 00961
    • SCB Research Center
  • Caguas, Puerto Rico, 00727
    • Dr. Samuel Sanchez PSC
  • San Juan, Puerto Rico, 00918
    • Mindful Medical Research
  • San Juan, Puerto Rico, 00918
    • Instituto De Neurologia Dra. Ivonne Fraga
  • San Juan, Puerto Rico, 00918
    • INSPIRA Clinical Research
  • San Juan, Puerto Rico, 00935
    • University of Puerto Rico - Medical Sciences Campus_Do not use - Duplicate facility
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35215
      • Parkway Medical Center
    • Homewood, Alabama, United States, 35209
      • Alabama Psychiatry - Birmingham - Brookwood Medical Center Drive
    • Huntsville, Alabama, United States, 35805
      • Rehabilitation & Neurological Services
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Care Access - 801 South Power Road, Mesa
    • Phoenix, Arizona, United States, 85006
      • Banner Alzheimer's Institute
    • Tucson, Arizona, United States, 85718
      • Center for Neurosciences
    • Tucson, Arizona, United States, 85718
      • Banner Alzheimer's Institute Tucson
  • California
    • Berkeley, California, United States, 94705
      • Care Access - Berkeley
    • Beverly Hills, California, United States, 90212
      • Care Access - Beverly Hills
    • Chula Vista, California, United States, 91911
      • Velocity Clinical Research, Chula Vista
    • Covina, California, United States, 91723
      • Valley Clinical Trials, Inc.
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • Gilroy, California, United States, 95020
      • Care Access - Gilroy
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research
    • Huntington Beach, California, United States, 92648
      • Care Access Research - Huntington Beach
    • Irvine, California, United States, 92614
      • Irvine Clinical Research
    • Irvine, California, United States, 92618
      • Option Care - Irvine
    • La Jolla, California, United States, 92037
      • Kaizen Brain Center
    • La Mesa, California, United States, 91942
      • Velocity Clinical Research, San Diego
    • Lemon Grove, California, United States, 91945
      • Pacific Research Network
    • Long Beach, California, United States, 90804
      • Healthy Brain Clinic
    • Napa, California, United States, 94558
      • Neurovations
    • Newport Beach, California, United States, 92660
      • Care Access - Newport Beach
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • Redlands, California, United States, 92374
      • Anderson Clinical Research
    • Redlands, California, United States, 92373
      • Inland Psychiatric Medical Group
    • Riverside, California, United States, 92503
      • Artemis Institute for Clinical Research
    • Riverside, California, United States, 92507
      • Option Care - Riverside
    • Sacramento, California, United States, 95821
      • Clinical Trials Research
    • San Diego, California, United States, 92123
      • Artemis Institute for Clinical Research
    • San Francisco, California, United States, 94114
      • Ray Dolby Brain Health Center
    • San Jose, California, United States, 95124
      • Care Access - Los Gatos
    • Santa Ana, California, United States, 92705
      • Syrentis Clinical Research
    • Santa Clarita, California, United States, 91321
      • Care Access - Santa Clarita
    • Santa Fe Springs, California, United States, 90670
      • Option Care - Los Angeles South
    • Santa Rosa, California, United States, 95403
      • Providence Medical Foundation
    • Thousand Oaks, California, United States, 91360
      • Mazur, Statner, Dutta, Nathan, PC
    • Tustin, California, United States, 92780
      • Tilda Research
    • Van Nuys, California, United States, 91405
      • Velocity Clinical Research, Panorama City
    • Walnut Creek, California, United States, 94598
      • Infectious Disease Doctors Medical Group, APC
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Care Access - Aurora
    • Basalt, Colorado, United States, 81621
      • Mountain Neurological Research Center
    • Denver, Colorado, United States, 80210
      • Denver Neurological Research
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Invicro
  • 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, 33434
      • Excel Medical Clinical Trials
    • Boca Raton, Florida, United States, 33487
      • SFM Clinical Research
    • Bradenton, Florida, United States, 34205
      • Bradenton Research Center, Inc.
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc. (Clearwater)
    • Daytona Beach, Florida, United States, 32114
      • Care Access - Daytona Beach
    • Delray Beach, Florida, United States, 33484
      • Care Access - Delray Beach
    • Greenacres City, Florida, United States, 33467
      • Finlay Medical Research
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc
    • Hollywood, Florida, United States, 33024
      • Infinity Clinical Research, LLC
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Lady Lake, Florida, United States, 32159
      • Care Access - Guava Street
    • Largo, Florida, United States, 33777
      • Accel Research Sites - St. Pete-Largo Clinical Research Unit
    • Maitland, Florida, United States, 32751
      • K2 Medical Research
    • Maitland, Florida, United States, 32751
      • ClinCloud - Maitland
    • Melbourne, Florida, United States, 32940
      • ClinCloud - Viera
    • Merritt Island, Florida, United States, 32952
      • Merritt Island Medical Research, LLC
    • Miami, Florida, United States, 33176
      • VIN-Victor Faradji
    • Miami, Florida, United States, 33126
      • Finlay Medical Research
    • Miami, Florida, United States, 33125
      • Optimus U Corporation
    • Miami, Florida, United States, 33176
      • IMIC, Inc.
    • Miami, Florida, United States, 33133
      • VIN-Andrew Lerman
    • Miami, Florida, United States, 33166
      • South Florida Research Phase I-IV
    • Miami, Florida, United States, 33176
      • Brainstorm Research Group
    • Miami Lakes, Florida, United States, 33014
      • San Marcus Research Clinic, Inc.
    • Mt. Dora, Florida, United States, 32757
      • Adult Medicine of Lake County
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc.
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Orlando, Florida, United States, 32806
      • Headlands Research Orlando
    • Orlando, Florida, United States, 32803
      • Charter Research - Winter Park
    • Pembroke Pines, Florida, United States, 33026
      • VIN- Margarita Almeida El-Ramey
    • Pembroke Pines, Florida, United States, 33024
      • Pines Care Research Center, LLC
    • Pensacola, Florida, United States, 32504
      • Emerald Coast Neurology - Airport Boulevard
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Tamarac, Florida, United States, 33321
      • Care Access - Tamarac
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
    • Tampa, Florida, United States, 33606
      • Clinical Research of West Florida
    • Tampa, Florida, United States, 33625
      • Care Access - Tampa
    • Tampa, Florida, United States, 33615
      • VICIS Clinical Research
    • Tampa, Florida, United States, 33634
      • Coram CVS/Specialty Infusion Services - Tampa
    • Tampa, Florida, United States, 33634
      • K2 Medical Research - Tampa
    • The Villages, Florida, United States, 32162
      • Charter Research - Lady Lake
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
    • Winter Park, Florida, United States, 32789
      • Conquest Research
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Masters of Clinical Research
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta
    • Gainesville, Georgia, United States, 30501
      • Center for Advanced Research & Education
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research, LLC
    • Union City, Georgia, United States, 30291
      • SKY Clinical Research Network Group-Blake
    • Woodstock, Georgia, United States, 30189
      • North Georgia Clinical Research
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trials
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials - Andersonville
    • Chicago, Illinois, United States, 60640
      • Uptown Research Institute
    • Chicago, Illinois, United States, 60602
      • IMA Clinical Research Chicago
    • Elk Grove Village, Illinois, United States, 60007
      • AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
    • Fairview Heights, Illinois, United States, 62208
      • Care Access - Fairview Heights
    • Gurnee, Illinois, United States, 60031
      • Great Lakes Clinical Trials - Gurnee
    • Lombard, Illinois, United States, 60148
      • Accellacare - DuPage
  • Indiana
    • Fort Wayne, Indiana, United States, 46805
      • Coram CVS/Specialty Infusion Services - Fort Wayne
    • Indianapolis, Indiana, United States, 46256
      • Josephson Wallack Munshower Neurology, PC
    • Indianapolis, Indiana, United States, 46227
      • Care Access - South Indianapolis
  • Iowa
    • Waterloo, Iowa, United States, 50702
      • Covenant Medical Center
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • College Park Specialty Center
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Norton Brownsboro Hospital
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Optum Infusion - Baton Rouge
    • Lake Charles, Louisiana, United States, 70601
      • Care Access - Lake Charles
  • Maryland
    • Oxon Hill, Maryland, United States, 20745
      • MD Medical Research
  • Massachusetts
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices and Research
    • Newton, Massachusetts, United States, 02459
      • Boston Center for Memory
    • Quincy, Massachusetts, United States, 02169
      • Care Access - Quincy
    • Waltham, Massachusetts, United States, 02451
      • MedVadis Research Corporation
  • Michigan
    • Southfield, Michigan, United States, 48075
      • Revival Research Institute
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Minneapolis Clinic of Neurology - Burnsville Office
    • Mendota Heights, Minnesota, United States, 55120
      • Coram CVS/Specialty Infusion Services - Mendota Heights
  • Mississippi
    • Fayette, Mississippi, United States, 39069
      • SKY Clinical Research Network Group - Hall
    • Ridgeland, Mississippi, United States, 39157
      • SKY Clinical Research Network Group-Quinn
  • Missouri
    • Bolivar, Missouri, United States, 65613
      • Citizens Memorial Hospital District
    • Chesterfield, Missouri, United States, 63005
      • Clinical Research Professionals
    • St Louis, Missouri, United States, 63117
      • IMA Clinical Research - St. Louis
  • Nevada
    • Henderson, Nevada, United States, 89014
      • Coram CVS/Specialty Infusion Services - Henderson
    • Las Vegas, Nevada, United States, 89128
      • Las Vegas Medical Research
    • Las Vegas, Nevada, United States, 89102
      • Option Care - Las Vegas
  • New Jersey
    • Hoboken, New Jersey, United States, 07030
      • IMA Clinical Research Hoboken
    • Springfield, New Jersey, United States, 07081
      • The Cognitive and Research Center of New Jersey
    • Warren Township, New Jersey, United States, 07059
      • IMA Clinical Research Warren
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Neuroscience Inc.
  • New York
    • Albany, New York, United States, 12208
      • Neurological Associates Albany
    • Albany, New York, United States, 12205
      • IMA Clinical Research Albany
    • East Syracuse, New York, United States, 13057
      • Velocity Clinical Research, Syracuse
    • Hartsdale, New York, United States, 10530
      • IMA Clinical Research Westchester
    • New York, New York, United States, 10036
      • Ima Clinical Research
    • Patchogue, New York, United States, 11772
      • South Shore Neurologic Associates
    • Staten Island, New York, United States, 10314
      • Richmond Behavioral Associates
    • The Bronx, New York, United States, 10456
      • Prime Global Research
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Asheville Neurology Specialists
    • Charlotte, North Carolina, United States, 28210
      • Care Access - Charlotte
    • Fayetteville, North Carolina, United States, 28314
      • Care Access - Fayetteville
    • Greensboro, North Carolina, United States, 27405
      • Medication Management
    • Greensboro, North Carolina, United States, 27401
      • Care Access - Greensboro
    • Kinston, North Carolina, United States, 28501
      • Care Access - Kinston
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research
    • Morehead City, North Carolina, United States, 28557
      • Carteret Medical Group
    • Raleigh, North Carolina, United States, 27607
      • Care Access - Raleigh
    • Winston-Salem, North Carolina, United States, 27103
      • Accellacare - Winston-Salem
  • Ohio
    • Canton, Ohio, United States, 44718
      • NeuroScience Research Center
    • Dayton, Ohio, United States, 45459
      • Neurology Diagnostics, Inc.
    • Dayton, Ohio, United States, 45424
      • Hometown Urgent Care and Research - Cincinnati
    • Lima, Ohio, United States, 45805
      • Care Access - Lima
    • Middleburg Heights, Ohio, United States, 44130
      • North Star Medical Research
    • Poland, Ohio, United States, 44514
      • Care Access - Youngstown
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Central States Research
  • Oregon
    • Bend, Oregon, United States, 97701
      • Optum Infusion - Bend
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research, Medford
    • Portland, Oregon, United States, 97225
      • Center for Cognitive Health
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
      • The Clinical Trial Center, LLC
    • Pottsville, Pennsylvania, United States, 17901
      • Care Access - Pottsville
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Care Access Research - Warwick
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Velocity Clinical Research, Anderson
    • Anderson, South Carolina, United States, 29621
      • Care Access - Anderson
    • Columbia, South Carolina, United States, 29204
      • VitaLink Research - Columbia
    • Gaffney, South Carolina, United States, 29340
      • Velocity Clinical Research, Gaffney
    • Greenville, South Carolina, United States, 29615
      • VitaLink Research - Greenville
    • Mauldin, South Carolina, United States, 29662
      • Care Access - Mauldin
    • Spartanburg, South Carolina, United States, 29303
      • VitaLink Research - Spartanburg
    • Union, South Carolina, United States, 29379
      • VitaLink Research - Union
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Neurology Clinic
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
  • Texas
    • Austin, Texas, United States, 78749
      • Texas Diabetes & Endocrinology, P.A.
    • Austin, Texas, United States, 78757
      • Senior Adults Specialty Research
    • Beaumont, Texas, United States, 77702
      • Gadolin Research
    • Brownsville, Texas, United States, 78526
      • Headlands Research - Brownsville
    • Conroe, Texas, United States, 77304
      • Conroe Willis Medical Research
    • El Paso, Texas, United States, 79912
      • Advanced Neuro Research Center - ANRC
    • Georgetown, Texas, United States, 78633
      • Care Access - Georgetown
    • Houston, Texas, United States, 77054
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77057
      • Next Level Urgent Care
    • Houston, Texas, United States, 77054
      • Optum Infusion - Houston
    • McAllen, Texas, United States, 78501
      • Family Practice Center
    • Rio Grande City, Texas, United States, 78582
      • El Faro Health and Therapeutics
    • San Angelo, Texas, United States, 76904
      • Benchmark Research - Knickerbocker
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, LLC
    • Weslaco, Texas, United States, 78596
      • Texas Valley Clinical Research
  • Vermont
    • Bennington, Vermont, United States, 05201-9810
      • The Memory Clinic
  • Virginia
    • Arlington, Virginia, United States, 22206
      • Care Access - Arlington
    • Chantilly, Virginia, United States, 20151
      • Option Care - Chantilly
    • Richmond, Virginia, United States, 23219
      • Dominion Medical Associates, Inc.
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Tacoma, Washington, United States, 98405
      • Universal Research Group
    • Woodinville, Washington, United States, 98072
      • Optum Infusion - Woodinville
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Exemplar Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A Telephone Interview for Cognitive Status - modified (TICS-M) score reflective of intact cognitive functioning.
• Has a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology.
• Has a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
• Have adequate literacy, vision, and hearing for neuropsychological testing at screening.
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• Female participants include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or post menopausal (women 55 or older not on hormone therapy and had at least 12 months of spontaneous amenorrhea; or with a diagnosis of menopause prior to starting hormone replacement therapy.

Treatment Extension: (Study Period II Placebo Group Only)

• Are actively participating in Study AACM at the conclusion of Study Period III.

Exclusion Criteria:

• Mild cognitive impairment or dementia, or significant other neurodegenerative disease that can affect cognition.
• Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease that could interfere with the analysis of the study or a life expectancy of approximately ≤5 years.
• History of cancer with high risk of recurrence and preventing completion of the trial.
• History of clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis).
• Have any clinically important abnormality at screening on magnetic resonance imaging (MRI) or clinical laboratory test results that could be detrimental to the participant or study integrity.
• Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
• Have a centrally read MRI demonstrating presence of amyloid-related imaging abnormalities (ARIA-E), >4 cerebral microhemorrhages, more than 1 area of superficial siderosis, any macrohemorrhage or severe white matter disease at screening.
• Have had prior treatment with a passive anti-amyloid immunotherapy <5 half-lives prior to randomization.
• Have received active immunization against amyloid beta (Aβ) in any other study.
• Have received active immunization against Aβ in any other study.
• Current or previous use of prescription medications used as treatment for mild cognitive impairment (MCI) or AD.

Addendum 7 Exclusion Criteria:

• Same as the main study except contraindications for florbetapir F 18 PET are exclusionary.

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; Donanemab administered intravenously (IV)	Drug: Donanemab; Administered intravenously; Other Names: LY3002813
Placebo Comparator: Placebo; Placebo is administered intravenously	Drug: Placebo; Administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Clinical Progression of Composite Endpoint as Measured by Clinical Dementia Rating (CDR) in the Primary Study Population (Baseline CDR-Global Score [GS 0])	Time to clinical progression as measured by CDR. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage on the spectrum of Alzheimer's Disease (AD) dementia	Estimated up to Week 332

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Cognitive Composite in the Primary Study Population (Baseline CDR-GS 0)	Change from baseline in Cognitive Composite in the Primary Study Population (CDR-GS 0)	Baseline, Up to Week 332
Change from Baseline in International Shopping List Test (ISLT) in the Primary Study Population (Baseline CDR-GS 0)	Change from baseline in clinical progression as measured by ISLT in the Primary Study Population (Baseline CDR-GS 0)	Baseline, Up to Week 332
Change from Baseline in Continuous Paired Associate Learning (CPAL ) in the Primary Study Population (Baseline CDR-GS 0)	Change from baseline in clinical progression as measured by CPAL in the Primary Study Population (baseline CDR-GS 0)	Baseline, Up to Week 332
Change from Baseline in International Daily Symbol Substitution Test-Medicines (iDSSTm) in the Primary Study Population (Baseline CDR-GS 0)	Change from baseline in clinical progression as measured by iDSSTm in the Primary Study Population (Baseline CDR-GS 0)	Baseline, Up to Week 332
Change from Baseline in Category Fluency in the Primary Study Population (Baseline CDR-GS 0)	Change from baseline in clinical progression as measured by Category Fluency in the Primary Study Population (Baseline CDR-GS 0)	Baseline, Up to Week 332
Change from Baseline in CDR-Sum of Boxes (CDR-SB) n the Primary Study Population (Baseline CDR-GS 0)	Change from baseline in clinical progression as measured by CDR-SB in the Primary Study Population (Baseline CDR-GS 0)	Baseline, Up Week 332
Change from Baseline in Cognitive Function Index (CFI) in the Primary Study Population (Baseline CDR-GS 0)	Change from baseline in clinical progression as measured by CFI in the Primary Study Population (Baseline CDR-GS 0)	Baseline, Up to Week 332
Change from Baseline in Montreal Cognitive Assessment (MoCA) Score in the Primary Study Population (Baseline CDR-GS 0)	Change from baseline in clinical progression as measured by MoCA score in the Primary Study Population (Baseline CDR-GS 0)	Baseline, Up to Week 332
Change from Baseline in Mild Behavioral Impairment Checklist (MBI-C) in the Primary Study Population (Baseline CDR-GS 0)	Change from baseline in MBI-C in the Primary Study Population (Baseline CDR-GS 0)	Baseline, Up to Week 332
Time to Clinical Progression of Composite Endpoint as Measured by CDR in the Overall Study Population (Baseline CDR-GS 0 or 0.5)	Time to clinical progression as measured by CDR in the Overall Study Population (Baseline CDR-GS 0 or 0.5)	Baseline, Up to Week 332
Time to Clinical Progression as Measured by CDR Memory Box in Primary Study Population (Baseline CDR-GS 0)	Time to clinical progression as measured by CDR Memory Box in the Primary Study Population (Baseline CDR-GS 0)	Estimated up to Week 332
Time to Clinical Progression as Measured by CDR Judgment and Problem Solving Box in the Primary Study Population (Baseline CDR-GS 0)	Time to clinical progression as measured by CDR Judgment and Problem Solving Box in the Primary Study Population (Baseline CDR-GS 0)	Estimated up to Week 332
Time to Clinical Progression as Measured by At Least 0.5 Change on CDR-SB in Primary Study Population (Baseline CDR-GS 0)	Time to clinical progression as measured by at least 0.5 change on CDR-SB in Primary Study Population (Baseline CDR-GS 0)	Estimated up to Week 332
Time to Clinical Progression of Composite Endpoint as Measured by CDR in Subpopulation Positive Based on Secondary Diagnostic Test	Time to clinical progression as measured by CDR in subpopulation positive based on secondary diagnostic test	Estimated up to Week 332
Change from Baseline in Plasma P-tau217	Change from baseline in Plasma P-tau217	Baseline, Up to Week 332
Pharmacokinetics (PK): Average Serum Donanemab Concentration at Steady State	PK: Average serum donanemab concentration at steady state	Baseline through Week 76
Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)	Percentage of participants with treatment-emergent anti-drug antibody (ADAs)	Baseline through Week 16

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

• Yaari R, Holdridge KC, Williamson M, Wessels AM, Shcherbinin S, Kotari V, Reiman EM, Tariot PN, Alexander R, Langbaum JB, Sims JR. Donanemab in preclinical Alzheimer's disease: Screening and baseline data from TRAILBLAZER-ALZ 3. Alzheimers Dement. 2025 Sep;21(9):e70662. doi: 10.1002/alz.70662.

Helpful Links

• A Donanemab (LY3002813) Prevention Study in Participants With Alzheimer's Disease (TRAILBLAZER-ALZ 3)

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2021
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; donanemab
• Other Study ID Numbers: 18284; I5T-MC-AACM (Other Identifier: Eli Lilly and Company)

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 European Union (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