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
2 other identifiers
interventional
2,996
3 countries
216
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 alzheimer-disease
Started Aug 2021
Longer than P75 for phase_3 alzheimer-disease
216 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2021
CompletedStudy Start
First participant enrolled
August 27, 2021
CompletedFirst Posted
Study publicly available on registry
August 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
January 21, 2026
January 1, 2026
6.2 years
August 27, 2021
January 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
Change from Baseline in Cognitive Composite in the Primary Study Population (Baseline 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)
Baseline, Up to Week 332
Change from Baseline in Continuous Paired Associate Learning (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)
Baseline, Up to Week 332
Change from Baseline in Category Fluency in the Primary Study Population (Baseline CDR-GS 0)
Baseline, Up to Week 332
- +12 more secondary outcomes
Study Arms (2)
Donanemab
EXPERIMENTALDonanemab administered intravenously (IV)
Placebo
PLACEBO COMPARATORPlacebo is administered intravenously
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (216)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
Alabama Psychiatry - Birmingham - Brookwood Medical Center Drive
Homewood, Alabama, 35209, United States
Rehabilitation & Neurological Services
Huntsville, Alabama, 35805, United States
Care Access - 801 South Power Road, Mesa
Mesa, Arizona, 85206, United States
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Banner Alzheimer's Institute Tucson
Tucson, Arizona, 85718, United States
Center for Neurosciences
Tucson, Arizona, 85718, United States
Care Access - Berkeley
Berkeley, California, 94705, United States
Care Access - Beverly Hills
Beverly Hills, California, 90212, United States
Velocity Clinical Research, Chula Vista
Chula Vista, California, 91911, United States
Valley Clinical Trials, Inc.
Covina, California, 91723, United States
Neurology Center of North Orange County
Fullerton, California, 92835, United States
Care Access - Gilroy
Gilroy, California, 95020, United States
Marvel Clinical Research
Huntington Beach, California, 92647, United States
Care Access Research - Huntington Beach
Huntington Beach, California, 92648, United States
Irvine Clinical Research
Irvine, California, 92614, United States
Option Care - Irvine
Irvine, California, 92618, United States
Kaizen Brain Center
La Jolla, California, 92037, United States
Velocity Clinical Research, San Diego
La Mesa, California, 91942, United States
Pacific Research Network
Lemon Grove, California, 91945, United States
Healthy Brain Clinic
Long Beach, California, 90804, United States
Neurovations
Napa, California, 94558, United States
Care Access - Newport Beach
Newport Beach, California, 92660, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
Inland Psychiatric Medical Group
Redlands, California, 92373, United States
Anderson Clinical Research
Redlands, California, 92374, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Option Care - Riverside
Riverside, California, 92507, United States
Clinical Trials Research
Sacramento, California, 95821, United States
Artemis Institute for Clinical Research
San Diego, California, 92123, United States
Ray Dolby Brain Health Center
San Francisco, California, 94114, United States
Care Access - Los Gatos
San Jose, California, 95124, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
Care Access - Santa Clarita
Santa Clarita, California, 91321, United States
Option Care - Los Angeles South
Santa Fe Springs, California, 90670, United States
Providence Medical Foundation
Santa Rosa, California, 95403, United States
Mazur, Statner, Dutta, Nathan, PC
Thousand Oaks, California, 91360, United States
Tilda Research
Tustin, California, 92780, United States
Velocity Clinical Research, Panorama City
Van Nuys, California, 91405, United States
Infectious Disease Doctors Medical Group, APC
Walnut Creek, California, 94598, United States
Care Access - Aurora
Aurora, Colorado, 80012, United States
Mountain Neurological Research Center
Basalt, Colorado, 81621, United States
Denver Neurological Research
Denver, Colorado, 80210, United States
Invicro
New Haven, Connecticut, 06510, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
VIN-Julie Schwartzbard
Aventura, Florida, 33180, United States
Neurology Offices of South Florida
Boca Raton, Florida, 33428, United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434, United States
SFM Clinical Research
Boca Raton, Florida, 33487, United States
Bradenton Research Center, Inc.
Bradenton, Florida, 34205, United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765, United States
Care Access - Daytona Beach
Daytona Beach, Florida, 32114, United States
Care Access - Delray Beach
Delray Beach, Florida, 33484, United States
Finlay Medical Research
Greenacres City, Florida, 33467, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
Infinity Clinical Research, LLC
Hollywood, Florida, 33024, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Care Access - Guava Street
Lady Lake, Florida, 32159, United States
Accel Research Sites - St. Pete-Largo Clinical Research Unit
Largo, Florida, 33777, United States
ClinCloud - Maitland
Maitland, Florida, 32751, United States
K2 Medical Research
Maitland, Florida, 32751, United States
ClinCloud - Viera
Melbourne, Florida, 32940, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952, United States
Optimus U Corporation
Miami, Florida, 33125, United States
Finlay Medical Research
Miami, Florida, 33126, United States
VIN-Andrew Lerman
Miami, Florida, 33133, United States
South Florida Research Phase I-IV
Miami, Florida, 33166, United States
Brainstorm Research Group
Miami, Florida, 33176, United States
IMIC, Inc.
Miami, Florida, 33176, United States
VIN-Victor Faradji
Miami, Florida, 33176, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014, United States
Adult Medicine of Lake County
Mt. Dora, Florida, 32757, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Charter Research - Winter Park
Orlando, Florida, 32803, United States
Headlands Research Orlando
Orlando, Florida, 32806, United States
Pines Care Research Center, LLC
Pembroke Pines, Florida, 33024, United States
VIN- Margarita Almeida El-Ramey
Pembroke Pines, Florida, 33026, United States
Emerald Coast Neurology - Airport Boulevard
Pensacola, Florida, 32504, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Care Access - Tamarac
Tamarac, Florida, 33321, United States
Clinical Research of West Florida
Tampa, Florida, 33606, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Vicis Clinical Research
Tampa, Florida, 33615, United States
Care Access - Tampa
Tampa, Florida, 33625, United States
Coram CVS/Specialty Infusion Services - Tampa
Tampa, Florida, 33634, United States
K2 Medical Research - Tampa
Tampa, Florida, 33634, United States
Charter Research - Lady Lake
The Villages, Florida, 32162, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Conquest Research
Winter Park, Florida, 32789, United States
Masters of Clinical Research
Augusta, Georgia, 30909, United States
iResearch Atlanta
Decatur, Georgia, 30030, United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501, United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406, United States
SKY Clinical Research Network Group-Blake
Union City, Georgia, 30291, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
IMA Clinical Research Chicago
Chicago, Illinois, 60602, United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, 60640, United States
Uptown Research Institute
Chicago, Illinois, 60640, United States
AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
Elk Grove Village, Illinois, 60007, United States
Care Access - Fairview Heights
Fairview Heights, Illinois, 62208, United States
Great Lakes Clinical Trials - Gurnee
Gurnee, Illinois, 60031, United States
Accellacare - DuPage
Lombard, Illinois, 60148, United States
Coram CVS/Specialty Infusion Services - Fort Wayne
Fort Wayne, Indiana, 46805, United States
Care Access - South Indianapolis
Indianapolis, Indiana, 46227, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256, United States
Covenant Medical Center
Waterloo, Iowa, 50702, United States
College Park Specialty Center
Overland Park, Kansas, 66212, United States
Norton Brownsboro Hospital
Louisville, Kentucky, 40241, United States
Optum Infusion - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Care Access - Lake Charles
Lake Charles, Louisiana, 70601, United States
MD Medical Research
Oxon Hill, Maryland, 20745, United States
ActivMed Practices and Research
Methuen, Massachusetts, 01844, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Care Access - Quincy
Quincy, Massachusetts, 02169, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Revival Research Institute
Southfield, Michigan, 48075, United States
Minneapolis Clinic of Neurology - Burnsville Office
Burnsville, Minnesota, 55337, United States
Coram CVS/Specialty Infusion Services - Mendota Heights
Mendota Heights, Minnesota, 55120, United States
SKY Clinical Research Network Group - Hall
Fayette, Mississippi, 39069, United States
SKY Clinical Research Network Group-Quinn
Ridgeland, Mississippi, 39157, United States
Citizens Memorial Hospital District
Bolivar, Missouri, 65613, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
IMA Clinical Research - St. Louis
St Louis, Missouri, 63117, United States
Coram CVS/Specialty Infusion Services - Henderson
Henderson, Nevada, 89014, United States
Option Care - Las Vegas
Las Vegas, Nevada, 89102, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89128, United States
IMA Clinical Research Hoboken
Hoboken, New Jersey, 07030, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081, United States
IMA Clinical Research Warren
Warren Township, New Jersey, 07059, United States
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, 87109, United States
IMA Clinical Research Albany
Albany, New York, 12205, United States
Neurological Associates Albany
Albany, New York, 12208, United States
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057, United States
IMA Clinical Research Westchester
Hartsdale, New York, 10530, United States
IMA Clinical Research
New York, New York, 10036, United States
South Shore Neurologic Associates
Patchogue, New York, 11772, United States
Richmond Behavioral Associates
Staten Island, New York, 10314, United States
Prime Global Research
The Bronx, New York, 10456, United States
Asheville Neurology Specialists
Asheville, North Carolina, 28806, United States
Care Access - Charlotte
Charlotte, North Carolina, 28210, United States
Care Access - Fayetteville
Fayetteville, North Carolina, 28314, United States
Care Access - Greensboro
Greensboro, North Carolina, 27401, United States
Medication Management
Greensboro, North Carolina, 27405, United States
Care Access - Kinston
Kinston, North Carolina, 28501, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Care Access - Raleigh
Raleigh, North Carolina, 27607, United States
Accellacare - Winston-Salem
Winston-Salem, North Carolina, 27103, United States
NeuroScience Research Center
Canton, Ohio, 44718, United States
Hometown Urgent Care and Research - Cincinnati
Dayton, Ohio, 45424, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, 45459, United States
Care Access - Lima
Lima, Ohio, 45805, United States
North Star Medical Research
Middleburg Heights, Ohio, 44130, United States
Care Access - Youngstown
Poland, Ohio, 44514, United States
Central States Research
Tulsa, Oklahoma, 74136, United States
Optum Infusion - Bend
Bend, Oregon, 97701, United States
Velocity Clinical Research, Medford
Medford, Oregon, 97504, United States
Center for Cognitive Health
Portland, Oregon, 97225, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
Care Access - Pottsville
Pottsville, Pennsylvania, 17901, United States
Care Access Research - Warwick
Warwick, Rhode Island, 02886, United States
Care Access - Anderson
Anderson, South Carolina, 29621, United States
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621, United States
VitaLink Research - Columbia
Columbia, South Carolina, 29204, United States
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, 29340, United States
VitaLink Research - Greenville
Greenville, South Carolina, 29615, United States
Care Access - Mauldin
Mauldin, South Carolina, 29662, United States
VitaLink Research - Spartanburg
Spartanburg, South Carolina, 29303, United States
VitaLink Research - Union
Union, South Carolina, 29379, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Neurology Clinic
Cordova, Tennessee, 38018, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Memphis, Tennessee, 38119, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78749, United States
Senior Adults Specialty Research
Austin, Texas, 78757, United States
Gadolin Research
Beaumont, Texas, 77702, United States
Headlands Research - Brownsville
Brownsville, Texas, 78526, United States
Conroe Willis Medical Research
Conroe, Texas, 77304, United States
Advanced Neuro Research Center - ANRC
El Paso, Texas, 79912, United States
Care Access - Georgetown
Georgetown, Texas, 78633, United States
Optum Infusion - Houston
Houston, Texas, 77054, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77054, United States
Next Level Urgent Care
Houston, Texas, 77057, United States
Family Practice Center
McAllen, Texas, 78501, United States
El Faro Health and Therapeutics
Rio Grande City, Texas, 78582, United States
Benchmark Research - Knickerbocker
San Angelo, Texas, 76904, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Texas Valley Clinical Research
Weslaco, Texas, 78596, United States
The Memory Clinic
Bennington, Vermont, 05201-9810, United States
Care Access - Arlington
Arlington, Virginia, 22206, United States
Option Care - Chantilly
Chantilly, Virginia, 20151, United States
Dominion Medical Associates, Inc.
Richmond, Virginia, 23219, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Universal Research Group
Tacoma, Washington, 98405, United States
Optum Infusion - Woodinville
Woodinville, Washington, 98072, United States
Exemplar Research
Morgantown, West Virginia, 26505, United States
The University of Tokyo Hospital
Bunkyō City, 113-8654, Japan
Tokyo-Eki Center-building Clinic
Chūōku, 103-0027, Japan
Fukuwa Clinic
Chūōku, 104-0031, Japan
Tokyo Asbo Clinic
Chūōku, 104-0031, Japan
P-One Clinic
Hachiōji, 192-0071, Japan
AMC Nishiumeda Clinic
Osaka, 530-0001, Japan
National Center for Geriatrics and Gerontology
Ōbu, 474-8511, Japan
Samoncho Clinic
Shinjuku, 160-0017, Japan
Heishinkai Medical Group ToCROM Clinic
Shinjuku-ku, 160-0008, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, 565-0853, Japan
Tokyo Metropolitan Geriatric Hospital
tabashi City, 173-0015, Japan
Oita University Hospital
Yufu, 879-5593, Japan
SCB Research Center
Bayamón, 00961, Puerto Rico
Dr. Samuel Sanchez PSC
Caguas, 00727, Puerto Rico
INSPIRA Clinical Research
San Juan, 00918, Puerto Rico
Instituto De Neurologia Dra. Ivonne Fraga
San Juan, 00918, Puerto Rico
Mindful Medical Research
San Juan, 00918, Puerto Rico
University of Puerto Rico - Medical Sciences Campus_Do not use - Duplicate facility
San Juan, 00935, Puerto Rico
Related Publications (1)
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.
PMID: 40955720DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2021
First Posted
August 30, 2021
Study Start
August 27, 2021
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.