AzTrials
AzTrials

Alzheimer DiseasePhase 3NCT05026866

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

A Phase 3 study testing Donanemab in people with Alzheimer Disease, run by Eli Lilly and Company at 216 sites in 3 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

The 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. Read more about this study

Who is it for?
Ages 55 to 80 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Donanemab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,996 participants
Where
216 sitesin 3 countries
Study dates
27 Aug 2021to Nov 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

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

  • Ages 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

216 sites in 3 countries.

216 sites in 3 countries

United States198 sites

  • IMA Clinical Research Albany

    Albany, New York, 12205

  • Neurological Associates Albany

    Albany, New York, 12208

  • Albuquerque Neuroscience Inc.

    Albuquerque, New Mexico, 87109

  • Care Access - Anderson

    Anderson, South Carolina, 29621

  • Velocity Clinical Research, Anderson

    Anderson, South Carolina, 29621

  • Care Access - Arlington

    Arlington, Virginia, 22206

  • Asheville Neurology Specialists

    Asheville, North Carolina, 28806

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Masters of Clinical Research

    Augusta, Georgia, 30909

  • Care Access - Aurora

    Aurora, Colorado, 80012

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78749

  • Senior Adults Specialty Research

    Austin, Texas, 78757

  • VIN-Julie Schwartzbard

    Aventura, Florida, 33180

  • Mountain Neurological Research Center

    Basalt, Colorado, 81621

  • Optum Infusion - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Gadolin Research

    Beaumont, Texas, 77702

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Optum Infusion - Bend

    Bend, Oregon, 97701

  • The Memory Clinic

    Bennington, Vermont, 05201-9810

  • Care Access - Berkeley

    Berkeley, California, 94705

  • Care Access - Beverly Hills

    Beverly Hills, California, 90212

  • Parkway Medical Center

    Birmingham, Alabama, 35215

  • Neurology Offices of South Florida

    Boca Raton, Florida, 33428

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434

  • SFM Clinical Research

    Boca Raton, Florida, 33487

  • Northwest Clinical Trials

    Boise, Idaho, 83704

  • Citizens Memorial Hospital District

    Bolivar, Missouri, 65613

  • Bradenton Research Center, Inc.

    Bradenton, Florida, 34205

  • Headlands Research - Brownsville

    Brownsville, Texas, 78526

  • Minneapolis Clinic of Neurology - Burnsville Office

    Burnsville, Minnesota, 55337

  • NeuroScience Research Center

    Canton, Ohio, 44718

  • Option Care - Chantilly

    Chantilly, Virginia, 20151

  • Care Access - Charlotte

    Charlotte, North Carolina, 28210

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • IMA Clinical Research Chicago

    Chicago, Illinois, 60602

  • Great Lakes Clinical Trials - Andersonville

    Chicago, Illinois, 60640

  • Uptown Research Institute

    Chicago, Illinois, 60640

  • Velocity Clinical Research, Chula Vista

    Chula Vista, California, 91911

  • Clinical Research of West Florida, Inc. (Clearwater)

    Clearwater, Florida, 33765

  • VitaLink Research - Columbia

    Columbia, South Carolina, 29204

  • Conroe Willis Medical Research

    Conroe, Texas, 77304

  • Neurology Clinic

    Cordova, Tennessee, 38018

  • Valley Clinical Trials, Inc.

    Covina, California, 91723

  • Hometown Urgent Care and Research - Cincinnati

    Dayton, Ohio, 45424

  • Neurology Diagnostics, Inc.

    Dayton, Ohio, 45459

  • Care Access - Daytona Beach

    Daytona Beach, Florida, 32114

  • iResearch Atlanta

    Decatur, Georgia, 30030

  • Care Access - Delray Beach

    Delray Beach, Florida, 33484

  • Denver Neurological Research

    Denver, Colorado, 80210

  • Velocity Clinical Research, Syracuse

    East Syracuse, New York, 13057

  • Advanced Neuro Research Center - ANRC

    El Paso, Texas, 79912

  • AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research

    Elk Grove Village, Illinois, 60007

  • Care Access - Fairview Heights

    Fairview Heights, Illinois, 62208

  • SKY Clinical Research Network Group - Hall

    Fayette, Mississippi, 39069

  • Care Access - Fayetteville

    Fayetteville, North Carolina, 28314

  • Coram CVS/Specialty Infusion Services - Fort Wayne

    Fort Wayne, Indiana, 46805

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Velocity Clinical Research, Gaffney

    Gaffney, South Carolina, 29340

  • Center for Advanced Research & Education

    Gainesville, Georgia, 30501

  • Care Access - Georgetown

    Georgetown, Texas, 78633

  • Care Access - Gilroy

    Gilroy, California, 95020

  • Finlay Medical Research

    Greenacres City, Florida, 33467

  • Care Access - Greensboro

    Greensboro, North Carolina, 27401

  • Medication Management

    Greensboro, North Carolina, 27405

  • VitaLink Research - Greenville

    Greenville, South Carolina, 29615

  • Great Lakes Clinical Trials - Gurnee

    Gurnee, Illinois, 60031

  • IMA Clinical Research Westchester

    Hartsdale, New York, 10530

  • Coram CVS/Specialty Infusion Services - Henderson

    Henderson, Nevada, 89014

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012

  • IMA Clinical Research Hoboken

    Hoboken, New Jersey, 07030

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33024

  • Alabama Psychiatry - Birmingham - Brookwood Medical Center Drive

    Homewood, Alabama, 35209

  • Optum Infusion - Houston

    Houston, Texas, 77054

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77054

  • Next Level Urgent Care

    Houston, Texas, 77057

  • Marvel Clinical Research

    Huntington Beach, California, 92647

  • Care Access Research - Huntington Beach

    Huntington Beach, California, 92648

  • Rehabilitation & Neurological Services

    Huntsville, Alabama, 35805

  • Care Access - South Indianapolis

    Indianapolis, Indiana, 46227

  • Josephson Wallack Munshower Neurology, PC

    Indianapolis, Indiana, 46256

  • Irvine Clinical Research

    Irvine, California, 92614

  • Option Care - Irvine

    Irvine, California, 92618

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • Care Access - Kinston

    Kinston, North Carolina, 28501

  • Kaizen Brain Center

    La Jolla, California, 92037

  • Velocity Clinical Research, San Diego

    La Mesa, California, 91942

  • Care Access - Guava Street

    Lady Lake, Florida, 32159

  • Care Access - Lake Charles

    Lake Charles, Louisiana, 70601

  • Accel Research Sites - St. Pete-Largo Clinical Research Unit

    Largo, Florida, 33777

  • Option Care - Las Vegas

    Las Vegas, Nevada, 89102

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89128

  • Pacific Research Network

    Lemon Grove, California, 91945

  • Care Access - Lima

    Lima, Ohio, 45805

  • Accellacare - DuPage

    Lombard, Illinois, 60148

  • Healthy Brain Clinic

    Long Beach, California, 90804

  • Norton Brownsboro Hospital

    Louisville, Kentucky, 40241

  • ClinCloud - Maitland

    Maitland, Florida, 32751

  • K2 Medical Research

    Maitland, Florida, 32751

  • Care Access - Mauldin

    Mauldin, South Carolina, 29662

  • Family Practice Center

    McAllen, Texas, 78501

  • Velocity Clinical Research, Medford

    Medford, Oregon, 97504

  • ClinCloud - Viera

    Melbourne, Florida, 32940

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Memphis, Tennessee, 38119

  • Coram CVS/Specialty Infusion Services - Mendota Heights

    Mendota Heights, Minnesota, 55120

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida, 32952

  • Care Access - 801 South Power Road, Mesa

    Mesa, Arizona, 85206

  • ActivMed Practices and Research

    Methuen, Massachusetts, 01844

  • Optimus U Corporation

    Miami, Florida, 33125

  • Finlay Medical Research

    Miami, Florida, 33126

  • VIN-Andrew Lerman

    Miami, Florida, 33133

  • South Florida Research Phase I-IV

    Miami, Florida, 33166

  • Brainstorm Research Group

    Miami, Florida, 33176

  • IMIC, Inc.

    Miami, Florida, 33176

  • VIN-Victor Faradji

    Miami, Florida, 33176

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014

  • North Star Medical Research

    Middleburg Heights, Ohio, 44130

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Exemplar Research

    Morgantown, West Virginia, 26505

  • Adult Medicine of Lake County

    Mt. Dora, Florida, 32757

  • Neurovations

    Napa, California, 94558

  • Invicro

    New Haven, Connecticut, 06510

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • IMA Clinical Research

    New York, New York, 10036

  • Care Access - Newport Beach

    Newport Beach, California, 92660

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Charter Research - Winter Park

    Orlando, Florida, 32803

  • Headlands Research Orlando

    Orlando, Florida, 32806

  • College Park Specialty Center

    Overland Park, Kansas, 66212

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • South Shore Neurologic Associates

    Patchogue, New York, 11772

  • Pines Care Research Center, LLC

    Pembroke Pines, Florida, 33024

  • VIN- Margarita Almeida El-Ramey

    Pembroke Pines, Florida, 33026

  • Emerald Coast Neurology - Airport Boulevard

    Pensacola, Florida, 32504

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Care Access - Youngstown

    Poland, Ohio, 44514

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Center for Cognitive Health

    Portland, Oregon, 97225

  • Care Access - Pottsville

    Pottsville, Pennsylvania, 17901

  • Care Access - Quincy

    Quincy, Massachusetts, 02169

  • Care Access - Raleigh

    Raleigh, North Carolina, 27607

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Inland Psychiatric Medical Group

    Redlands, California, 92373

  • Anderson Clinical Research

    Redlands, California, 92374

  • Dominion Medical Associates, Inc.

    Richmond, Virginia, 23219

  • SKY Clinical Research Network Group-Quinn

    Ridgeland, Mississippi, 39157

  • El Faro Health and Therapeutics

    Rio Grande City, Texas, 78582

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

  • Option Care - Riverside

    Riverside, California, 92507

  • Clinical Trials Research

    Sacramento, California, 95821

  • Benchmark Research - Knickerbocker

    San Angelo, Texas, 76904

  • Diagnostics Research Group

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research

    San Diego, California, 92123

  • Ray Dolby Brain Health Center

    San Francisco, California, 94114

  • Care Access - Los Gatos

    San Jose, California, 95124

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Care Access - Santa Clarita

    Santa Clarita, California, 91321

  • Option Care - Los Angeles South

    Santa Fe Springs, California, 90670

  • Providence Medical Foundation

    Santa Rosa, California, 95403

  • Meridian Clinical Research, LLC

    Savannah, Georgia, 31406

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Revival Research Institute

    Southfield, Michigan, 48075

  • VitaLink Research - Spartanburg

    Spartanburg, South Carolina, 29303

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey, 07081

  • IMA Clinical Research - St. Louis

    St Louis, Missouri, 63117

  • Richmond Behavioral Associates

    Staten Island, New York, 10314

  • Universal Research Group

    Tacoma, Washington, 98405

  • Care Access - Tamarac

    Tamarac, Florida, 33321

  • Clinical Research of West Florida

    Tampa, Florida, 33606

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Vicis Clinical Research

    Tampa, Florida, 33615

  • Care Access - Tampa

    Tampa, Florida, 33625

  • Coram CVS/Specialty Infusion Services - Tampa

    Tampa, Florida, 33634

  • K2 Medical Research - Tampa

    Tampa, Florida, 33634

  • Prime Global Research

    The Bronx, New York, 10456

  • Charter Research - Lady Lake

    The Villages, Florida, 32162

  • Mazur, Statner, Dutta, Nathan, PC

    Thousand Oaks, California, 91360

  • Banner Alzheimer's Institute Tucson

    Tucson, Arizona, 85718

  • Center for Neurosciences

    Tucson, Arizona, 85718

  • Central States Research

    Tulsa, Oklahoma, 74136

  • Tilda Research

    Tustin, California, 92780

  • VitaLink Research - Union

    Union, South Carolina, 29379

  • SKY Clinical Research Network Group-Blake

    Union City, Georgia, 30291

  • Velocity Clinical Research, Panorama City

    Van Nuys, California, 91405

  • Infectious Disease Doctors Medical Group, APC

    Walnut Creek, California, 94598

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451

  • IMA Clinical Research Warren

    Warren Township, New Jersey, 07059

  • Care Access Research - Warwick

    Warwick, Rhode Island, 02886

  • Covenant Medical Center

    Waterloo, Iowa, 50702

  • Texas Valley Clinical Research

    Weslaco, Texas, 78596

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Accellacare - Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Conquest Research

    Winter Park, Florida, 32789

  • Optum Infusion - Woodinville

    Woodinville, Washington, 98072

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

Other trials in United States

Japan12 sites

  • The University of Tokyo Hospital

    Bunkyō City, 113-8654

  • Tokyo-Eki Center-building Clinic

    Chūōku, 103-0027

  • Fukuwa Clinic

    Chūōku, 104-0031

  • Tokyo Asbo Clinic

    Chūōku, 104-0031

  • P-One Clinic

    Hachiōji, 192-0071

  • National Center for Geriatrics and Gerontology

    Ōbu, 474-8511

  • AMC Nishiumeda Clinic

    Osaka, 530-0001

  • Samoncho Clinic

    Shinjuku, 160-0017

  • Heishinkai Medical Group ToCROM Clinic

    Shinjuku-ku, 160-0008

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, 565-0853

  • Tokyo Metropolitan Geriatric Hospital

    tabashi City, 173-0015

  • Oita University Hospital

    Yufu, 879-5593

Other trials in Japan

Puerto Rico6 sites

  • SCB Research Center

    Bayamón, 00961

  • Dr. Samuel Sanchez PSC

    Caguas, 00727

  • INSPIRA Clinical Research

    San Juan, 00918

  • Instituto De Neurologia Dra. Ivonne Fraga

    San Juan, 00918

  • Mindful Medical Research

    San Juan, 00918

  • University of Puerto Rico - Medical Sciences Campus_Do not use - Duplicate facility

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Donanemab, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

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

  • DonanemabDrug

    Also called LY3002813

    Administered intravenously

  • PlaceboDrug

    Administered intravenously

Study groups in NCT05026866
Study groupRoleWhat they receive
DonanemabExperimentalDonanemab administered intravenously (IV)
Receives: Drug: Donanemab
PlaceboPlacebo comparatorPlacebo is administered intravenously
Receives: Drug: Placebo

What is being measured

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

  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

    Measured: Estimated up to Week 332

Secondary outcomes (17)

  1. 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)

    Measured: Baseline, Up to Week 332

  2. 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)

    Measured: Baseline, Up to Week 332

  3. 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)

    Measured: Baseline, Up to Week 332

  4. 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)

    Measured: Baseline, Up to Week 332

  5. 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)

    Measured: Baseline, Up to Week 332

  6. 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)

    Measured: Baseline, Up Week 332

  7. 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)

    Measured: Baseline, Up to Week 332

  8. 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)

    Measured: Baseline, Up to Week 332

  9. 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)

    Measured: Baseline, Up to Week 332

  10. 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)

    Measured: Baseline, Up to Week 332

  11. 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)

    Measured: Estimated up to Week 332

  12. 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)

    Measured: Estimated up to Week 332

  13. 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)

    Measured: Estimated up to Week 332

  14. 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

    Measured: Estimated up to Week 332

  15. Change from Baseline in Plasma P-tau217

    Change from baseline in Plasma P-tau217

    Measured: Baseline, Up to Week 332

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

    PK: Average serum donanemab concentration at steady state

    Measured: Baseline through Week 76

  17. Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)

    Percentage of participants with treatment-emergent anti-drug antibody (ADAs)

    Measured: Baseline through Week 16

Timeline

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

  1. First posted30 Aug 2021
  2. Study start27 Aug 2021
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,996 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05026866
Sponsor's protocol ID
18284
Other IDs
I5T-MC-AACM
Status last verified
Jan 2026
First submitted
27 Aug 2021
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • 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.

    PubMed 40955720

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Donanemab in people with Alzheimer Disease, run by Eli Lilly and Company at 216 sites in 3 countries.

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

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 216 sites in United States, Japan, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

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

What does the primary outcome measure?

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 frame: Estimated up to Week 332). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05026866, which also lists 1 linked publication.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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