A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Last updated: February 27, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Alzheimer's Disease

Dementia

Memory Loss

Treatment

Donanemab

Placebo

Clinical Study ID

NCT05738486
18648
2022-502268-18-00
U1111-1285-9438
I5T-MC-AACQ
  • Ages 60-85
  • All Genders

Study Summary

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Gradual and progressive change in memory function reported by the participant orinformant for ≥6 months.

  • A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening.

  • Have an amyloid PET scan result from central read, consistent with the presence ofamyloid pathology.

Exclusion

Exclusion Criteria:

  • Have significant neurological disease affecting the central nervous system otherthan AD, that may affect cognition or ability to complete the study, including butnot limited to, other dementias, serious infection of the brain, Parkinson'sdisease, multiple concussions, or epilepsy or recurrent seizures, except febrilechildhood seizures.

  • Has current serious or unstable illnesses including cardiovascular, hepatic, renal,gastroenterologic, respiratory, endocrinologic, neurologic (other than AD),psychiatric, immunologic, or hematologic disease and other conditions that, in theinvestigator's opinion, could interfere with the analyses in this study.

  • A life expectancy of <24 months

  • Have a presence or history of malignant neoplasms within the past 5 years prior toVisit 1.

Exceptions:

  • non-metastatic basal- or squamous-cell skin cancer

  • Stage 0 non-invasive carcinoma of the cervix

  • Stage 0 non-invasive prostate cancer, or

  • other cancers with low risk of recurrence or spread

  • Contraindication to MRI or PET scans

  • Have had prior treatment with a passive anti-amyloid immunotherapy.

Study Design

Total Participants: 800
Treatment Group(s): 2
Primary Treatment: Donanemab
Phase: 3
Study Start date:
February 28, 2023
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • AOU Policlinico Umberto I

    Roma, Lazio 00185
    Italy

    Site Not Available

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milano, Lombardia 20122
    Italy

    Site Not Available

  • IRCCS Istituto Neurologico Carlo Besta

    Milano, Lombardia 20133
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • "Fatebenefratelli Isola Tiberina - Gemelli Isola"

    Rome, Roma 00186
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, Toscana 56126
    Italy

    Site Not Available

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Site Not Available

  • Fondazione Istituto Neurologico C. Mondino

    Pavia, 27100
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, 00168
    Italy

    Site Not Available

  • Re:Cognition Health - Bristol

    Bristol, Bristol, City Of BS32 4SY
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Winchester

    Winchester, Hampshire SO21 1HU
    United Kingdom

    Site Not Available

  • Re:Cognition Health - London

    London, London, City Of W1G 9JF
    United Kingdom

    Site Not Available

  • Re:Cognition Health Guildford

    Guildford, Reading GU2 7YD
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Birmingham

    Birmingham, B16 8LT
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Plymouth

    Plymouth, PL6 8BT
    United Kingdom

    Site Not Available

  • MD First Research - Chandler

    Chandler, Arizona 85286
    United States

    Site Not Available

  • Irvine Clinical Research

    Irvine, California 92614
    United States

    Site Not Available

  • Healthy Brain Clinic

    Long Beach, California 90804
    United States

    Site Not Available

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • California Neuroscience Research, LLC

    Sherman Oaks, California 91403
    United States

    Active - Recruiting

  • JEM Research Institute

    Atlantis, Florida 33462
    United States

    Site Not Available

  • VIN-Julie Schwartzbard

    Aventura, Florida 33180
    United States

    Site Not Available

  • Excel Medical Clinical Trials

    Boca Raton, Florida 33434
    United States

    Site Not Available

  • K2 Medical Research

    Clermont, Florida 34711
    United States

    Site Not Available

  • Brain Matters Research

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Finlay Medical Research

    Greenacres City, Florida 33467
    United States

    Site Not Available

  • Infinity Clinical Research, LLC

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Encore Research Group- Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Charter Research - Lady Lake

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • ClinCloud - Maitland

    Maitland, Florida 32751
    United States

    Site Not Available

  • K2 Medical Research

    Maitland, Florida 32751
    United States

    Site Not Available

  • ClinCloud - Viera

    Melbourne, Florida 32940
    United States

    Site Not Available

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Site Not Available

  • K2 Medical Research

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Charter Research - Winter Park

    Orlando, Florida 32803
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Alzheimer's Research and Treatment Center

    Stuart, Florida 34997
    United States

    Site Not Available

  • K2 Medical Research - Tampa

    Tampa, Florida 33607
    United States

    Site Not Available

  • Charter Research - Lady Lake

    The Villages, Florida 32162
    United States

    Site Not Available

  • K2 Summit Research

    The Villages, Florida 32159
    United States

    Site Not Available

  • ClinCloud - Maitland

    Viera, Florida 32940
    United States

    Site Not Available

  • Alzheimer's Research and Treatment Center

    Wellington, Florida 33414
    United States

    Site Not Available

  • Palm Beach Neurology

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Charter Research - Winter Park

    Winter Park, Florida 32792
    United States

    Active - Recruiting

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Columbus Memory Center, LLC

    Columbus, Georgia 31909
    United States

    Site Not Available

  • Columbus Memory Center, PC

    Columbus, Georgia 31909
    United States

    Active - Recruiting

  • CenExel iResearch, LLC

    Decatur, Georgia 30030
    United States

    Site Not Available

  • iResearch Atlanta

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Center for Advanced Research & Education

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • CenExel iResearch, LLC

    Savannah, Georgia 31405
    United States

    Site Not Available

  • MedVadis Research Corporation

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Adams Clinical

    Watertown, Massachusetts 02472
    United States

    Site Not Available

  • QUEST Research Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey 07081
    United States

    Site Not Available

  • Butler Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Neurology Clinic, P.C.

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Gadolin Research

    Beaumont, Texas 77702
    United States

    Site Not Available

  • Kerwin Medical Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77054
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Re:Cognition Health

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Universal Research Group

    Tacoma, Washington 98405
    United States

    Site Not Available

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