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

Last updated: October 30, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Memory Loss

Dementia

Multiple Sclerosis

Treatment

Dexamethasone

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.

Approximately 375 additional participants will be enrolled per addendum.

The study will last approximately 91 weeks and include up to 26 visits in the main study.

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.

  • Contraindication to MRI or PET scans

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

  • 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

Study Design

Total Participants: 1175
Treatment Group(s): 3
Primary Treatment: Dexamethasone
Phase: 3
Study Start date:
February 28, 2023
Estimated Completion Date:
May 31, 2027

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 - Bristol

    Bristol 2654675, 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 - Winchester

    Winchester 2633858, 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 - London

    London 2643743, 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 Guildford

    Guildford 2647793, Reading GU2 7YD
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Birmingham

    Birmingham, B16 8LT
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Birmingham

    Birmingham 2655603, B16 8LT
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Plymouth

    Plymouth, PL6 8BT
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Plymouth

    Plymouth 2640194, PL6 8BT
    United Kingdom

    Site Not Available

  • MD First Research - Chandler

    Chandler, Arizona 85286
    United States

    Site Not Available

  • MD First Research - Chandler

    Chandler 5289282, Arizona 5551752 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

  • Irvine Clinical Research

    Irvine 5359777, California 5332921 92614
    United States

    Site Not Available

  • Healthy Brain Clinic

    Long Beach 5367929, California 5332921 90804
    United States

    Site Not Available

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks 5395244, California 5332921 91403
    United States

    Site Not Available

  • 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

    Site Not Available

  • 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

    Site Not Available

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Site Not Available

  • JEM Research Institute

    Atlantis 4146372, Florida 4155751 33462
    United States

    Site Not Available

  • VIN-Julie Schwartzbard

    Aventura 4146429, Florida 4155751 33180
    United States

    Site Not Available

  • Excel Medical Clinical Trials

    Boca Raton 4148411, Florida 4155751 33434
    United States

    Site Not Available

  • K2 Medical Research

    Clermont 4151352, Florida 4155751 34711
    United States

    Site Not Available

  • Brain Matters Research

    Delray Beach 4153132, Florida 4155751 33445
    United States

    Site Not Available

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers 4155995, Florida 4155751 33912
    United States

    Site Not Available

  • Finlay Medical Research

    Greenacres City 4157467, Florida 4155751 33467
    United States

    Site Not Available

  • Infinity Clinical Research, LLC

    Hollywood 4158928, Florida 4155751 33024
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville 4160021, Florida 4155751 32216
    United States

    Site Not Available

  • ClinCloud - Maitland

    Maitland 4163220, Florida 4155751 32751
    United States

    Site Not Available

  • K2 Medical Research

    Maitland 4163220, Florida 4155751 32751
    United States

    Site Not Available

  • ClinCloud - Viera

    Melbourne 4163971, Florida 4155751 32940
    United States

    Site Not Available

  • Suncoast Clinical Research, Inc.

    New Port Richey 4165869, Florida 4155751 34652
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala 4166673, Florida 4155751 34470
    United States

    Site Not Available

  • Charter Research - Winter Park

    Orlando 4167147, Florida 4155751 32803
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange 4169156, Florida 4155751 32127
    United States

    Site Not Available

  • Alzheimer's Research and Treatment Center

    Stuart 4174201, Florida 4155751 34997
    United States

    Site Not Available

  • K2 Medical Research - Tampa

    Tampa 4174757, Florida 4155751 33607
    United States

    Site Not Available

  • Charter Research - Lady Lake

    The Villages 4175179, Florida 4155751 32162
    United States

    Site Not Available

  • K2 Summit Research

    The Villages 4175179, Florida 4155751 32159
    United States

    Site Not Available

  • Alzheimer's Research and Treatment Center

    Wellington 4177703, Florida 4155751 33414
    United States

    Site Not Available

  • Palm Beach Neurology

    West Palm Beach 4177887, Florida 4155751 33407
    United States

    Site Not Available

  • Conquest Research

    Winter Park 4178560, Florida 4155751 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

    Site Not Available

  • CenExel iResearch, LLC

    Decatur, Georgia 30030
    United States

    Site Not Available

  • iResearch Atlanta

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Center for Advanced Research & Education

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • CenExel iResearch, LLC

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Columbus Memory Center, LLC

    Columbus 4188985, Georgia 4197000 31909
    United States

    Site Not Available

  • CenExel iResearch, LLC

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • Center for Advanced Research & Education

    Gainesville 4196586, Georgia 4197000 30501
    United States

    Site Not Available

  • CenExel iResearch, LLC

    Savannah 4221552, Georgia 4197000 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

  • MedVadis Research Corporation

    Waltham 4954380, Massachusetts 6254926 02451
    United States

    Site Not Available

  • Adams Clinical

    Watertown 4954611, Massachusetts 6254926 02472
    United States

    Site Not Available

  • QUEST Research Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • QUEST Research Institute

    Farmington Hills 4992523, Michigan 5001836 48334
    United States

    Site Not Available

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey 07081
    United States

    Site Not Available

  • The Cognitive and Research Center of New Jersey

    Springfield 5104952, New Jersey 5101760 07081
    United States

    Site Not Available

  • Butler Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Butler Hospital

    Providence 5224151, Rhode Island 5224323 02906
    United States

    Site Not Available

  • Neurology Clinic, P.C.

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Neurology Clinic, P.C.

    Cordova 4050552, Tennessee 4662168 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

  • Gadolin Research

    Beaumont 4672989, Texas 4736286 77702
    United States

    Site Not Available

  • Kerwin Medical Center

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston 4699066, Texas 4736286 77054
    United States

    Site Not Available

  • Re:Cognition Health

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Re:Cognition Health

    Fairfax 4758023, Virginia 6254928 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

  • Northwest Clinical Research Center

    Bellevue 5786882, Washington 5815135 98007
    United States

    Site Not Available

  • Universal Research Group

    Tacoma 5812944, Washington 5815135 98405
    United States

    Site Not Available

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