A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)
NCT ID: NCT05108922
Last Updated: 2024-11-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
148 participants
INTERVENTIONAL
2021-11-16
2023-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Donanemab
Donanemab is administered intravenously (IV) every 4 weeks (Q4W).
Donanemab
Participants received 700 milligram (mg) donanemab administered by intravenous (IV) infusion every 4 weeks (Q4W) for first three doses and then 1400 mg IV Q4W.
Aducanumab
Aducanumab administered IV per US label.
Aducanumab
Participants received aducanumab administered by IV infusion per US label (prescribing information/routine clinical practice).
Interventions
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Donanemab
Participants received 700 milligram (mg) donanemab administered by intravenous (IV) infusion every 4 weeks (Q4W) for first three doses and then 1400 mg IV Q4W.
Aducanumab
Participants received aducanumab administered by IV infusion per US label (prescribing information/routine clinical practice).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Meet florbetapir F18 PET scan criteria.
* A Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1.
* Must consent to apolipoprotein E (ApoE) genotyping
* Must have a mini mental state examination (MMSE) score between 20 and 30
* Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to study visits or be available by telephone at designated times.
* Have adequate literacy, vision, and hearing for neuropsychological testing in the opinion of the investigator at the time of screening.
* Women not of childbearing potential may participate
Exclusion Criteria
* Current serious or unstable medical illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, psychiatric (including actively suicidal or deemed at risk of suicide, or current alcohol or substance abuse), immunologic, infectious, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of approximately
≤24 months.
* 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).
* History of bleeding disorder or use of medications with platelet anti-aggregant or anti-coagulant properties (unless aspirin at ≤325 milligram (mg).
* Have had prior or current treatment with donanemab or aducanumab
* Have known allergies to donanemab or aducanumab, related compounds, or any components of the formulation
* Prior or current participation in any immunotherapy study targeting Amyloid beta
50 Years
85 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-2559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern time (UTC/GMT) - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Neurology Center of North Orange County
Fullerton, California, United States
Irvine Clinical Research
Irvine, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
JEM Research Institute
Atlantis, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Infinity Clinical Research, LLC
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Charter Research - Lady Lake
Lady Lake, Florida, United States
ClinCloud - Maitland
Maitland, Florida, United States
ClinCloud - Viera
Melbourne, Florida, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, United States
Optimus U Corporation
Miami, Florida, United States
Brainstorm Research
Miami, Florida, United States
Brain Matters Research
Stuart, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
Conquest Research
Winter Park, Florida, United States
Columbus Memory Center, PC
Columbus, Georgia, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, United States
Donald S. Marks M.D., P.C.
Plymouth, Massachusetts, United States
Adams Clinical
Watertown, Massachusetts, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, United States
Abington Neurological Associates, Ltd.
Abington, Pennsylvania, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Kerwin Medical Center
Dallas, Texas, United States
National Clinical Research, Inc
Richmond, Virginia, United States
Countries
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References
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Salloway S, Pain A, Lee E, Papka M, Ferguson MB, Wang H, Hu H, Lu M, Oru E, Ardayfio PA, Hoban DB, Collins EC, Brooks DA, Sims JR. TRAILBLAZER-ALZ 4: A phase 3 trial comparing donanemab with aducanumab on amyloid plaque clearance in early, symptomatic Alzheimer's disease. Alzheimers Dement. 2025 May;21(5):e70293. doi: 10.1002/alz.70293.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)
Other Identifiers
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I5T-MC-AACN
Identifier Type: OTHER
Identifier Source: secondary_id
18369
Identifier Type: -
Identifier Source: org_study_id