A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)
NCT ID: NCT03367403
Last Updated: 2022-10-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
272 participants
INTERVENTIONAL
2017-12-18
2021-09-21
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
DOUBLE
Study Groups
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Donanemab Monotherapy (Donanemab-M)
Participants received 700 milligram (mg) donanemab intravenously (IV) every 4 weeks (Q4W) x 3 doses, then 1400 mg donanemab IV Q4W for up to 72 weeks.
Donanemab
Administered IV
Placebo
Participants received placebo IV Q4W for up to 72 weeks.
Placebo
Administered IV
Donanemab in Combination With LY3202626 (Donanemab-C)
Participants received 700 mg donanemab IV Q4W x 3 doses, then 1400 mg donanemab IV Q4W in combination with 12 mg of LY3202626 orally for up to 72 weeks.
As per protocol amendment (d) approved on Oct 9, 2018, donanemab in combination with LY3202626 (donanemab-C) arm discontinued as there was a low probability of identifying a statistically significant effect of 12mg of LY3202626 slowing cognitive decline.
Donanemab
Administered IV
LY3202626
Administered orally
Interventions
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Donanemab
Administered IV
Placebo
Administered IV
LY3202626
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* MMSE score of 20 to 28 (inclusive) at baseline or an acceptable historical flortaucipir PET scan within 6 months prior to baseline that meets the central read criteria.
* Meet 18F flortaucipir PET scan eligibility criteria.
* Meet 18F florbetapir PET scan (central read) eligibility criteria.
Exclusion Criteria
* Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than 2 months before randomization.
* Contraindication to MRI.
60 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 (1-877-285-4559) 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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Banner Alzheimer's Institute
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
Neurology Center of North Orange County
Fullerton, California, United States
Irvine Clinical Research Center
Irvine, California, United States
Institute for Memory Impairment & Neurological Disorders
Irvine, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
Pacific Research Network Inc
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Associated Neurologists, PC - Danbury
Danbury, Connecticut, United States
KI Health Partners, LLC d/b/a NE Inst. for Clin. Res.
Stamford, Connecticut, United States
JEM Research Institute
Atlantis, Florida, United States
Bradenton Research Center
Bradenton, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Infinity Clinical Research, LLC
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Merritt Island Medical Research LLC
Merritt Island, Florida, United States
Pharmax Research Clinic
Miami, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Compass Research
Orlando, Florida, United States
Palm Beach Neurological Group
Palm Beach Gardens, Florida, United States
Quantum Laboratories
Pompano Beach, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Intercoastal Medical Group
Sarasota, Florida, United States
Axiom Research
Tampa, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Compass Research
The Villages, Florida, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Josephson Wallack Munshower Neurology
Indianapolis, Indiana, United States
University of Kansas Hospital
Fairway, Kansas, United States
Cotton O'Neil Clinic
Topeka, Kansas, United States
McLean Hospital
Belmont, Massachusetts, United States
ActivMed Practices & Research, Inc
Methuen, Massachusetts, United States
Boston Center for Memory
Newton, Massachusetts, United States
Donald S Marks
Plymouth, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, United States
Behavioral Health Center Research
Charlotte, North Carolina, United States
Guilford Neurologic Associates
Greensboro, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Piedmont Medical Research
Winston-Salem, North Carolina, United States
Insight Clinical Trials
Beachwood, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Butler Hospital
Providence, Rhode Island, United States
Texas Neurology, PA
Dallas, Texas, United States
Houston Methodist
Houston, Texas, United States
The Memory Clinic
Bennington, Vermont, United States
Cognition Health
Fairfax, Virginia, United States
National Clinical Research - Richmond
Richmond, Virginia, United States
Bruyere Research Institute
Ottawa, Ontario, Canada
Kawartha Regional Memory Clinic
Peterborough, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Clinique de la Memoire de l'Outaouais
Gatineau, Quebec, Canada
DIEX Recherche Sherbrooke, Inc
Sherbrooke, Quebec, Canada
Countries
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References
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Chandler JM, Lansdall CJ, Ye W, McDougall F, Belger M, Toth B, Mi X, Sink KM, Atkins AS. The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity. J Prev Alzheimers Dis. 2025 Sep;12(8):100261. doi: 10.1016/j.tjpad.2025.100261. Epub 2025 Jul 1.
Zimmer JA, Ardayfio P, Wang H, Khanna R, Evans CD, Lu M, Sparks J, Andersen S, Lauzon S, Nery ESM, Battioui C, Engle SE, Biffi A, Svaldi D, Salloway S, Greenberg SM, Sperling RA, Mintun M, Brooks DA, Sims JR. Amyloid-Related Imaging Abnormalities With Donanemab in Early Symptomatic Alzheimer Disease: Secondary Analysis of the TRAILBLAZER-ALZ and ALZ 2 Randomized Clinical Trials. JAMA Neurol. 2025 May 1;82(5):461-469. doi: 10.1001/jamaneurol.2025.0065.
Klein EG, Schroeder K, Wessels AM, Phipps A, Japha M, Schilling T, Zimmer JA. How donanemab data address the coverage with evidence development questions. Alzheimers Dement. 2024 Apr;20(4):3127-3140. doi: 10.1002/alz.13700. Epub 2024 Feb 7.
Pontecorvo MJ, Lu M, Burnham SC, Schade AE, Dage JL, Shcherbinin S, Collins EC, Sims JR, Mintun MA. Association of Donanemab Treatment With Exploratory Plasma Biomarkers in Early Symptomatic Alzheimer Disease: A Secondary Analysis of the TRAILBLAZER-ALZ Randomized Clinical Trial. JAMA Neurol. 2022 Dec 1;79(12):1250-1259. doi: 10.1001/jamaneurol.2022.3392.
Shcherbinin S, Evans CD, Lu M, Andersen SW, Pontecorvo MJ, Willis BA, Gueorguieva I, Hauck PM, Brooks DA, Mintun MA, Sims JR. Association of Amyloid Reduction After Donanemab Treatment With Tau Pathology and Clinical Outcomes: The TRAILBLAZER-ALZ Randomized Clinical Trial. JAMA Neurol. 2022 Oct 1;79(10):1015-1024. doi: 10.1001/jamaneurol.2022.2793.
Mintun MA, Lo AC, Duggan Evans C, Wessels AM, Ardayfio PA, Andersen SW, Shcherbinin S, Sparks J, Sims JR, Brys M, Apostolova LG, Salloway SP, Skovronsky DM. Donanemab in Early Alzheimer's Disease. N Engl J Med. 2021 May 6;384(18):1691-1704. doi: 10.1056/NEJMoa2100708. Epub 2021 Mar 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease
Other Identifiers
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I5T-MC-AACG
Identifier Type: OTHER
Identifier Source: secondary_id
16933
Identifier Type: -
Identifier Source: org_study_id
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