A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)
Assessment of Safety, Tolerability and Efficacy of LY3002813 in Early Symptomatic Alzheimer's Disease
2 other identifiers
interventional
272
2 countries
61
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 alzheimer-disease
Started Dec 2017
Typical duration for phase_2 alzheimer-disease
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2017
CompletedFirst Posted
Study publicly available on registry
December 8, 2017
CompletedStudy Start
First participant enrolled
December 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2021
CompletedResults Posted
Study results publicly available
February 15, 2022
CompletedMarch 19, 2026
September 1, 2022
3 years
December 5, 2017
December 1, 2021
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the cognitive and functional decline associated with AD compared with placebo. iADRS is a simple linear combination of 13-item alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance. Least Squares (LS) Mean value was controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, acetylcholinesterase inhibitor (AChEI) and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Baseline, 76 Weeks
Secondary Outcomes (7)
Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) Score
Baseline, 76 Weeks
Change From Baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score
Baseline, 76 Weeks
Change From Baseline in the Mini Mental State Examination (MMSE) Score
Baseline, 76 Weeks
Change From Baseline in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score
Baseline, 76 Weeks
Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan
Baseline, 76 Weeks
- +2 more secondary outcomes
Study Arms (3)
Donanemab Monotherapy (Donanemab-M)
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants received placebo IV Q4W for up to 72 weeks.
Donanemab in Combination With LY3202626 (Donanemab-C)
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months.
- 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.
You may not qualify if:
- Have a history of long QT syndrome.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
Neurology Center of North Orange County
Fullerton, California, 92835, United States
Irvine Clinical Research Center
Irvine, California, 92614, United States
Institute for Memory Impairment & Neurological Disorders
Irvine, California, 92697, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Pacific Research Network Inc
San Diego, California, 92103, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
Associated Neurologists, PC - Danbury
Danbury, Connecticut, 06810, United States
KI Health Partners, LLC d/b/a NE Inst. for Clin. Res.
Stamford, Connecticut, 06905, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Bradenton Research Center
Bradenton, Florida, 34205, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Infinity Clinical Research, LLC
Hollywood, Florida, 33021, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Merritt Island Medical Research LLC
Merritt Island, Florida, 32592, United States
Pharmax Research Clinic
Miami, Florida, 33126, United States
Miami Jewish Health Systems
Miami, Florida, 33137, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Compass Research
Orlando, Florida, 32806, United States
Palm Beach Neurological Group
Palm Beach Gardens, Florida, 33410, United States
Quantum Laboratories
Pompano Beach, Florida, 33064, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Intercoastal Medical Group
Sarasota, Florida, 34239, United States
Axiom Research
Tampa, Florida, 33609, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Compass Research
The Villages, Florida, 32162, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Josephson Wallack Munshower Neurology
Indianapolis, Indiana, 46256, United States
University of Kansas Hospital
Fairway, Kansas, 66160, United States
Cotton O'Neil Clinic
Topeka, Kansas, 66606, United States
McLean Hospital
Belmont, Massachusetts, 02478, United States
ActivMed Practices & Research, Inc
Methuen, Massachusetts, 01844, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Donald S Marks
Plymouth, Massachusetts, 02360-4843, United States
Washington University
St Louis, Missouri, 63108, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, 08755, United States
Behavioral Health Center Research
Charlotte, North Carolina, 28211, United States
Guilford Neurologic Associates
Greensboro, North Carolina, 27405, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607, United States
Piedmont Medical Research
Winston-Salem, North Carolina, 27103, United States
Insight Clinical Trials
Beachwood, Ohio, 44122, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, 45459, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, 19090, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Texas Neurology, PA
Dallas, Texas, 75214, United States
Houston Methodist
Houston, Texas, 77030, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
Cognition Health
Fairfax, Virginia, 22031, United States
National Clinical Research - Richmond
Richmond, Virginia, 23294, United States
Bruyere Research Institute
Ottawa, Ontario, K1N 5C8, Canada
Kawartha Regional Memory Clinic
Peterborough, Ontario, K9H2P4, Canada
Toronto Memory Program
Toronto, Ontario, M3B2S7, Canada
Clinique de la Memoire de l'Outaouais
Gatineau, Quebec, J8T 8J1, Canada
DIEX Recherche Sherbrooke, Inc
Sherbrooke, Quebec, J1L 0H8, Canada
Related Publications (7)
Ardayfio P, Mullins GR, Khanna R, Zimmer JA, Wang H, Nery ESM, Evans CD, Piela P, Battioui C, Lauzon S, Anglin G, Ng HW, Jayaraman AR, Agada N, Natalie CR, Brooks DA, Sims JR. Infusion-related reactions in donanemab-treated participants with early symptomatic Alzheimer's disease. Alzheimers Dement (N Y). 2026 Mar 8;12(1):e70229. doi: 10.1002/trc2.70229. eCollection 2026 Jan-Mar.
PMID: 41804324DERIVEDChandler 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.
PMID: 40603145DERIVEDZimmer 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.
PMID: 40063015DERIVEDKlein 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.
PMID: 38323738DERIVEDPontecorvo 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.
PMID: 36251300DERIVEDShcherbinin 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.
PMID: 36094645DERIVEDMintun 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.
PMID: 33720637DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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. Clinical efficacy was not reported for this group.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2017
First Posted
December 8, 2017
Study Start
December 18, 2017
Primary Completion
December 4, 2020
Study Completion
September 21, 2021
Last Updated
March 19, 2026
Results First Posted
February 15, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
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.