Status:
COMPLETED
A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Alzheimer Disease
Eligibility:
All Genders
60-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2021
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT03367403
Start Date
December 18 2017
End Date
September 21 2021
Last Update
October 13 2022
Active Locations (61)
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1
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
2
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
3
Neurology Center of North Orange County
Fullerton, California, United States, 92835
4
Irvine Clinical Research Center
Irvine, California, United States, 92614