Status:
ACTIVE_NOT_RECRUITING
A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Alzheimer Disease
Eligibility:
All Genders
60-85 years
Phase:
PHASE3
Brief Summary
The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety c...
Detailed Description
TRAILBLAZER-ALZ 2 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of N3pG antibody (donanemab) in participants with early symptomatic AD (prodromal AD and mild...
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
- Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort
- Meet 18F florbetapir PET scan (central read) criteria
- Have a study partner who will provide written informed consent to participate
Exclusion
- Contraindication to MRI or PET scans
- Current treatment with immunoglobulin G (IgG) therapy
Key Trial Info
Start Date :
June 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2028
Estimated Enrollment :
1736 Patients enrolled
Trial Details
Trial ID
NCT04437511
Start Date
June 19 2020
End Date
November 1 2028
Last Update
August 29 2025
Active Locations (274)
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1
Gilbert Neurology
Gilbert, Arizona, United States, 85297
2
Xenoscience
Phoenix, Arizona, United States, 85004
3
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
4
Perseverance Research Center
Scottsdale, Arizona, United States, 85254