A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)

• Status: Active, not recruiting
• Trial end date: 2021-11-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion Criteria:

• 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 criteria.

• Meet 18F florbetapir PET scan (central read) criteria.

Exclusion Criteria:

• 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.