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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 16 (61 locations)

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