A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease

Purpose

The purpose of this study is to assess the safety, tolerability and effect of study drug LY3372689 in participants with early symptomatic Alzheimer's Disease

Condition

  • Alzheimer Disease

Eligibility

Eligible Ages
Between 60 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months - MMSE score of 22 to 30 (inclusive) at screening - CDR global score of 0.5 to 1.0 (inclusive), with a memory box score ≥0.5. - Meet 18F flortaucipir positron emission tomography (PET) scan (central analysis) criteria - Have a study partner who will provide written informed consent to participate

Exclusion Criteria

  • Contraindication to MRI or PET scans - Have known allergies to LY3372689, related compounds, or any components of the formulations

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Based on a common closed study design. Participants final endpoint time will be between 76-124 weeks.
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
0.75 Milligram (mg) LY3372689 		Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks
  • Drug: LY3372689
    given orally
Experimental
3 mg LY3372689 		Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
  • Drug: LY3372689
    given orally
Placebo Comparator
Placebo 		Participants received placebo administered orally once daily for up to 124 weeks.
  • Drug: Placebo
    given orally

More Details

Status
Completed
Sponsor
Eli Lilly and Company

Study Contact