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 Genders
- 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 baseline - 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental LY3372689 High Dose |
LY3372689 given orally |
|
|
Experimental LY3372689 Low Dose |
LY3372689 given orally |
|
|
Placebo Comparator Placebo |
Placebo given orally |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company