2023-507303-55-00RecruitingPhase 2
I5T-MC-AACI: Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Eli Lilly & Co.
- Enrollment
- 224
- Locations
- 20
- Primary Endpoint
- Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population).
Study Overview
Brief Summary
To assess the effect of donanemab versus placebo on clinical progression in participants with early symptomatic AD
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
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
- •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 Criteria
- •Contraindication to MRI or PET scans
- •Current treatment with immunoglobulin G (IgG) therapy
Outcomes
Primary Outcomes
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population).
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population).
Secondary Outcomes
No secondary outcomes reported
Investigators
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
Study Sites (20)
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