Actively Recruiting
A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease
Led by Eli Lilly and Company · Updated on 2025-10-09
6250
Participants Needed
1
Research Sites
434 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this study is to evaluate the long-term effectiveness of donanemab plus usual care versus usual care alone in participants with early symptomatic AD. The study will employ a prospective, observational cohort design with participant management resembling real-world practice to the greatest extent possible via prospective assessments and linkage to historical and prospective electronic health records. The study will last about 273 weeks and may include up to 28 visits.
CONDITIONS
Official Title
A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Under care for presumed mild cognitive impairment or mild dementia stage of Alzheimer's disease
- Telephone Interview for Cognitive Status (TICS) score of 21 or higher
- Presence of amyloid beta pathology supported by biomarker results within 12 months before study entry
- Have a reliable study partner in frequent contact and available by phone every 6 months
- Willing to provide access to electronic health records for study duration
You will not qualify if you...
- Prior ischemic or hemorrhagic stroke causing inability to perform one or more basic daily activities independently
- Current or recent serious or unstable illness that may interfere with study completion (e.g., life expectancy under 36 months, need for long-term institutional care, serious psychiatric illness)
- Currently enrolled or planning to enroll in another investigational product clinical trial
- Contraindications to donanemab, MRI, or amyloid PET tracers (for donanemab group only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rehabilitation & Neurological Services
Huntsville, Alabama, United States, 35805-4046
Actively Recruiting
Research Team
T
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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