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A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease
Sponsor: Eli Lilly and Company
Summary
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.
Official title: Long-Term Real-World Comparative Effectiveness of Donanemab Plus Usual Care Versus Usual Care Alone in US Patients With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-REAL US)
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
OBSERVATIONAL
Enrollment
6250
Start Date
2024-10-07
Completion Date
2033-02
Last Updated
2025-10-09
Healthy Volunteers
No
Conditions
Interventions
Donanemab
Administered IV
Usual Care
Medication (excluding amyloid-targeting agents) or non-pharmacological therapy including watchful waiting.
Locations (1)
Rehabilitation & Neurological Services
Huntsville, Alabama, United States