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RECRUITING
NCT06566170

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Donanemab

Administered IV

DRUG

Usual Care

Medication (excluding amyloid-targeting agents) or non-pharmacological therapy including watchful waiting.

Locations (1)

Rehabilitation & Neurological Services

Huntsville, Alabama, United States