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

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 6,250 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Donanemab	Administered IV
DRUG	Usual Care	Medication (excluding amyloid-targeting agents) or non-pharmacological therapy including watchful waiting.

Timeline

• Start date: 2024-10-07
• Primary completion: 2033-02-01
• Completion: 2033-02-01
• First posted: 2024-08-22
• Last updated: 2025-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study