NCT04640077

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

Donanemab Follow-On Study: Safety, Tolerability, And Efficacy in Symptomatic Alzheimer's Disease With Validation of Remote Neuropsychological Assessments

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with Alzheimer's disease and to validate neuropsychological assessments administered over videoconferencing

Conditions

• Alzheimer Disease
• Dementia
• Brain Diseases
• Central Nervous System Diseases
• Cognitive Impairment

Interventions

Type	Name	Description
OTHER	No Intervention	No intervention
DRUG	donanemab	Administered IV

Timeline

• Start date: 2020-11-23
• Primary completion: 2024-02-27
• Completion: 2024-02-27
• First posted: 2020-11-23
• Last updated: 2025-06-13
• Results posted: 2025-06-13

Locations

27 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study