NCT05108922

A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic Alzheimer's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to compare donanemab to aducanumab on brain amyloid plaque clearance in participants with early symptomatic Alzheimer's Disease (AD).

Conditions

• Mild Cognitive Impairment (MCI)
• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Donanemab	Participants received 700 milligram (mg) donanemab administered by intravenous (IV) infusion every 4 weeks (Q4W) for first three doses and then 1400 mg IV Q4W.
DRUG	Aducanumab	Participants received aducanumab administered by IV infusion per US label (prescribing information/routine clinical practice).

Timeline

• Start date: 2021-11-16
• Primary completion: 2022-09-09
• Completion: 2023-09-19
• First posted: 2021-11-05
• Last updated: 2024-11-29
• Results posted: 2023-11-02

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study