NCT03443973

Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 975 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Gantenerumab	Gantenerumab will be administered as per the schedule specified in the respective arm.
DRUG	Placebo	Placebo matching to gantenerumab will be administered as per the schedule specified in the respective arm.

Timeline

• Start date: 2018-08-22
• Primary completion: 2022-09-23
• Completion: 2022-11-28
• First posted: 2018-02-23
• Last updated: 2024-01-17
• Results posted: 2024-01-17

Locations

155 sites across 19 countries: United States, Argentina, Belgium, Chile, Croatia, Denmark, Finland, Japan, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study