NCT05256134

A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD)

A Phase III, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the efficacy and safety of gantenerumab in amyloid-positive, cognitively unimpaired participants at risk for or at the earliest stages of AD. The planned number of participants for this study is approximately 1200 participants randomized in a 1:1 ratio to receive either gantenerumab or placebo (600 participants randomized to gantenerumab and 600 participants randomized to placebo).

Conditions

• Alzheimers Disease

Interventions

Type	Name	Description
DRUG	Gantenerumab	Gantenerumab will be administered as per the dosing schedule described in the Arm description.
DRUG	Placebo	Placebo will be administered as per the dosing schedule described in the Arm description.

Timeline

• Start date: 2022-04-19
• Primary completion: 2023-03-13
• Completion: 2023-03-13
• First posted: 2022-02-25
• Last updated: 2025-06-12
• Results posted: 2024-07-09

Locations

63 sites across 10 countries: United States, Argentina, Australia, Canada, Italy, Poland, South Korea, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study