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)

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).

Timeline

Start

2022-04-19

Primary completion

2023-03-13

Completion

2023-03-13

Outcome

Outcome not reported

Stopped: “Decision to terminate development of gantenerumab for treatment of people at risk for or at earliest stages of Alzheimer disease (AD) following results of a pre-planned analysis of safety \& efficacy of gantenerumab in Graduate I\&II (WN29922/WN39658).”

Publications

• Hibar DP, Bauer A, Rabe C, Borlinghaus N, Jethwa A, Kollmorgen G, Di Domenico A, Zetterberg H, Blennow K, Masters CL, Sperling RA, Bittner T. Elecsys pTau217 plasma immunoassay detection of amyloid pathology in clinical cohorts. Alzheimers Dement. 2026 Jan;22(1):e71009. doi: 10.1002/alz.71009.
• Bauer A, Rabe C, Schiffman C, Rose F, Respondek G, Gullotta F, Schlieker L, Jethwa A, Schrurs I, Manuilova E, Ostrowitzki S, Bittner T. Blood-based pre-screening in the SKYLINE secondary prevention Ph3 gantenerumab study. Alzheimers Dement. 2025 Oct;21(10):e70676. doi: 10.1002/alz.70676.

Drugs

Indications