drugset / Trial / NCT04339413

A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)

NCT04339413

Phase 3 Terminated 116 enrolled Hoffmann-La Roche
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of the study was to evaluate the safety and tolerability of long-term administration of gantenerumab in participants with AD. All participants who have completed the open-label extensions (OLEs) of studies WN25203 or WN28745 were enrolled in Part 1 of this study. Of these, participants who completed Week 104 visit in Part 1. Participants received open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) at the same dose as administered in the parent studies (part 1)/ Week 104 visit.

Timeline

Start
2020-05-22
Primary completion
2023-01-04
Completion
2023-01-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Gantenerumab Monoclonal antibody 1200 mg Subcutaneous

Indications