drugset / Trial / NCT04592341

A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

NCT04592341

Phase 2 Terminated 192 enrolled Hoffmann-La Roche
NaSequentialOpen-labelTreatment

Summary

This is a Phase II, multicenter, open-label, single arm, PD study in participants with early (prodromal to mild) AD to evaluate the effect of a once weekly (Q1W) dosing regimen of gantenerumab on deposited amyloid as measured by change from baseline to Week 104 (primary) and Week 208 in brain amyloid positron emission tomography (PET). The administration of gantenerumab as a single injection of Q1W will be investigated in this study, to simplify the dosing regimen for participants.

Timeline

Start
2020-11-18
Primary completion
2023-01-11
Completion
2023-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Gantenerumab Monoclonal antibody 255 mg Subcutaneous

Indications