drugset / Trial / NCT00531804

A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.

NCT00531804

Phase 1 Completed 60 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to receive either R1450 or placebo by intravenous infusion for a total of 7 doses. The starting dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Timeline

Start
2006-12
Primary completion
2010-09
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Gantenerumab Monoclonal antibody Intravenous

Indications