drugset / Trial / NCT00884507

A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease

NCT00884507

Phase 2 Completed 389 enrolled Hoffmann-La Roche
Parallel-groupDouble-blindTreatment

Summary

This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated time on study treatment is 6 months, and the target sample size is 100-500 individuals.

Timeline

Start
2009-05
Primary completion
2010-11
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject RO5313534 Unknown 1 mg Oral
Subject RO5313534 Unknown 5 mg Oral
Subject RO5313534 Unknown 15 mg Oral

Indications