drugset / Trial / NCT01677754

A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy

NCT01677754

Phase 2 Completed 542 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4602522 in participants with moderate severity Alzheimer's disease. Participants who are taking background therapy of acetylcholinesterase inhibitors (AChEI) alone or in combination with memantine for at least 4 months before screening will be randomized to receive either one of two doses of RO4602522 or placebo for 12 months.

Timeline

Start
2012-10-24
Primary completion
2015-06-12
Completion
2015-06-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Sembragiline Small molecule 1 mg Oral
Subject Sembragiline Small molecule 5 mg Oral
Background Donepezil Small molecule
Background Galantamine Small molecule
Background Memantine Unknown
Background Rivastigmine Small molecule

Indications