A Phase 3, Double-blind, Randomized Study of RVT-101 Versus Placebo When Added to Existing Stable Donepezil Treatment in Subjects With Mild to Moderate Alzheimer's Disease
A Phase 3, Double-blind, Randomized Study of RVT-101 Versus Placebo When Added to Existing Stable Donepezil Treatment in Subjects With Mild to Moderate Alzheimer's Disease
This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.
This Phase 3 study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) on both cognition and activities of daily living when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease after 24 weeks of double-blind treatment. This study will also provide further information on the safety and tolerability of the 35-mg dose of intepirdine (RVT-101) when used in combination with donepezil compared to donepezil alone. This study is being conducted under the agreement of a Special Protocol Assessment by FDA. Subjects completing this study will be eligible to enroll in a 12 month open-label study of RVT-101 (RVT-101-3002) in which concomitant medications for the treatment of Alzheimer's disease including memantine will be allowed.
Inclusion Criteria:
Exclusion Criteria:
Other Causes for Dementia
Confounding Medical Conditions
Ciudad Autónoma de Buenos Aire, C1012AAR, Argentina
Ciudad Autónoma de Buenos Aire, C1058AAJ, Argentina
Ciudad Autónoma de Buenos Aire, C1111AAL, Argentina
Ciudad Autónoma de Buenos Aire, C1117ABH, Argentina
Ciudad Autónoma de Buenos Aire, C1405BCK, Argentina
Ciudad Autónoma de Buenos Aire, C1406BOA, Argentina
Ciudad Autónoma de Buenos Aire, C1425AHQ, Argentina
Ciudad Autónoma de Buenos Aire, C1428AQK, Argentina
North York, Ontario M3B 2S7, Canada