NCT02585934

Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,315 (actual)
• Sponsor: Axovant Sciences Ltd. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	RVT-101	once daily, oral, 35 mg tablets
DRUG	Placebo	once daily, oral, pill manufactured to match RVT-101 35 mg tablet

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2015-10-26
• Last updated: 2018-12-05
• Results posted: 2018-12-05

Locations

197 sites across 19 countries: United States, Argentina, Australia, Bulgaria, Canada, Chile, Croatia, Czechia, France, Germany, Italy, Poland, Serbia, Singapore, Slovakia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study