drugset / Trial / NCT02585934

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

NCT02585934 ↗

Phase 3 Completed 1315 enrolled Axovant Sciences Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-10
Primary completion
2017-09
Completion
2017-09

Outcome

Missed primary endpoint

registry analysis (superiority test); RVT-101 vs Placebo; p = 0.2249 NCT02585934 ↗

registry analysis (superiority test); RVT-101 vs Placebo; p = 0.8260 NCT02585934 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject intepirdine Small molecule 35 mg Oral

Indications