At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,315 enrolled
Drug / intervention
RVT-101 +1 moredrug
Likely dose
RVT-101 35 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating RVT-101 and Placebo for Alzheimer's Disease. Completed, enrolled 1,315 participants across 197 sites in 19 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesArgentina, Australia, Bulgaria, Canada, Chile, Croatia, Czechia, France, Germany, Italy, Poland, Serbia, Singapore, Slovakia, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartOct 2015
First PostedOct 2015
Primary CompletionSep 2017
TodayJul 2026
First PostedOct 26, 2015
Enrollment StartOct 1, 2015
Primary CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.7 years ago
Interventions
RVT-101drug
once daily, oral, 35 mg tablets
Placebodrug
once daily, oral, pill manufactured to match RVT-101 35 mg tablet