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

NCT02585934 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1315

Last updated 2018-12-05

Study results available
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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.

Conditions

Interventions

DRUG

RVT-101

once daily, oral, 35 mg tablets

DRUG

Placebo

once daily, oral, pill manufactured to match RVT-101 35 mg tablet

Sponsors & Collaborators

  • Axovant Sciences Ltd.

    lead INDUSTRY

Principal Investigators

  • Ilise Lombardo, MD · Axovant Sciences, Inc., Vice President, Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-09-30
Completion
2017-09-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • Canada
  • Chile
  • Croatia
  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • Serbia
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02585934 on ClinicalTrials.gov