12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension

NCT02586909 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1099

Last updated 2020-04-17

Study results available
· View outcomes & findings →

Summary

This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind study).

Conditions

Interventions

DRUG

RVT-101 35 mg tablets

once daily, oral tablets

Sponsors & Collaborators

  • Axovant Sciences Ltd.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-04-26
Primary Completion
2018-03-12
Completion
2018-03-12

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

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 NCT02586909 on ClinicalTrials.gov