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
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
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