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12-Month Open-Label Extension...

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

Last Updated: 2020-04-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1099 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-26

Study Completion Date

2018-03-12

Brief Summary

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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).

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RVT-101 35 mg tablets

once daily, oral tablets

Group Type EXPERIMENTAL

RVT-101 35 mg tablets

Intervention Type DRUG

once daily, oral tablets

Interventions

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RVT-101 35 mg tablets

once daily, oral tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Completed last on-treatment visit of the lead-in study RVT-101-3001

Exclusion Criteria

* Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.

Minimum Eligible Age

50 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ilise Lombardo, MD

Role: STUDY_DIRECTOR

Axovant Sciences, Inc., Vice President, Clinical Research

Locations

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US112

Phoenix, Arizona, United States

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US220

Tucson, Arizona, United States

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US096

Rancho Mirage, California, United States

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US195

Santa Ana, California, United States

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US016

Simi Valley, California, United States

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US106

Temecula, California, United States

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US179

Hamden, Connecticut, United States

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US171

Norwich, Connecticut, United States

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US088

Atlantis, Florida, United States

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US007

Brooksville, Florida, United States

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US002

Hallandale, Florida, United States

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US140

Hialeah, Florida, United States

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US216

Miami, Florida, United States

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US110

Miami, Florida, United States

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US172

North Palm Beach, Florida, United States

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US003

Orlando, Florida, United States

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US256

Pensacola, Florida, United States

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US037

Tampa, Florida, United States

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US042

Tampa, Florida, United States

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US004

The Villages, Florida, United States

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US048

Atlanta, Georgia, United States

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US046

Atlanta, Georgia, United States

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US217

Columbus, Georgia, United States

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US111

Baton Rouge, Louisiana, United States

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US095

Shreveport, Louisiana, United States

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US116

Newton, Massachusetts, United States

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US174

Quincy, Massachusetts, United States

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US144

Hattiesburg, Mississippi, United States

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US094

Las Vegas, Nevada, United States

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US135

Berlin, New Jersey, United States

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US197

Lawrenceville, New Jersey, United States

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US215

Mount Arlington, New Jersey, United States

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US057

Paterson, New Jersey, United States

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US209

Toms River, New Jersey, United States

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US036

West Long Branch, New Jersey, United States

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US001

Albany, New York, United States

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US049

Brooklyn, New York, United States

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US097

New Hyde Park, New York, United States

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US044

New York, New York, United States

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US150

Chapel Hill, North Carolina, United States

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US185

Charlotte, North Carolina, United States

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US008

Cincinnati, Ohio, United States

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US113

Cleveland, Ohio, United States

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US119

Shaker Heights, Ohio, United States

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US134

Portland, Oregon, United States

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US169

Media, Pennsylvania, United States

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US162

Plains, Pennsylvania, United States

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US148

Willow Grove, Pennsylvania, United States

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US043

San Antonio, Texas, United States

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US143

Orem, Utah, United States

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US149

Charlottesville, Virginia, United States

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US170

Spokane, Washington, United States

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AR130

La Plata, Buenos Aires, Argentina

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AR101

Buenos Aires, , Argentina

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