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Study Evaluating Intepirdine ...

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

Last Updated: 2018-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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This Phase 3 study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) on both cognition and activities of daily living when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease after 24 weeks of double-blind treatment. This study will also provide further information on the safety and tolerability of the 35-mg dose of intepirdine (RVT-101) when used in combination with donepezil compared to donepezil alone. This study is being conducted under the agreement of a Special Protocol Assessment by FDA. Subjects completing this study will be eligible to enroll in a 12 month open-label study of RVT-101 (RVT-101-3002) in which concomitant medications for the treatment of Alzheimer's disease including memantine will be allowed.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RVT-101

RVT-101 adjunct to 5 mg or 10 mg donepezil

Group Type EXPERIMENTAL

RVT-101

Intervention Type DRUG

once daily, oral, 35 mg tablets

Placebo

Placebo adjunct to 5 mg or 10 mg donepezil

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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RVT-101

once daily, oral, 35 mg tablets

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subject with AD
* Ongoing donepezil therapy for AD
* An MMSE score 12 to 24 inclusive at Screening; MMSE score 10-26 inclusive at Baseline
* Hachinski Ischaemia score less than or equal to 4 at Screening.
* If female, subject must be: a. of non-childbearing potential or surgically sterile; or, b. willing to use an adequate methods of birth control. Male subjects who are sexually active will also be required to use an adequate form of birth control.
* Subject has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator.
* Subject has a reliable caregiver who is willing to report on subject's status throughout the study.

Exclusion Criteria

Other Causes for Dementia

* Diagnosis of vascular dementia
* Atypical clinical features or clinical course of dementia that would lead the investigator to conclude symptoms are more likely due to an alternate dementia diagnosis including, but not limited to, frontotemporal dementia, Lewy body dementia, or others.

Confounding Medical Conditions

* History of significant psychiatric illness such as schizophrenia or bipolar affective disorder or any other significant psychiatric illness that in the opinion of the investigator would interfere with participation in the study;
* 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

85 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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UK063

Bath, , United Kingdom

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UK038

Blackpool, , United Kingdom

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UK233

Cambridge, , United Kingdom

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UK033

Cannock, , United Kingdom

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UK211

Epping, , United Kingdom

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UK234

Guildford, , United Kingdom

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UK055

Leeds, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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UK229

Norwich, , United Kingdom

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Oxford, , United Kingdom

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Plymouth, , United Kingdom

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Sheffield, , United Kingdom

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Southampton, , United Kingdom

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UK152

Southampton, , United Kingdom

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UK153

Swindon, , United Kingdom

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UK154

Warrington, , United Kingdom

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SK066

Busan, , South Korea

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SK067

Seoul, , South Korea

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SK190

Seoul, , South Korea

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SP249

Alicante, , Spain

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SP176

Barcelona, , Spain

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SP022

Barcelona, , Spain

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Barcelona, , Spain

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SP250

Barcelona, , Spain

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SP019

Ceuta, , Spain

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Donostia / San Sebastian, , Spain

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SP222

Getxo, , Spain

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Madrid, , Spain

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SP093

Madrid, , Spain

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SP184

Sant Cugat del Vallès, , Spain

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SP020

Terrassa, , Spain

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TA065

Kaohsiung City, , Taiwan

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TA086

Taipei, , Taiwan

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TA121

Taoyuan District, , Taiwan

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US112

Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Encino, California, United States

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Fullerton, California, United States

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US214

Los Angeles, California, United States

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US189

Pasadena, California, United States

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Rancho Mirage, California, United States

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US0195

Santa Ana, California, United States

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Simi Valley, California, United States

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Temecula, California, United States

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Hamden, Connecticut, United States

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Norwich, Connecticut, United States

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Atlantis, Florida, United States

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Brooksville, Florida, United States

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Hallandale, Florida, United States

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Hialeah, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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North Palm Beach, Florida, United States

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Orlando, Florida, United States

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Pensacola, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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The Villages, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Baton Rouge, Louisiana, United States

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Shreveport, Louisiana, United States

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Newton, Massachusetts, United States

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Quincy, Massachusetts, United States

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Hattiesburg, Mississippi, United States

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Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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Lawrenceville, New Jersey, United States

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Mount Arlington, New Jersey, United States

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Paterson, New Jersey, United States

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Toms River, New Jersey, United States

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West Long Branch, New Jersey, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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New Hyde Park, New York, United States

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New Windsor, New York, United States

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New York, New York, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Beachwood, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Shaker Heights, Ohio, United States

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Portland, Oregon, United States

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Media, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Plains, Pennsylvania, United States

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Willow Grove, Pennsylvania, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Orem, Utah, United States

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Charlottesville, Virginia, United States

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Spokane, Washington, United States

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AR130

La Plata, Buenos Aires, Argentina

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AR041

La Plata, Buenos Aires, Argentina

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AR101

Buenos Aires, , Argentina

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