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

NCT02585934 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: RVT-101-3001
• Study Type: interventional
• Target: 1,315
• Locations: 19 countries
• Sites: 197

Brief 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

Alzheimer's Disease

Keywords

Alzheimer's disease; RVT-101; donepezil; intepirdine; dementia

Outcome Measures

Primary Outcomes (2)

• Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24

  The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.

  Baseline, 24 weeks

• Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score Change From Baseline to Week 24

  The ADCS-ADL scale measures functional impairment in terms of activities of daily living. The score ranges from 0 to 78. The lower the score, the greater the impairment; higher scores indicate better (more desirable) function

  Baseline, 24 weeks

Secondary Outcomes (5)

• Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24

  24 weeks

• The Dependence Scale (DS) Score Change From Baseline to Week 24

  Baseline, 24 weeks

• Neuropsychiatric Inventory (NPI) Score Change From Baseline to Week 24

  Baseline and Week 24

• ADAS-Cog-13 Score Change From Baseline to Week 24

  Baseline, 24 weeks

• Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma

  Week 6, Week 12, Week 18, Week 24

Study Arms (2)

RVT-101

EXPERIMENTAL

RVT-101 adjunct to 5 mg or 10 mg donepezil

Drug: RVT-101

Placebo

PLACEBO COMPARATOR

Placebo adjunct to 5 mg or 10 mg donepezil

Drug: Placebo

Interventions

RVT-101 DRUG

once daily, oral, 35 mg tablets

RVT-101

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Axovant Sciences Ltd.: lead

Study Sites (197)

US112

Phoenix, Arizona, 85005, United States

Location

US220

Tucson, Arizona, 85704, United States

Location

US168

Encino, California, 91436, United States

Location

US117

Fullerton, California, 92835, United States

Location

US214

Los Angeles, California, 90024, United States

Location

US189

Pasadena, California, 91105, United States

Location

US096

Rancho Mirage, California, 92270, United States

Location

US0195

Santa Ana, California, 92705, United States

Location

US016

Simi Valley, California, 93065, United States

Location

US106

Temecula, California, 92591, United States

Location

US179

Hamden, Connecticut, 06518, United States

Location

US171

Norwich, Connecticut, 06360, United States

Location

US088

Atlantis, Florida, 33462, United States

Location

US007

Brooksville, Florida, 34601, United States

Location

US002

Hallandale, Florida, 33009, United States

Location

US140

Hialeah, Florida, 33012, United States

Location

US216

Miami, Florida, 33137, United States

Location

US110

Miami, Florida, 33165, United States

Location

US172

North Palm Beach, Florida, 33408, United States

Location

US003

Orlando, Florida, 32806, United States

Location

US256

Pensacola, Florida, 32502, United States

Location

US037

Tampa, Florida, 33613, United States

Location

US042

Tampa, Florida, 33613, United States

Location

US004

The Villages, Florida, 32162, United States

Location

US048

Atlanta, Georgia, 30331, United States

Location

US046

Atlanta, Georgia, 30342, United States

Location

US217

Columbus, Georgia, 31909, United States

Location

US111

Baton Rouge, Louisiana, 70808, United States

Location

US095

Shreveport, Louisiana, 71104, United States

Location

US116

Newton, Massachusetts, 02459, United States

Location

US174

Quincy, Massachusetts, 02169, United States

Location

US144

Hattiesburg, Mississippi, 39401, United States

Location

US094

Las Vegas, Nevada, 89113, United States

Location

US135

Berlin, New Jersey, 08009, United States

Location

US197

Lawrenceville, New Jersey, 08648, United States

Location

US215

Mount Arlington, New Jersey, 07856, United States

Location

US057

Paterson, New Jersey, 08759, United States

Location

US209

Toms River, New Jersey, 08755, United States

Location

US036

West Long Branch, New Jersey, 07764, United States

Location

US001

Albany, New York, 12208, United States

Location

US049

Brooklyn, New York, 11235, United States

Location

US097

New Hyde Park, New York, 11040, United States

Location

US177

New Windsor, New York, 12553, United States

Location

US142

New York, New York, 10021, United States

Location

US044

New York, New York, 10022, United States

Location

US150

Chapel Hill, North Carolina, 27599, United States

Location

US185

Charlotte, North Carolina, 28270, United States

Location

US113

Beachwood, Ohio, 44122, United States

Location

US136

Cincinnati, Ohio, 45220, United States

Location

US008

Cincinnati, Ohio, 45227, United States

Location

US119

Shaker Heights, Ohio, 44122, United States

Location

US134

Portland, Oregon, 97210, United States

Location

US169

Media, Pennsylvania, 19063, United States

Location

US187

Philadelphia, Pennsylvania, 19102, United States

Location

US162

Plains, Pennsylvania, 18075, United States

Location

US148

Willow Grove, Pennsylvania, 19001, United States

Location

US115

Houston, Texas, 77074, United States

Location

US043

San Antonio, Texas, 78229, United States

Location

US143

Orem, Utah, 84058, United States

Location

US149

Charlottesville, Virginia, 22903, United States

Location

US170

Spokane, Washington, 99202, United States

Location

AR130

La Plata, Buenos Aires, A1902AJU, Argentina

Location

AR041

La Plata, Buenos Aires, B1900BOM, Argentina

Location

AR101

Buenos Aires, B1828CKR, Argentina

Location

AR060

Buenos Aires, C1199ABB, Argentina

Location

AR084

Ciudad Autónoma de Buenos Aire, C1012AAR, Argentina

Location

AR027

Ciudad Autónoma de Buenos Aire, C1058AAJ, Argentina

Location

AR012

Ciudad Autónoma de Buenos Aire, C1111AAL, Argentina

Location

AR160

Ciudad Autónoma de Buenos Aire, C1117ABH, Argentina

Location

AR040

Ciudad Autónoma de Buenos Aire, C1405BCK, Argentina

Location

AR028

Ciudad Autónoma de Buenos Aire, C1406BOA, Argentina

Location

AR081

Ciudad Autónoma de Buenos Aire, C1425AHQ, Argentina

Location

AR035

Ciudad Autónoma de Buenos Aire, C1428AQK, Argentina

Location

AR051

Córdoba, X5000DCE, Argentina

Location

AR137

Córdoba, X5000FJF, Argentina

Location

AR210

Mendoza, M5501ACP, Argentina

Location

AR219

Mendoza, M5502AHV, Argentina

Location

AR059

Santiago del Estero, G4200DND, Argentina

Location

AU227

Caulfield, VIC3162, Australia

Location

AU079

Chermside, QLD 4032, Australia

Location

AU032

Heidelberg West, VIC 3081, Australia

Location

AU062

Herston, QLD 4209, Australia

Location

AU011

Hornsby, NSW 2077, Australia

Location

AU138

West Perth, WA 6005, Australia

Location

BU125

Rousse, 7003, Bulgaria

Location

BU131

Sofia, 1431, Bulgaria

Location

BU198

Sofia, 1632, Bulgaria

Location

BU073

Varna, 9000, Bulgaria

Location

CA151

Medicine Hat, Alberta, T1B4E7, Canada

Location

CA120

Kamloops, British Columbia, V2C 1K7, Canada

Location

CA054

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

CA188

Kelowna, British Columbia, V1Y 4N7, Canada

Location

CA186

Penticton, British Columbia, V2A 5C8, Canada

Location

CA141

West Vancouver, British Columbia, V7T 2Z3, Canada

Location

CA147

Newmarket, Ontario, L3Y 5G8, Canada

Location

CA196

North York, Ontario, M3B 2S7, Canada

Location

CA237

Toronto, Ontario, M4G 0A1, Canada

Location

CA236

Gatineau, Quebec, J8T8JI, Canada

Location

CH212

Antofagasta, Antofagasta, 1270244, Chile

Location

CH061

Santiago, Santiago Metropolitan, 7510186, Chile

Location

CH075

Santiago, Santiago Metropolitan, 7520338, Chile

Location

CH076

Santiago, Santiago Metropolitan, 7560356, Chile

Location

CR069

Zagreb, 10000, Croatia

Location

CR122

Zagreb, 10000, Croatia

Location

CR068

Zagreb, 10090, Croatia

Location

CR070

Zagreb, 10090, Croatia

Location

CR083

Zagreb, 10090, Croatia

Location

CZ128

Prague, 100 00, Czechia

Location

CZ207

Prague, 109 00, Czechia

Location

CZ132

Prague, 120 00, Czechia

Location

CZ129

Prague, 160 00, Czechia

Location

CZ161

Rychnov nad Kněžnou, 516 01, Czechia

Location

FR231

Lille, 59037, France

Location

FR182

Marseille, 13385, France

Location

FR221

Paris, 75013, France

Location

FR202

Villeurbanne, 69 100, France

Location

GE206

Bad Homburg, 61348, Germany

Location

GE091

Berlin, 10117, Germany

Location

GE071

Berlin, 12203, Germany

Location

GE139

Berlin, 13125, Germany

Location

GE230

Cologne, 50937, Germany

Location

GE252

Ellwangen, 73479, Germany

Location

GE180

Leipzig, 04107, Germany

Location

GE228

Mannheim, 68165, Germany

Location

GE017

München, 81675, Germany

Location

GE157

Nuremberg, 90402, Germany

Location

GE098

Ulm, 89081, Germany

Location

GE251

Westerstede, 26655, Germany

Location

IT053

Brescia, 25125, Italy

Location

IT124

Cefalù, 90015, Italy

Location

IT030

Pavia, 27100, Italy

Location

IT103

Perugia, 06156, Italy

Location

IT072

Roma, 00168, Italy

Location

IT183

Roma, 00179, Italy

Location

IT029

Roma, 00189, Italy

Location

IT175

Rome, 00185, Italy

Location

IT085

Torino, 10 126, Italy

Location

PO013

Bialystok, 15-756, Poland

Location

PO024

Bydgoszcz, 85-080, Poland

Location

PO010

Bydgoszcz, 85-796, Poland

Location

PO107

Katowice, 40-123, Poland

Location

PO092

Katowice, 40-749, Poland

Location

PO023

Krakow, 30-349, Poland

Location

PO025

Krakow, 35-505, Poland

Location

PO009

Poznan, 61-853, Poland

Location

PO014

Szczecin, 70-111, Poland

Location

PO074

Warsaw, 01-697, Poland

Location

SE164

Belgrade, 11 000, Serbia

Location

SE090

Belgrade, 11000, Serbia

Location

SE166

Belgrade, 11000, Serbia

Location

SE193

Belgrade, 11000, Serbia

Location

SE155

Kragujevac, 34000, Serbia

Location

SE031

Novi Kneževac, 23330, Serbia

Location

SE165

Vršac, 26300, Serbia

Location

SI052

Singapore, 119074, Singapore

Location

SI026

Singapore, 308433, Singapore

Location

SL056

Banská Bystrica, 97404, Slovakia

Location

SL192

Bratislava, 820 07, Slovakia

Location

SL200

Dubnica nad Váhom, 01841, Slovakia

Location

SL191

Košice, 040 17, Slovakia

Location

SL078

Krompachy, 05342, Slovakia

Location

SL077

Svidník, 08901, Slovakia

Location

SK066

Busan, 49201, South Korea

Location

SK067

Seoul, 06351, South Korea

Location

SK190

Seoul, 07061, South Korea

Location

SP249

Alicante, 03690, Spain

Location

SP176

Barcelona, 08003, Spain

Location

SP022

Barcelona, 08028, Spain

Location

SP021

Barcelona, 08035, Spain

Location

SP250

Barcelona, 08036, Spain

Location

SP019

Ceuta, 51003, Spain

Location

SP194

Donostia / San Sebastian, 20014, Spain

Location

SP222

Getxo, 48993, Spain

Location

SP018

Madrid, 28040, Spain

Location

SP093

Madrid, 28046, Spain

Location

SP184

Sant Cugat del Vallès, 08190, Spain

Location

SP020

Terrassa, 08221, Spain

Location

TA065

Kaohsiung City, 833, Taiwan

Location

TA086

Taipei, 100, Taiwan

Location

TA121

Taoyuan District, 333, Taiwan

Location

UK063

Bath, BA1 3NG, United Kingdom

Location

UK038

Blackpool, FY2 0JH, United Kingdom

Location

UK233

Cambridge, CB21 5EF, United Kingdom

Location

UK033

Cannock, WS11 0BN, United Kingdom

Location

UK211

Epping, CM16 6TN, United Kingdom

Location

UK234

Guildford, GU2 7YD, United Kingdom

Location

UK055

Leeds, LS10 1DU, United Kingdom

Location

UK039

London, W1G 9JF, United Kingdom

Location

UK034

Manchester, M13 9NQ, United Kingdom

Location

UK229

Norwich, NR2 3TD, United Kingdom

Location

UK087

Oxford, OX3 9DU, United Kingdom

Location

UK235

Plymouth, PL5 8BT, United Kingdom

Location

UK100

Sheffield, S5 7JT, United Kingdom

Location

UK064

Southampton, SO16 6YD, United Kingdom

Location

UK152

Southampton, SO30 3JB, United Kingdom

Location

UK153

Swindon, SN3 6BW, United Kingdom

Location

UK154

Warrington, WA22 8WA, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

3-benzenesulfonyl-8-piperazin-1-ylquinoline

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Ilise Lombardo, MD
• Organization: Axovant Sciences, Inc.

ilise.lombardo@axovant.com

646-822-8626

Study Officials

• Ilise Lombardo, MD

  Axovant Sciences, Inc., Vice President, Clinical Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 26, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 5, 2018
• Results First Posted: December 5, 2018

Record last verified: 2018-11

Locations

BU (4); IT (9); SL (6); CZ (5); US (61); AR (17); CL (4); SE (7); DE (12); CA (10); CR (5); FR (4); TW (3); GB (17); PL (10); AU (6); KR (3); ES (12); SG (2)