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

NCT02586909 | Terminated Phase 3 Results DMC

• 1 other identifier: RVT-101-3002
• Study Type: interventional
• Target: 1,099
• Locations: 19 countries
• Sites: 169

Brief 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

Alzheimer's Disease

Keywords

Alzheimer's disease; RVT-101; donepezil

Outcome Measures

Primary Outcomes (1)

• Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments

  The primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments

  Baseline to 12 months or Early Termination

Study Arms (1)

RVT-101 35 mg tablets

EXPERIMENTAL

once daily, oral tablets

Drug: RVT-101 35 mg tablets

Interventions

RVT-101 35 mg tablets DRUG

once daily, oral tablets

RVT-101 35 mg tablets

Eligibility Criteria

• Age: 50 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Axovant Sciences Ltd.: lead

Study Sites (169)

US112

Phoenix, Arizona, 85005, United States

Location

US220

Tucson, Arizona, 85704, United States

Location

US096

Rancho Mirage, California, 92270, United States

Location

US195

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

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

US008

Cincinnati, Ohio, 45227, United States

Location

US113

Cleveland, Ohio, 44106, 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

US162

Plains, Pennsylvania, 18075, United States

Location

US148

Willow Grove, Pennsylvania, 19001, 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

AR101

Buenos Aires, B1828CKR, Argentina

Location

AR060

Buenos Aires, C1199ABB, Argentina

Location

AR084

Ciudad Autonoma de Buenos Aire, C1012AAR, Argentina

Location

AR027

Ciudad Autonoma de Buenos Aire, C1058AAJ, Argentina

Location

AR012

Ciudad Autonoma de Buenos Aire, C1111AAL, Argentina

Location

AR160

Ciudad Autonoma de Buenos Aire, C1117ABH, Argentina

Location

AR028

Ciudad Autonoma de Buenos Aire, C1406BOA, Argentina

Location

AR035

Ciudad Autonoma de Buenos Aire, C1428AQK, Argentina

Location

AR040

Ciudad Autónoma de Buenos Aire, C1405BCK, Argentina

Location

AR081

Ciudad Autónoma de Buenos Aire, C1425AHQ, Argentina

Location

AR051

Córdoba, X5000DCE, Argentina

Location

AR137

Córdoba, X5000FJF, Argentina

Location

AR126

Córdoba, X5004AOA, Argentina

Location

AR210

Mendoza, M5501ACP, Argentina

Location

AR219

Mendoza, M5502AHV, Argentina

Location

AR059

Santiago del Estero, G4200DND, Argentina

Location

AU227

Caulfield, VIC 3162, Australia

Location

AU032

Heidelberg West, VIC 3081, 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

BU073

Varna, 9000, Bulgaria

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

CA236

Gatineau, Quebec, J8T 8JI, 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

CR070

Zagreb, 10090, Croatia

Location

CZE128

Prague, 100 00, Czechia

Location

CZE207

Prague, 100 00, Czechia

Location

CZE132

Prague, 12000, Czechia

Location

CZE129

Prague, 160 00, Czechia

Location

CZE161

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

IT029

Roma, 00189, Italy

Location

IT183

Rome, 00179, 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

PO009

Poznan, 61-853, Poland

Location

PO014

Szczecin, 70-111, Poland

Location

PO074

Warsaw, 01-697, Poland

Location

SE164

Belgrade, 11 000, Serbia

Location

SE193

Belgrade, 11 000, Serbia

Location

SE090

Belgrade, 11000, Serbia

Location

SE155

Kragujevac, 34 000, 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, 974 04, Slovakia

Location

SL200

Dubnica nad Váhom, 018 41, Slovakia

Location

SL078

Krompachy, 040 01, 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

SP184

Barcelona, 08195, Spain

Location

SP222

Getxo, 48993, Spain

Location

SP194

San Sebastián, 20014, Spain

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

Carnoch, 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 9RU, United Kingdom

Location

UK034

Manchester, M13 9NQ, 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

Interventions

3-benzenesulfonyl-8-piperazin-1-ylquinoline

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Yi Mo, PhD
• Organization: Axovant Gene Therapies

yi.mo@axovant.com

1-929-227-3828

Study Officials

• Ilise Lombardo, MD

  Axovant Sciences, Inc., Vice President, Clinical Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 27, 2015
• Study Start: April 26, 2016
• Primary Completion: March 12, 2018
• Study Completion: March 12, 2018
• Last Updated: April 17, 2020
• Results First Posted: April 17, 2020

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); SE (6); SL (5); ES (8); US (52); KR (3); TW (1); AR (17); CR (3); CL (4); CA (7); PL (8); DE (12); IT (9); CZ (5); SG (2); GB (16); AU (4); BU (3)