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

Alzheimer's Disease Clinical Trial

Official title:

A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Alzheimer's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02586909
• Other study ID #: RVT-101-3002
• Status: Terminated
• Phase: Phase 3
• Start date: April 26, 2016
• Est. completion date: March 12, 2018

Study information

• Verified date: March 2018
• Source: Axovant Sciences Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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. Various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1099
• Est. completion date: March 12, 2018
• Est. primary completion date: March 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 86 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• RVT-101 35 mg tablets
once daily, oral tablets

Locations

Country	Name	City	State
Argentina	AR060	Buenos Aires
Argentina	AR101	Buenos Aires
Argentina	AR012	Ciudad Autonoma de Buenos Aire
Argentina	AR027	Ciudad Autonoma de Buenos Aire
Argentina	AR028	Ciudad Autonoma de Buenos Aire
Argentina	AR035	Ciudad Autonoma de Buenos Aire
Argentina	AR084	Ciudad Autonoma de Buenos Aire
Argentina	AR160	Ciudad Autonoma de Buenos Aire
Argentina	AR040	Ciudad Autónoma de Buenos Aire
Argentina	AR081	Ciudad Autónoma de Buenos Aire
Argentina	AR051	Córdoba
Argentina	AR126	Córdoba
Argentina	AR137	Córdoba
Argentina	AR130	La Plata	Buenos Aires
Argentina	AR210	Mendoza
Argentina	AR219	Mendoza
Argentina	AR059	Santiago del Estero
Australia	AU227	Caulfield
Australia	AU032	Heidelberg West
Australia	AU011	Hornsby
Australia	AU138	West Perth
Bulgaria	BU125	Ruse
Bulgaria	BU131	Sofia
Bulgaria	BU073	Varna
Canada	CA236	Gatineau	Quebec
Canada	CA054	Kelowna	British Columbia
Canada	CA188	Kelowna	British Columbia
Canada	CA147	Newmarket	Ontario
Canada	CA196	North York	Ontario
Canada	CA186	Penticton	British Columbia
Canada	CA141	West Vancouver	British Columbia
Chile	CH212	Antofagasta	II Región
Chile	CH061	Santiago	Región Metropolitana
Chile	CH075	Santiago	Región Metropolitana
Chile	CH076	Santiago	Region Metropolitana
Croatia	CR069	Zagreb
Croatia	CR070	Zagreb
Croatia	CR122	Zagreb
Czechia	CZE207	Praha
Czechia	CZE128	Praha 10
Czechia	CZE132	Praha 2
Czechia	CZE129	Praha 6
Czechia	CZE161	Rychnov nad Kneznou
France	FR231	Lille Cedex
France	FR182	Marseille Cedex 5
France	FR221	Paris Cedex
France	FR202	Villeurbanne
Germany	GE206	Bad Homburg
Germany	GE071	Berlin
Germany	GE091	Berlin
Germany	GE139	Berlin
Germany	GE230	Cologne
Germany	GE252	Ellwangen
Germany	GE180	Leipzig
Germany	GE228	Mannheim
Germany	GE017	Munchen
Germany	GE157	Nürnberg
Germany	GE098	Ulm
Germany	GE251	Westerstede
Italy	IT053	Brescia
Italy	IT124	Cefalu
Italy	IT030	Pavia
Italy	IT103	Perugia
Italy	IT029	Roma
Italy	IT072	Roma
Italy	IT175	Rome
Italy	IT183	Rome
Italy	IT085	Torino
Korea, Republic of	SK066	Busan
Korea, Republic of	SK067	Seoul
Korea, Republic of	SK190	Seoul
Poland	PO013	Bialystok
Poland	PO010	Bydgoszcz
Poland	PO024	Bydgoszcz
Poland	PO092	Katowice
Poland	PO107	Katowice
Poland	PO009	Poznan
Poland	PO014	Szczecin
Poland	PO074	Warszawa
Serbia	SE090	Belgrade
Serbia	SE164	Belgrade
Serbia	SE193	Belgrade
Serbia	SE155	Kragujevac
Serbia	SE031	Novi Kneževac
Serbia	SE165	Vršac
Singapore	SI026	Singapore
Singapore	SI052	Singapore
Slovakia	SL056	Banska Bystrica
Slovakia	SL200	Dubnica nad Vahom
Slovakia	SL078	Krompachy
Slovakia	SL078	Krompachy
Slovakia	SL077	Svidník
Spain	SP249	Alicante
Spain	SP021	Barcelona
Spain	SP022	Barcelona
Spain	SP176	Barcelona
Spain	SP184	Barcelona
Spain	SP250	Barcelona
Spain	SP222	Getxo
Spain	SP194	San Sebastián
Taiwan	TA121	Taoyuan
United Kingdom	UK063	Bath
United Kingdom	UK038	Blackpool
United Kingdom	UK233	Cambridge
United Kingdom	UK033	Carnoch
United Kingdom	UK211	Epping
United Kingdom	UK234	Guildford
United Kingdom	UK055	Leeds
United Kingdom	UK039	London
United Kingdom	UK034	Manchester
United Kingdom	UK087	Oxford
United Kingdom	UK235	Plymouth
United Kingdom	UK100	Sheffield
United Kingdom	UK064	Southampton
United Kingdom	UK152	Southampton
United Kingdom	UK153	Swindon
United Kingdom	UK154	Warrington
United States	US001	Albany	New York
United States	US046	Atlanta	Georgia
United States	US048	Atlanta	Georgia
United States	US088	Atlantis	Florida
United States	US111	Baton Rouge	Louisiana
United States	US135	Berlin	New Jersey
United States	US049	Brooklyn	New York
United States	US007	Brooksville	Florida
United States	US150	Chapel Hill	North Carolina
United States	US185	Charlotte	North Carolina
United States	US149	Charlottesville	Virginia
United States	US008	Cincinnati	Ohio
United States	US113	Cleveland	Ohio
United States	US217	Columbus	Georgia
United States	US002	Hallandale Beach	Florida
United States	US179	Hamden	Connecticut
United States	US144	Hattiesburg	Mississippi
United States	US140	Hialeah	Florida
United States	US094	Las Vegas	Nevada
United States	US197	Lawrenceville	New Jersey
United States	US057	Manchester	New Jersey
United States	US169	Media	Pennsylvania
United States	US110	Miami	Florida
United States	US216	Miami	Florida
United States	US215	Mount Arlington	New Jersey
United States	US097	New Hyde Park	New York
United States	US044	New York	New York
United States	US116	Newton	Massachusetts
United States	US172	North Palm Beach	Florida
United States	US171	Norwich	Connecticut
United States	US143	Orem	Utah
United States	US003	Orlando	Florida
United States	US256	Pensacola	Florida
United States	US112	Phoenix	Arizona
United States	US162	Plains	Pennsylvania
United States	US134	Portland	Oregon
United States	US174	Quincy	Massachusetts
United States	US096	Rancho Mirage	California
United States	US043	San Antonio	Texas
United States	US195	Santa Ana	California
United States	US119	Shaker Heights	Ohio
United States	US095	Shreveport	Louisiana
United States	US016	Simi Valley	California
United States	US170	Spokane	Washington
United States	US037	Tampa	Florida
United States	US042	Tampa	Florida
United States	US106	Temecula	California
United States	US004	The Villages	Florida
United States	US209	Toms River	New Jersey
United States	US220	Tucson	Arizona
United States	US036	West Long Branch	New Jersey
United States	US148	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Axovant Sciences Ltd.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bulgaria,  Canada,  Chile,  Croatia,  Czechia,  France,  Germany,  Italy,  Korea, Republic of,  Poland,  Serbia,  Singapore,  Slovakia,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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