Clinical trial NCT02586909: 12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension
Official title: A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
RVT-101
donepezil
Lead sponsor: Sio Gene Therapies
Sponsor class: INDUSTRY
First posted: 2015-10-27
Enrollment: 1099
Sex: ALL
Minimum age (years): 50
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments
timeFrame: Baseline to 12 months or Early Termination
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: US112
state: Arizona
city: Tucson
country: United States
facility: US220
state: Arizona
city: Rancho Mirage
country: United States
facility: US096
state: California
city: Santa Ana
country: United States
facility: US195
state: California
city: Simi Valley
country: United States
facility: US016
state: California
city: Temecula
country: United States
facility: US106
state: California
city: Hamden
country: United States
facility: US179
state: Connecticut
city: Norwich
country: United States
facility: US171
state: Connecticut
city: Atlantis
country: United States
facility: US088
state: Florida
city: Brooksville
country: United States
facility: US007
state: Florida
city: Hallandale Beach
country: United States
facility: US002
state: Florida
city: Hialeah
country: United States
facility: US140
state: Florida
city: Miami
country: United States
facility: US216
state: Florida
city: Miami
country: United States
facility: US110
state: Florida
city: North Palm Beach
country: United States
facility: US172
state: Florida
city: Orlando
country: United States
facility: US003
state: Florida
city: Pensacola
country: United States
facility: US256
state: Florida
city: Tampa
country: United States
facility: US037
state: Florida
city: Tampa
country: United States
facility: US042
state: Florida
city: The Villages
country: United States
facility: US004
state: Florida
city: Atlanta
country: United States
facility: US048
state: Georgia
city: Atlanta
country: United States
facility: US046
state: Georgia
city: Columbus
country: United States
facility: US217
state: Georgia
city: Baton Rouge
country: United States
facility: US111
state: Louisiana
city: Shreveport
country: United States
facility: US095
state: Louisiana
city: Newton
country: United States
facility: US116
state: Massachusetts
city: Quincy
country: United States
facility: US174
state: Massachusetts
city: Hattiesburg
country: United States
facility: US144
state: Mississippi
city: Las Vegas
country: United States
facility: US094
state: Nevada
city: Berlin
country: United States
facility: US135
state: New Jersey
city: Lawrenceville
country: United States
facility: US197
state: New Jersey
city: Manchester
country: United States
facility: US057
state: New Jersey
city: Mount Arlington
country: United States
facility: US215
state: New Jersey
city: Toms River
country: United States
facility: US209
state: New Jersey
city: West Long Branch
country: United States
facility: US036
state: New Jersey
city: Albany
country: United States
facility: US001
state: New York
city: Brooklyn
country: United States
facility: US049
state: New York
city: New Hyde Park
country: United States
facility: US097
state: New York
city: New York
country: United States
facility: US044
state: New York
city: Chapel Hill
country: United States
facility: US150
state: North Carolina
city: Charlotte
country: United States
facility: US185
state: North Carolina
city: Cincinnati
country: United States
facility: US008
state: Ohio
city: Cleveland
country: United States
facility: US113
state: Ohio
city: Shaker Heights
country: United States
facility: US119
state: Ohio
city: Portland
country: United States
facility: US134
state: Oregon
city: Media
country: United States
facility: US169
state: Pennsylvania
city: Plains
country: United States
facility: US162
state: Pennsylvania
city: Willow Grove
country: United States
facility: US148
state: Pennsylvania
city: San Antonio
country: United States
facility: US043
state: Texas
city: Orem
country: United States
facility: US143
state: Utah
city: Charlottesville
country: United States
facility: US149
state: Virginia
city: Spokane
country: United States
facility: US170
state: Washington
city: La Plata
country: Argentina
facility: AR130
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: AR101
city: Buenos Aires
country: Argentina
facility: AR060
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: AR084
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: AR027
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: AR012
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: AR160
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: AR028
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: AR035
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: AR040
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: AR081
city: Córdoba
country: Argentina
facility: AR051
city: Córdoba
country: Argentina
facility: AR137
city: Córdoba
country: Argentina
facility: AR126
city: Mendoza
country: Argentina
facility: AR210
city: Mendoza
country: Argentina
facility: AR219
city: Santiago del Estero
country: Argentina
facility: AR059
city: Caulfield
country: Australia
facility: AU227
city: Heidelberg West
country: Australia
facility: AU032
city: Hornsby
country: Australia
facility: AU011
city: West Perth
country: Australia
facility: AU138
city: Ruse
country: Bulgaria
facility: BU125
city: Sofia
country: Bulgaria
facility: BU131
city: Varna
country: Bulgaria
facility: BU073
city: Kelowna
country: Canada
facility: CA054
state: British Columbia
city: Kelowna
country: Canada
facility: CA188
state: British Columbia
city: Penticton
country: Canada
facility: CA186
state: British Columbia
city: West Vancouver
country: Canada
facility: CA141
state: British Columbia
city: Newmarket
country: Canada
facility: CA147
state: Ontario
city: North York
country: Canada
facility: CA196
state: Ontario
city: Gatineau
country: Canada
facility: CA236
state: Quebec
city: Antofagasta
country: Chile
facility: CH212
state: II Región
city: Santiago
country: Chile
facility: CH076
state: Region Metropolitana
city: Santiago
country: Chile
facility: CH061
state: Región Metropolitana
city: Santiago
country: Chile
facility: CH075
state: Región Metropolitana
city: Zagreb
country: Croatia
facility: CR069
city: Zagreb
country: Croatia
facility: CR122
city: Zagreb
country: Croatia
facility: CR070
city: Praha 10
country: Czechia
facility: CZE128
city: Praha 2
country: Czechia
facility: CZE132
city: Praha 6
country: Czechia
facility: CZE129
city: Praha
country: Czechia
facility: CZE207
city: Rychnov nad Kneznou
country: Czechia
facility: CZE161
city: Lille Cedex
country: France
facility: FR231
city: Marseille Cedex 5
country: France
facility: FR182
city: Paris Cedex
country: France
facility: FR221
city: Villeurbanne
country: France
facility: FR202
city: Bad Homburg
country: Germany
facility: GE206
city: Berlin
country: Germany
facility: GE091
city: Berlin
country: Germany
facility: GE071
city: Berlin
country: Germany
facility: GE139
city: Cologne
country: Germany
facility: GE230
city: Ellwangen
country: Germany
facility: GE252
city: Leipzig
country: Germany
facility: GE180
city: Mannheim
country: Germany
facility: GE228
city: Munchen
country: Germany
facility: GE017
city: Nürnberg
country: Germany
facility: GE157
city: Ulm
country: Germany
facility: GE098
city: Westerstede
country: Germany
facility: GE251
city: Brescia
country: Italy
facility: IT053
city: Cefalu
country: Italy
facility: IT124
city: Pavia
country: Italy
facility: IT030
city: Perugia
country: Italy
facility: IT103
city: Roma
country: Italy
facility: IT072
city: Roma
country: Italy
facility: IT029
city: Rome
country: Italy
facility: IT183
city: Rome
country: Italy
facility: IT175
city: Torino
country: Italy
facility: IT085
city: Busan
country: Korea, Republic of
facility: SK066
city: Seoul
country: Korea, Republic of
facility: SK067
city: Seoul
country: Korea, Republic of
facility: SK190
city: Bialystok
country: Poland
facility: PO013
city: Bydgoszcz
country: Poland
facility: PO024
city: Bydgoszcz
country: Poland
facility: PO010
city: Katowice
country: Poland
facility: PO107
city: Katowice
country: Poland
facility: PO092
city: Poznan
country: Poland
facility: PO009
city: Szczecin
country: Poland
facility: PO014
city: Warszawa
country: Poland
facility: PO074
city: Belgrade
country: Serbia
facility: SE164
city: Belgrade
country: Serbia
facility: SE193
city: Belgrade
country: Serbia
facility: SE090
city: Kragujevac
country: Serbia
facility: SE155
city: Novi Kneževac
country: Serbia
facility: SE031
city: Vršac
country: Serbia
facility: SE165
city: Singapore
country: Singapore
facility: SI052
city: Singapore
country: Singapore
facility: SI026
city: Banska Bystrica
country: Slovakia
facility: SL056
city: Dubnica nad Vahom
country: Slovakia
facility: SL200
city: Krompachy
country: Slovakia
facility: SL078
city: Krompachy
country: Slovakia
facility: SL078
city: Svidník
country: Slovakia
facility: SL077
city: Alicante
country: Spain
facility: SP249
city: Barcelona
country: Spain
facility: SP176
city: Barcelona
country: Spain
facility: SP022
city: Barcelona
country: Spain
facility: SP021
city: Barcelona
country: Spain
facility: SP250
city: Barcelona
country: Spain
facility: SP184
city: Getxo
country: Spain
facility: SP222
city: San Sebastián
country: Spain
facility: SP194
city: Taoyuan
country: Taiwan
facility: TA121
city: Bath
country: United Kingdom
facility: UK063
city: Blackpool
country: United Kingdom
facility: UK038
city: Cambridge
country: United Kingdom
facility: UK233
city: Carnoch
country: United Kingdom
facility: UK033
city: Epping
country: United Kingdom
facility: UK211
city: Guildford
country: United Kingdom
facility: UK234
city: Leeds
country: United Kingdom
facility: UK055
city: London
country: United Kingdom
facility: UK039
city: Manchester
country: United Kingdom
facility: UK034
city: Oxford
country: United Kingdom
facility: UK087
city: Plymouth
country: United Kingdom
facility: UK235
city: Sheffield
country: United Kingdom
facility: UK100
city: Southampton
country: United Kingdom
facility: UK064
city: Southampton
country: United Kingdom
facility: UK152
city: Swindon
country: United Kingdom
facility: UK153
city: Warrington
country: United Kingdom
facility: UK154
Study officials:
affiliation: Axovant Sciences, Inc., Vice President, Clinical Research
name: Ilise Lombardo, MD
role: STUDY_DIRECTOR
References: