12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension
- Conditions
- Alzheimer's Disease
- Interventions
- Drug: RVT-101 35 mg tablets
- Registration Number
- NCT02586909
- Lead Sponsor
- Axovant Sciences Ltd.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1099
- Completed last on-treatment visit of the lead-in study RVT-101-3001
- Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RVT-101 35 mg tablets RVT-101 35 mg tablets once daily, oral tablets
- Primary Outcome Measures
Name Time Method Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments Baseline to 12 months or Early Termination 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (168)
US220
🇺🇸Tucson, Arizona, United States
US209
🇺🇸Toms River, New Jersey, United States
US171
🇺🇸Norwich, Connecticut, United States
US036
🇺🇸West Long Branch, New Jersey, United States
AR084
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
AR028
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
AR027
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
CR070
🇭🇷Zagreb, Croatia
AR035
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
AR219
🇦🇷Mendoza, Argentina
CA186
🇨🇦Penticton, British Columbia, Canada
CA236
🇨🇦Gatineau, Quebec, Canada
CH061
🇨🇱Santiago, Región Metropolitana, Chile
CH075
🇨🇱Santiago, Región Metropolitana, Chile
US113
🇺🇸Cleveland, Ohio, United States
US016
🇺🇸Simi Valley, California, United States
US096
🇺🇸Rancho Mirage, California, United States
US195
🇺🇸Santa Ana, California, United States
US106
🇺🇸Temecula, California, United States
US179
🇺🇸Hamden, Connecticut, United States
US088
🇺🇸Atlantis, Florida, United States
US002
🇺🇸Hallandale Beach, Florida, United States
US007
🇺🇸Brooksville, Florida, United States
US140
🇺🇸Hialeah, Florida, United States
US172
🇺🇸North Palm Beach, Florida, United States
US256
🇺🇸Pensacola, Florida, United States
US004
🇺🇸The Villages, Florida, United States
US111
🇺🇸Baton Rouge, Louisiana, United States
US048
🇺🇸Atlanta, Georgia, United States
US046
🇺🇸Atlanta, Georgia, United States
US095
🇺🇸Shreveport, Louisiana, United States
US185
🇺🇸Charlotte, North Carolina, United States
US149
🇺🇸Charlottesville, Virginia, United States
US148
🇺🇸Willow Grove, Pennsylvania, United States
US162
🇺🇸Plains, Pennsylvania, United States
AR130
🇦🇷La Plata, Buenos Aires, Argentina
AR101
🇦🇷Buenos Aires, Argentina
AR060
🇦🇷Buenos Aires, Argentina
AR012
🇦🇷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
AR210
🇦🇷Mendoza, Argentina
AR137
🇦🇷Córdoba, Argentina
AR126
🇦🇷Córdoba, Argentina
AR059
🇦🇷Santiago del Estero, Argentina
AU227
🇦🇺Caulfield, Australia
AU032
🇦🇺Heidelberg West, Australia
AU011
🇦🇺Hornsby, Australia
BU131
🇧🇬Sofia, Bulgaria
AU138
🇦🇺West Perth, Australia
BU125
🇧🇬Ruse, Bulgaria
BU073
🇧🇬Varna, Bulgaria
CA188
🇨🇦Kelowna, British Columbia, Canada
CA054
🇨🇦Kelowna, British Columbia, Canada
CA196
🇨🇦North York, Ontario, Canada
CA141
🇨🇦West Vancouver, British Columbia, Canada
CA147
🇨🇦Newmarket, Ontario, Canada
CH076
🇨🇱Santiago, Region Metropolitana, Chile
CH212
🇨🇱Antofagasta, II Región, Chile
CR122
🇭🇷Zagreb, Croatia
CZE132
🇨🇿Praha 2, Czechia
CZE128
🇨🇿Praha 10, Czechia
CZE129
🇨🇿Praha 6, Czechia
CZE161
🇨🇿Rychnov nad Kneznou, Czechia
CZE207
🇨🇿Praha, Czechia
GE091
🇩🇪Berlin, Germany
FR182
🇫🇷Marseille Cedex 5, France
GE206
🇩🇪Bad Homburg, Germany
FR221
🇫🇷Paris Cedex, France
FR202
🇫🇷Villeurbanne, France
GE071
🇩🇪Berlin, Germany
GE139
🇩🇪Berlin, Germany
GE228
🇩🇪Mannheim, Germany
GE230
🇩🇪Cologne, Germany
GE017
🇩🇪Munchen, Germany
GE098
🇩🇪Ulm, Germany
GE180
🇩🇪Leipzig, Germany
GE252
🇩🇪Ellwangen, Germany
GE157
🇩🇪Nürnberg, Germany
GE251
🇩🇪Westerstede, Germany
IT029
🇮🇹Roma, Italy
IT072
🇮🇹Roma, Italy
SK066
🇰🇷Busan, Korea, Republic of
PO009
🇵🇱Poznan, Poland
PO013
🇵🇱Bialystok, Poland
SE193
🇷🇸Belgrade, Serbia
SE165
🇷🇸Vršac, Serbia
SI052
🇸🇬Singapore, Singapore
SI026
🇸🇬Singapore, Singapore
SL200
🇸🇰Dubnica nad Vahom, Slovakia
SL078
🇸🇰Krompachy, Slovakia
SP249
🇪🇸Alicante, Spain
SP021
🇪🇸Barcelona, Spain
SP022
🇪🇸Barcelona, Spain
SP184
🇪🇸Barcelona, Spain
SP250
🇪🇸Barcelona, Spain
TA121
🇨🇳Taoyuan, Taiwan
SP222
🇪🇸Getxo, Spain
UK063
🇬🇧Bath, United Kingdom
SP194
🇪🇸San Sebastián, Spain
UK038
🇬🇧Blackpool, United Kingdom
UK233
🇬🇧Cambridge, United Kingdom
UK055
🇬🇧Leeds, United Kingdom
UK234
🇬🇧Guildford, United Kingdom
UK033
🇬🇧Carnoch, United Kingdom
UK039
🇬🇧London, United Kingdom
UK211
🇬🇧Epping, United Kingdom
UK034
🇬🇧Manchester, United Kingdom
UK087
🇬🇧Oxford, United Kingdom
UK100
🇬🇧Sheffield, United Kingdom
UK235
🇬🇧Plymouth, United Kingdom
UK152
🇬🇧Southampton, United Kingdom
UK064
🇬🇧Southampton, United Kingdom
UK153
🇬🇧Swindon, United Kingdom
UK154
🇬🇧Warrington, United Kingdom
IT053
🇮🇹Brescia, Italy
IT124
🇮🇹Cefalu, Italy
IT030
🇮🇹Pavia, Italy
IT103
🇮🇹Perugia, Italy
US143
🇺🇸Orem, Utah, United States
US144
🇺🇸Hattiesburg, Mississippi, United States
US116
🇺🇸Newton, Massachusetts, United States
US174
🇺🇸Quincy, Massachusetts, United States
US049
🇺🇸Brooklyn, New York, United States
US197
🇺🇸Lawrenceville, New Jersey, United States
US215
🇺🇸Mount Arlington, New Jersey, United States
US057
🇺🇸Manchester, New Jersey, United States
US135
🇺🇸Berlin, New Jersey, United States
US001
🇺🇸Albany, New York, United States
US119
🇺🇸Shaker Heights, Ohio, United States
US170
🇺🇸Spokane, Washington, United States
US169
🇺🇸Media, Pennsylvania, United States
PO024
🇵🇱Bydgoszcz, Poland
PO010
🇵🇱Bydgoszcz, Poland
PO092
🇵🇱Katowice, Poland
SE164
🇷🇸Belgrade, Serbia
SE155
🇷🇸Kragujevac, Serbia
SE031
🇷🇸Novi Kneževac, Serbia
SL056
🇸🇰Banska Bystrica, Slovakia
CR069
🇭🇷Zagreb, Croatia
FR231
🇫🇷Lille Cedex, France
IT175
🇮🇹Rome, Italy
IT085
🇮🇹Torino, Italy
PO014
🇵🇱Szczecin, Poland
IT183
🇮🇹Rome, Italy
PO107
🇵🇱Katowice, Poland
SE090
🇷🇸Belgrade, Serbia
PO074
🇵🇱Warszawa, Poland
SK067
🇰🇷Seoul, Korea, Republic of
SL077
🇸🇰Svidník, Slovakia
US037
🇺🇸Tampa, Florida, United States
US217
🇺🇸Columbus, Georgia, United States
US097
🇺🇸New Hyde Park, New York, United States
US044
🇺🇸New York, New York, United States
SP176
🇪🇸Barcelona, Spain
US042
🇺🇸Tampa, Florida, United States
SK190
🇰🇷Seoul, Korea, Republic of
US112
🇺🇸Phoenix, Arizona, United States
US216
🇺🇸Miami, Florida, United States
US110
🇺🇸Miami, Florida, United States
US003
🇺🇸Orlando, Florida, United States
US094
🇺🇸Las Vegas, Nevada, United States
US150
🇺🇸Chapel Hill, North Carolina, United States
US008
🇺🇸Cincinnati, Ohio, United States
US134
🇺🇸Portland, Oregon, United States
US043
🇺🇸San Antonio, Texas, United States