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12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension
This study is enrolling participants by invitation only.
Sponsor:
Axovant Sciences Ltd.
Information provided by (Responsible Party):
Axovant Sciences Ltd.
ClinicalTrials.gov Identifier:
NCT02586909
First received: October 23, 2015
Last updated: June 29, 2017
Last verified: June 2017
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Alzheimer's Disease | Drug: RVT-101 35 mg tablets | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Alzheimer's Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Axovant Sciences Ltd.:
Primary Outcome Measures:
- Occurrence of adverse events (AEs) and or reported changes in physical examinations, vital signs measurements, electrocardiograms (ECGs), routine laboratory assessments [ Time Frame: Baseline to 12 months or Early Termination ]
| Estimated Enrollment: | 1150 |
| Study Start Date: | April 2016 |
| Estimated Study Completion Date: | June 2018 |
| Estimated Primary Completion Date: | June 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: RVT-101 35 mg tablets
once daily, oral tablets
|
Drug: RVT-101 35 mg tablets
once daily, oral tablets
|
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| Ages Eligible for Study: | 50 Years to 86 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02586909
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02586909
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Locations
| United States, Arizona | |
| US112 | |
| Phoenix, Arizona, United States, 85005 | |
| US220 | |
| Tucson, Arizona, United States, 85704 | |
| United States, California | |
| US096 | |
| Rancho Mirage, California, United States, 92270 | |
| US195 | |
| Santa Ana, California, United States, 92705 | |
| US016 | |
| Simi Valley, California, United States, 93065 | |
| US106 | |
| Temecula, California, United States, 92591 | |
| United States, Connecticut | |
| US179 | |
| Hamden, Connecticut, United States, 06518 | |
| US171 | |
| Norwich, Connecticut, United States, 06360 | |
| United States, Florida | |
| US088 | |
| Atlantis, Florida, United States, 33462 | |
| US007 | |
| Brooksville, Florida, United States, 34601 | |
| US002 | |
| Hallandale Beach, Florida, United States, 33009 | |
| US140 | |
| Hialeah, Florida, United States, 33012 | |
| US216 | |
| Miami, Florida, United States, 33137 | |
| US110 | |
| Miami, Florida, United States, 33165 | |
| US172 | |
| North Palm Beach, Florida, United States, 33408 | |
| US003 | |
| Orlando, Florida, United States, 32806 | |
| US256 | |
| Pensacola, Florida, United States, 32502 | |
| US037 | |
| Tampa, Florida, United States, 33613 | |
| US042 | |
| Tampa, Florida, United States, 33613 | |
| US004 | |
| The Villages, Florida, United States, 32162 | |
| United States, Georgia | |
| US048 | |
| Atlanta, Georgia, United States, 30331 | |
| US046 | |
| Atlanta, Georgia, United States, 30342 | |
| US217 | |
| Columbus, Georgia, United States, 31909 | |
| United States, Louisiana | |
| US111 | |
| Baton Rouge, Louisiana, United States, 70808 | |
| US095 | |
| Shreveport, Louisiana, United States, 71104 | |
| United States, Massachusetts | |
| US116 | |
| Newton, Massachusetts, United States, 02459 | |
| US174 | |
| Quincy, Massachusetts, United States, 02169 | |
| United States, Mississippi | |
| US144 | |
| Hattiesburg, Mississippi, United States, 39401 | |
| United States, Nevada | |
| US094 | |
| Las Vegas, Nevada, United States, 89113 | |
| United States, New Jersey | |
| US135 | |
| Berlin, New Jersey, United States, 08009 | |
| US197 | |
| Lawrenceville, New Jersey, United States, 08648 | |
| US057 | |
| Manchester Township, New Jersey, United States, 08759 | |
| US215 | |
| Mount Arlington, New Jersey, United States, 07856 | |
| US209 | |
| Toms River, New Jersey, United States, 08755 | |
| US036 | |
| West Long Branch, New Jersey, United States, 07764 | |
| United States, New York | |
| US001 | |
| Albany, New York, United States, 12208 | |
| US049 | |
| Brooklyn, New York, United States, 11235 | |
| US097 | |
| New Hyde Park, New York, United States, 11040 | |
| US044 | |
| New York, New York, United States, 10022 | |
| United States, North Carolina | |
| US150 | |
| Chapel Hill, North Carolina, United States, 27599 | |
| US185 | |
| Charlotte, North Carolina, United States, 28270 | |
| United States, Ohio | |
| US008 | |
| Cincinnati, Ohio, United States, 45227 | |
| US113 | |
| Cleveland, Ohio, United States, 44106 | |
| US119 | |
| Shaker Heights, Ohio, United States, 44122 | |
| United States, Oregon | |
| US134 | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| US169 | |
| Media, Pennsylvania, United States, 19063 | |
| US162 | |
| Plains, Pennsylvania, United States, 18075 | |
| US148 | |
| Willow Grove, Pennsylvania, United States, 19001 | |
| United States, Texas | |
| US043 | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| US143 | |
| Orem, Utah, United States, 84058 | |
| United States, Virginia | |
| US149 | |
| Charlottesville, Virginia, United States, 22903 | |
| United States, Washington | |
| US170 | |
| Spokane, Washington, United States, 99202 | |
| Argentina | |
| AR101 | |
| Buenos Aires, Argentina, B1828CKR | |
| AR084 | |
| Ciudad Autonoma de Buenos Aire, Argentina, C1012AAR | |
| AR027 | |
| Ciudad Autonoma de Buenos Aire, Argentina, C1058AAJ | |
| AR012 | |
| Ciudad Autonoma de Buenos Aire, Argentina, C1111AAL | |
| AR160 | |
| Ciudad Autonoma de Buenos Aire, Argentina, C1117ABH | |
| AR028 | |
| Ciudad Autonoma de Buenos Aire, Argentina, C1406BOA | |
| AR040 | |
| Ciudad Autónoma de Buenos Aire, Argentina, C1405BCK | |
| AR081 | |
| Ciudad Autónoma de Buenos Aire, Argentina, C1425AHQ | |
| AR051 | |
| Córdoba, Argentina, X5000DCE | |
| AR137 | |
| Córdoba, Argentina, X5000FJF | |
| AR126 | |
| Córdoba, Argentina, X5004AOA | |
| AR210 | |
| Mendoza, Argentina, M5501ACP | |
| AR219 | |
| Mendoza, Argentina, M5502AHV | |
| AR059 | |
| Santiago del Estero, Argentina, G4200DND | |
| Australia | |
| AU227 | |
| Caulfield, Australia, VIC 3162 | |
| AU032 | |
| Heidelberg West, Australia, VIC 3081 | |
| AU011 | |
| Hornsby, Australia, NSW 2077 | |
| AU138 | |
| West Perth, Australia, WA 6005 | |
| Bulgaria | |
| BU125 | |
| Ruse, Bulgaria, 7003 | |
| BU131 | |
| Sofia, Bulgaria, 1431 | |
| BU073 | |
| Varna, Bulgaria, 9000 | |
| Canada, British Columbia | |
| CA054 | |
| Kelowna, British Columbia, Canada, V1Y 1Z9 | |
| CA188 | |
| Kelowna, British Columbia, Canada, V1Y 4N7 | |
| CA186 | |
| Penticton, British Columbia, Canada, V2A 5C8 | |
| CA141 | |
| West Vancouver, British Columbia, Canada, V7T 2Z3 | |
| Canada, Ontario | |
| CA147 | |
| Newmarket, Ontario, Canada, L3Y 5G8 | |
| CA196 | |
| North York, Ontario, Canada, M3B 2S7 | |
| Canada, Quebec | |
| CA236 | |
| Gatineau, Quebec, Canada, J8T 8JI | |
| Croatia | |
| CR069 | |
| Zagreb, Croatia, 10000 | |
| CR122 | |
| Zagreb, Croatia, 10000 | |
| CR070 | |
| Zagreb, Croatia, 10090 | |
| Czechia | |
| CZE128 | |
| Praha 10, Czechia, 100 00 | |
| CZE132 | |
| Praha 2, Czechia, 12000 | |
| CZE129 | |
| Praha 6, Czechia, 160 00 | |
| CZE207 | |
| Praha, Czechia, 100 00 | |
| CZE161 | |
| Rychnov nad Kneznou, Czechia, 516 01 | |
| France | |
| FR231 | |
| Lille Cedex, France, 59037 | |
| FR182 | |
| Marseille Cedex 5, France, 13385 | |
| FR221 | |
| Paris Cedex, France, 75013 | |
| FR202 | |
| Villeurbanne, France, 69 100 | |
| Germany | |
| GE206 | |
| Bad Homburg, Germany, 61348 | |
| GE091 | |
| Berlin, Germany, 10117 | |
| GE071 | |
| Berlin, Germany, 12203 | |
| GE139 | |
| Berlin, Germany, 13125 | |
| GE230 | |
| Cologne, Germany, 50937 | |
| GE252 | |
| Ellwangen, Germany, 73479 | |
| GE180 | |
| Leipzig, Germany, 04107 | |
| GE228 | |
| Mannheim, Germany, 68165 | |
| GE017 | |
| Munchen, Germany, 81675 | |
| GE157 | |
| Nürnberg, Germany, 90402 | |
| GE098 | |
| Ulm, Germany, 89081 | |
| GE251 | |
| Westerstede, Germany, 26655 | |
| Italy | |
| IT053 | |
| Brescia, Italy, 25125 | |
| IT124 | |
| Cefalu, Italy, 90015 | |
| IT030 | |
| Pavia, Italy, 27100 | |
| IT103 | |
| Perugia, Italy, 06156 | |
| IT072 | |
| Roma, Italy, 00168 | |
| IT029 | |
| Roma, Italy, 00189 | |
| IT183 | |
| Rome, Italy, 00179 | |
| IT175 | |
| Rome, Italy, 00185 | |
| IT085 | |
| Torino, Italy, 10 126 | |
| Korea, Republic of | |
| SK066 | |
| Busan, Korea, Republic of, 49201 | |
| SK067 | |
| Seoul, Korea, Republic of, 06351 | |
| SK190 | |
| Seoul, Korea, Republic of, 07061 | |
| Poland | |
| PO013 | |
| Bialystok, Poland, 15-756 | |
| PO024 | |
| Bydgoszcz, Poland, 85-080 | |
| PO010 | |
| Bydgoszcz, Poland, 85-796 | |
| PO107 | |
| Katowice, Poland, 40-123 | |
| PO092 | |
| Katowice, Poland, 40-749 | |
| PO009 | |
| Poznan, Poland, 61-853 | |
| PO014 | |
| Szczecin, Poland, 70-111 | |
| PO074 | |
| Warszawa, Poland, 01-697 | |
| Serbia | |
| SE164 | |
| Belgrade, Serbia, 11 000 | |
| SE193 | |
| Belgrade, Serbia, 11 000 | |
| SE090 | |
| Belgrade, Serbia, 11000 | |
| SE155 | |
| Kragujevac, Serbia, 34 000 | |
| SE031 | |
| Novi Kneževac, Serbia, 23330 | |
| SE165 | |
| Vršac, Serbia, 26300 | |
| Singapore | |
| SI052 | |
| Singapore, Singapore, 119074 | |
| SI026 | |
| Singapore, Singapore, 308433 | |
| Slovakia | |
| SL056 | |
| Banska Bystrica, Slovakia, 974 04 | |
| SL200 | |
| Dubnica nad Vahom, Slovakia, 018 41 | |
| SL078 | |
| Krompachy, Slovakia, 040 01 | |
| SL078 | |
| Krompachy, Slovakia, 05342 | |
| SL077 | |
| Svidník, Slovakia, 08901 | |
| Spain | |
| SP249 | |
| Alicante, Spain, 03690 | |
| SP176 | |
| Barcelona, Spain, 08003 | |
| SP022 | |
| Barcelona, Spain, 08028 | |
| SP021 | |
| Barcelona, Spain, 08035 | |
| SP250 | |
| Barcelona, Spain, 08036 | |
| SP194 | |
| Donostia, Gipuzkoa, Spain, 20014 | |
| SP222 | |
| Getxo-Vizcaya, Spain, 48993 | |
| SP184 | |
| Sant Cugat del Valles, Barcelona, Spain, 08190 | |
| United Kingdom | |
| UK063 | |
| Bath, United Kingdom, BA1 3NG | |
| UK038 | |
| Blackpool, United Kingdom, FY2 0JH | |
| UK233 | |
| Cambridge, United Kingdom, CB21 5EF | |
| UK033 | |
| Carnoch, United Kingdom, WS11 0BN | |
| UK211 | |
| Epping, United Kingdom, CM16 6TN | |
| UK234 | |
| Guildford, United Kingdom, GU2 7YD | |
| UK055 | |
| Leeds, United Kingdom, LS10 1DU | |
| UK039 | |
| London, United Kingdom, W1G 9RU | |
| UK034 | |
| Manchester, United Kingdom, M13 9NQ | |
| UK087 | |
| Oxford, United Kingdom, OX3 9DU | |
| UK235 | |
| Plymouth, United Kingdom, PL5 8BT | |
| UK100 | |
| Sheffield, United Kingdom, S5 7JT | |
| UK064 | |
| Southampton, United Kingdom, SO16 6YD | |
| UK152 | |
| Southampton, United Kingdom, SO30 3JB | |
| UK153 | |
| Swindon, United Kingdom, SN3 6BW | |
| UK154 | |
| Warrington, United Kingdom, WA22 8WA | |
Sponsors and Collaborators
Axovant Sciences Ltd.
Investigators
| Study Director: | Ilise Lombardo, MD | Axovant Sciences, Inc., Vice President, Clinical Research |
More Information
| Responsible Party: | Axovant Sciences Ltd. |
| ClinicalTrials.gov Identifier: | NCT02586909 History of Changes |
| Other Study ID Numbers: |
RVT-101-3002 |
| Study First Received: | October 23, 2015 |
| Last Updated: | June 29, 2017 |
Keywords provided by Axovant Sciences Ltd.:
|
Alzheimer's disease RVT-101 donepezil |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on July 14, 2017