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

April 14, 2020 updated by: Axovant Sciences Ltd.

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1099

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1828CKR
        • AR101
      • Buenos Aires, Argentina, C1199ABB
        • AR060
      • Ciudad Autonoma de Buenos Aire, Argentina, C1012AAR
        • AR084
      • Ciudad Autonoma de Buenos Aire, Argentina, C1058AAJ
        • AR027
      • Ciudad Autonoma de Buenos Aire, Argentina, C1111AAL
        • AR012
      • Ciudad Autonoma de Buenos Aire, Argentina, C1117ABH
        • AR160
      • Ciudad Autonoma de Buenos Aire, Argentina, C1406BOA
        • AR028
      • Ciudad Autonoma de Buenos Aire, Argentina, C1428AQK
        • AR035
      • Ciudad Autónoma de Buenos Aire, Argentina, C1405BCK
        • AR040
      • Ciudad Autónoma de Buenos Aire, Argentina, C1425AHQ
        • AR081
      • Córdoba, Argentina, X5000DCE
        • AR051
      • Córdoba, Argentina, X5000FJF
        • AR137
      • Córdoba, Argentina, X5004AOA
        • AR126
      • Mendoza, Argentina, M5501ACP
        • AR210
      • Mendoza, Argentina, M5502AHV
        • AR219
      • Santiago del Estero, Argentina, G4200DND
        • AR059
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, A1902AJU
        • AR130
  • Australia
      • Caulfield, Australia, VIC 3162
        • AU227
      • Heidelberg West, Australia, VIC 3081
        • AU032
      • Hornsby, Australia, NSW 2077
        • AU011
      • West Perth, Australia, WA 6005
        • AU138
  • Bulgaria
      • Ruse, Bulgaria, 7003
        • BU125
      • Sofia, Bulgaria, 1431
        • BU131
      • Varna, Bulgaria, 9000
        • BU073
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • CA054
      • Kelowna, British Columbia, Canada, V1Y 4N7
        • CA188
      • Penticton, British Columbia, Canada, V2A 5C8
        • CA186
      • West Vancouver, British Columbia, Canada, V7T 2Z3
        • CA141
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 5G8
        • CA147
      • North York, Ontario, Canada, M3B 2S7
        • CA196
    • Quebec
      • Gatineau, Quebec, Canada, J8T 8JI
        • CA236
  • Chile
    • II Región
      • Antofagasta, II Región, Chile, 1270244
        • CH212
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 7560356
        • CH076
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 7510186
        • CH061
      • Santiago, Región Metropolitana, Chile, 7520338
        • CH075
  • Croatia
      • Zagreb, Croatia, 10000
        • CR069
      • Zagreb, Croatia, 10000
        • CR122
      • Zagreb, Croatia, 10090
        • CR070
  • Czechia
      • Praha, Czechia, 100 00
        • CZE207
      • Praha 10, Czechia, 100 00
        • CZE128
      • Praha 2, Czechia, 12000
        • CZE132
      • Praha 6, Czechia, 160 00
        • CZE129
      • Rychnov nad Kneznou, Czechia, 516 01
        • CZE161
  • France
      • Lille Cedex, France, 59037
        • FR231
      • Marseille Cedex 5, France, 13385
        • FR182
      • Paris Cedex, France, 75013
        • FR221
      • Villeurbanne, France, 69 100
        • FR202
  • Germany
      • Bad Homburg, Germany, 61348
        • GE206
      • Berlin, Germany, 10117
        • GE091
      • Berlin, Germany, 12203
        • GE071
      • Berlin, Germany, 13125
        • GE139
      • Cologne, Germany, 50937
        • GE230
      • Ellwangen, Germany, 73479
        • GE252
      • Leipzig, Germany, 04107
        • GE180
      • Mannheim, Germany, 68165
        • GE228
      • Munchen, Germany, 81675
        • GE017
      • Nürnberg, Germany, 90402
        • GE157
      • Ulm, Germany, 89081
        • GE098
      • Westerstede, Germany, 26655
        • GE251
  • Italy
      • Brescia, Italy, 25125
        • IT053
      • Cefalu, Italy, 90015
        • IT124
      • Pavia, Italy, 27100
        • IT030
      • Perugia, Italy, 06156
        • IT103
      • Roma, Italy, 00168
        • IT072
      • Roma, Italy, 00189
        • IT029
      • Rome, Italy, 00179
        • IT183
      • Rome, Italy, 00185
        • IT175
      • Torino, Italy, 10 126
        • IT085
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • SK066
      • Seoul, Korea, Republic of, 06351
        • SK067
      • Seoul, Korea, Republic of, 07061
        • SK190
  • Poland
      • Bialystok, Poland, 15-756
        • PO013
      • Bydgoszcz, Poland, 85-080
        • PO024
      • Bydgoszcz, Poland, 85-796
        • PO010
      • Katowice, Poland, 40-123
        • PO107
      • Katowice, Poland, 40-749
        • PO092
      • Poznan, Poland, 61-853
        • PO009
      • Szczecin, Poland, 70-111
        • PO014
      • Warszawa, Poland, 01-697
        • PO074
  • Serbia
      • Belgrade, Serbia, 11 000
        • SE164
      • Belgrade, Serbia, 11 000
        • SE193
      • Belgrade, Serbia, 11000
        • SE090
      • Kragujevac, Serbia, 34 000
        • SE155
      • Novi Kneževac, Serbia, 23330
        • SE031
      • Vršac, Serbia, 26300
        • SE165
  • Singapore
      • Singapore, Singapore, 119074
        • SI052
      • Singapore, Singapore, 308433
        • SI026
  • Slovakia
      • Banska Bystrica, Slovakia, 974 04
        • SL056
      • Dubnica nad Vahom, Slovakia, 018 41
        • SL200
      • Krompachy, Slovakia, 040 01
        • SL078
      • Krompachy, Slovakia, 05342
        • SL078
      • Svidník, Slovakia, 08901
        • SL077
  • Spain
      • Alicante, Spain, 03690
        • SP249
      • Barcelona, Spain, 08003
        • SP176
      • Barcelona, Spain, 08028
        • SP022
      • Barcelona, Spain, 08035
        • SP021
      • Barcelona, Spain, 08036
        • SP250
      • Barcelona, Spain, 08195
        • SP184
      • Getxo, Spain, 48993
        • SP222
      • San Sebastián, Spain, 20014
        • SP194
  • Taiwan
      • Taoyuan, Taiwan, 333
        • TA121
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • UK063
      • Blackpool, United Kingdom, FY2 0JH
        • UK038
      • Cambridge, United Kingdom, CB21 5EF
        • UK233
      • Carnoch, United Kingdom, WS11 0BN
        • UK033
      • Epping, United Kingdom, CM16 6TN
        • UK211
      • Guildford, United Kingdom, GU2 7YD
        • UK234
      • Leeds, United Kingdom, LS10 1DU
        • UK055
      • London, United Kingdom, W1G 9RU
        • UK039
      • Manchester, United Kingdom, M13 9NQ
        • UK034
      • Oxford, United Kingdom, OX3 9DU
        • UK087
      • Plymouth, United Kingdom, PL5 8BT
        • UK235
      • Sheffield, United Kingdom, S5 7JT
        • UK100
      • Southampton, United Kingdom, SO16 6YD
        • UK064
      • Southampton, United Kingdom, SO30 3JB
        • UK152
      • Swindon, United Kingdom, SN3 6BW
        • UK153
      • Warrington, United Kingdom, WA22 8WA
        • UK154
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85005
        • US112
      • Tucson, Arizona, United States, 85704
        • US220
    • California
      • Rancho Mirage, California, United States, 92270
        • US096
      • Santa Ana, California, United States, 92705
        • US195
      • Simi Valley, California, United States, 93065
        • US016
      • Temecula, California, United States, 92591
        • US106
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • US179
      • Norwich, Connecticut, United States, 06360
        • US171
    • Florida
      • Atlantis, Florida, United States, 33462
        • US088
      • Brooksville, Florida, United States, 34601
        • US007
      • Hallandale Beach, Florida, United States, 33009
        • US002
      • Hialeah, Florida, United States, 33012
        • US140
      • Miami, Florida, United States, 33137
        • US216
      • Miami, Florida, United States, 33165
        • US110
      • North Palm Beach, Florida, United States, 33408
        • US172
      • Orlando, Florida, United States, 32806
        • US003
      • Pensacola, Florida, United States, 32502
        • US256
      • Tampa, Florida, United States, 33613
        • US037
      • Tampa, Florida, United States, 33613
        • US042
      • The Villages, Florida, United States, 32162
        • US004
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • US048
      • Atlanta, Georgia, United States, 30342
        • US046
      • Columbus, Georgia, United States, 31909
        • US217
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • US111
      • Shreveport, Louisiana, United States, 71104
        • US095
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • US116
      • Quincy, Massachusetts, United States, 02169
        • US174
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • US144
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • US094
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • US135
      • Lawrenceville, New Jersey, United States, 08648
        • US197
      • Manchester, New Jersey, United States, 08759
        • US057
      • Mount Arlington, New Jersey, United States, 07856
        • US215
      • Toms River, New Jersey, United States, 08755
        • US209
      • West Long Branch, New Jersey, United States, 07764
        • US036
    • New York
      • Albany, New York, United States, 12208
        • US001
      • Brooklyn, New York, United States, 11235
        • US049
      • New Hyde Park, New York, United States, 11040
        • US097
      • New York, New York, United States, 10022
        • US044
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • US150
      • Charlotte, North Carolina, United States, 28270
        • US185
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • US008
      • Cleveland, Ohio, United States, 44106
        • US113
      • Shaker Heights, Ohio, United States, 44122
        • US119
    • Oregon
      • Portland, Oregon, United States, 97210
        • US134
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • US169
      • Plains, Pennsylvania, United States, 18075
        • US162
      • Willow Grove, Pennsylvania, United States, 19001
        • US148
    • Texas
      • San Antonio, Texas, United States, 78229
        • US043
    • Utah
      • Orem, Utah, United States, 84058
        • US143
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • US149
    • Washington
      • Spokane, Washington, United States, 99202
        • US170

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RVT-101 35 mg tablets
once daily, oral tablets
Drug: RVT-101 35 mg tablets
once daily, oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axovant Sciences Ltd.

Investigators

  • Study Director: Ilise Lombardo, MD, Axovant Sciences, Inc., Vice President, Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2016

Primary Completion (Actual)

March 12, 2018

Study Completion (Actual)

March 12, 2018

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Actual)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVT-101-3002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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