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

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ClinicalTrials.gov Identifier: NCT02586909
Recruitment Status : Terminated (Intepirdine did't meet primary efficacy endpoints in lead-in study RVT-101-3001)
First Posted : October 27, 2015
Results First Posted : April 17, 2020
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Sio Gene Therapies ( Axovant Sciences Ltd. )

Study Description
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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).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: RVT-101 35 mg tablets Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1099 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Actual Study Start Date : April 26, 2016
Actual Primary Completion Date : March 12, 2018
Actual Study Completion Date : March 12, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RVT-101 35 mg tablets
once daily, oral tablets
 Drug: RVT-101 35 mg tablets
once daily, oral tablets


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 86 Years   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02586909


Locations
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Sponsors and Collaborators
Axovant Sciences Ltd.
Investigators
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Study Director: Ilise Lombardo, MD Axovant Sciences, Inc., Vice President, Clinical Research
  Study Documents (Full-Text)

Documents provided by Sio Gene Therapies ( Axovant Sciences Ltd. ):
Study Protocol and Statistical Analysis Plan  [PDF] May 12, 2016

More Information
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Responsible Party: Axovant Sciences Ltd.
ClinicalTrials.gov Identifier: NCT02586909    
Other Study ID Numbers: RVT-101-3002
First Posted: October 27, 2015    Key Record Dates
Results First Posted: April 17, 2020
Last Update Posted: April 17, 2020
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sio Gene Therapies ( Axovant Sciences Ltd. ):
Alzheimer's disease
RVT-101
donepezil
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders