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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 not meet its primary efficacy endpoints in lead-in study RVT-101-3001.)
First Posted : October 27, 2015
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
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).

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1100 participants
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 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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.

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


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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

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Responsible Party: Axovant Sciences Ltd.
ClinicalTrials.gov Identifier: NCT02586909     History of Changes
Other Study ID Numbers: RVT-101-3002
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by 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