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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:
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
History of Changes
October 23, 2015
June 29, 2017
April 2016
June 2018   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT02586909 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension
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).
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.
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Alzheimer's Disease
Drug: RVT-101 35 mg tablets
once daily, oral tablets
Experimental: RVT-101 35 mg tablets
once daily, oral tablets
Intervention: Drug: RVT-101 35 mg tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
1150
June 2018
June 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years to 86 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Bulgaria,   Canada,   Croatia,   Czechia,   France,   Germany,   Italy,   Korea, Republic of,   Poland,   Serbia,   Singapore,   Slovakia,   Spain,   United Kingdom,   United States
Czech Republic
 
NCT02586909
RVT-101-3002
Yes
Not Provided
Not Provided
Axovant Sciences Ltd.
Axovant Sciences Ltd.
Not Provided
Study Director: Ilise Lombardo, MD Axovant Sciences, Inc., Vice President, Clinical Research
Axovant Sciences Ltd.
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP