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 :
(Intepirdine did't meet primary efficacy endpoints in lead-in study RVT-101-3001)
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
Drug: RVT-101 35 mg tablets
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.
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
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Layout table for eligibility information
Ages Eligible for Study:
50 Years to 86 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Completed last on-treatment visit of the lead-in study RVT-101-3001
Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.