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

Phase 3

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Drug: RVT-101 35 mg tablets

• Registration Number: NCT02586909
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-27
• Study Start: 2016-04-26
• Status Verified: 2018-03
• Primary Completion: 2018-03-12
• Study Completion: 2018-03-12
• Results First Submitted: 2020-01-06
• Results First Submitted QC: 2020-04-14
• Last Update Submitted: 2020-04-14
• Results First Posted: 2020-04-17
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1099

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RVT-101 35 mg tablets	RVT-101 35 mg tablets	once daily, oral tablets

Primary Outcome Measures

Name	Time	Method
Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments	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

Trial Locations

Locations (168)

US112; 🇺🇸 Phoenix, Arizona, United States

US220; 🇺🇸 Tucson, Arizona, United States

US096; 🇺🇸 Rancho Mirage, California, United States

US195; 🇺🇸 Santa Ana, California, United States

US016; 🇺🇸 Simi Valley, California, United States

US106; 🇺🇸 Temecula, California, United States

US179; 🇺🇸 Hamden, Connecticut, United States

US171; 🇺🇸 Norwich, Connecticut, United States

US088; 🇺🇸 Atlantis, Florida, United States

US007; 🇺🇸 Brooksville, Florida, United States

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