Clinical Trial: Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
Brief Summary: This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.
Detailed Summary:
The efficacy and safety of RVT-101 at doses of 70 mg and 35 mg daily will be evaluated over a 24-week double-blind treatment period in patients with dementia with Lewy bodies.
The randomization ratio will be 1:1:1 (70 mg RVT-101: 35 mg RVT-101: placebo).
Subjects completing this study will be eligible to enroll in an extension study of RVT-101 (Study RVT-101-2002).
Sponsor: Axovant Sciences Ltd.
Current Primary Outcome:
- Change from baseline on Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) [ Time Frame: 24 weeks ]
- Change from baseline on a computerized cognitive battery [ Time Frame: 24 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline on a clinical assessment of visual hallucinations [ Time Frame: up to 24 weeks ]
- Occurrence of reported adverse events and findings noted by investigators on clinical examination, electrocardiograms, and routine laboratory assessments [ Time Frame: 24 weeks ]
Original Secondary Outcome: Same as current
Information By: Axovant Sciences Ltd.
Dates:
Date Received: January 25, 2016
Date Started: January 2016
Date Completion: October 2017
Last Updated: May 12, 2017
Last Verified: May 2017
