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A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.
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).
Age
50 - 85 years
Sex
ALL
Healthy Volunteers
No
US138
Phoenix, Arizona, United States
US108
Phoenix, Arizona, United States
US139
Sun City, Arizona, United States
US125
Tucson, Arizona, United States
US119
Irvine, California, United States
US134
Oxnard, California, United States
US133
Rancho Mirage, California, United States
US140
Sacramento, California, United States
US141
Englewood, Colorado, United States
US123
Washington D.C., District of Columbia, United States
Start Date
January 1, 2016
Primary Completion Date
December 1, 2017
Completion Date
December 1, 2017
Last Updated
April 26, 2019
484
ACTUAL participants
RVT-101 35 mg
DRUG
RVT-101 70 mg
DRUG
Placebo
DRUG
Lead Sponsor
Axovant Sciences Ltd.
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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