W. Wen, S. Ramaswamy, Kunal S. Kishnani
Apr 18, 2017
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Journal
Neurology
Abstract
Objective: To evaluate the safety and efficacy of nelotanserin in Lewy body dementia subjects experiencing visual hallucinations. Background: Nelotanserin is a potent and highly selective 5HT2A receptor inverse agonist in development for the treatment of behavioral disturbances in Lewy body dementia, a neurodegenerative disease that affects approximately 1.4 million elderly individuals in the U.S. alone. Lewy body dementia includes two related disorders: dementia with Lewy bodies (DLB) and Parkinson’s disease dementia (PDD). Visual hallucinations are a significant symptom affecting individuals with Lewy body dementia. However there are limited options available for its safe and effective treatment. This abstract presents an overview of a Phase 2 study of nelotanserin in DLB and PDD subjects experiencing visual hallucinations. Design/Methods: This is a Phase 2, double-blind, randomized, placebo-controlled cross-over study of nelotanserin versus placebo in subjects with Lewy body dementia (ClinicalTrials.gov: NCT02640729). The study includes approximately 20 subjects with a diagnosis of DLB or PDD who are experiencing frequent visual hallucinations and have a baseline MMSE score ≥ 18. The primary objective is to assess the safety of nelotanserin in this patient population. Secondary objectives include the assessment of the efficacy of nelotanserin in reducing visual hallucinations and other behavioral disturbances. Stable concomitant use of quetiapine, an atypical antipsychotic commonly used off-label to treat visual hallucinations in Lewy body dementia, is permitted at certain doses. Results: Results from the study will be presented at the AAN conference. Conclusions: This study represents a major effort to develop a treatment specifically for individuals with Lewy body dementia experiencing visual hallucinations. Nelotanserin is also being investigated in a separate Phase 2 study in DLB subjects experiencing REM sleep behavior disorder. Study Supported by: Axovant Sciences Disclosure: Dr. Wen has received personal compensation for activities with Axovant as an employee. Dr. Ramaswamy has received personal compensation for activities with Axovant Sciences, Inc., as an employee. Dr. Ramaswamy holds stock and/or stock options in Axovant Sciences, Inc. Dr. Kishnani has received personal compensation for activities with Axovant as an employee. Dr. Kishnani holds stock and/or stock options in Axovant. Dr. Ramaswamy has received personal compensation for activities with Axovant Sciences, Inc., as an employee. Dr. Ramaswamy holds stock and/or stock options in Axovant Sciences, Inc. Dr. Friedhoff has received personal compensation for activities with Axovant Sciences Inc and Roivant Sciences Inc. as an employee.