Session Information
Date: Thursday, June 8, 2017
Session Title: Clinical Trials and Therapy in Movement Disorders
Session Time: 1:15pm-2:45pm
Location: Exhibit Hall C
Objective: To evaluate the safety and efficacy of nelotanserin in Lewy body dementia subjects experiencing visual hallucinations.
Background: Nelotanserin is a selective 5HT2A receptor inverse agonist in development for the treatment of behavioral disturbances in Lewy body dementia, a neurodegenerative disorder 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 the safe and effective treatment of Lewy body dementia. This abstract presents an overview of a Phase 2 study of nelotanserin in DLB and PDD subjects experiencing visual hallucinations.
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 this conference.
Conclusions: This study represents a significant effort to develop a treatment specifically for individuals with Lewy body dementia experiencing visual hallucinations. Nelotanserin is also being studied in a separate Phase 2 study in DLB subjects experiencing REM sleep behavior disorder.
This abstract was also submitted to the 2017 Annual Meeting of the American Academy of Neurology (April 22-28, 2017), where certain results of the study described above were presented.
To cite this abstract in AMA style:
S. Ramaswamy, W. Wen, G. Ramaswamy, L. Friedhoff. A Phase 2 Study of Nelotanserin, a Novel 5HT2A Receptor Inverse Agonist, in Dementia with Lewy Bodies and Parkinson’s Disease Dementia Subjects Experiencing Visual Hallucinations [abstract]. Mov Disord. 2017; 32 (suppl 2). https://www.mdsabstracts.org/abstract/a-phase-2-study-of-nelotanserin-a-novel-5ht2a-receptor-inverse-agonist-in-dementia-with-lewy-bodies-and-parkinsons-disease-dementia-subjects-experiencing-visual-hallucinations/. Accessed June 14, 2025.« Back to 2017 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/a-phase-2-study-of-nelotanserin-a-novel-5ht2a-receptor-inverse-agonist-in-dementia-with-lewy-bodies-and-parkinsons-disease-dementia-subjects-experiencing-visual-hallucinations/