A Phase 2 interventional study of Nelotanserin and Placebo in Lewy Body Dementia and Visual Hallucinations, sponsored by Axovant Sciences Ltd.. Completed at 10 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-01-18.
Sponsored by Axovant Sciences Ltd. · Phase 2, Interventional, and Treatment
This study seeks to evaluate safety and efficacy of Nelotanserin for the treatment of visual hallucinations in subjects with Lewy body dementia.
This is a double-blind, randomized, placebo-controlled, cross-over study in subjects with Lewy body dementia who experience frequent visual hallucinations.
Subjects who meet the randomization criteria enter the double-blind treatment period.
Each subject will be randomized 1:1 to one of the 2 treatment sequences: Nelotanserin in the first treatment period followed by placebo in the second treatment period, or placebo in the first treatment period followed by Nelotanserin in the second treatment period.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 30 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Axovant Sciences Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nelotanserin 40mg then nelotanserin 80 mg
Drug: Nelotanserin
Placebo
Drug: Placebo
once daily, oral, 20-mg tablets
once daily, oral, matching tablets
Safety will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and routine clinical laboratory assessments from baseline to the end of each treatment period (28 days).
Time frame: 28 days
Extrapyramidal signs are assessed with the motor subsection of the Unified Parkinson's Disease Rating Scale (UPDRS, Parts II and III).
Time frame: 28 days
Change in the frequency and severity of visual hallucinations from baseline to the end of each treatment period (28 days) with Nelotanserin or placebo, as recorded and documented by the patient's caregiver
Time frame: 28 days
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Axovant Sciences Ltd.