Lewy Body Dementia, Visual Hallucinations
Conditions
Keywords
Lewy body dementia, Dementia with Lewy bodies, Parkinson's disease dementia, Lewy bodies, Visual hallucinations
Brief summary
This study seeks to evaluate safety and efficacy of Nelotanserin for the treatment of visual hallucinations in subjects with Lewy body dementia.
Detailed description
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.
Interventions
DRUGNelotanserin
once daily, oral, 20-mg tablets
DRUGPlacebo
once daily, oral, matching tablets
Sponsors
Axovant Sciences Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult subjects at least 50 years of age, with a diagnosis of LBD based on DSM-5 diagnostic criteria or diagnosis of Parkinson's disease dementia (PDD) based on DSM-5 diagnostic criteria; * Presence of frequent visual hallucinations * Mini Mental State Examination score ≥ 18
Exclusion criteria
* Subjects have a current diagnosis of significant psychotic disorders including, but not limited to, schizophrenia or bipolar disorder * Subjects' psychotic symptoms are secondary to or better accounted for by another medical condition, psychiatric disorder, or substance abuse * Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | 28 days |
| Extrapyramidal signs are assessed with the motor subsection of the Unified Parkinson's Disease Rating Scale (UPDRS, Parts II and III). | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 28 days |
Countries
United States
Outcome results
None listed