Study Evaluating Nelotanserin for Treatment of Visual Hallucinations in Subjects With Lewy Body Dementia

Axovant Sciences Ltd.30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Lewy Body Dementia Visual Hallucinations

Interventions

NelotanserinDRUG

once daily, oral, 20-mg tablets

PlaceboDRUG

once daily, oral, matching tablets

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (10)

US123

Fountain Valley, California, United States

US114

Boca Raton, Florida, United States

US113

Orlando, Florida, United States

US132

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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