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

Phase 2

Completed

• Conditions: Lewy Body Dementia; Visual Hallucinations
• Interventions: Drug: Nelotanserin; Drug: Placebo

• Registration Number: NCT02640729
• Lead Sponsor: Axovant Sciences Ltd.

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-19
• Study First Submitted QC: 2015-12-28
• Study First Posted: 2015-12-29
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nelotanserin	Nelotanserin	Nelotanserin 40mg then nelotanserin 80 mg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

US114; 🇺🇸 Boca Raton, Florida, United States

US104; 🇺🇸 Cleveland, Ohio, United States

US105; 🇺🇸 Columbus, Ohio, United States

US113; 🇺🇸 Orlando, Florida, United States

US101; 🇺🇸 Chapel Hill, North Carolina, United States

US123; 🇺🇸 Fountain Valley, California, United States

US103; 🇺🇸 Rochester, Minnesota, United States

US131; 🇺🇸 San Antonio, Texas, United States

US132; 🇺🇸 Lenexa, Kansas, United States

US129; 🇺🇸 Lincoln, Nebraska, United States