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

Lewy Body Dementia Clinical Trial

Official title:

A Phase 2, Double-blind, Randomized, Placebo-controlled Cross-over Study of Nelotanserin Versus Placebo in Lewy Body Dementia (LBD) Subjects Experiencing Visual Hallucinations (VH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640729
• Other study ID #: RVT-102-2001
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2015
• Last updated: January 16, 2018
• Start date: December 2015
• Est. completion date: November 2017

Study information

• Verified date: January 2018
• Source: Axovant Sciences Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to evaluate safety and efficacy of Nelotanserin for the treatment of visual hallucinations in subjects with Lewy body dementia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Hallucinations
• Lewy Body Dementia
• Lewy Body Disease
• Visual Hallucinations

Intervention

Drug:
• Nelotanserin
once daily, oral, 20-mg tablets
• Placebo
once daily, oral, matching tablets

Locations

Country	Name	City	State
United States	US114	Boca Raton	Florida
United States	US101	Chapel Hill	North Carolina
United States	US104	Cleveland	Ohio
United States	US105	Columbus	Ohio
United States	US123	Fountain Valley	California
United States	US132	Lenexa	Kansas
United States	US129	Lincoln	Nebraska
United States	US113	Orlando	Florida
United States	US103	Rochester	Minnesota
United States	US131	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Axovant Sciences Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Extrapyramidal signs are assessed with the motor subsection of the Unified Parkinson's Disease Rating Scale (UPDRS, Parts II and III).		28 days
Secondary	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

External Links

•   Click here for more information about Nelotanserin.