NCT02640729

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Axovant Sciences Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lewy Body Dementia
• Visual Hallucinations

Interventions

Type	Name	Description
DRUG	Nelotanserin	once daily, oral, 20-mg tablets
DRUG	Placebo	once daily, oral, matching tablets

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2015-12-29
• Last updated: 2018-01-18

Locations

10 sites across 1 country: United States