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

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axovant Sciences Ltd.

Criteria

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