Overview

Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)

Status:
Completed

Trial end date:
2018-05-01

Target enrollment:
0

Participant gender:
All

Summary

This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD).

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Axovant Sciences Ltd.

Criteria

Inclusion Criteria:

- Adult subjects at least 50 years of age, with a diagnosis of DLB or PDD and RBD based
on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)
diagnostic criteria

- Presence of frequent REM sleep behavior episodes

- 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' RBD 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