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

Dementia With Lewy Bodies Clinical Trial

Official title:

A Phase 2, Double-blind, Randomized, Placebo-controlled Study of Nelotanserin Versus Placebo in Subjects With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) Who Have REM Sleep Behavior Disorder (RBD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708186
• Other study ID #: RVT-102-2002
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: May 2018

Study information

• Verified date: April 2020
• Source: Axovant Sciences Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

This is a double-blind, randomized, placebo-controlled, parallel-arm study in subjects with DLB or PDD who have RBD.

Subjects who meet the randomization criteria will be randomized 1:1 to receive Nelotanserin or placebo for 28 days during the double-blind period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• 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 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia With Lewy Bodies
• Disease
• Lewy Body Disease
• Mental Disorders
• Parkinson Disease
• Parkinson's Disease Dementia
• REM Sleep Behavior Disorder

Intervention

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

Locations

Country	Name	City	State
United States	US163	Atlanta	Georgia
United States	US120	Birmingham	Alabama
United States	US101	Chapel Hill	North Carolina
United States	US111	Cincinnati	Ohio
United States	US104	Cleveland	Ohio
United States	US105	Columbus	Ohio
United States	US122	Englewood	Colorado
United States	US147	Fargo	North Dakota
United States	US107	Indianapolis	Indiana
United States	US132	Lenexa	Kansas
United States	US129	Lincoln	Nebraska
United States	US173	Lincoln	Rhode Island
United States	US143	Little Rock	Arkansas
United States	US180	Maitland	Florida
United States	US128	Memphis	Tennessee
United States	US159	New Bern	North Carolina
United States	US154	Ocala	Florida
United States	US113	Orlando	Florida
United States	US152	Ormond Beach	Florida
United States	US164	Phoenix	Arizona
United States	US131	San Antonio	Texas
United States	US145	Sun City	Arizona
United States	US153	Tampa	Florida

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	Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator.	The number of RBD (sum of simple/major and complex RBD events) per 10 minutes, based on video/audio assessment conducted at a sleep laboratory. Simple/major behaviors are jerks with higher movement amplitude, or intensity (e.g., whole body jerks, single limb jerk); Complex behaviors are Movements showing complexity of action and involving more muscle groups simultaneously or violent movements, and can be seen as the enactment of dream contents.	28 days