Clinical trial NCT02708186: Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dementia With Lewy Bodies
REM Sleep Behavior Disorder
Parkinson's Disease Dementia
Keywords: Dementia with Lewy bodies
Lewy bodies
REM sleep behavior disorder
Parkinson's disease dementia
Lead sponsor: Sio Gene Therapies
Sponsor class: INDUSTRY
First posted: 2016-03-15
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: US120
state: Alabama
city: Phoenix
country: United States
facility: US164
state: Arizona
city: Sun City
country: United States
facility: US145
state: Arizona
city: Little Rock
country: United States
facility: US143
state: Arkansas
city: Englewood
country: United States
facility: US122
state: Colorado
city: Maitland
country: United States
facility: US180
state: Florida
city: Ocala
country: United States
facility: US154
state: Florida
city: Orlando
country: United States
facility: US113
state: Florida
city: Ormond Beach
country: United States
facility: US152
state: Florida
city: Tampa
country: United States
facility: US153
state: Florida
city: Atlanta
country: United States
facility: US163
state: Georgia
city: Indianapolis
country: United States
facility: US107
state: Indiana
city: Lenexa
country: United States
facility: US132
state: Kansas
city: Lincoln
country: United States
facility: US129
state: Nebraska
city: Chapel Hill
country: United States
facility: US101
state: North Carolina
city: New Bern
country: United States
facility: US159
state: North Carolina
city: Fargo
country: United States
facility: US147
state: North Dakota
city: Cincinnati
country: United States
facility: US111
state: Ohio
city: Cleveland
country: United States
facility: US104
state: Ohio
city: Columbus
country: United States
facility: US105
state: Ohio
city: Lincoln
country: United States
facility: US173
state: Rhode Island
city: Memphis
country: United States
facility: US128
state: Tennessee
city: San Antonio
country: United States
facility: US131
state: Texas
Study officials:
affiliation: Axovant Sciences, Inc., Clinical Research
name: Ilise Lombardo, MD
role: STUDY_DIRECTOR
References:
citation: Stefani A, Santamaria J, Iranzo A, Hackner H, Schenck CH, Hogl B. Nelotanserin as symptomatic treatment for rapid eye movement sleep behavior disorder: a double-blind randomized study using video analysis in patients with dementia with Lewy bodies or Parkinson's disease dementia. Sleep Med. 2021 May;81:180-187. doi: 10.1016/j.sleep.2021.02.038. Epub 2021 Feb 25.