A Phase 2 double-blind randomized placebo-controlled study of Nelotanserin versus placebo in patients with dementia with Lewy bodies (DLB) experiencing REM sleep behaviors (RBD)
Jared Brosch, MD
Primary Investigator
Overview
The purpose of this study is to evaluate the safety of the study drug Nelotanserin and to assess the effects of Nelotanserin in subjects experiencing frequent REM sleep behavior disorders due to dementia with Lewy bodies.
Description
The purpose of this study is to evaluate the efficacy of Nelotanserin in reducing the nightly frequency of characteristic RBD behaviors following four weeks of treatment.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
dementia,Lewy bodies,REM sleep behavior disorder
-
Age: Between 50 Years - 85 Years
-
Gender: All
Inclusion Criteria
Diagnosis of a probable major neurocognitive disorder (dementia) with Lewy bodies (DLB) based on DSM-5 criteria
A concurrent diagnosis of REM sleep behavior disorder (RBD) based on DSM-5 criteria
Mild obstructive sleep apnea (OSA) or optimally controlled (OSA)
Must have a caregiver or family member who can serve as a collateral informant for study assessments and, if necessary, provide proxy consent to participate in the study
Exclusion Criteria
Sleep behavioral symptoms are secondary to or better accounted for by another medical condition, psychiatric disorder, or substance abuse
Current diagnosis of significant psychotic disorders including, but not limited to, schizophrenia or bipolar disorder
Any significant change in the subject's environment within the past four weeks
History of significant cerebrovascular events
Current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder
Use of any antipsychotic medication other than stable quetiapine at a dose of greater than 25 mg/day
Current use of sedative-hypnotic medication
Medication-induced RBD or receiving venlafaxine and mirtazapine that may induce RBD behaviors
Current use of anti-epileptic medication or a history of epilepsy
Allergic or hypersensitive to nelotanserin
Evidence of impaired liver function at screening
Have used any investigational medication within 30 days prior to the first dose of study medication
