Phase 2
N=34
Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)
Dementia With Lewy Bodies · REM Sleep Behavior Disorder · Parkinson's Disease Dementia
Bottom Line
View on ClinicalTrials.gov: NCT02708186 ↗Enrolled (actual)
34
Serious AEs
5.9%
Results posted
May 2020
Primary outcome: 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. — -1.47; -0.26 Number of RBD per 10 min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nelotanserin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Axovant Sciences Ltd.
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
-1.47; -0.26 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT02708186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.