Phase 2 Completed N=34 Randomized Quadruple-blind Treatment

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

Source: ClinicalTrials.gov NCT02708186 ↗

Enrolled (actual)

Serious AEs

5.9%

Results posted

May 2020

Primary outcomePrimary: 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

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).

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	—

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

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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. Informational only — not medical advice.