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
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 34
Healthy volunteers: no

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.

Arms:
arm 1: Nelotanserin 80 mg arm 2: Placebo

Interventions: intervention 1: Nelotanserin intervention 2: Placebo
Intervention descriptions: intervention 1: once daily, oral, 20-mg tablets intervention 2: once daily, oral, matching tablets

Protocol document:
Prot_SAP_000.pdf: 






























Primary Efficacy Evaluation: 
Key Secondary Evaluation: 
Other Secondary Efficacy Evaluation: 


Safety Evaluation: 
Pharmacokinetic Evaluation: 
Sample Size: 
f
Primary Efficacy Analysis: 
Secondary and Exploratory Efficacy Analysis


Safety:
Pharmacokinetics/Pharmacodynamics (PK/PD):






Primary
Key Secondary 
Other Secondary




Safety
Pharmacokinetic
























Run-In Visit (Visit 2) 


Baseline Sleep Laboratory Visits (Visit 3 – up to 10 days) 
Management of patients with OSA and CSA: 


Baseline/Randomization (Visit 4 – Day 0) 


Phone call/Liver Function Tests (Day 14, +/- 3 days) 
End of Study Sleep Laboratory Visits (Visit 5 on Day 28 – up to 10 days)
Final Study Clinic Visit (Visit 5 on Day 30, + 10 days) 














slept very well 
slept 
very badly














RBC Indices 
WBC Count with Differential 










f




















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in the past month 
at
night
during the day
too often
too long 
too early 
too little