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)
Phase: PHASE2
Conditions: Dementia With Lewy Bodies, REM Sleep Behavior Disorder, Parkinson's Disease Dementia
Sponsor: Axovant Sciences Ltd.



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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Acta Neurol Scand
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Pharmacother

Lancet Neurol
Lancet Neurol
Swiss Med 
Wkly
J Am Geriatr Soc
et al
Mov Disord. 
Parkinson’s disease and non-motor function, Second edition
Biometrics
J Clin 
Psychiatry

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