Pimavanserin for Sleep in Parkinson Disease

Study Overview
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Brief Summary
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This pilot, self-control study is for patients with Parkinson's Disease (PD) psychosis (e.g., visual hallucinations, delusions) and sleep problems.

Detailed Description
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This is a feasibility study to determine whether pimavanserin improves sleep quality in patients with PD and visual hallucinations/delusions. Patients will complete a Screening Visit to assess eligibility to participate in the study. For more information, please contact Sofya Glazman, a study coordinator, at sofya.glazman@downstate.edu

Official Title
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Does Pimavanserin (Nuplazid) Improve Sleep in Patients With Parkinson Disease Psychosis? A Pilot Study

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Pimavanserin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Has a diagnosis of idiopathic PD according to UK (United Kingdom) PD Society Brain Bank diagnostic criteria Has a history of hallucinations or delusions associated with PD Has a history of sleep disturbance Is between the ages of 40 and 85 Has been on a stable dose of all PD medications for at least 30 days prior to enrolment Exclusion criteria Has evidence of an atypical or secondary parkinsonian disorder Has a contraindication to taking pimavanserin Has contraindication to PSG There has been a change to patient's neuropsychiatric medications including dopaminergic medications (Sinemet, dopamine agonists, MAO(monoamine oxidaze)-B inhibitors), SSRIs (Selective Serotonin Reuptake Inhibitors), SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), dopamine-blocking agents, anti-epileptics, anticholinergics, or benzodiazepines for at least 30 days prior to enrollment Has traveled through 3 or more time zones within 60 days prior to study screening Patient is a night-shift worker

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: self-control, pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pimavanserin (Nuplazid)<br>Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks for patients with Parkinson disease psychosis (e.g., visual hallucinations, delusions) and sleep problems | Drug: Pimavanserin<br>* Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks<br>* Other names: Nuplazid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of pimavanserin on sleep fragmentation | Number of arousals and the arousal index (arousals per hour of sleep) measured on polysomnography | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of pimavanserin on REM (Rapid Eye Movements) sleep behavior disorder | Presence fo REM sleep without atonia (RWA) on polysomnograophy | 6 weeks | 
| Effect of pimavanserin on sleep latency | Time to first epoch on polysomnography | 6 weeks | 
| Effect of pimavanserin on total sleep time | Total sleep time measured on polysomnography | 6 weeks | 
| Effect of pimavanserin on sleep efficiency | Sleep Efficiency Index in percent is the ratio of total sleep time (based on polysomnography recordings) to time in bed | 6 weeks | 
| Effect of pimavanserin on time in each sleep stage | Time in each sleep stage as measured on polysomnography | 6 weeks | 
| Effect of pimavanserin on subjective measure of REM Sleep behavior disorder | RBDSQ (REM (Rapid Eye Movements) Sleep Behavior Disorder Screening Questionnaire to assess the most prominent clinical features of RBD. It is a 10-item, patient self-rating instrument with short questions to be answered by either 'yes' or 'no'. | 6 weeks | 
| Effect of pimavanserin on subjective measures of sleep | PDSS-2 (Parkinson's Disease Sleep Scale Version 2) total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). Scores > 18 are considered as relevant sleep disturbances | 6 weeks | 
| Effect of pimavanserin on subjective measures of fatigue | PFS-16 (Parkinson's disease Fatigue Scale): 16-item scale with the following scoring for each item: strong disagree -1, disagree - 2, neither agree or disagree - 3, agree - 4, strongly agree - 5; with overall score of ≥8 indicates the presence of significant fatigue. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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visual hallucinations, delusions, sleep