Parkinson Disease
Conditions
Keywords
sleep, visual hallucinations, delusions
Brief summary
This pilot, self-control study is for patients with Parkinson's Disease (PD) psychosis (e.g., visual hallucinations, delusions) and sleep problems.
Detailed description
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
Interventions
DRUGPimavanserin
Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks
Sponsors
ACADIA Pharmaceuticals Inc.
State University of New York - Downstate Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
self-control, pilot study
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Has a diagnosis of idiopathic PD according to UK (United Kingdom) PD Society Brain Bank diagnostic criteria 2. Has a history of hallucinations or delusions associated with PD 3. Has a history of sleep disturbance 4. Is between the ages of 40 and 85 5. Has been on a stable dose of all PD medications for at least 30 days prior to enrolment
Exclusion criteria
1. Has evidence of an atypical or secondary parkinsonian disorder 2. Has a contraindication to taking pimavanserin 3. Has contraindication to PSG 4. 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 5. Has traveled through 3 or more time zones within 60 days prior to study screening 6. Patient is a night-shift worker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of pimavanserin on sleep fragmentation | 6 weeks | Number of arousals and the arousal index (arousals per hour of sleep) measured on polysomnography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of pimavanserin on sleep latency | 6 weeks | Time to first epoch on polysomnography |
| Effect of pimavanserin on total sleep time | 6 weeks | Total sleep time measured on polysomnography |
| Effect of pimavanserin on sleep efficiency | 6 weeks | Sleep Efficiency Index in percent is the ratio of total sleep time (based on polysomnography recordings) to time in bed |
| Effect of pimavanserin on REM (Rapid Eye Movements) sleep behavior disorder | 6 weeks | Presence fo REM sleep without atonia (RWA) on polysomnograophy |
| Effect of pimavanserin on subjective measure of REM Sleep behavior disorder | 6 weeks | 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'. |
| Effect of pimavanserin on subjective measures of sleep | 6 weeks | 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 |
| Effect of pimavanserin on subjective measures of fatigue | 6 weeks | 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. |
| Effect of pimavanserin on time in each sleep stage | 6 weeks | Time in each sleep stage as measured on polysomnography |
Countries
United States
Outcome results
None listed