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

22-02-723-205

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

2024-04-04

2024-09-01

2024-09-01

Recruiting

Early phase I

10

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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'self-control, pilot study', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}

2024-03-08