Pimavanserin for Sleep in Parkinson Disease

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York - Downstate Medical Center
• Collaborator: ACADIA Pharmaceuticals Inc.
• Treatments: Pimavanserin

Criteria

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