Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT05796167
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT05796167
Study Brief:
Protocol Section:
NCT05796167