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:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
NCT ID:
NCT05357612
Eligibility Criteria:
Inclusion Criteria:
* Patient arm - clinical diagnosis of Parkinson disease, diffuse Lewy body disease, multiple systems atrophy, Huntington's Disease, Frontotemporal Dementia, and other variants
* Healthy arm - age and gender matched to patient arm
* Psychosis (presence of hallucinations or delusions) starting after the diagnosis of Parkinson's disease, occurring at least weekly for 4 weeks, severe enough to warrant treatment.
* Study partner available for study visits
Exclusion Criteria:
* Prior stroke or other uncontrolled serious neurological or medical illness
* Contra-indication or inability to tolerate MRI scan
* Use of serotonergic medications in the last 6 weeks
* Incapable of providing independent consent.
* Pregnant or breastfeeding women
* psychosis due to a metabolic, toxic, or primary psychiatric disease
* Deemed unable to complete neurocognitive testing
* For PD Participants: current or prior use of pimavanserin
* Use of antipsychotics in the last 2 weeks
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT05357612
Study Brief:
Protocol Section:
NCT05357612