It is hypothesize that patients with clinically diagnosed neurodegenerative diseases will have significantly different receptor occupancy of 5HT2A receptors compared to a healthy age/sex-matched control group. This will be tested by measuring 5HT2A receptor density using the PET radioligand (R)-\[18F\]MH.MZ in both populations.
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
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.
Single group
Pimavanserin
DrugPD related Psychosis
Change in 5HT2A receptor density measured using the PET radioligand MH.MZ
Receptor density (Bmax) of 5HT2A receptors measured using the PET radioligand MH.MZ uptake in regions of interest.
Change in 5HT2A receptor binding occupancy measured using the PET radioligand MH.MZ
Receptor binding occupancy (RO) of 5HT2A receptors measured using the PET radioligand MH.MZ uptake in regions of interest.
Change in psychosis severity
Change in psychosis severity 6 weeks after starting pimavanserin, as measured by Clinician-Rated Dimensions of Psychosis Symptom Severity (CRD-PSS)18; Domain I (Delusions). Low scores indicate better outcome.
Change in psychosis severity
Change in psychosis severity 6 weeks after starting pimavanserin, as measured by Clinician-Rated Dimensions of Psychosis Symptom Severity (CRD-PSS)18; Domain II (Hallucinations). Low scores indicate better outcome.
Changes to functional connectivity and ASL bloodflow
Changes to functional connectivity and ASL bloodflow (mL/g/min) within pre-defined networks for delusions, hallucinations, and sleep after 6 weeks of Pimavanserin.
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Vanderbilt University Medical Center
Lead sponsor
ACADIA Pharmaceuticals Inc.
Collaborator
