RecruitingPhase 4NCT05357612
Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases
Sponsor
Vanderbilt University Medical Center
Enrollment
75 participants
Start Date
Jan 23, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 50 YearsMax Age: 85 Years
Inclusion Criteria4
- 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 Criteria9
- 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
Interventions
DRUGPimavanserin
PD related Psychosis
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05357612
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