Status:
RECRUITING
Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
ACADIA Pharmaceuticals Inc.
Conditions:
Neurodegenerative Diseases
Parkinson Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE4
Brief 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 contr...
Detailed Description
It is hypothesized that improvement in psychosis symptoms in patients taking pimavanserin will be associated with increased baseline receptor density (Hypothesis 1A), and increased receptor occupancy ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05357612
Start Date
January 23 2023
End Date
August 1 2026
Last Update
August 12 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212