Using a PET tracer to study serotonin receptors in neurodegenerative diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to investigate the differences in serotonin 2A receptor occupancy between patients with neurodegenerative diseases, such as Parkinson's disease, and healthy controls. It will utilize the PET radioligand (R)-[18F]MH.MZ to measure receptor density and assess the impact of the drug pimavanserin on psychosis symptoms. Patients will undergo PET and MRI scans at baseline and after six weeks of treatment to evaluate changes in receptor occupancy and functional connectivity related to psychotic symptoms. The study seeks to establish a correlation between receptor density, drug effects, and neuroimaging changes.

Why it matters

Who can join: the full rules

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

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Ciaran Considine, PhD — Vanderbilt University Medical Center
• Study coordinator: Levi Pettit, BA
• Email: levi.f.pettit@vumc.org
• Phone: 6154210569

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.