Recruiting

Serotonin 2A Receptor

Sponsor:

Vanderbilt University Medical Center

Code:

NCT05357612

Conditions

Neurodegenerative Diseases

Parkinson Disease

Parkinson Disease Psychosis

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Pimavanserin

Study Details

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 control group. This will be tested by measuring 5HT2A receptor density using the PET radioligand (R)-\[18F\]MH.MZ in both populations.

Conditions

Neurodegenerative Diseases

Parkinson Disease

Parkinson Disease Psychosis

Study ID

NCT05357612

Start date

Jan 23, 2023

Status verified date

Aug, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Pimavanserin

Interventions

Pimavanserin

PD related Psychosis

Primary outcome measure

  • Change in 5HT2A receptor density measured using the PET radioligand MH.MZ [ Time Frame: Baseline and 6 weeks after intervention of Pimavanserin ]
  • Change in 5HT2A receptor binding occupancy measured using the PET radioligand MH.MZ [ Time Frame: Baseline and 6 weeks after intervention of Pimavanserin ]

Central Contacts and Locations

Central contacts

Levi Pettit, BA

6154210569levi.f.pettit@vumc.org

Katie Hay, MS

kaitlyn.r.hay@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Levi Pettit, BA

615-421-0569levi.f.pettit@vumc.org

Katie Hay, MS

6158757403katie.orourke@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Aug 7, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-08-07.