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Recruiting NCT05357612

Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases

Phase IV Interventional Neurodegenerative Diseases Parkinson Disease Parkinson Disease Psychosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pimavanserin.
Who it may be relevant to
Registry conditions: Neurodegenerative Diseases, Parkinson Disease, Parkinson Disease Psychosis. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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 of 5HT2A receptors following pimavanserin administration (Hypothesis 1B). This will be done by measuring 5HT2A receptor density using the PET radioligand (R)-\[18F\]MH.MZ within predefined symptom networks for hallucinations, delusions, and sleep. A PET scan will be obtained in PD patients with psychosis at enrollment to measure baseline 5HT2A receptor density and then again after 6 weeks of pimavanserin. The change in binding between baseline and post-drug treatment window will be used to measure 5HT2A receptor occupancy.

It is hypothesize that improvement in psychosis symptoms in patients taking pimavanserin will be associated with increased functional connectivity and cerebral blood flow within predefined symptom networks for hallucinations, delusions, and sleep. This will be tested by obtaining MRI scans assessing resting state functional connectivity and arterial spin labeling in PD patients with psychosis at enrollment (baseline) and then again after 6 weeks of pimavanserin.

It is hypothesized that functional neuroimaging changes in response to pimavanserin will be associated with baseline 5HT2A receptor density and 5HT2A receptor occupancy after pimavanserin administration. To test this hypothesis, the differences in functional neuroimaging measures and PET 5HT2A receptor will be measured in PD psychosis patients off (at baseline) and on Pimavanserin (post-treatment window).

Interventions

  • Drug Pimavanserin
    PD related Psychosis

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Change in psychosis severity [Time frame: Baseline and 6 weeks after intervention of Pimavanserin]
  • Change in psychosis severity [Time frame: Baseline and 6 weeks after intervention of Pimavanserin]
  • Changes to functional connectivity and ASL bloodflow [Time frame: Baseline and 6 weeks after intervention of Pimavanserin]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT05357612 · 212028

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗