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RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 85 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: PET scans, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses a PET scan and a tracer called [18F]MH.MZ to measure serotonin 2A receptors, which receive chemical signals in the brain. It compares people with diseases that damage brain and nerve cells with healthy people of similar age and gender.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patient group: A diagnosis of Parkinson’s disease, diffuse Lewy body disease, multiple system atrophy, Huntington’s disease, frontotemporal dementia, or related forms of these diseases.
  • Healthy group: Similar in age and gender to people in the patient group.
  • Psychosis that began after a Parkinson’s diagnosis, happens at least weekly for 4 weeks, and is serious enough to need treatment. Psychosis means seeing or hearing things that are not there, or having beliefs that are not true.
  • A study partner who can attend study visits.

Who can't join

  • A past stroke or another serious brain, nerve, or medical illness that is not controlled.
  • Cannot safely have or tolerate an MRI scan.
  • Used medicines that affect serotonin in the past 6 weeks, or antipsychotic medicines in the past 2 weeks.
  • Cannot independently agree to take part in the study.
  • Pregnant or breastfeeding.
  • Psychosis caused by problems with the body’s chemical processes, toxic substances, or a primary mental illness.
  • The study team believes you cannot complete tests of memory and thinking.
  • For people with Parkinson’s disease: Current or past use of pimavanserin.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

TN