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Brain scan tracer could reveal hidden signs of psychosis in Parkinson's

NCT ID NCT05357612

Knowledge-focused Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study uses a special PET scan tracer, [18F]MH.MZ, to measure serotonin 2A receptors in the brains of people with neurodegenerative diseases like Parkinson's. Researchers want to see if these receptors differ between patients with psychosis and healthy people of the same age. Some participants will also take the drug pimavanserin to see how it affects receptor binding. The goal is to better understand the brain changes behind psychosis in these diseases.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a radioactive PET tracer called [18F]MH.MZ, and the drug pimavanserin for some participants
What this could lead to
If successful, this could help doctors better understand and diagnose psychosis in neurodegenerative diseases like Parkinson's.
What could go wrong
This is an early-stage imaging study, not a treatment trial. The tracer may not reliably distinguish between patient groups, and results may not lead to direct clinical benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

frontotemporal dementia Huntington disease Lewy body dementia multiple system atrophy neurodegenerative disease Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neurodegenerative diseases Parkinson disease Parkinson disease psychosis

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37212, United States

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