Actively Recruiting
Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases
Led by Vanderbilt University Medical Center · Updated on 2025-08-12
75
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
A
ACADIA Pharmaceuticals Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with neurodegenerative diseases such as Parkinson disease, diffuse Lewy body disease, multiple systems atrophy, Huntington's Disease, and Frontotemporal Dementia. They aim to investigate differences in the 5HT2A receptor occupancy compared to healthy individuals matched by age and sex. The study focuses on how changes in receptor density and occupancy relate to psychosis symptoms, particularly hallucinations and delusions, in Parkinson's disease patients treated with pimavanserin. The study involves measuring 5HT2A receptor density using a PET radioligand called (R)-[18F]MH.MZ. Parkinson's disease patients with psychosis will have PET scans at enrollment to assess baseline receptor density and again after six weeks of pimavanserin treatment to measure receptor occupancy changes. MRI scans will also be performed at these two time points to evaluate functional connectivity and cerebral blood flow changes associated with the treatment. Participants will undergo assessments including PET and MRI scans at baseline and after six weeks of pimavanserin. Researchers will monitor psychosis severity, receptor binding changes, and brain functional changes related to treatment. The study includes patients aged 50 to 85 years with psychosis symptoms starting after Parkinson's diagnosis. Study partners are required for visits, and participants will be followed over the six-week treatment period to evaluate outcomes and safety.
CONDITIONS
Brief Title
Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of Parkinson disease, diffuse Lewy body disease, multiple systems atrophy, Huntington's Disease, Frontotemporal Dementia, or related variants
- Healthy participants matched by age and gender to patient group
- Psychosis symptoms (hallucinations or delusions) occurring at least weekly for 4 weeks after Parkinson's diagnosis
- Availability of a study partner for study visits
- Age between 50 and 85 years
You will not qualify if you...
- History of stroke or other uncontrolled serious neurological or medical illness
- Unable to tolerate or contraindicated for MRI scan
- Use of serotonergic medications within the last 6 weeks
- Unable to provide independent consent
- Pregnant or breastfeeding women
- Psychosis caused by metabolic, toxic, or primary psychiatric conditions
- Unable to complete neurocognitive testing
- Current or prior use of pimavanserin for Parkinson's disease participants
- Use of antipsychotic medications within the last 2 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive pimavanserin to assess changes in 5HT2A receptor density and psychosis symptoms.
2 visits including baseline and post-treatment PET and MRI scans
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
Research Team
L
Levi Pettit, BA
K
Katie Hay, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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