Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2023
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2022
CompletedFirst Posted
Study publicly available on registry
May 3, 2022
CompletedStudy Start
First participant enrolled
January 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
August 12, 2025
August 1, 2025
3.4 years
April 20, 2022
August 6, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in 5HT2A receptor density measured using the PET radioligand MH.MZ
Receptor density (Bmax) of 5HT2A receptors measured using the PET radioligand MH.MZ uptake in regions of interest.
Baseline and 6 weeks after intervention of Pimavanserin
Change in 5HT2A receptor binding occupancy measured using the PET radioligand MH.MZ
Receptor binding occupancy (RO) of 5HT2A receptors measured using the PET radioligand MH.MZ uptake in regions of interest.
Baseline and 6 weeks after intervention of Pimavanserin
Secondary Outcomes (3)
Change in psychosis severity
Baseline and 6 weeks after intervention of Pimavanserin
Change in psychosis severity
Baseline and 6 weeks after intervention of Pimavanserin
Changes to functional connectivity and ASL bloodflow
Baseline and 6 weeks after intervention of Pimavanserin
Study Arms (1)
Pimavanserin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt University Medical Centerlead
- ACADIA Pharmaceuticals Inc.collaborator
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ciaran Considine, PhD
Vanderbilt University Medical Center
- PRINCIPAL INVESTIGATOR
Richard Darby, MD
Vanderbilt University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc Professor
Study Record Dates
First Submitted
April 20, 2022
First Posted
May 3, 2022
Study Start
January 23, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
August 12, 2025
Record last verified: 2025-08