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Pimavanserin PET Tracer for Neurodegenerative Disease

Phase 4
Recruiting
Led By Richard Darby, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient arm - clinical diagnosis of Parkinson disease, diffuse Lewy body disease, multiple systems atrophy, Huntington's Disease, Frontotemporal Dementia, and other variants
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 weeks after intervention of pimavanserin
Awards & highlights

Study Summary

This trialwill compare 5HT2A receptor density between neurodegenerative patients and healthy controls to see if there's a difference.

Who is the study for?
This trial is for people with neurodegenerative diseases like Parkinson's, Lewy body disease, and others who experience psychosis. Participants need a study partner and must not have had strokes or serious illnesses that could interfere with the study. Pregnant women and those on certain medications recently are excluded.Check my eligibility
What is being tested?
The trial is testing how a PET tracer called [18F]MH.MZ binds to serotonin receptors in patients compared to healthy controls. It aims to show differences in receptor occupancy between these groups using this imaging technique.See study design
What are the potential side effects?
While specific side effects aren't listed for the PET tracer itself, potential risks may include discomfort from the injection of the tracer, allergic reactions, or anxiety during the MRI scan required by the protocol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a neurodegenerative disease like Parkinson's or Huntington's.
Select...
I have had severe hallucinations or delusions weekly for a month after being diagnosed with Parkinson's.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 weeks after intervention of pimavanserin
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 weeks after intervention of pimavanserin for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 5HT2A receptor binding occupancy measured using the PET radioligand MH.MZ
Change in 5HT2A receptor density measured using the PET radioligand MH.MZ
Secondary outcome measures
Change in psychosis severity
Changes to functional connectivity and ASL bloodflow

Side effects data

From 2021 Phase 4 trial • 6 Patients • NCT04188392
33%
sleepiness
17%
diarrhea
17%
weight gain
17%
arthralgia
17%
dry mouth
17%
headache
17%
skin irritation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label Treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: PimavanserinExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pimavanserin
2018
Completed Phase 4
~3010

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
853 Previous Clinical Trials
670,993 Total Patients Enrolled
ACADIA Pharmaceuticals Inc.Industry Sponsor
46 Previous Clinical Trials
10,865 Total Patients Enrolled
Richard Darby, MDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Pimavanserin Clinical Trial Eligibility Overview. Trial Name: NCT05357612 — Phase 4
Parkinson's Disease Research Study Groups: Pimavanserin
Parkinson's Disease Clinical Trial 2023: Pimavanserin Highlights & Side Effects. Trial Name: NCT05357612 — Phase 4
Pimavanserin 2023 Treatment Timeline for Medical Study. Trial Name: NCT05357612 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals aged 45+ able to join this clinical investigation?

"This trial is only open to patients aged 50-85. However, there are 30 trials available for those under 18 and 502 that cater to individuals over 65 years of age."

Answered by AI

Has Pimavanserin been granted clearance by the Food and Drug Administration?

"The safety profile of Pimavanserin is rated highly, as it has achieved Phase 4 approval and thus earned a score of 3."

Answered by AI

Are there any vacancies left in this investigation for participants?

"Affirmative. Clinicaltrials.gov's data reveals that this research is still recruiting, having first been posted on the 23rd of January 2023 and last edited 24 hours later. The study requires 75 patients from a single site to complete it."

Answered by AI

How many individuals have registered to participate in this trial?

"That is correct. According to clinicaltrials.gov, the medical investigation was first published on January 23rd of 2023 and has been actively searching for participants since then. The study requires 75 patients from a single research site."

Answered by AI

Is eligibility open to me for this research endeavor?

"75 participants with Parkinson's disease between the ages of 50 and 85 are eligible to partake in this medical research. Those hoping to be included must meet further criteria, such as having a study partner available for visits, psychoses (including delusions or hallucinations) that require treatment occurring weekly over four weeks post-diagnosis, and healthy counterparts who match participant age and gender."

Answered by AI
~37 spots leftby Jun 2025