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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
Must not have
For PD Participants: current or prior use of pimavanserin
Deemed unable to complete neurocognitive testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 weeks after intervention of pimavanserin
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial tests if pimavanserin can help improve psychosis symptoms in Parkinson's Disease patients by affecting specific brain receptors. Pimavanserin is an atypical antipsychotic approved for treating hallucinations and delusions in Parkinson's disease psychosis. The study uses brain scans to measure changes over time.
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have Parkinson's and have taken or am taking pimavanserin.
Select...
I am unable to complete tests for brain function.
Select...
I have not had a stroke or any serious uncontrolled illness.
Select...
I am unable to give consent on my own.
Select...
I have psychosis not caused by substance abuse or a primary mental health condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 6 weeks after intervention of pimavanserin
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 weeks after intervention of pimavanserin
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Change in psychosis severity
Changes to functional connectivity and ASL bloodflow
Side effects data
From 2021 Phase 4 trial • 6 Patients • NCT0418839233%
sleepiness
17%
arthralgia
17%
headache
17%
weight gain
17%
skin irritation
17%
diarrhea
17%
dry mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label Treatment
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active 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
~3250
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Parkinson's Disease (PD) include levodopa, dopamine agonists, and MAO-B inhibitors. Levodopa replenishes dopamine levels, directly addressing the dopamine deficiency in PD.
Dopamine agonists mimic dopamine by stimulating its receptors, helping manage symptoms and potentially slowing disease progression. MAO-B inhibitors increase dopamine availability by preventing its breakdown.
Amantadine and anticholinergics are also used to manage symptoms. The PET tracer (R)-[18F]MH.MZ, which binds to 5HT2A receptors, is used for imaging and quantification of these receptors, which may be altered in PD.
Understanding these mechanisms is crucial for tailoring treatments to manage symptoms effectively and potentially slow disease progression.
Dopamine agonists in Parkinson's disease.Efficacy and safety of 5-Hydroxytryptophan on levodopa-induced motor complications in Parkinson's disease: A preliminary finding.Pharmacologic approaches to the treatment of Huntington's disease.
Dopamine agonists in Parkinson's disease.Efficacy and safety of 5-Hydroxytryptophan on levodopa-induced motor complications in Parkinson's disease: A preliminary finding.Pharmacologic approaches to the treatment of Huntington's disease.
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
903 Previous Clinical Trials
934,011 Total Patients Enrolled
ACADIA Pharmaceuticals Inc.Industry Sponsor
47 Previous Clinical Trials
11,529 Total Patients Enrolled
Richard Darby, MDPrincipal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a neurodegenerative disease like Parkinson's or Huntington's.I am the same age and gender as the patient group.I have Parkinson's and have taken or am taking pimavanserin.I have not taken antipsychotic medications in the last 2 weeks.I have had severe hallucinations or delusions weekly for a month after being diagnosed with Parkinson's.I am unable to complete tests for brain function.I have not had a stroke or any serious uncontrolled illness.I am unable to give consent on my own.I haven't taken any serotonergic medications in the last 6 weeks.I have psychosis not caused by substance abuse or a primary mental health condition.
Research Study Groups:
This trial has the following groups:- Group 1: Pimavanserin
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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