CS1P1 PET Studies of Neuroinflammation in Parkinson Disease

NCT ID: NCT06084533

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-10

Study Completion Date

2029-02-28

Brief Summary

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Parkinson disease (PD) is a progressive neurological disorder strongly linked to advancing age that results in decline in mobility and thinking. Based on prior research, the investigators think that small amounts of inflammation in the brain may contribute to the mobility and thinking problems in people with PD. They are trying to measure inflammation in the brain in order to understand how this inflammation could be contributing to the symptoms of PD. This study involves a brain positron emission tomography (PET) scan with a new, investigational radioactive tracer called \[11C\]-CS1P1 to identify inflammation in the brain.The goal of this project is to quantify neuroinflammation with \[11C\]-CS1P1 PET and compare to motor and cognitive function in participants with various stages of severity of PD compared to controls.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Parkinson Disease

[11C]-CS1P1

Intervention Type DRUG

Participants will receive a single intravenous bolus injection of 10.0 - 20.0 milliCurie (mCi) of the investigational radiotracer \[11C\]-CS1P1. Participants will then undergo a \[11C\]-CS1P1 PET scan.

Healthy Control

[11C]-CS1P1

Intervention Type DRUG

Participants will receive a single intravenous bolus injection of 10.0 - 20.0 milliCurie (mCi) of the investigational radiotracer \[11C\]-CS1P1. Participants will then undergo a \[11C\]-CS1P1 PET scan.

Interventions

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[11C]-CS1P1

Participants will receive a single intravenous bolus injection of 10.0 - 20.0 milliCurie (mCi) of the investigational radiotracer \[11C\]-CS1P1. Participants will then undergo a \[11C\]-CS1P1 PET scan.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Parkinson Disease (PD) participants must be at least 50 years old and meet clinical diagnostic criteria of idiopathic PD.
* Control participants must be at least 50 years old and not have PD, no first-degree family member with PD, and no evidence of PD or dementia on examination.

Exclusion Criteria

* any history of other neurologic illness (e.g. stroke, seizure, multiple sclerosis)
* history of brain surgery or major head trauma
* major medical/systemic illness
* severe psychiatric illness (e.g. bipolar disorder, schizophrenia)
* major drug abuse
* history of long term use of anti-dopaminergic medication
* chronic treatment with immunomodulatory or anti-inflammatory medications
* weight over 300 lbs
* contraindication to or inability to tolerate MRI
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert L White, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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202306067

Identifier Type: -

Identifier Source: org_study_id

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