CS1P1 PET Studies of Neuroinflammation in Parkinson Disease

March 31, 2026 updated by: Washington University School of Medicine
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63105
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A total of 50 participants with idiopathic PD and up to 30 healthy control participants are to be studied. Some of these participants will be recruited from existing research studies. Others will be recruited from the clinic, the community, and a registry of healthy volunteers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Control
Drug: [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.
Parkinson Disease
Drug: [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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PET imaging studies of [11C]-CS1P1 in healthy control participants and participants with Parkinson Disease.
Time Frame: At the time of PET scan
The investigators hypothesize that specific binding of [11C]-CS1P1 is elevated in participants with neurodegenerative disease of the central nervous system compared to healthy control participants.
At the time of PET scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Robert L White, MD, PhD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 28, 2029

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202306067

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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