CS1P1 PET Studies of Neuroinflammation in Parkinson Disease

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: Parkinson Disease
• Intervention / Treatment: Drug: [11C]-CS1P1

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Jessica Hudson; Phone Number: 314-747-3085; Email: jessicahudson@wustl.edu
• Study Contact Backup: Name: Andrea Slavik; Phone Number: 314-273-8313‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬; Email: andreaslavik@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63105
      • Washington University School of Medicine
      • Contact: Jessica Hudson
      • Sub-Investigator: Tammie L. S. Benzinger, MD, PhD
      • Sub-Investigator: Joel S. Perlmutter, MD

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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.	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

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

Study record dates

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): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Inflammation; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Neuroinflammatory Diseases
• 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