CS1P1 PET Studies of Neuroinflammation in Parkinson Disease

NCT06084533 | Enrolling By Invitation FDA Drug

• 1 other identifier: 202306067
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Parkinson Disease

Drug: [11C]-CS1P1

Healthy Control

Drug: [11C]-CS1P1

Interventions

[11C]-CS1P1 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; Parkinson Disease

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63105, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Robert L White, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: January 10, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (1)