CS1P1 PET Studies of Neuroinflammation in Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

CS1P1 PET Studies of Neuroinflammation in Parkinson Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06084533
• Other study ID #: 202306067
• Status: Enrolling by invitation
• Start date: January 10, 2024
• Est. completion date: February 28, 2029

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: February 28, 2029
• Est. primary completion date: February 1, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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