CS1P1 PET Studies of Neuroinflammation in Parkinson Disease

Sponsor

Washington University School of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06084533

Collaborator

(none)

Enrollment

Location

63.9

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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, we think that small amounts of inflammation in the brain may contribute to the mobility and thinking problems in people with PD. We 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 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: [11C]-CS1P1

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

CS1P1 PET Studies of Neuroinflammation in Parkinson Disease

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2029

Anticipated Study Completion Date :

Feb 28, 2029

Arms and Interventions

Arm	Intervention/Treatment
Parkinson Disease	Drug: [11C]-CS1P1 Participants will receive a single intravenous bolus injection of 10.0 - 20.0 mCi of the investigational radiotracer [11C]-CS1P1. Participants will then undergo a [11C]-CS1P1 PET scan.
Healthy Control	Drug: [11C]-CS1P1 Participants will receive a single intravenous bolus injection of 10.0 - 20.0 mCi of the investigational radiotracer [11C]-CS1P1. Participants will then undergo a [11C]-CS1P1 PET scan.

Arm

Intervention/Treatment

Parkinson Disease

Drug: [11C]-CS1P1

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

Healthy Control

Drug: [11C]-CS1P1

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63105

Sponsors and Collaborators

Washington University School of Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT06084533

Other Study ID Numbers:

202306067

First Posted:

Oct 16, 2023

Last Update Posted:

Oct 16, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Neuroinflammatory Diseases

Study Results

No Results Posted as of Oct 16, 2023