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OpenTrials
Enrolling by Invitation

NCT Number: NCT06084533

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.

Enrolling by Invitation

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63105, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 16, 2023
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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