Parkinson DiseaseNCT06084533
CS1P1 PET Studies of Neuroinflammation in Parkinson Disease
An observational study of Parkinson Disease, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- [11C]-CS1P1
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2024to 28 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- chronic treatment with immunomodulatory or anti-inflammatory medications
- weight over 300 lbs
- contraindication to or inability to tolerate MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63105
About this study
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
- Being tested
- [11C]-CS1P1
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]-CS1P1Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease | Not described Receives: Drug: [11C]-CS1P1 | |
| Healthy Control | Not described Receives: Drug: [11C]-CS1P1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of PET scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start10 Jan 2024
- Primary completion1 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert L White, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084533
- Sponsor's protocol ID
- 202306067
- Status last verified
- Mar 2026
- First submitted
- 10 Oct 2023
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CS1P1 PET Studies of Neuroinflammation in Parkinson Disease
- ClinicalTrials.gov ID
- NCT06084533
- Acronym / sponsor ID
- 202306067
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease | – | Drug: [11C]-CS1P1 |
| Healthy Control | – | Drug: [11C]-CS1P1 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C]-CS1P1Participants 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. | Drug | Healthy Control, Parkinson Disease |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert L White, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET imaging studies of [11C]-CS1P1 in healthy control participants and participants with Parkinson Disease. (time frame: At the time of PET scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.