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Parkinson DiseaseEarly Phase 1NCT04062526

Evaluation of Neuroinflammation in Parkinson's Disease Using 18F-NOS PET/CT

A Early Phase 1 study testing [18F]NOS in people with Parkinson Disease and Healthy Volunteer, run by University of Pennsylvania at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The research study is being conducted to test how a specialized type of Positron Emission Tomography (PET/CT) scan could potentially be useful in diagnosing or monitoring treatment in people with Parkinson's disease. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Parkinson Disease, Healthy Volunteer
What is being tested?
[18F]NOS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
14 Aug 2019to Apr 2027
Phase
Early Phase 1
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 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants will be 18-75 years of age.
  • Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
  • Subjects with known neuropsychiatric disorder may be eligible if, in the opinion of an investigator, the psychiatric condition would not compromise subject safety or successful participation in the study.
  • History of diagnosis of probable idiopathic PD derived from UK Brain Bank Diagnostic criteria(1) per neurologist review.
  • Diagnosed with Parkinson's Disease at least 3 year prior to enrollment.
  • Subjects will be selected who have the capacity to give their own informed consent, in the opinion of a neurology investigator.

Who cannot join

  • Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child- bearing potential within one day of the PET/CT scan.
  • At screening, the participant's weight is > 350 lb.
  • Subject reported claustrophobia that in the opinion of an investigator would interfere with acquisition of the structural MRI required for PET co-registration, and/or the PET scan itself.
  • History of epilepsy or seizure disorder as assessed by medical record review and/or self-report.
  • History of head trauma that in the opinion of an investigator may interfere with the uptake of applicable radiotracer as assessed by medical record review and/or self- report.
  • Current tobacco or nicotine dependence. History of greater than 5 pack years of smoking and less than 2 years since smoking cessation.
Show all 11Show fewer
  • Self-reported current alcohol consumption of greater than or equal to 25 drinks per week.
  • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
  • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician or investigator to be a condition that could compromise participant safety or successful participation in the study.
  • History of first degree relative with Parkinson's Disease.
  • Use of a CNS drug (prescription, over-the counter or recreational) within 30 days of screening, as assessed by review of medical history and concomitant medication review at screening (from medical record and/or self-report) that are deemed by a physician or investigator to have a potential influence on the binding of the applicable radiotracer.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Evaluation of in Vivo Neuroinflammation in Parkinson's Disease Using 18F-NOS Positron Emission Tomography (PET/CT)

The research study is being conducted to test how a specialized type of Positron Emission Tomography (PET/CT) scan could potentially be useful in diagnosing or monitoring treatment in people with Parkinson's disease. If the subject decide to be in this study he/she will have a PET/CT scans using an imaging drug called 18F-NOS which will be used to measure inflammation in the brain.

Read the detailed description

The purpose of this research is to test whether it is possible to measure inflammation in subject's brain using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT). There are two groups of people who will participate in this study, a Parkinson's disease (PD) group and a Control group Both groups will have imaging with a radioactive drug called 18F-NOS which is an experimental radioactive drug used in PET/CT imaging to measure inflammation in the brain. 18F-NOS has not yet been approved by the Food and Drug Administration (FDA) for use except in a research study. The use 18F-NOS in this study is allowed under an Investigational New Drug Application approved by the FDA.

If subject agree to participate in this study, she/ he will undergo one experimental 18F-NOS PET/CT scan. During the scan, PET/CT images will be taken of subject head in order to capture pictures of their brain. The imaging procedures will be explained to subject in more detail below. Blood samples will be taken at various time points to measure the concentration of the imaging drug in your blood during the scan and a blood sample will be collected to measure specialized inflammation markers in the blood.

Investigator hopes to compare the PET/CT scans for the two groups to see if there are differences between Parkinson patients and Controls. Investigator will also compare the results with other informationgathered about subject during their participation, including brain MRI and inflammation markers.

Being tested
[18F]NOS
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]NOSDrug

    Also called [18F]-6-(2-fluoro-propyl)-4-methylpyridin-2-amine

    [18F]NOS is an investigational radiotracer which each subject will have one [18F]NOS positron emission tomography/computed tomography (PET/CT) scan performed.

Study groups in NCT04062526
Study groupRoleWhat they receive
Patient with Parkinson DiseaseExperimentalSubject should have a history of diagnosis of probable idiopathic PD derived from UK Brain Bank Diagnostic criteria per neurologist review. Subject must have been diagnosed with Parkinson's Disease at least 3 year prior to enrollment.
Receives: Drug: [18F]NOS
Healthy ControlExperimentalSubject must be a Healthy.
Receives: Drug: [18F]NOS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Characterize the uptake of [18F]NOS

    Characterize the uptake of [18F]NOS in the human brain for healthy controls and PD patients.

    Measured: 3 years

Secondary outcomes (2)

  1. Compare patterns of uptake

    Compare patterns of [18F]NOS brain uptake in patients with PD versus healthy controls.

    Measured: 3 years

  2. Compare peripheral blood inflammatory biomarkers

    Compare peripheral blood inflammatory biomarkers, including cytokines and mtDAMPs, in PD patients with healthy controls.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2019
  2. Study start14 Aug 2019
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04062526
Sponsor's protocol ID
833589
Status last verified
Apr 2026
First submitted
14 Aug 2019
Last updated
1 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [18F]NOS in people with Parkinson Disease and Healthy Volunteer, run by University of Pennsylvania 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 6 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 1 May 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Characterize the uptake of [18F]NOS (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04062526.

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 1 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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