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

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ClinicalTrials.gov Identifier: NCT04062526
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Healthy Volunteer Drug: [18F]NOS Early Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of in Vivo Neuroinflammation in Parkinson's Disease Using 18F-NOS Positron Emission Tomography (PET/CT)
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patient with Parkinson Disease

Subject 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.

 Drug: [18F]NOS
[18F]NOS is an investigational radiotracer which each subject will have one [18F]NOS positron emission tomography/computed tomography (PET/CT) scan performed.
Experimental: Healthy Control
Subject must be a Healthy.
 Drug: [18F]NOS
[18F]NOS is an investigational radiotracer which each subject will have one [18F]NOS positron emission tomography/computed tomography (PET/CT) scan performed.


Outcome Measures
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Primary Outcome Measures :
  1. measure the uptake of [18F]NOS in the human brain for healthy controls and PD patients using PET/CT [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Compare patterns of [18F]NOS brain uptake in patients with PD versus healthy controls using PET/CT scan [ Time Frame: 3 years ]
  2. Compare peripheral blood inflammatory biomarkers, including cytokines and mtDAMPs, in PD patients with healthy controls. [ Time Frame: 3 years ]
    Mean mitochondrial damage associated molecular patterns (mtDAMPs) in the plasma and pro-inflammatory cytokines in the serum will be compared (PD vs HC) also using one-way Student's t-test assuming equal variances. For exploratory purposes, Pearson correlation will be determined for each of the serum inflammatory markers and whole brain [18F]NOS VT/fp in each experimental group.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  1. Participants will be 18-75 years of age
  2. 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.

  3. 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.

    Inclusion Criteria (PD cohort only)

  4. History of diagnosis of probable idiopathic PD derived from UK Brain Bank Diagnostic criteria(1) per neurologist review.
  5. Diagnosed with Parkinson's Disease at least 3 year prior to enrollment.
  6. Subjects will be selected who have the capacity to give their

Exclusion Criteria (HC and PD cohorts):

  1. 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.
  2. At screening, the participant's weight is > 350 lb.
  3. 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.
  4. History of epilepsy or seizure disorder as assessed by medical record review and/or self-report
  5. 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
  6. Current tobacco or nicotine dependence. History of greater than 5 pack years of smoking and less than 2 years since smoking cessation.
  7. Self-reported current alcohol consumption of greater than or equal to 25 drinks per week
  8. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician

  9. 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

    Exclusion Criteria (HC cohort only)

  10. History of first degree relative with Parkinson's Disease
  11. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062526


Contacts
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Contact: Zeinab Helili 215-746-3230 zeinab.helili@pennmedicine.upenn.edu
Contact: Erin Schubert 215-573-6569 Erin.Schubert@uphs.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Zeinab Helili    215-746-3230    zeinab.helili@uphs.upenn.edu   
Contact: Erin Schubert    215-573-6569    Erin.Schubert@uphs.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04062526    
Other Study ID Numbers: 833589
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases