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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease; Healthy Volunteer
• Intervention / Treatment: Drug: [18F]NOS

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Erin Schubert; Phone Number: 215-573-6569; Email: erinschu@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria (HC and PD cohorts)

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)

1. History of diagnosis of probable idiopathic PD derived from UK Brain Bank Diagnostic criteria(1) per neurologist review.
2. Diagnosed with Parkinson's Disease at least 3 year prior to enrollment.
3. Subjects will be selected who have the capacity to give their own informed consent, in the opinion of a neurology investigator.

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)

1. History of first degree relative with Parkinson's Disease.
2. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.; Other Names: [18F]-6-(2-fluoro-propyl)-4-methylpyridin-2-amine
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.; Other Names: [18F]-6-(2-fluoro-propyl)-4-methylpyridin-2-amine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the uptake of [18F]NOS	Characterize the uptake of [18F]NOS in the human brain for healthy controls and PD patients.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare patterns of uptake	Compare patterns of [18F]NOS brain uptake in patients with PD versus healthy controls.	3 years
Compare peripheral blood inflammatory biomarkers	Compare peripheral blood inflammatory biomarkers, including cytokines and mtDAMPs, in PD patients with healthy controls.	3 years

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Jacob Dubroff, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2019
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Inflammation; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Neuroinflammatory Diseases
• Other Study ID Numbers: 833589

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No