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

NCT04062526 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 833589
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Compare patterns of uptake

  3 years

• Compare peripheral blood inflammatory biomarkers

  3 years

Study Arms (2)

Patient with Parkinson Disease

EXPERIMENTAL

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

Healthy Control

EXPERIMENTAL

Subject must be a Healthy.

Drug: [18F]NOS

Interventions

[18F]NOS DRUG

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

Also known as: [18F]-6-(2-fluoro-propyl)-4-methylpyridin-2-amine

Healthy Control; Patient with Parkinson Disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Fluorine-18

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jacob Dubroff, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 20, 2019
• Study Start: August 14, 2019
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)