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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT04062526
• Date of registration: 14/08/2019
• Prospective Registration: Yes
• Primary sponsor: University of Pennsylvania
• Public title: Evaluation of Neuroinflammation in Parkinson's Disease Using 18F-NOS PET/CT
• Scientific title: Evaluation of in Vivo Neuroinflammation in Parkinson's Disease Using 18F-NOS Positron Emission Tomography (PET/CT)
• Date of first enrolment: August 14, 2019
• Target sample size: 11
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04062526
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Jacob Dubroff, MD
• Affiliation: University of Pennsylvania

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Healthy Volunteer

Intervention(s)

Drug: [18F]NOS

Primary Outcome(s)

Characterize the uptake of [18F]NOS [Time Frame: 3 years]

Secondary Outcome(s)

Compare peripheral blood inflammatory biomarkers [Time Frame: 3 years]

Compare patterns of uptake [Time Frame: 3 years]

Secondary ID(s)

833589

Source(s) of Monetary Support

Please refer to primary and secondary sponsors