The University of Alabama at Birmingham (UAB) Neuroinflammation in Parkinson's Disease-TSPO- Positron Emission Tomography (PET) Substudy

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2024
• Main ID: NCT03457493
• Date of registration: 23/02/2018
• Prospective Registration: Yes
• Primary sponsor: University of Alabama at Birmingham
• Public title: The University of Alabama at Birmingham (UAB) Neuroinflammation in Parkinson's Disease-TSPO- Positron Emission Tomography (PET) Substudy
• Scientific title: UAB Neuroinflammation in Parkinson's Disease - TSPO-PET Substudy
• Date of first enrolment: March 22, 2018
• Target sample size: 205
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03457493
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Jonathan McConathy, MD
• Affiliation: University of Alabama at Birmingham

• Name: Evan Hudson

• Name: Jonathan McConathy, MD

Key inclusion & exclusion criteria

Inclusion Criteria for all cohorts:

1. Enrollment in either the UAB Innate and Adaptive Immunity in Parkinson Disease
(Clinical Research Core) study or UAB Longitudinal [18F]DPA-714 Imaging in a Parkinson
Disease Cohort study under the separate UAB-approved research protocols (IRB-300001745
and IRB-300011684 respectively, PI Yacoubian)

2. Negative urine or serum Human chorionic gonadotropin (hCG) test within 2 days of
[18F]DPA-714-PET administration in women of childbearing potential. Women who are
post-menopausal with at least 1 year since last menses or documented surgical
sterilization will not require pregnancy testing.

3. High or mixed affinity binder for TSPO ligands based on genotyping for single
nucleotide polymorphism (SNP) rs6971.

Exclusion Criteria for all cohorts:

1. Meets any exclusion criteria for the UAB Innate and Adaptive Immunity in Parkinson's
Disease (Clinical Research Core) study or UAB Longitudinal [18F]DPA-714 Imaging in a
Parkinson's Disease Cohort study.

2. Contraindication to MRI and/or PET imaging

3. Inability to participate in the imaging studies due to severity of PD or other medical
comorbidities.

4. Low-affinity binder for TSPO ligands based on genotyping for SNP rs6971.

Inclusion Criteria specific for UDALL 5-year Follow-up Cohort

1. Parkinson's Disease participant enrolled in UDALL Baseline Cohort. Baseline imaging to
be completed no more than 6 years prior.

Inclusion of Women and Minorities

Participants 30 years of age or older will be eligible for study participation. No other
discriminatory factors, including age, sex, or ethnic background will be used to determine
eligibility. Every effort will be made to ensure that minorities are recruited for study
participation.



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: 5-year Follow-up DPA-714-PET/MRI

Drug: DPA-714 Metabolite Analysis

Drug: DPA-714-PET/MRI

Primary Outcome(s)

Comparison of TSPO-PET measures of neuroinflammation between PD patients and healthy controls. [Time Frame: 2 years]

Correlation of DPA-714-PET/MRI with demographics, clinical and biospecimen assessments from Neuroinflammation in PD study [Time Frame: 2 years]

Secondary ID(s)

IRB-300001025

Source(s) of Monetary Support

Please refer to primary and secondary sponsors