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

Study Overview
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Brief Summary
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The primary objective of this substudy is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET (Positron Emission Tomography) ligand Fluorodeoxyglucose dimethylpyrazolo ([18F]DPA-714) in participants enrolled in the UAB Neuroinflammation in Parkinsons Disease (PD) study. The PET tracer [18F]DPA-714 binds to the 18 kilodaltons (kDa) translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The amount and distribution of [18F]DPA-714 in the brain will be correlated to clinical data acquired through the separate ongoing Neuroinflammation in PD study. The primary objective of this study is to determine if patients with PD have higher levels of neuroinflammation than healthy controls as measured with [18F]DPA-714-PET/MRI.

Official Title
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UAB Neuroinflammation in Parkinson's Disease - TSPO-PET Substudy

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: DPA-714-PET/MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrollment in the UAB Neuroinflammation in PD study under the separate UAB approved research protocol Institutional Review Board number (IRB)-300000690. Negative urine or serum Human chorionic gonadotropin (hCG) test within 2 days of [18F]DPA-714-PET administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971. Exclusion Criteria: Meets any exclusion criteria for the UAB Neuroinflammation in PD study. Contraindication to MRI and/or PET imaging Inability to participate in the imaging studies due to severity of PD or other medical comorbidities. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971. -

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Controls, DPA-714-PET/MRI<br> | Drug: DPA-714-PET/MRI<br>* DPA-714-PET/MRI<br>|
| Experimental: Early Parkinson's Disease, DPA-714-PET/MRI<br> | Drug: DPA-714-PET/MRI<br>* DPA-714-PET/MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of TSPO-PET measures of neuroinflammation between PD patients and healthy controls. | Estimates of brain TSPO concentrations measured with PET will serve as a marker for neuroinflammation. TSPO-PET measures will be compared between PD patients and healthy controls. We expect the PD patients to have higher measures of neuroinflammation than healthy controls. | 2 years | 
| Correlation of DPA-714-PET/MRI with demographics, clinical and biospecimen assessments from Neuroinflammation in PD study | The estimates of neuroinflammation measured with TSPO-PET will be correlated with clinical assessments of PD severity and biospecimens collected through the UAB Neuroinflammation in PD study. | 2 years |