Parkinson's Disease Inflammatory Biomarker Profiling

Study Overview
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Brief Summary
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This study compares a comprehensive panel of immunological biomarkers between Parkinson's disease patients and healthy, environmentally matched participants. This unique study design provides the ability to control for differences in environment between study subjects. The goal of this study is to 1) identify a specific set of immunological markers that correlate with a clinical diagnosis of Parkinson's disease and 2) stratify patients by disease severity using these same biomarkers.

Official Title
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Inflammatory Parkinson's Disease (PD) Clinical Biomarker Profiling in T Cells

Conditions
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Parkinson Disease

Intervention / Treatment
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* Diagnostic Test: LBT-3627
* Diagnostic Test: Immunological profiling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria All Participants Subjects must be willing and able to participate in study Subjects must be willing and able to provide written consent to participate. Subjects must be willing and able to comply with scheduled clinic visits and study procedures (UPDRS exam, blood draw and complete a questionnaire) Subjects are not currently taking an immunomodulatory (e.g. anti- tumor necrosis factor (TNF), immunosuppressants/stimulants) agent in the past 90 days No active or recent (< 3 weeks) infection requiring clinical intervention and/or pharmaceutical treatment or febrile neutropenia within the last week. 18-89 years old Parkinson's Disease Patients Clinical diagnosis of PD by a movement disorders specialist consistent with standard criteria Able to attend a clinical visit in the 'off' state Hoehn and Yahr stage I-IV Caregiver Controls • Individuals without PD who share environmental exposures (i.e. spouses, children, caregivers or other individuals who frequently spend significant time (>6 hours) in proximity to the PD subject) OR age and sex matched healthy individuals from general population Exclusion Criteria All Participants Unstable cardiopulmonary or cerebrovascular disease Renal disease or failure w/ serum creatinine greater than 2.5 Severe or unstable depression or other axis I psychopathology Epilepsy Prior brain surgery related to PD (DBS, cell implantation, gene therapy, etc.) Severe head injury with evidence of brain injury Essential Thrombocythemia (ET) (>450,000 platelets/mL) Patients currently being treated with any of the following, within the past 5 days: Immunomodulatory agents (e.g. Remicade®, Humira®, Enbrel®) (within the past 90 days) Corticosteroids Probenecid® Coenzyme Q10® Anticoagulants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Clinical diagnosed Parkinson's disease patients | Diagnostic Test: LBT-3627<br>* Immunomodulatory agent<br>Diagnostic Test: Immunological profiling<br>* Comprehensive profiling of inflammatory and anti-inflammatory markers (incl. cellular, molecular) including cellular functional assays<br>|
| Caregivers<br>Environmentally matched healthy control subjects | Diagnostic Test: LBT-3627<br>* Immunomodulatory agent<br>Diagnostic Test: Immunological profiling<br>* Comprehensive profiling of inflammatory and anti-inflammatory markers (incl. cellular, molecular) including cellular functional assays<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson Disease Rating Scale | Clinical scoring system to evaluate severity of Parkinson's disease in patients | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-17 | Proinflammatory cytokine | 48 hours | 
| FoxP3 | Regulatory Tcell marker | 48 hours | 
| GM-CSF | Cytokine | 48 hours | 
| LRRK2 | Leucine rich region kinase 2 protein | 48 hours | 
| VPAC2 | Regulates TH1/TH2 balance of inflammatory system | 48 hours | 
| Interferon gamma | Inflammatory cytokine | 48 hours | 
| Tumor necrosis factor alpha | Inflammatory cytokine | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune System, Immunology, Neuroinflammation, Inflammation, Neuroprotection