Parkinson Disease
Conditions
Keywords
Immune System, Immunology, Neuroinflammation, Inflammation, Neuroprotection
Brief summary
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.
Interventions
DIAGNOSTIC_TESTLBT-3627
Immunomodulatory agent
DIAGNOSTIC_TESTImmunological profiling
Comprehensive profiling of inflammatory and anti-inflammatory markers (incl. cellular, molecular) including cellular functional assays
Sponsors
Michael J. Fox Foundation for Parkinson's Research
Corporal Michael J. Crescenz VA Medical Center - Philadelphia
Longevity Biotech
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson Disease Rating Scale | 1 hour | Clinical scoring system to evaluate severity of Parkinson's disease in patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin-17 | 48 hours | Proinflammatory cytokine |
| FoxP3 | 48 hours | Regulatory Tcell marker |
| GM-CSF | 48 hours | Cytokine |
| VPAC2 | 48 hours | Regulates TH1/TH2 balance of inflammatory system |
| Interferon gamma | 48 hours | Inflammatory cytokine |
| Tumor necrosis factor alpha | 48 hours | Inflammatory cytokine |
| LRRK2 | 48 hours | Leucine rich region kinase 2 protein |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immune cell functional analysis | 1 week | Performance evaluation of protective immune cells (Tregs) compared to responder immune cells (Tresp) |
Countries
United States
Outcome results
None listed