Parkinson's Disease Inflammatory Biomarker Profiling
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 8/18/2018 |
| Start Date: | July 10, 2018 |
| End Date: | December 31, 2019 |
Inflammatory Parkinson's Disease (PD) Clinical Biomarker Profiling in T Cells
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
