Parkinson's Disease Inflammatory Biomarker Profiling
Stopped early
Conditions studied: Parkinson Disease
In brief
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.
Key facts
- Study ID
- NCT03633513
- Run by
- Longevity Biotech
- People needed
- 99
- Starts
- 2018-07-10
- Expected to finish
- 2020-03-13
- Last updated by the study team
- 2024-04-18
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Corporal Michael J. Crescenz VA Medical Center — Philadelphia, Pennsylvania, United States
- Longevity Biotech, Inc — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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