Parkinson's Disease Inflammatory Biomarker Profiling

Longevity Biotech

Status

Terminated

Conditions

Parkinson Disease

Treatments

Diagnostic Test: LBT-3627

Diagnostic Test: Immunological profiling

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT03633513

LBT-PD-003

Details and patient eligibility

About

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.

Enrollment

99 patients

Sex

All

Ages

18 to 89 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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