Parkinson's Disease Inflammatory Biomarker Profiling

L

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

Trial design

99 participants in 2 patient groups

Patients
Description:
Clinical diagnosed Parkinson's disease patients
Treatment:
Diagnostic Test: Immunological profiling
Diagnostic Test: LBT-3627
Caregivers
Description:
Environmentally matched healthy control subjects
Treatment:
Diagnostic Test: Immunological profiling
Diagnostic Test: LBT-3627

Trial contacts and locations

2

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Central trial contact

Scott Shandler, PhD

Data sourced from clinicaltrials.gov

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