Clinical trial NCT03633513: Parkinson's Disease Inflammatory Biomarker Profiling
Official title: Inflammatory Parkinson's Disease (PD) Clinical Biomarker Profiling in T Cells
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parkinson Disease
Keywords: Immune System
Immunology
Neuroinflammation
Inflammation
Neuroprotection
Lead sponsor: Longevity Biotech
Sponsor class: INDUSTRY
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
name: Corporal Michael J. Crescenz VA Medical Center - Philadelphia
First posted: 2018-08-16
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Parkinson's disease and their caregivers.

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.


Eligibility 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

Primary outcomes:
measure: Unified Parkinson Disease Rating Scale
timeFrame: 1 hour
Secondary outcomes:
measure: Interleukin-17
timeFrame: 48 hours
measure: FoxP3
timeFrame: 48 hours
measure: GM-CSF
timeFrame: 48 hours
measure: LRRK2
timeFrame: 48 hours
measure: VPAC2
timeFrame: 48 hours
measure: Interferon gamma
timeFrame: 48 hours
measure: Tumor necrosis factor alpha
timeFrame: 48 hours
Other outcomes:
measure: Immune cell functional analysis
timeFrame: 1 week
Locations:
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Longevity Biotech, Inc
state: Pennsylvania
Study officials:
affiliation: Longevity Biotech, Inc
name: Scott Shandler, PhD
role: PRINCIPAL_INVESTIGATOR
References: