Parkinson's Disease Inflammatory Biomarker Profiling

Parkinson Disease Clinical Trial

Official title:

Inflammatory Parkinson's Disease (PD) Clinical Biomarker Profiling in T Cells

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03633513
• Other study ID #: LBT-PD-003
• Status: Terminated
• Start date: July 10, 2018
• Est. completion date: March 13, 2020

Study information

• Verified date: April 2024
• Source: Longevity Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 99
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Diagnostic Test:
• LBT-3627
Immunomodulatory agent
• Immunological profiling
Comprehensive profiling of inflammatory and anti-inflammatory markers (incl. cellular, molecular) including cellular functional assays

Locations

Country	Name	City	State
United States	Corporal Michael J. Crescenz VA Medical Center	Philadelphia	Pennsylvania
United States	Longevity Biotech, Inc	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Longevity Biotech	Corporal Michael J. Crescenz VA Medical Center - Philadelphia, Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immune cell functional analysis	Performance evaluation of protective immune cells (Tregs) compared to responder immune cells (Tresp)	1 week
Primary	Unified Parkinson Disease Rating Scale	Clinical scoring system to evaluate severity of Parkinson's disease in patients	1 hour
Secondary	Interleukin-17	Proinflammatory cytokine	48 hours
Secondary	FoxP3	Regulatory Tcell marker	48 hours
Secondary	GM-CSF	Cytokine	48 hours
Secondary	LRRK2	Leucine rich region kinase 2 protein	48 hours
Secondary	VPAC2	Regulates TH1/TH2 balance of inflammatory system	48 hours
Secondary	Interferon gamma	Inflammatory cytokine	48 hours
Secondary	Tumor necrosis factor alpha	Inflammatory cytokine	48 hours

External Links

•   Michael J. Fox Trial Finder