Parkinson's Disease Inflammatory Biomarker Profiling

April 16, 2024 updated by: Longevity Biotech

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Corporal Michael J. Crescenz VA Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Longevity Biotech, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Parkinson's disease and their caregivers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Clinical diagnosed Parkinson's disease patients
Diagnostic test: LBT-3627
Immunomodulatory agent
Diagnostic test: Immunological profiling
Comprehensive profiling of inflammatory and anti-inflammatory markers (incl. cellular, molecular) including cellular functional assays
Caregivers
Environmentally matched healthy control subjects
Diagnostic test: LBT-3627
Immunomodulatory agent
Diagnostic test: Immunological profiling
Comprehensive profiling of inflammatory and anti-inflammatory markers (incl. cellular, molecular) including cellular functional assays

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Parkinson Disease Rating Scale
Time Frame: 1 hour
Clinical scoring system to evaluate severity of Parkinson's disease in patients
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleukin-17
Time Frame: 48 hours
Proinflammatory cytokine
48 hours
FoxP3
Time Frame: 48 hours
Regulatory Tcell marker
48 hours
GM-CSF
Time Frame: 48 hours
Cytokine
48 hours
LRRK2
Time Frame: 48 hours
Leucine rich region kinase 2 protein
48 hours
VPAC2
Time Frame: 48 hours
Regulates TH1/TH2 balance of inflammatory system
48 hours
Interferon gamma
Time Frame: 48 hours
Inflammatory cytokine
48 hours
Tumor necrosis factor alpha
Time Frame: 48 hours
Inflammatory cytokine
48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune cell functional analysis
Time Frame: 1 week
Performance evaluation of protective immune cells (Tregs) compared to responder immune cells (Tresp)
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Longevity Biotech

Collaborators

Michael J. Fox Foundation for Parkinson's Research
Corporal Michael J. Crescenz VA Medical Center - Philadelphia

Investigators

  • Principal Investigator: Scott Shandler, PhD, Longevity Biotech, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2018

Primary Completion (Actual)

March 13, 2020

Study Completion (Actual)

March 13, 2020

Study Registration Dates

First Submitted

July 15, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 16, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBT-PD-003

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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