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Parkinson's Disease Inflammatory Biomarker Profiling

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ClinicalTrials.gov Identifier: NCT03633513
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : May 22, 2019
Sponsor:
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
Corporal Michael J. Crescenz VA Medical Center - Philadelphia
Information provided by (Responsible Party):
Longevity Biotech

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.

Condition or disease Intervention/treatment
Parkinson Disease Diagnostic Test: LBT-3627 Diagnostic Test: Immunological profiling

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Study Type : Observational
Estimated Enrollment : 134 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Inflammatory Parkinson's Disease (PD) Clinical Biomarker Profiling in T Cells
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Unified Parkinson Disease Rating Scale [ Time Frame: 1 hour ]
    Clinical scoring system to evaluate severity of Parkinson's disease in patients


Secondary Outcome Measures :
  1. Interleukin-17 [ Time Frame: 48 hours ]
    Proinflammatory cytokine

  2. FoxP3 [ Time Frame: 48 hours ]
    Regulatory Tcell marker

  3. GM-CSF [ Time Frame: 48 hours ]
    Cytokine

  4. LRRK2 [ Time Frame: 48 hours ]
    Leucine rich region kinase 2 protein

  5. VPAC2 [ Time Frame: 48 hours ]
    Regulates TH1/TH2 balance of inflammatory system

  6. Interferon gamma [ Time Frame: 48 hours ]
    Inflammatory cytokine

  7. Tumor necrosis factor alpha [ Time Frame: 48 hours ]
    Inflammatory cytokine


Other Outcome Measures:
  1. Immune cell functional analysis [ Time Frame: 1 week ]
    Performance evaluation of protective immune cells (Tregs) compared to responder immune cells (Tresp)


Biospecimen Retention:   Samples Without DNA
Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Parkinson's disease and their caregivers.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633513


Contacts
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Contact: Scott Shandler, PhD 215-689-1042 scott@longevitybiotech.com

Locations
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United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center Enrolling by invitation
Philadelphia, Pennsylvania, United States, 19104
Longevity Biotech, Inc Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Scott Shandler, Ph.D.    215-689-1042    clinical@longevitybiotech.com   
Sponsors and Collaborators
Longevity Biotech
Michael J. Fox Foundation for Parkinson's Research
Corporal Michael J. Crescenz VA Medical Center - Philadelphia
Investigators
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Principal Investigator: Scott Shandler, PhD Longevity Biotech, Inc

Additional Information:
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Responsible Party: Longevity Biotech
ClinicalTrials.gov Identifier: NCT03633513     History of Changes
Other Study ID Numbers: LBT-PD-003
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Product Manufactured in and Exported from the U.S.: No

Keywords provided by Longevity Biotech:
Immune System
Immunology
Neuroinflammation
Inflammation
Neuroprotection

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases