NCT03633513

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

July 15, 2018

Last Update Submit

April 16, 2024

Conditions

Parkinson Disease

Keywords

Immune SystemImmunologyNeuroinflammationInflammationNeuroprotection

Outcome Measures

Primary Outcomes (1)

  • Unified Parkinson Disease Rating Scale

    Clinical scoring system to evaluate severity of Parkinson's disease in patients

    1 hour

Secondary Outcomes (7)

  • Interleukin-17

    48 hours

  • FoxP3

    48 hours

  • GM-CSF

    48 hours

  • LRRK2

    48 hours

  • VPAC2

    48 hours

  • +2 more secondary outcomes

Other Outcomes (1)

  • Immune cell functional analysis

    1 week

Study Arms (2)

Patients

Clinical diagnosed Parkinson's disease patients

Diagnostic Test: LBT-3627Diagnostic Test: Immunological profiling

Caregivers

Environmentally matched healthy control subjects

Diagnostic Test: LBT-3627Diagnostic Test: Immunological profiling

Interventions

LBT-3627DIAGNOSTIC_TEST

Immunomodulatory agent

CaregiversPatients
Immunological profilingDIAGNOSTIC_TEST

Comprehensive profiling of inflammatory and anti-inflammatory markers (incl. cellular, molecular) including cellular functional assays

CaregiversPatients

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with Parkinson's disease and their caregivers.

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Corporal Michael J. Crescenz VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Longevity Biotech, Inc

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Parkinson DiseaseNeuroinflammatory DiseasesInflammation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Scott Shandler, PhD

    Longevity Biotech, Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2018

First Posted

August 16, 2018

Study Start

July 10, 2018

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

April 18, 2024

Record last verified: 2024-04

Locations

US(2)