Parkinson's Disease Inflammatory Biomarker Profiling

NCT ID: NCT03633513

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-10

Study Completion Date

2020-03-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients

Clinical diagnosed Parkinson's disease patients

LBT-3627

Intervention Type DIAGNOSTIC_TEST

Immunomodulatory agent

Immunological profiling

Intervention Type DIAGNOSTIC_TEST

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

Caregivers

Environmentally matched healthy control subjects

LBT-3627

Intervention Type DIAGNOSTIC_TEST

Immunomodulatory agent

Immunological profiling

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LBT-3627

Immunomodulatory agent

Intervention Type DIAGNOSTIC_TEST

Immunological profiling

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role collaborator

Corporal Michael J. Crescenz VA Medical Center - Philadelphia

UNKNOWN

Sponsor Role collaborator

Longevity Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Scott Shandler, PhD

Role: PRINCIPAL_INVESTIGATOR

Longevity Biotech, Inc

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Corporal Michael J. Crescenz VA Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Longevity Biotech, Inc

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LBT-PD-003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Measuring Parkinson's Disease Progression
NCT03205956 COMPLETED PHASE1
Biomarkers in Neural Disorders
NCT02761707 COMPLETED