Parkinson's Disease Inflammatory Biomarker Profiling

Terminated

• Conditions: Parkinson Disease
• Interventions: Diagnostic Test: LBT-3627; Diagnostic Test: Immunological profiling

• Registration Number: NCT03633513
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-10
• Study First Submitted: 2018-07-15
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-16
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	LBT-3627	Clinical diagnosed Parkinson's disease patients
Patients	Immunological profiling	Clinical diagnosed Parkinson's disease patients
Caregivers	LBT-3627	Environmentally matched healthy control subjects
Caregivers	Immunological profiling	Environmentally matched healthy control subjects

Primary Outcome Measures

Name	Time	Method
Unified Parkinson Disease Rating Scale	1 hour	Clinical scoring system to evaluate severity of Parkinson's disease in patients

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Corporal Michael J. Crescenz VA Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Longevity Biotech, Inc; 🇺🇸 Philadelphia, Pennsylvania, United States