Antigen Presentation and Lymphocyte Response in Parkinson's Disease

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT02939534
• Lead Sponsor: Columbia University

Brief Summary

The way the immune system responds to certain PD-related proteins in PD donors compared to the way it responds in persons without or fewer PD related proteins is not well studied and this study aims to analyze the autoimmune response in each group. The study involves a one time visit involving brief questionnaires and a blood draw of 30 mL (approximately 2 tablespoons) to be collected.

Detailed Description

The role of the immune response in Parkinson's disease (PD) is controversial. Recent studies show that neurons can present MHC-I (major histocompatibility complex - class 1) molecules and therefore may be susceptible to an attack by immune cells. The investigators anticipate that the results of this study will improve our understanding of the mechanisms of immune mediated neuronal degeneration in PD. Initial results suggest that antigens are presented by neuronal MHC-I in PD, and that this could lead to T-cell mediated neuronal death. The most obvious antigen that could be differentially expressed in PD patients and controls would be alpha-synuclein (-syn): -syn oligomers appear in all Lewy bodies and Lewy neurites and are the hallmark of PD changes in the brain. This study will offer the opportunity to further characterize the immune mediated component of PD, and to continue elucidating the biology that underlies antigen presentation and T-cell cytolytic activity.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-20
• Status Verified: 2021-02
• Primary Completion: 2021-02
• Study Completion: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Moderate to advanced PD with classic motor features, and must demonstrate two of the following three: rest tremor, rigidity, or bradykinesia
• Dopaminergic medication benefit (self-reported improvement)
• Age at recruitment: 50 - 90 years
• Age at diagnosis > 47
• PD duration > 3 years
• Willingness to have genotyping and genetic studies as part of laboratory research

Read More

Exclusion Criteria

• Atypical parkinsonism or other neurological disorders
• Recent history of cancer (past 3 years)
• Autoimmune disease (except thyroid disease)
• On chronic immune-modulatory therapy (e.g. SIT (specific immunotherapy), anti-IgE)
• Inability to provide informed consent

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with T-cell immune response	Day 1-2	Blood samples from PD patients and controls will be processed. The presence of T cell response against the candidate antigens by patient blood-derived peripheral blood mononuclear cells (PBMC) will be assessed using an enzyme-linked immunosorbent spot (ELISPOT) assay.

Trial Locations

Locations (3)

Columbia University Medical Center; 🇺🇸 New York, New York, United States

University of California San Diego School of Medicine; 🇺🇸 La Jolla, California, United States

Shirley Ryan Ability Lab; 🇺🇸 Chicago, Illinois, United States