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OpenTrials
Completed

NCT Number: NCT02939534

Antigen Presentation and Lymphocyte Response in Parkinson's Disease

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.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. Percentage of subjects with T-cell immune response

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Oct 20, 2016
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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