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Antigen Presentation and Lymphocyte Response in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02939534
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : January 23, 2020
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Roy Alcalay, 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.

Condition or disease
Parkinson's Disease

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.

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Antigen Presentation and Lymphocyte Response in Parkinson's Disease
Study Start Date : February 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

PD and Controls
50% of the participants will be healthy controls and 50% will be patients diagnosed with Parkinson's disease

Primary Outcome Measures :
  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.

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with clinically confirmed Parkinson's disease and age matched controls

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02939534

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Contact: Yaqian Xu, MD 646-774-5023

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United States, California
University of California San Diego School of Medicine Recruiting
La Jolla, California, United States, 92037
Contact: Ileana Rubio    858-822-5751   
United States, Illinois
Shirley Ryan Ability Lab Recruiting
Chicago, Illinois, United States, 60611
Contact: Douglas Merkitch   
United States, New York
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Michael J. Fox Foundation for Parkinson's Research
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Principal Investigator: Roy Alcalay, MD Columbia University
Additional Information:
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Responsible Party: Roy Alcalay, Principal Investigator, Columbia University Identifier: NCT02939534    
Other Study ID Numbers: AAAN7912
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roy Alcalay, Columbia University:
Parkinson's disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases