Antigen Presentation and Lymphocyte Response in Parkinson's Disease

NCT ID: NCT02939534

Last Updated: 2021-02-21

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

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2021-02-28

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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PD and Controls

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Roy Alcalay

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roy Alcalay, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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University of California San Diego School of Medicine

La Jolla, California, United States

Site Status

Shirley Ryan Ability Lab

Chicago, Illinois, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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Cebrian C, Zucca FA, Mauri P, Steinbeck JA, Studer L, Scherzer CR, Kanter E, Budhu S, Mandelbaum J, Vonsattel JP, Zecca L, Loike JD, Sulzer D. MHC-I expression renders catecholaminergic neurons susceptible to T-cell-mediated degeneration. Nat Commun. 2014 Apr 16;5:3633. doi: 10.1038/ncomms4633.

Reference Type BACKGROUND
PMID: 24736453 (View on PubMed)

Related Links

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https://foxtrialfinder.michaeljfox.org/trial/4772/

Michael J Fox Foundation ad for study

Other Identifiers

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AAAN7912

Identifier Type: -

Identifier Source: org_study_id

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