Antigen Presentation and Lymphocyte Response in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Antigen Presentation and Lymphocyte Response in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939534
• Other study ID #: AAAN7912
• Status: Completed
• Start date: February 2015
• Est. completion date: February 2021

Study information

• Verified date: February 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	Shirley Ryan Ability Lab	Chicago	Illinois
United States	University of California San Diego School of Medicine	La Jolla	California
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cebrián 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with T-cell immune response	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.	Day 1-2

External Links

•   Michael J Fox Foundation ad for study