Clinical trial NCT02939534: Antigen Presentation and Lymphocyte Response in Parkinson's Disease
Official title: Antigen Presentation and Lymphocyte Response in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
autoimmunity
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2016-10-20
Enrollment: 95
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinically confirmed Parkinson's disease and age matched controls

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of subjects with T-cell immune response
timeFrame: Day 1-2
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego School of Medicine
state: California
city: Chicago
country: United States
facility: Shirley Ryan Ability Lab
state: Illinois
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Roy Alcalay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.