Antigen Presentation and Lymphocyte Response in Parkinson's Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02939534

Enrollment

Registered

2016-10-20

Start date

2015-02-28

Completion date

2021-02-28

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, autoimmunity

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of subjects with T-cell immune response	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.

Countries

United States

Outcome results