Antigen Presentation and Lymphocyte Response in Parkinson's Disease
1 other identifier
observational
95
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2015
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 17, 2016
CompletedFirst Posted
Study publicly available on registry
October 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedFebruary 21, 2021
February 1, 2021
6 years
October 17, 2016
February 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
PD and Controls
50% of the participants will be healthy controls and 50% will be patients diagnosed with Parkinson's disease
Eligibility Criteria
Patients with clinically confirmed Parkinson's disease and age matched controls
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of California San Diego School of Medicine
La Jolla, California, 92037, United States
Shirley Ryan Ability Lab
Chicago, Illinois, 60611, United States
Columbia University Medical Center
New York, New York, 10032, United States
Related Publications (1)
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.
PMID: 24736453BACKGROUND
Related Links
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roy Alcalay, MD
Columbia University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 17, 2016
First Posted
October 20, 2016
Study Start
February 1, 2015
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
February 21, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share