Parkinson's DiseaseNCT02939534
Antigen Presentation and Lymphocyte Response in Parkinson's Disease
An observational study of Parkinson's Disease, run by Columbia University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- How many people
- 95 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2015to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with clinically confirmed Parkinson's disease and age matched controls
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Shirley Ryan Ability Lab
Chicago, Illinois, 60611
University of California San Diego School of Medicine
La Jolla, California, 92037
Columbia University Medical Center
New York, New York, 10032
About this study
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, autoimmunity
- Medical subject headings
- Parkinson Disease, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PD and Controls | 50% of the participants will be healthy controls and 50% will be patients diagnosed with Parkinson's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startFeb 2015
- Primary completionFeb 2021
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Roy Alcalay, Columbia University
- Investigators
- Roy Alcalay, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939534
- Sponsor's protocol ID
- AAAN7912
- Status last verified
- Feb 2021
- First submitted
- 17 Oct 2016
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24736453
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antigen Presentation and Lymphocyte Response in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02939534
- Acronym / sponsor ID
- AAAN7912
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, autoimmunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Feb 2015
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD and Controls | – | –50% of the participants will be healthy controls and 50% will be patients diagnosed with Parkinson's disease |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically confirmed Parkinson's disease and age matched controls
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of subjects with T-cell immune response
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 24736453Cebrian 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.
- Michael J Fox Foundation ad for studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Alcalay, MD principal investigator
Columbia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Columbia University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with T-cell immune response (time frame: Day 1-2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02939534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.