Autoimmune Features of Neurodegenerative Disorders

May 23, 2023 updated by: Chih-Chun Lin, MD, PhD, Columbia University

This study is being conducted to better understand the role of inflammation in Parkinson's disease (PD) and Alzheimer's disease (AD). The investigators plan to recruit 30 PD, 30 AD/Amnestic Mild Cognitive Impairment (aMCI), and 60 age matched healthy controls in this study to study the role of immune response in PD and AD.

The study involves up to two study visits involving brief questionnaires and blood draw of up to 250cc (approximately 17 tablespoons) to be collected. More ways to participate, including 1) smaller amount blood donation (up to 100cc per visit for 1-2 visits); and 2) participation via tele-visit and mobile phlebotomy visits (blood donation up to 50cc, ~5 tubes, by a certified mobile phlebotomist at home/location of choice) now available.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Neurodegenerative diseases are characterized by the misprocessing of specific proteins, but how and if this results in cell death is unknown. This study is being conducted to better understand the role of inflammation in Parkinson's disease (PD) and Alzheimer's disease (AD). Both AD and PD have long been known to feature prominent neuroinflammatory components. Preliminary studies have found autoimmune features in several patients including recognition of self-antigens by specific T cells. This study will test the hypothesis that AD and PD are associated with self-derived antigens (alpha-syn and tau protein) that become recognized by T cells during aging and disease. The overall aim is to identify antigenic responses associated with PD and AD. The specific aims include:

  1. Identify the protein(s) or protein segments that may trigger inflammation
  2. Identify the T cells (immune cells) that may recognize and kill brain cells (neurons and astrocytes)
  3. Identify the genetic profile associated with this immune response (genetic analysis of the immune system)

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with clinically confirmed Parkinson's disease and age matched controls; Patients with clinically confirmed Alzheimer's disease/ amnestic Mild Cognitive Impairment and age matched controls

Description

PD and age matched controls:

For PD participants (n=30):

Inclusion criteria:

  • Clinical diagnosed PD based on UK Brain Bank criteria for the clinical diagnosis of PD. And must demonstrate two of the following three, as modified from BioFIND criteria: rest tremor, rigidity, or bradykinesia, with dopaminergic medication benefit
  • Age at recruitment ≥ 55
  • Age at motor onset > 45
  • PD onset age between 50-75 years
  • Willingness to have genotyping and genetic studies

Exclusion criteria:

  • Atypical features indicative of a Parkinson-Plus disorder (Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), Corticobasal Degeneration (CBD)) including cerebellar signs, supranuclear gaze palsy, apraxia and other cortical signs, or prominent autonomic failure, neuroleptic treatment at time of onset of parkinsonism, active treatment with a neuroleptic at time of study entry, history of repeated strokes with stepwise progression of parkinsonism, history of repeated head injury, history of definite encephalitis, prominent gait imbalance early in the course (< 5 years)
  • History of Dementia
  • Recent history of cancer (past 3 years), except skin cancer
  • Autoimmune disease
  • Disease of the immune system (e.g. chronic leukemia, HIV)
  • On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)
  • Inability to provide informed consent.

For age-matched control participants (n=30):

Inclusion criteria:

  • Ages ≥55 years old
  • With lack of PD in first-degree blood relatives
  • Montreal Cognitive Assessment (MoCA): ≥26
  • Willingness to have genotyping and genetic studies

Exclusion criteria:

  • Recent history of cancer (past 3 years), except skin cancer
  • Autoimmune disease
  • Disease of the immune system (e.g. chronic leukemia, HIV)
  • On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)
  • Inability to provide informed consent

AD/aMCI and age matched controls:

For AD/aMCI participants (n=30):

Inclusion criteria:

  • Clinically diagnosed mild AD/amnestic MCI. The severity will be accessed through the Clinical Dementia Rating Scale (CDR). CDR equal to 0.5 or 1 will be necessary to meet criteria. Participants with advanced AD stage will not be capable to give their consent.
  • Age ≥55 years old
  • Mini-Mental State Exam (MMSE): 20-26
  • Willingness to have genotyping and genetic studies

Exclusion criteria:

  • Other forms of dementia including frontotemporal dementia or other dementia associated with parkinsonism such as Dementia with Lewy bodies (DLB), or Parkinson's disease Dementia (PDD), Progressive Supranuclear Palsy or corticobasal degeneration.
  • History of Parkinson's disease (PD)
  • Recent history of cancer (past 3 years), except skin cancer
  • Autoimmune disease
  • Disease of the immune system (e.g. chronic leukemia, HIV)
  • On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)
  • Inability to provide informed consent

For age-matched control participants (n=30):

Inclusion criteria:

  • Healthy volunteers ≥55 years old
  • CDR: 0
  • MoCA: ≥26
  • Willingness to have genotyping and genetic studies

Exclusion criteria:

  • History of Parkinson's disease (PD)
  • Recent history of cancer (past 3 years), except skin cancer
  • Autoimmune disease
  • Disease of the immune system (e.g. chronic leukemia, HIV)
  • On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)
  • Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
PD and Controls
50% of the participants will be healthy controls and 50% will be patients diagnosed with Parkinson's disease
AD/aMCI and Controls
50% of the participants will be healthy controls and 50% will be patients diagnosed with Alzheimer's disease or Amnestic Mild Cognitive Impairment (aMCI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects with T-cell immune response
Time Frame: Week 1-2
Blood samples from 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.
Week 1-2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Karen Marder, MD, MPH, Columbia University
  • Principal Investigator: David Sulzer, PhD, Columbia University
  • Principal Investigator: Chih-Chun Lin, MD, PhD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Estimated)

June 1, 2023

Study Completion (Estimated)

June 1, 2023

Study Registration Dates

First Submitted

January 21, 2020

First Submitted That Met QC Criteria

January 21, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAS1669
  • 1R01NS095 435-01A1 (Other Grant/Funding Number: National Institute of Neurological Disorders and Stroke)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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