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Autoimmune Features of Neurodegenerative Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04239079
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Roy Alcalay, Columbia University

Brief Summary:
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.

Condition or disease
Parkinson Disease Alzheimer Disease Mild Cognitive Impairment

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)

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Autoimmune Features of Neurodegenerative Disorders
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2023


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)



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239079


Contacts
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Contact: Yaqian Xu, MD, MPH (646)774-5023 yx2389@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Yaqian Xu, MD, MPH    646-774-5023    yx2389@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Roy Alcalay, MD, MS Columbia University
Principal Investigator: Karen Marder, MD, MPH Columbia University
Principal Investigator: David Sulzer, PhD Columbia University
Publications:
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Responsible Party: Roy Alcalay, Alfred and Minnie Bressler Associate Professor of Neurology, Columbia University
ClinicalTrials.gov Identifier: NCT04239079    
Other Study ID Numbers: AAAS1669
1R01NS095 435-01A1 ( Other Grant/Funding Number: National Institute of Neurological Disorders and Stroke )
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roy Alcalay, Columbia University:
Autoimmune features
Parkinson's disease
Alzheimer's disease
Mild Cognitive Impairment
Additional relevant MeSH terms:
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Parkinson Disease
Alzheimer Disease
Neurodegenerative Diseases
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Dementia
Tauopathies
Neurocognitive Disorders
Mental Disorders
Cognition Disorders