Image

Autoimmune Features of Neurodegenerative Disorders

Autoimmune Features of Neurodegenerative Disorders

Recruiting
55-90 years
All
Phase N/A

Powered by AI

Overview

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.

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)

Eligibility

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 details
    Parkinson Disease
    Alzheimer Disease
    Mild Cognitive Impairment

NCT04239079

Columbia University

13 August 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.