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Understanding Autoimmune Features in Parkinson's and Alzheimer's Disease

This study aims to understand how inflammation, specifically the immune system's T-cells, might be involved in Parkinson's disease (PD) and Alzheimer's disease (AD). Researchers want to see if certain proteins in the body (alpha-synuclein and tau protein) trigger an immune response in these conditions. They will study 30 people with PD, 30 with AD or mild cognitive impairment (aMCI), and 60 healthy individuals who are similar in age. The main goal is to identify which proteins or protein segments might cause inflammation and which T-cells recognize them. This study is observational, meaning there are no interventions or treatments being tested. Success will be measured by the percentage of participants who show a T-cell immune response within 1-2 weeks.

Study design
This is an observational study involving 120 participants. It is not specified if it is randomized or blinded.
What's involved
You would have up to two study visits, which include brief questionnaires and blood draws. You can choose to donate up to 250cc of blood, or smaller amounts (up to 100cc per visit, or 50cc via mobile phlebotomy).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring T-cell immune response is at Week 1-2.

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NCT04239079

Autoimmune Features of Neurodegenerative Disorders

Recruiting
Not specifiedAges 55–90Observational
Columbia University
~120 participants
Updated 2026-08-04 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of subjects with T-cell immune response
Measured over Week 1-2

Conditions

Parkinson Disease
Alzheimer Disease
Mild Cognitive Impairment

Explore related trials

Alzheimer's DiseaseMild cognitive disorderParkinson Disease

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Karen Marder, MD, MPH · STUDY_CHAIR · Columbia University
  • David Sulzer, PhD · STUDY_CHAIR · Columbia University
  • Julian P Agin-Liebes, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Ellen Kanter
[email protected]
646-774-5064
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.
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
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
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

What this trial measures

  • Percentage of subjects with T-cell immune responseWeek 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.