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Autoimmune Features of Neurodegenerative Disorders

Columbia University · NCT04239079

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55–90 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
120
US sites recruiting
1
Study start
May 1, 2019
Record last updated
August 4, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Conditions: Parkinson Disease; Alzheimer Disease; Mild Cognitive Impairment

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

Study contacts (from the official record)

  • Ellen Kanter · 646-774-5064 · ek289@cumc.columbia.edu
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Autoimmune Features of Neurodegenerative Disorders (NCT04239079) | Bored Studies