Actively Recruiting

Age: 55Years - 90Years
All Genders
Healthy Volunteers
NCT04239079

Autoimmune Features of Neurodegenerative Disorders

Led by Columbia University · Updated on 2025-08-08

120

Participants Needed

1

Research Sites

369 weeks

Total Duration

On this page

AI-Summary

What this Trial 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

Official Title

Autoimmune Features of Neurodegenerative Disorders

Who Can Participate

Age: 55Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of Parkinson's disease based on UK Brain Bank criteria with at least two of rest tremor, rigidity, or bradykinesia and benefit from dopaminergic medication
  • Age 55 years or older
  • Age at motor onset of Parkinson's disease greater than 45 years
  • Parkinson's disease onset age between 50 and 75 years
  • Willingness to undergo genotyping and genetic studies
  • Age 55 years or older for Parkinson's disease age-matched controls
  • No Parkinson's disease in first-degree relatives for controls
  • Montreal Cognitive Assessment (MoCA) score of 26 or higher for controls
  • Willingness to undergo genotyping and genetic studies for controls
  • Clinical diagnosis of mild Alzheimer's disease or amnestic Mild Cognitive Impairment with Clinical Dementia Rating Scale (CDR) of 0.5 or 1
  • Age 55 years or older for Alzheimer's disease/aMCI participants
  • Mini-Mental State Exam (MMSE) score between 20 and 26
  • Willingness to undergo genotyping and genetic studies
  • Healthy volunteers aged 55 years or older for Alzheimer's disease/aMCI controls
  • CDR score of 0 for Alzheimer's disease/aMCI controls
  • MoCA score of 26 or higher for Alzheimer's disease/aMCI controls
  • Willingness to undergo genotyping and genetic studies
Not Eligible

You will not qualify if you...

  • Atypical features indicating Parkinson-Plus disorders such as Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration, cerebellar signs, supranuclear gaze palsy, apraxia, cortical signs, or prominent autonomic failure
  • Neuroleptic treatment at time of onset of parkinsonism or active neuroleptic treatment at 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 Parkinson's disease course (less than 5 years)
  • History of dementia
  • Recent history of cancer within the past 3 years except skin cancer
  • Autoimmune disease
  • Disease of the immune system such as chronic leukemia or HIV
  • On chronic immune-modulatory therapy such as oral steroids, azathioprine, or rituximab
  • Inability to provide informed consent
  • Other forms of dementia including frontotemporal dementia, Dementia with Lewy bodies, Parkinson's disease Dementia, Progressive Supranuclear Palsy, or corticobasal degeneration
  • History of Parkinson's disease for Alzheimer's disease/aMCI and controls

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

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Research Team

E

Ellen Kanter

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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