Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT04239079

Conditions

Parkinson Disease

Alzheimer Disease

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

Study Details

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. 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

Study ID

NCT04239079

Start date

May 1, 2019

Status verified date

Jul, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

  • Percentage of subjects with T-cell immune response [ Time Frame: Week 1-2 ]

Central Contacts and Locations

Central contacts

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

More Information

Sponsor

Columbia University

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Keywords

  • Autoimmune features
  • Parkinson's disease
  • Alzheimer's disease
  • Mild Cognitive Impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-08-04.