NCT04239079 · Columbia University
Autoimmune Features of Neurodegenerative Disorders
What this 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.
View original scientific description
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.
Primary outcome measures
Percentage of subjects with T-cell immune response
Time frame: Week 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- New York, New York
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 8, 2025 · Source of record for eligibility and locations