RecruitingNot Applicable

Autoimmune Features of Neurodegenerative Disorders

United States120 participantsStarted 2019-05-01

Plain-language 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.

Who can participate

Age range

55 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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-degre…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is measuring whether people with Parkinson's, Alzheimer's, or mild cognitive impairment show a T-cell immune response — what does that mean for me personally, and could what they find change how my condition might be treated in the future?
2Since this study is listed as 'Phase NA,' it sounds like it's focused on observing and collecting data rather than testing a new treatment — can you help me understand exactly what would be done to me if I participated, and whether it involves anything beyond blood draws or standard tests?
3This trial is actively recruiting right now — do you think my current diagnosis and health history would make me a reasonable candidate to discuss with the research team, or are there factors that might make it a poor fit?
4Given that this study is about understanding the immune system's possible role in neurodegeneration rather than offering a new therapy, would participating in it conflict with, delay, or complement any standard treatments you might recommend for me right now?
5If the researchers find that I do have a T-cell immune response linked to my condition, would that information be shared with me or my care team, and could it influence any decisions about my treatment going forward?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of subjects with T-cell immune response

Timeframe: Week 1-2

Trial details

NCT IDNCT04239079

SponsorColumbia University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-07

Contact for this trial

Ellen Kanter

646-774-5064 ek289@cumc.columbia.edu

View on ClinicalTrials.gov More Parkinson Disease trials