Autoimmune Features of Neurodegenerative Disorders
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 55 Years to 90 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 2 visits
- Procedures mentioned: Blood draws, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how inflammation and the body's defense system may play a role in Parkinson's and Alzheimer's disease. It is for adults age 55 or older with Parkinson's, mild Alzheimer's, or mild memory problems, and healthy adults of similar ages. It involves brief surveys and blood samples, with home visits and smaller blood samples available.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- All groups: Be age 55 or older and willing to have tests that study your genes.
- Parkinson's group: Have a doctor's diagnosis of Parkinson's and at least two signs: shaking at rest, stiff muscles, or slow movements. Parkinson's medicine must help.
- Parkinson's group: Disease started between ages 50 and 75, and movement symptoms started after age 45.
- Healthy comparison group for Parkinson's: Have no parent, sibling, or child with Parkinson's. Score at least 26 on the MoCA thinking and memory test.
- Alzheimer's or mild memory problem group: Have diagnosed mild Alzheimer's or mild cognitive impairment that affects memory. Have a Clinical Dementia Rating of 0.5 or 1, which measures how much symptoms affect daily life.
- Alzheimer's or mild memory problem group: Score 20–26 on the MMSE thinking and memory test.
- Healthy comparison group for Alzheimer's: Be healthy, have a Clinical Dementia Rating of 0, and score at least 26 on the MoCA thinking and memory test.
Who can't join
- All groups: Cancer within the past 3 years, except skin cancer.
- All groups: A disease that makes the body's defense system attack healthy tissue, or another disease of that system, such as HIV or chronic leukemia.
- All groups: Long-term use of medicines that change the body's defense system, such as steroid pills, azathioprine, or rituximab.
- All groups: Unable to understand the study and agree to take part.
- Parkinson's group: A history of dementia, which causes serious problems with memory or thinking.
- Parkinson's group: Signs of a different Parkinson-like disorder; repeated strokes with worsening movement; repeated head injuries; past brain inflammation; or major balance problems in the first 5 years.
- Parkinson's group: Use of antipsychotic medicines when movement symptoms began or when joining the study.
- Alzheimer's or mild memory problem group: Other types of dementia or a history of Parkinson's. Healthy comparison group for Alzheimer's: A history of Parkinson's.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (1)
NY
- Columbia University Medical Center · New York, NY 10032More trials in New York