Parkinson's Trial NCT04239079
Identify immune triggers of Parkinson
- Trial ID
- NCT04239079
- Official Title
- Autoimmune Features of Neurodegenerative Disorders
- Goal
- Identify immune triggers of Parkinson
- Status
- RECRUITING
- Sponsor
- Columbia University
- Study Type
- OBSERVATIONAL
- Enrollment
- 120 participants
- Conditions
- Parkinson Disease, Alzheimer Disease, Mild Cognitive Impairment
Summary For Families
The goal is to find out whether inflammation and the immune system help drive Parkinson's and Alzheimer's, in part by testing whether immune cells start to recognize brain proteins such as alpha-synuclein and tau. Participants answer brief questionnaires and give blood during up to two visits so researchers can study immune cells and genes; blood draws can be up to 250 cc, with options for smaller amounts or home visits by a trained person to collect blood. They plan to enroll about 30 people with Parkinson's, 30 people with mild Alzheimer's disease or amnestic mild cognitive impairment, and about 60 healthy volunteers matched by age. Parkinson's volunteers must be at least 55 years old, have a clinical diagnosis with motor symptoms that began roughly between ages 50 and 75 and that respond to Parkinson's medications, and none of the groups can have dementia, autoimmune or other immune-system diseases, recent cancer, or be on long-term medicines that change the immune system; everyone must agree to genetic testing.
Locations
- Columbia University Medical Center, New York, New York, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to find out whether inflammation and the immune system help drive Parkinson's and Alzheimer's, in part by testing whether immune cells start to recognize brain proteins such as alpha-synuclein and tau. Participants answer brief questionnaires and give blood during up to two visits so researchers can study immune cells and genes; blood draws can be up to 250 cc, with options for smaller amounts or home visits by a trained person to collect blood. They plan to enroll about 30 people with Parkinson's, 30 people with mild Alzheimer's disease or amnestic mild cognitive impairment, and about 60 healthy volunteers matched by age. Parkinson's volunteers must be at least 55 years old, have a clinical diagnosis with motor symptoms that began roughly between ages 50 and 75 and that respond to Parkinson's medications, and none of the groups can have dementia, autoimmune or other immune-system diseases, recent cancer, or be on long-term medicines that change the immune system; everyone must agree to genetic testing.
- Who can participate?
- Participants must be between 55 Years and 90 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 7 years and 1 month.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- Up to two study visits are required.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Blood draw (minimally invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.