Find immune signs identifying Parkinson
- Trial ID
- NCT04239079
- Official Title
- Autoimmune Features of Neurodegenerative Disorders
- Goal
- Find immune signs identifying 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 look for autoimmune or immune-system patterns that might be linked to Parkinson's, Alzheimer's, and amnestic mild cognitive impairment, to better understand whether immune responses play a role in these brain disorders. Instead of testing a treatment, researchers will collect genetic data and immune-related measurements along with clinical assessments to compare immune markers and genotypes across people with PD, AD/aMCI, and age-matched healthy volunteers. The idea is to identify immune pathways or biomarkers that could guide future treatments or help distinguish disease types. Enrollment is for people aged 55 to 90, with about 30 in each group: PD participants with motor onset between 50 and 75 who show classic signs and dopaminergic benefit, people with mild AD/aMCI (MMSE about 20,26), and healthy controls; anyone with autoimmune disease, major immune disorders, recent cancer, or on chronic immune-modulating therapy is excluded.
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 look for autoimmune or immune-system patterns that might be linked to Parkinson's, Alzheimer's, and amnestic mild cognitive impairment, to better understand whether immune responses play a role in these brain disorders. Instead of testing a treatment, researchers will collect genetic data and immune-related measurements along with clinical assessments to compare immune markers and genotypes across people with PD, AD/aMCI, and age-matched healthy volunteers. The idea is to identify immune pathways or biomarkers that could guide future treatments or help distinguish disease types. Enrollment is for people aged 55 to 90, with about 30 in each group: PD participants with motor onset between 50 and 75 who show classic signs and dopaminergic benefit, people with mild AD/aMCI (MMSE about 20,26), and healthy controls; anyone with autoimmune disease, major immune disorders, recent cancer, or on chronic immune-modulating therapy is excluded.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 7 years and 1 month.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.