Determine whether immunosuppression slows progression
- Trial ID
- NCT06834191
- Official Title
- Analysis of the Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease
- Goal
- Determine whether immunosuppression slows progression
- Status
- RECRUITING
- Sponsor
- Medical University of Warsaw
- Study Type
- OBSERVATIONAL
- Enrollment
- 80 participants
- Conditions
- Parkinson Disease
Summary For Families
Researchers want to find out whether long-term use of systemic immunosuppressive medications changes the clinical course of Parkinson's disease, for example by slowing or altering symptom progression that may be linked to neuroinflammation. They will observe people with Parkinson's who have been on regular immunosuppressants for more than 12 months, such as corticosteroids, methotrexate, calcineurin or mTOR inhibitors, or biologics, and compare them to people with Parkinson's who have not used these drugs; these medicines reduce immune activity and might lower harmful neuroinflammation, they do not directly replace levodopa but can affect infection risk and may require monitoring for interactions with other treatments. The study is enrolling adults with a confirmed Parkinson's diagnosis who either have taken effective systemic immunosuppressive therapy for over 12 months or who have no history of regular immunosuppressive use, and it excludes people with dementia, advanced organ failure, active inflammation, irregular or short-term immunosuppressant use.
Locations
- Department of Neurology, Faculty of Health Science, Medical University of Warsaw, Warsaw, Poland
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. Researchers want to find out whether long-term use of systemic immunosuppressive medications changes the clinical course of Parkinson's disease, for example by slowing or altering symptom progression that may be linked to neuroinflammation. They will observe people with Parkinson's who have been on regular immunosuppressants for more than 12 months, such as corticosteroids, methotrexate, calcineurin or mTOR inhibitors, or biologics, and compare them to people with Parkinson's who have not used these drugs; these medicines reduce immune activity and might lower harmful neuroinflammation, they do not directly replace levodopa but can affect infection risk and may require monitoring for interactions with other treatments. The study is enrolling adults with a confirmed Parkinson's diagnosis who either have taken effective systemic immunosuppressive therapy for over 12 months or who have no history of regular immunosuppressive use, and it excludes people with dementia, advanced organ failure, active inflammation, irregular or short-term immunosuppressant use.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- 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 2 years and 9 months.
- 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.