Parkinson's Trial NCT06834191
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?
- 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 2 years and 9 months.
- 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?
- Each participant attends one hospital appointment lasting approximately one hour.