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

Plain-Language Summary

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.

View on ClinicalTrials.gov