Exploring how immunosuppressive treatment affects Parkinson's disease progression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate whether immunosuppressive drug treatment influences the clinical course of Parkinson's disease. Researchers will recruit individuals diagnosed with Parkinson's disease who are receiving long-term immunosuppressive treatment for other chronic conditions, as well as a control group of individuals with Parkinson's disease who have not received such treatment. The study will compare the rates of Parkinson's disease progression and serum inflammatory marker levels between these two groups to determine if immunosuppressive therapy has a beneficial effect on disease progression.

Why it matters

Who can join: the full rules

Inclusion criteria for the study group:

1. Diagnosis of Parkinson's disease according to the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease;
2. Immunosuppressive medication use - medication taken regularly, which we have defined as administered at a dose and frequency effective for the indicated disease, for over 12 months, systemic administration route (oral, intramuscular, subcutaneous, intravenous and inhaled); The most commonly used immunosuppressive drugs that we anticipate will be used by the study group participants include: glucocorticosteroids (GC) - budesonide, cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, triamcinolone; calcineurin inhibitors - tacrolimus, cyclosporine; inosine monophosphate dehydrogenase (IMDH) inhibitors - azathioprine, leflunomide, mycophenolate; mammalian target of rapamycin (mTOR) inhibitors - sirolimus, everolimus; biologics - abatacept, adalimumab, anakinra, certolizumab, etanercept, infliximab, ixekizumab, natalizumab, rituximab, secukinumab, tocilizumab, ustekinumab, vedolizumab; antimetabolites - methotrexate; inclusion of participants taking immunosuppressive drugs not listed above will be considered individually;
3. Provision of informed consent to participate in the study.

Inclusion criteria for the control group:

1. Diagnosis of Parkinson's disease according to the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease;
2. No history of regular use of immunosuppressive medications;
3. Provision of informed consent to participate in the study.

Exclusion criteria for the study group:

1. Immunosuppressive drug administration at an ad hoc basis (i.e. when symptoms occur) or irregularly (i.e. drug taken at an inappropriate dose and/or with a regularity ineffective for the indicated disease);
2. Use of immunosuppressive drugs for a period of less than 12 months;
3. Ineffective treatment of the disease requiring the use of immunosuppressive drugs (no improvement/progression of disease symptoms);

Additional exclusion criteria for both the study and control groups:

1. Advanced cancer; severe heart failure; severe renal failure; untreated autoimmune disease; active inflammation; diseases that impair drug absorption/metabolism;
2. Dementia;
3. Failure/inability to provide informed consent.

Where it's running

• Department of Neurology, Faculty of Health Science, Medical University of Warsaw
  Warsaw, Poland Recruiting

Study contacts

• Study coordinator: Julia M Nowak, MD
• Email: julia.nowak@wum.edu.pl
• Phone: +48223265427

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.