Phase
Condition
N/ATreatment
N/AClinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria for the study group:
Diagnosis of Parkinson's disease according to the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease;
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, regardless of administration route (e.g., oral, intramuscular, subcutaneous); 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;
Provision of informed consent to participate in the study.
Inclusion criteria for the control group:
Diagnosis of Parkinson's disease according to the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease;
No history of regular use of immunosuppressive medications;
Provision of informed consent to participate in the study.
Exclusion criteria for the study group:
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);
Use of immunosuppressive drugs for a period of less than 12 months;
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:
Advanced cancer; severe heart failure; severe renal failure; untreated autoimmune disease; active inflammation; diseases that impair drug absorption/metabolism;
Dementia;
Failure/inability to provide informed consent.
Study Design
Connect with a study center
Department of Neurology, Faculty of Health Science, Medical University of Warsaw
Warsaw, 02-091
PolandActive - Recruiting
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