Exploring how immunosuppressive treatment affects Parkinson's disease progression

Analysis of the Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease

This study is trying to see if long-term immunosuppressive treatment helps slow down the progression of Parkinson's disease in people who are already diagnosed with it.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Sex: All
• Sponsor: Medical University of Warsaw (other)
• Drugs / interventions: adalimumab, certolizumab, infliximab, ixekizumab, natalizumab, rituximab, secukinumab, tocilizumab, ustekinumab, vedolizumab, methotrexate, prednisone
• Locations: 1 site (Warsaw)
• Trial ID: NCT06834191 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with Parkinson's disease who have been on immunosuppressive medication for over 12 months.

Not a fit: Patients with Parkinson's disease who have never received immunosuppressive treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into new therapeutic strategies for managing Parkinson's disease.

How similar studies have performed: While there is emerging evidence suggesting a link between inflammation and Parkinson's disease, this specific approach of examining immunosuppressive treatment's effects is relatively novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Warsaw

• Department of Neurology, Faculty of Health Science, Medical University of Warsaw — Warsaw, Poland (RECRUITING)

Study contacts

• Study coordinator: Julia M Nowak, MD

Conditions: Parkinson Disease, Immunosuppression, Immunosuppressive treatment, cross-sectional study, observational study, Parkinson disease