Recruiting · registry statusHow immune-suppressing treatment relates to Parkinson’s over time
Researchers observe whether use of medicines that reduce immune activity is associated with the course of Parkinson’s.
Learning by observing or collecting information · Study reference: NCT06834191
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
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Looking for volunteers
- Start (reported actual date)
- 2025-03-01
- Main measurements finished (planned)
- 2027-12
- Study finished (planned)
- 2028-09
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Age range not listed · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
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.
Full study name & original research details
Official study title
Analysis of the Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease
Short title used by the registry
Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease
Original description
The goal of this observational study is to learn if immunosuppressive drug treatment influences the clinical course of Parkinson's disease. Recent research suggests that Parkinson's disease may have an inflammatory background. Numerous studies have identified elevated levels of pro-inflammatory markers in people with Parkinson's disease. Therefore, immunosuppressive drugs may potentially affect the course of this disease.
The investigators will recruit people with Parkinson's disease, who receive long-term immunosuppressive treatment for other chronic illnesses, into the study group. The study will also recruit people with Parkinson's disease with no history of immunosuppressive drug treatment into the control group. The main question this study aims to answer is:
\> Does immunosuppressive drug treatment slow down the onset and/or progression of Parkinson's disease?
Researchers will compare Parkinson's disease progression rates and serum inflammatory marker levels between the study and control group, to see if immunosuppressive drug treatment influences the course of Parkinson's disease.
The study requires each participant to attend one hospital appointment. This appointment will be approximately one hour long, and will involve:
1. clinical Parkinson's disease motor assessments conducted by the research team -\> participants will be evaluated in the OFF state, meaning they will not have taken their Parkinson's disease medication the day of the assessment;
2. completion of Parkinson's disease symptom scales;
3. a one-time serum sample collection;
4. detailed medical history obtainment from the participant by the research team, with a primary focus on the patient's immunosuppressive treatment history and individual clinical course of Parkinson's disease.
Conditions reported: Parkinson Disease
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Observational
- Interventions
- Not reported
- Phases
- Not reported
- Sponsor
- Medical University of Warsaw
- Start date reported by registry
- 2025-03-01 (actual)
Registry updated: 2025-12-23 · Status last verified by the registry submitter: 2025-01
Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Julia M Nowak, MD · +48223265427 · julia.nowak@wum.edu.pl
Monika Figura, MD, PhD · +48223265427 · monika.figura@wum.edu.pl
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
Department of Neurology, Faculty of Health Science, Medical University of Warsaw
Warsaw, Poland
RecruitingMonika Figura, MD, PhD · +48223265427 · monika.figura@wum.edu.pl
Facility not reported
Poland
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.