Actively Recruiting

All Genders
NCT06834191

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

Led by Medical University of Warsaw · Updated on 2025-12-23

80

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Parkinson's disease according to the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria
  • For study group: Regular use of immunosuppressive medication at an effective dose and frequency for over 12 months by systemic administration (oral, intramuscular, subcutaneous, intravenous, inhaled)
  • For control group: No history of regular immunosuppressive medication use
  • Ability and willingness to provide informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Irregular or ad hoc use of immunosuppressive drugs (inappropriate dose or frequency)
  • Use of immunosuppressive drugs for less than 12 months
  • Ineffective treatment requiring immunosuppressive drugs (no improvement or disease progression)
  • Advanced cancer, severe heart failure, severe renal failure, untreated autoimmune disease, active inflammation, or diseases impairing drug absorption or metabolism
  • Dementia
  • Inability or failure to provide informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Neurology, Faculty of Health Science, Medical University of Warsaw

Warsaw, Poland, 02-091

Actively Recruiting

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Research Team

J

Julia M Nowak, MD

CONTACT

M

Monika Figura, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease | DecenTrialz