---
title: Determine whether immunosuppression slows progression
nct_id: NCT06834191
status: RECRUITING
sponsor: Medical University of Warsaw
study_type: OBSERVATIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06834191"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06834191"
last_fetched: "2026-05-10T14:05:12.145Z"
source: "Parkinson's Pathways (curated)"
---
# Determine whether immunosuppression slows progression

**Goal (in five words):** Determine whether immunosuppression slows progression

**Official Title:** Analysis of the Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease

**Trial ID:** [NCT06834191](https://clinicaltrials.gov/study/NCT06834191)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Sponsor:** Medical University of Warsaw
- **Target Enrollment:** 80 participants
- **Start Date:** 2025-03-01
- **Completion Date:** 2027-12
- **Conditions:** Parkinson Disease

## Summary For Families

Researchers want to find out whether long-term use of systemic immunosuppressive medications changes the clinical course of Parkinson's disease, for example by slowing or altering symptom progression that may be linked to neuroinflammation. They will observe people with Parkinson's who have been on regular immunosuppressants for more than 12 months, such as corticosteroids, methotrexate, calcineurin or mTOR inhibitors, or biologics, and compare them to people with Parkinson's who have not used these drugs; these medicines reduce immune activity and might lower harmful neuroinflammation, they do not directly replace levodopa but can affect infection risk and may require monitoring for interactions with other treatments. The study is enrolling adults with a confirmed Parkinson's diagnosis who either have taken effective systemic immunosuppressive therapy for over 12 months or who have no history of regular immunosuppressive use, and it excludes people with dementia, advanced organ failure, active inflammation, irregular or short-term immunosuppressant use.

## Eligibility

- **Sex:** ALL

### Full 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.
```

## Locations (1)

- Department of Neurology, Faculty of Health Science, Medical University of Warsaw, Warsaw, Poland _(52.2298, 21.0118)_
  - Monika Figura, MD, PhD — (CONTACT) — +48223265427 — monika.figura@wum.edu.pl

## Central Contacts

- Julia M Nowak, MD — (CONTACT) — +48223265427 — julia.nowak@wum.edu.pl
- Monika Figura, MD, PhD — (CONTACT) — +48223265427 — monika.figura@wum.edu.pl

---

*Canonical: https://parkinsonspathways.com/trial/NCT06834191*  
*HTML version: https://parkinsonspathways.com/trial/NCT06834191*  
*Source data: https://clinicaltrials.gov/study/NCT06834191*