Department of Neurology, Faculty of Health Science, Medical University of Warsaw
Warsaw, 02-091, Poland
Location status: Recruiting
NCT Number: NCT06834191
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.
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Observational
Warsaw, 02-091, Poland
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for the study group:
Inclusion criteria
for the control group:
Exclusion criteria
for the study group:
Additional exclusion criteria for both the study and control groups:
Time frame: Day 1
This primary outcome will measure annual Parkinson's disease motor symptom progression rates using Part III (Motor Examination) of the Unified Parkinson's Disease Rating Scale (UPDRS). Assessments will be conducted in the OFF state, meaning the participant will not have taken any Parkinson's disease medication the day of the assessment. Part III of the UPDRS contains 18 items, the minimum value of UPDRS Part III is 0 points, and the maximum value is 132 points. In UPDRS Part III the higher the score, the worse the outcome. Annual progression rates will be calculated based on the time from the participant's motor symptom onset to the time of the appointment.
Time frame: Day 1
This secondary outcome will measure annual Parkinson's disease levodopa equivalent daily dose (LEDD) increase rates for each participant. Parkinson's disease medication taken by the participant will be procured at each participant's individual appointment. LEDD values will then be calculated based on the doses and types of Parkinson's disease medication taken by the participant. Annual LEDD rates will be calculated based on the LEDD value and time from the participant's motor symptom onset to the time of the appointment.
Time frame: Day 1
This secondary outcome will measure the age of onset of Parkinson's disease motor symptoms.
Time frame: Day 1
This primary outcome will measure annual Parkinson's disease motor symptom progression rates using the Hoehn and Yahr scale. This scale is used for staging functional disability associated with Parkinson's disease. The stages range from 1 to 5, and the higher the score the worse the outcome. Annual progression rates will be calculated based on the time from the participant's motor symptom onset to the time of the appointment.
Time frame: Day 1
This primary outcome will measure annual Parkinson's disease motor symptom progression rates using Part II (Motor Aspects of Experiences of Daily Living ) of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Part II of the MDS-UPDRS contains 13 items, the minimum value of MDS-UPDRS Part II is 0 points, and the maximum value is 52 points. In UPDRS Part II the higher the score, the worse the outcome. Annual progression rates will be calculated based on the time from the participant's motor symptom onset to the time of the appointment.
Time frame: Day 1
This secondary outcome measures the level of IL-1β in each participant at a single time-point.
Time frame: Day 1
This secondary outcome measures the level of IL-6 in each participant at a single time-point.
Time frame: Day 1
This secondary outcome measures the level of calprotectin in each participant at a single time-point.
Time frame: Day 1
This secondary outcome measures the level of TNFα in each participant at a single time-point.
Contact information is provided by the study sponsor or research team.
Julia M Nowak, MD
CONTACT
Monika Figura, MD, PhD
CONTACT
Medical University of Warsaw
Other
Analysis of the Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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