Analysis of the Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Annual motor progression rate - Unified Parkinson's Disease Rating Scale PART III OFF
研究概览
简要总结
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:
- 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;
- completion of Parkinson's disease symptom scales;
- a one-time serum sample collection;
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Annual motor progression rate - Unified Parkinson's Disease Rating Scale PART III OFF
时间窗: 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.
Annual LEDD increase rate
时间窗: 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.
Age of motor symptom onset
时间窗: Day 1
This secondary outcome will measure the age of onset of Parkinson's disease motor symptoms.
次要结局
- Annual motor progression rate - Hoehn and Yahr scale(Day 1)
- Serum inflammatory marker levels - calprotectin(Day 1)
- Annual motor progression rate - Unified Parkinson's Disease Rating Scale PART II(Day 1)
- Serum inflammatory marker levels - IL-1β(Day 1)
- Serum inflammatory marker levels - TNFα(Day 1)
- Serum inflammatory marker levels - IL-6(Day 1)