Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 33
- 主要终点
- Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months
研究概览
简要总结
This study aims to assess the levels of phosphorylated alpha-synuclein (P-SYN) in patients with Parkinson's disease and REM Behavior Disorder using a minimally invasive skin punch biopsy. It seeks to understand the natural progression of P-SYN deposition over time to explore the potential of P-SYN quantification as a biomarker for disease progression.
详细描述
This is a prospective, longitudinal study involving 75 Parkinson's disease patients and 25 patients with REM Behavior Disorder. Each participant will undergo a baseline evaluation followed by follow-ups every six months over an 18-month period. The evaluations will include clinical assessments, neurologic exams, and skin biopsies from three locations. Data will be collected on disease progression and the amount of P-SYN in cutaneous nerve fibers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female 50 to 85 years of age
- •Clinical confirmed diagnosis of Parkinson's disease or REM Sleep Behavior
排除标准
- •Clinical evidence of severe vascular disease (history of ulceration, poor wound healing or vascular claudication)
- •History of allergic reaction to Lidocaine for local anesthesia needed for skin biopsies
- •Use of blood thinners (Plavix or Aspirin used separately is allowed)
- •Significantly impaired wound healing or history of scarring or keloid formation
结局指标
主要结局
Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months
时间窗: 18 months
The accuracy of the pathological test in detecting α-synuclein aggregation and deposition in skin punch biopsies. Measurement of the quantity of phosphorylated alpha-synuclein (P-SYN) in each biopsy to determine whether cutaneous biopsies can serve as a biomarker for changes in P-SYN deposition over time .
次要结局
未报告次要终点