Systemic Synuclein Sampling Study (S4)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- α-syn deposits in submandibular gland
研究概览
简要总结
The purpose of this study is to measure alpha-synuclein in peripheral body tissues and fluids in Parkinson's disease (PD). This may help in developing better treatments for PD patients in the future.
详细描述
This is a multi-center, cross-sectional, observational study to evaluate α-syn pathology in multiple tissues and biofluids in individual subjects with PD and HC at a single time point.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Early PD
20 early PD not requiring dopamine replacement therapy have been enrolled.
干预措施: Tissue samplings (Procedure)
Healthy Controls
21 healthy controls have been enrolled.
干预措施: Biofluid samplings (Procedure)
Early PD
20 early PD not requiring dopamine replacement therapy have been enrolled.
干预措施: Biofluid samplings (Procedure)
Advanced PD
21 advanced PD with motor fluctuations have been enrolled.
干预措施: Tissue samplings (Procedure)
Advanced PD
21 advanced PD with motor fluctuations have been enrolled.
干预措施: DaTSCAN™ (Drug)
Healthy Controls
21 healthy controls have been enrolled.
干预措施: DaTSCAN™ (Drug)
Moderate PD
20 moderate PD on dopamine replacement therapy without motor fluctuations have been enrolled.
干预措施: Tissue samplings (Procedure)
Early PD
20 early PD not requiring dopamine replacement therapy have been enrolled.
干预措施: DaTSCAN™ (Drug)
Moderate PD
20 moderate PD on dopamine replacement therapy without motor fluctuations have been enrolled.
干预措施: DaTSCAN™ (Drug)
Moderate PD
20 moderate PD on dopamine replacement therapy without motor fluctuations have been enrolled.
干预措施: Biofluid samplings (Procedure)
Advanced PD
21 advanced PD with motor fluctuations have been enrolled.
干预措施: Biofluid samplings (Procedure)
Healthy Controls
21 healthy controls have been enrolled.
干预措施: Tissue samplings (Procedure)
结局指标
主要结局
α-syn deposits in submandibular gland
时间窗: 24 months
α-syn burden in the submandibular tissue will be expressed as 1) simply positive or negative, i.e. whether any two slides are positive out of all examined 2) by total percentage of slides examined that are positive 3) by site of highest density of positive α-syn fibers.
α-syn levels in blood
时间窗: 24 months
Blood will be analyzed using the most optimal, currently available, quantitative assays. The outcome will be expressed as a concentration of α-syn levels.
α-syn levels in saliva
时间窗: 24 months
Saliva will be analyzed using the most optimal, currently available, quantitative assays. The outcome will be expressed as a concentration of α-syn levels.
α-syn deposits in colon
时间窗: 24 months
α-syn burden in the colon tissue will be expressed as 1) simply positive or negative, i.e. whether any two slides are positive out of all examined 2) by total percentage of slides examined that are positive 3) by site of highest density of positive α-syn fibers.
α-syn levels in CSF
时间窗: 24 months
CSF will be analyzed using the most optimal, currently available, quantitative assays. The outcome will be expressed as a concentration of α-syn levels.
α-syn deposits in skin
时间窗: 24 months
α-syn burden in skin biopsies will be expressed as 1) simply positive or negative, i.e. whether any two slides are positive out of all examined 2) by total percentage of slides examined that are positive 3) by site of highest density of positive α-syn fibers.
次要结局
未报告次要终点
研究者
Lana Chahine, MD
Clinical Co-PI
University of Pennsylvania