NCT04724941招募中不适用
Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study
University Hospital Schleswig-Holstein1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Risk marker profile
研究概览
简要总结
The PASS-PD study is set out to screen individuals from the general population with an increased risk for the development of Parkinson's Disease (PD) and to investigate this highly enriched cohort longitudinally for five year. A special focus is placed on implementation of ethical standards for early risk disclosure in PD.
详细描述
The PASS-PP Study is designed to combine the latest developments in clinical and biomarker research to
- understand the distribution of risk profiles for PD in the general population, especially regarding non-motor symptoms
- identify subjects with a likelihood of developing PD
- follow individuals with a high likelihood/risk to develop PD in the future (compared to individuals with low risk and) in a prospective study
- understand the potential of biological markers to increase prediction of progression/conversion
- identify subtypes of PD patients, by providing a detailed clinical phenotyping with a main focus on non-motor symptoms cluster
- provide a framework of ethical handling of early risk disclosure in PD
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 50 and 99
排除标准
- •Presence of clinical PD at the time of study inclusion
- •Other significant neurologic diseases affecting the central nervous system (e.g. Multiple sclerosis)
- •other significant diseases e.g. orthopaedic diseases affecting quantitative motor assessment
- •in case of participation in the lumbal puncture substudy: contraindications for the performance of lumbal puncture (bleeding tendency, intake of anticoagulants)
结局指标
主要结局
Risk marker profile
时间窗: Analysis after three years.
Extend and progression of risk marker profile
次要结局
- Non-motor and motor symptoms(Analysis after three years)
研究者
Eva Schaeffer
Dr. Eva Schaeffer, Department for Neurology
University Hospital Schleswig-Holstein
研究点 (1)
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