Progression of Prodromal Markers of α-synucleinopathy Neurodegeneration in the First-degree Relatives of Patients With REM Sleep Behavior Disorder: a 5-year Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Changes of the overall probability of prodromal Parkinson's disease in the FDRs of patients with RBD.
研究概览
简要总结
This study is a prospective study with a mean of 5-year follow-up interval, aims to monitor the progression of α-synucleinopathy neurodegeneration by the evolution of prodromal markers and development of clinical disorders in first-degree relatives (FDRs) of idiopathic REM Sleep Behavior Disorder (RBD) patients and healthy controls.
详细描述
Idiopathic RBD is implicated as an integral part of progression of α-synucleinopathy neurodegeneration, and patients with idiopathic RBD have increased prevalence of non-motor symptoms (or prodromal markers) closely related to Parkinson's disease(PD). Moreover, the investigator's previous studies have further confirmed the familial aggregation of RBD, and first-degree relatives (FDRs) of RBD patients had more prodromal markers of Parkinson's disease compared with FDRs of healthy controls.
In these regards, current prospective study aims to map the progression and evolution of prodromal markers (including autonomic dysfunction, olfactory loss, color vision impairment, neurocognitive impairment, neuroimaging of dopamine dysfunction, daytime sleepiness and psychiatric disorders), onset of RBD, and neurodegenerative diseases. Finally, other markers, such as physical activity and circadian rhythm and tonic electromyography (EMG) activity level, which have been found to be reliably associated with Parkinson's disease or other neurodegenerative diseases. In this regard, it is also interesting to investigate whether these indicators will additionally predict the progression of prodromal markers of PD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Chinese aged 40 or above;
- •Being capable of giving informed consent for participation of the study;
- •Sex-matched.
排除标准
- •Younger than 40 years old (as the supposed neurodegenerative process may not have occurred);
- •Not capable of giving informed consent for participation of the study.
结局指标
主要结局
Changes of the overall probability of prodromal Parkinson's disease in the FDRs of patients with RBD.
时间窗: Baseline and 5 years
Changes of the overall probability of prodromal Parkinson's disease will be calculated based on the Movement Disorder Society (MDS) research criteria for prodromal Parkinson's disease in the FDRs of patients with RBD.
次要结局
- Changes of tonic EMG activity in the FDRs of patients with RBD.(Baseline and 5 years)
- Changes of physical activity level and circadian in the FDRs of patients with RBD.(Baseline and 5 years)
- New incidence of RBD and α-synucleinopathy in the FDRs of patients with RBD.(Baseline and 5 years)
研究者
Dr. Zhang Jihui
Assistant Professor
Chinese University of Hong Kong