A Prospective Longitudinal Neuroimaging and Biomarker Cohort Study in Idiopathic Rapid Eye Movement(REM) Sleep Behavior Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Frequency of development of Lewy body diseases
研究概览
简要总结
This is a prospective cohort study to evaluate degenerative changes in the brain by performing functional imaging analysis in patients with RBD and its correlations with clinical symptoms and dopaminergic degeneration. This study also evaluates cognitive changes with functional imaging measures and olfactory and other premotor symptoms of Lewy body disease. This study also collects gene extracts and sera to develop a biomarker for early detection of neurodegeneration.
详细描述
This study will include 3 groups in relation with RBD: idiopathic RBD (iRBD), PD- RBD, normal controls without RBD. In all groups, neurological examinations, olfactory testings, nonmotor symptoms evaluations, neuropsychological evaluations (detailed outcomes are in the outcome section) will be performed at baseline evaluation after enrollment. Image data will be obtained on following modalities: brain magnetic resonance imaging (MRI), 18F-N-ω-fluoropropyl- 2β-carbomethoxy- 3β-(4-iodophenyl) nortropane ([18F]FP-CIT) positron emission tomography (PET), and 18F-fludeoxyglucose([18F]FDG) PET.
To assess progression toward Lewy body disorders, patients in iRBD group will be evaluated at 2, and 4 years of follow-up visit. Clinical, neuropsychological tests, brain MRI, and two PET scans will be administered. After 4 years, patients who are willing to participate will be additionally followed-up yearly as a routine clinical visit with clinical and neurological examinations until obvious signs of Lewy body diseases will develop.
In PD-RBD group, patients will be evaluated at 3-year follow-up period amongst days of routine clinic visits with administering clinical and neuropsychological tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •iRBD group:
- •A diagnosis of RBD according to the international classification of sleep disorders-2 (ICSD-2) criteria
- •No current neurological diseases related with RBD
- •Male or female aged from 30 to 80 years old at screening
- •Subject enrolled voluntarily and understood the contents of the study
- •A diagnosis of PD according to the UK Brain Bank Diagnostic Criteria
- •A diagnosis of RBD according to the international classification of sleep disorders-2 (ICSD-2) criteria
- •Male or female aged from 30 to 80 years old at screening
- •Subject enrolled voluntarily and understood the contents of the study
- •Control group:
- •No current neurological or psychiatric diseases related with RBD
- •Male or female aged from 30 to 80 years old at screening
- •Age and sex matched with those of subjects in iRBD group
- •Subject enrolled voluntarily and understood the contents of the study
排除标准
- •Clinically significant cognitive decline unable to follow the study (Mini-mental state examination [MMSE] score less than 20)
- •History of psychiatric illnesses (ex. depression)
- •Unable to walk and cooperate to the examination
- •Unable to take magnetic resonance imaging or positron emission tomography
- •Existence of illness or problems which makes difficult to be enrolled to the study judged by clinicians
研究组 & 干预措施
idiopathic RBD group
A group of patients diagnosed as idiopathic RBD that is confirmed by polysomnography. Interventions as testing, evaluation, samplings at baseline, then repeat at 2 years and 4 years of prospective follow-up. thereafter only clinical observations until Lewy body disease is diagnosed.
干预措施: testing, evaluation, sampling (Other)
incident PD group
A group of patients who are newly diagnosed as Parkinson's disease, and never been treated with prolonged history of probable RBD. Interventions as testing, evaluation, sampling at baseline and then evaluations only at 3 year follow-up after anti-parkinsonian treatment.
干预措施: testing, evaluation, sampling (Other)
Control
Control group includes elderly controls without neurodegerative diseases examined by neurologists. Interventions as testing, evaluation, sampling at baseline only.
干预措施: testing, evaluation, sampling (Other)
结局指标
主要结局
Frequency of development of Lewy body diseases
时间窗: up to 4-years follow-up
idiopathic RBD group only
次要结局
- Cognitive change measured by the neuropsychological test battery(from baseline to 2-years ad 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group))
- Degenerative brain changes predicted by MRI (diffusion tensor analysis and volumetry)(from baseline to 2-years and 4-years follow-up (iRBD group only))
- Degenerative brain changes predicted by [18F]FP-CIT PET(from baseline to 2-years and 4-years follow-up (iRBD group only))
- Parkinsonian motor symptoms score change measured by the unified Parkinson's disease rating scale (MDS-UPDRS)(from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group))
- Nonmotor symptoms profile change assessed by a combined evaluatin using the non-motor symptom scale and part I of the MDS-UPDRS(from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group))
- Functional network changes predicted by the resting-state functional MRI(from baseline to 2-years and 4-years follow-up (iRBD group only))
- Functional network changes predicted by [18F]FDG PET(from baseline to 2-years and 4-years follow-up (iRBD group only))
研究者
Jee-Young Lee
Associate Professor
Seoul National University Hospital