Biomarkers in Neurodegenerative Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- the score change in Unified Parkinson's Disease Rating Scale (UPDRS)
研究概览
简要总结
With the increase in life expectancy of our population due to advancement of medical diagnosis and treatments, the incidence of age dependent neurodegenerative diseases increased, including Alzheimer's disease (AD), parkinsonian syndromes (PS), small vessel disease (SVD) and motor neuron disease (MND). In spite of the progress of knowing the pathogenesis of various neurodegenerative diseases at molecular and genetic level, they are still very incompletely understood and often cause diagnostic and therapeutic challenges to physicians. Due to the overlapping presentation and similar brain pathology, especially in the early stage of the diseases, it is difficult to differentiate idiopathic Parkinson's disease (iPD) from atypical parkinsonian syndromes, such as multiple system atrophy (MSA) and progressive supranuclear palsy (PSP). Similarly, distinguishing AD from other dementia syndromes including frontotemporal dementia (FTD), dementia with Lewy Bodies (DLB), corticobasal degeneration (CBD) and vascular dementia can be difficult. It is necessary to develop accurate and comprehensive diagnostic tests to properly prognosticate the diseases, start treatments in early stage of the diseases and maximize the accuracy of drug trials for more effective preventive and therapeutic measures for these neurodegenerative diseases.
Therefore, the registry aims to generate a large database of cognitive, behavioral, lifestyle and psychological information of the subjects who suffered from neurodegenerative diseases, as well as to examine the genetic basis of neurodegenerative diseases to help decode the pathogenic mechanisms of the diseases. The registry may provide important information to understand symptom development of the neurodegenerative diseases, in which may help physicians to diagnose the diseases more accurately and provide better treatment plans.
详细描述
This is a cohort study. It involves baseline, 1st follow up visit and 2nd follow up visit. At baseline visit, all participants will go through a list of assessments and questionnaires and blood taking. Follow-up visit(s) will be scheduled every one to two years, in which the same set of assessments and questionnaires will be administered.
- Clinical assessments and questionnaires
Different clinical assessments would be administered depending on the group that the participant belongs to:
- Hoehn and Yahr Stage and the Unified Parkinson's Disease Rating Scale (UPDRS) for iPD, PSP and SVD patients with parkinsonism features
- Unified MSA Rating Scale (UMSARS) for MSA
- Levodopa Equivalent Dosage for medication burden for parkinsonian syndromes patients
- Amyotrophic lateral sclerosis functional rating scale revised (ALSFRS-R), body weight and forced vital capacity (FVC) for MND group
- Montreal Cognitive Assessment Hong Kong version (HK-MoCA), Olfactory Identification Test (OIT) and Farnsworth-Munsell 100 Hue test for all groups
Video taking would be administered to record participants' eye movement if necessary. For example, video of eye movement is useful to rate MSA patients' ocular motor dysfunction, such as gaze-evoke nystagmus.
Patients with parkinsonian syndromes will fill in a set of questionnaires, including demographic information, medical history, history and current medications, wearing-off questionnaire, impulsiveness questionnaire, Buss-Perry Aggression Questionnaire (BPAQ), rapid eye movement sleep behavior disorder questionnaire (RBDQ), Epworth Sleepiness Scale (ESS), Morningness-Eveningness Questionnaire (MEQ), Insomnia Severity Index (ISI), Beck's Scale for Suicide Ideation (BSSI), Scales for Outcomes in Parkinson's Disease-Autonomic questionnaire (SCOPA-AUT), Hospital Anxiety and Depression Scale (HADS), Patient Health Questionnaire (PHQ9), lifestyle and life history, and occupation history. 2. Blood sampling Blood taking would be carried out at Prince of Wales Hospital and will be processed and transported to the laboratory according to standard procedure.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age should be between 18-80 years old.
排除标准
- •Patients with ongoing central nervous system infection and/or acute stroke or active brain tumor.
研究组 & 干预措施
Early idiopathic Parkinson's Disease
200 patients with iPD based on Movement Disorder Society clinical diagnostic criteria for Parkinson's disease with disease onset less than 5 years
Non-early idiopathic Parkinson's Disease
200 patients with iPD based on Movement Disorder Society clinical diagnostic criteria for Parkinson's disease with disease onset more than 5 years
Multiple System Atrophy
100 patients with Multiple System Atrophy based on Second consensus statement on the diagnosis of MSA
Progressive Supranuclear Palsy
100 patients with Progressive Supranuclear Palsy based on Clinical research criteria for diagnosis of PSP
Alzheimer's Disease
100 patients with Alzheimer's Disease by Diagnostic and Statistical Manual of Mental disorder, Fifth edition (DSM-5) criteria
Motor Neuron Disease
200 patients with Motor Neuron Diseases by revised El Escorial criteria or Awaji ALS criteria
Small Vessel Disease
200 patients with cerebral Small Vessel Diseases
Frontotemporal Dementia
100 patients with Frontotemporal Dementia by International consensus criteria for behavioral variant FTD (FTDC) or Primary Progressive Aphasia by Gorno-Tempini
Healthy Control
200 age and sex matched healthy controls
结局指标
主要结局
the score change in Unified Parkinson's Disease Rating Scale (UPDRS)
时间窗: baseline visit, 2 years after baseline visit, 4 years after baseline visit
The Unified Parkinson's Disease Rating Scale (UPDRS) would be administered to assess disease severity for iPD, PSP and SVD patients with parkinsonism features
the score change in Montreal Cognitive Assessment Hong Kong version (HK-MoCA)
时间窗: baseline visit, 2 years after baseline visit, 4 years after baseline visit
Montreal Cognitive Assessment Hong Kong version (HK-MoCA) is used to assess participants' cognitive functions for all groups
the score change in Unified MSA Rating Scale (UMSARS)
时间窗: baseline visit, 2 years after baseline visit, 4 years after baseline visit
The Unified MSA Rating Scale (UMSARS) would be administered to assess disease severity for patients with MSA
次要结局
未报告次要终点
研究者
Vincent Mok
Professor
Chinese University of Hong Kong