Prospective, Observational Study to Identify Biomarkers in Parkinsonian Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Blood samples analysis (DNA)
研究概览
简要总结
This is a prospective observational study to identify biomarkers in parkinson syndromes. Patients with parkinsonian syndromes at the early stages of disease will be recruited and will be followed up until their established clinical diagnosis or for at least 5 years. In this population, imaging and wet biomarkers as well as clinical data will b systematically collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IΙnclusion Criteria:
- •Written informed consent, including consent to monitoring
- •Patients with Parkinsonism and disease duration < 2 years
- •Patients with Parkinsonism and disease duration > 2 years
- •Healthy individuals without any neurological disease
排除标准
- •Drug-induced parkinsonism (eg, neuroleptics, lithium, valproic acid, metoclopramide).
- •Metabolic conditions related parkinsonism (eg, Wilson's disease, hypoparathyroidism).
- •Structural lesions on brain magnetic resonance imaging (MRI) that explain the symptoms, such as normal pressure hydrocephalus, moderate to severe chronic vascular encephalopathy, cerebral infarction, neoplasm
- •Other serious diseases that indicate a life expectancy of <5 years.
- •Active participation in other interventional clinical studies
结局指标
主要结局
Blood samples analysis (DNA)
时间窗: At enrolment
Whole exome sequencing - genetic testing
Age
时间窗: At enrolment
Age at onset in years
First motor symptom
时间窗: At enrolment
First motor symptom time of onset
Disease duration
时间窗: At enrolment
Disease duration in years
Staging
时间窗: At enrolment and every six months over 5 years
Hoehn and Yahr stage (H\&Y) stage (1-5, higher score indicate higher impairment)
Imaging outcome measures - nuclear medicine investigations
时间窗: At enrolment
(meta-iodobenzylguanidine) MIBG-Scintigraphy heart
First non-motor symptom
时间窗: At enrolment
First non-motor symptom time of onset
Clinical scale for frontal dysfunction
时间窗: At enrolment and every six months over 5 years
Frontal assessment battery (FAB) (0-18, lower scores indicate higher impairment)
Imaging outcome measures - Positron emission tomography (PET)
时间窗: At enrolment
fluorodeoxyglucose (FDG) -PET brain
Imaging outcome measures - Dopamine Transporters imaging (DaTScan)
时间窗: At enrolment
MRI brain
Side of onset
时间窗: At enrolment
Side of onset of first motor symptom
Demographics
时间窗: At enrolment
Age, gender, education, origin, race
Family history
时间窗: At enrolment
Family history of Parkinson's, dementia, tremor, other movement disorders, other neurological disorders
Clinical scales for apathy
时间窗: At enrolment and every six months over 5 years
Starkstein Apathy Scale (SAS) (0-56; higher scores indicate higher impairment)
Clinical scales - Unified Parkinson's disease rating scale (UPDRS)
时间窗: At enrolment and every six months over 5 years
Unified Parkinson's disease rating scale I-IV (UPDRS I-IV, 0-260; higher scores indicate higher impairment)
Clinical scales for Progressive supranuclear palsy (PSP)
时间窗: At enrolment and every six months over 5 years
Progressive supranuclear palsy rating scale (PSP-RS) (0-100; higher scores indicate higher impairment)
Clinical scales for Multiple system atrophy (MSA)
时间窗: At enrolment and every six months over 5 years
Unified Multiple system atrophy rating scale (UMSAPRS)(0-104; higher scores indicate higher impairment)
Clinical scales for PSP short
时间窗: At enrolment and every six months over 5 years
Progressive Supranuclear Palsy Clinical Deflicts Scale (PSP-CDS)(0-21; higher scores indicate higher impairment)
Clinical scale for autonomic dysfunction
时间窗: At enrolment and every six months over 5 years
The Scale for Outcomes in Parkinson's disease for Autonomic symptoms - (0-100; higher scores indicate higher impairment)
Imaging outcome measures - Magnetic resonance imaging (MRI)
时间窗: At enrolment
MRI brain
Blood samples analysis (biomarkers, exosomes)
时间窗: At enrolment and after 2 years
Peripheral blood mononuclear cell (PBMCs), peripheral blood mononuclear cells, exosomes
Clinical scale for cognition
时间窗: At enrolment and every six months over 5 years
Montreal Cognitive Assessment (MOCA) (0-30, lower scores indicate higher impairment)
次要结局
未报告次要终点