Cohort of the French Clinical Research Network for Parkinson's Disease (NS-PARK Cohort)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30,000
- 试验地点
- 2
- 主要终点
- Modification of antiparkinsonian treatment doses
研究概览
简要总结
The aim of NS-PARK cohort are to describe the natural history of Parkinson's disease (PD), and to propose patients stratification models based on PD pathophysiological mechanisms. Patients are included at all PD expert centers in France. Standardized demographic, diagnosis, motor and non-motor symptoms evaluation, and treatment information are collected, and clinical data are updated at each visit of the patient at the center. A blood sampling is perform at baseline for genetic testing and implement an associated biocollection.
详细描述
The national clinical research network for Parkinson's disease (NS-PARK/FCRIN) reassembles all expert centers in Parkinson's disease (PD) in France. Its aim is to promote clinical research in Parkinson's disease and movement disorder, to better understand the pathophysiology of PD, foster the development of new therapeutic strategies, and move towards personalized medicine. To help centers for prescreening, a national registry of PD patients followed in each centers has been implemented in 2016 to collect minimal relevant clinical information of patients followed in each center including demographic data, age at diagnosis, standardized motor and non-motor symptoms evaluation, and treatment. Data are updated at each visit of the patient in the center. De facto, this registry became a longitudinal cohort of PD patients followed in NS-PARK centers. In 2020, NS-PARK received funding to associate a biocollection to this clinical cohort.
The aim of NS-PARK cohort are to describe the natural history of PD progression in clinical routine in France, to develop new models of PD describing the different progression profiles, and to propose patients stratification based on PD pathophysiological mechanisms. The cohort will also serve as a platform to discover new PD genes and genetic modifiers of disease progression or response to treatment.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of Parkinson's disease according to UK PD brain bak criteria
- •OR diagnosis of parkinsonian syndrome: multiple system atrophy, progressive supranuclear palsy, dementia with Lewy body, or corticobasal syndrom
- •OR Subjects at risk of PD defined as :
- •No symptom or diagnosis of Parkinson's disease nor parkinsonian syndrome, and relative to a patient with a diagosis of PD or parkinsonian syndrome, or carrier of a known mutation responsible for a genetic form of PD or patient with a diagnosis of idiopathic REEM sleep disorder or prodromal form of PD as defined by MDS criteria (Berg et al., 2015)
- •AND for all participants
- •Affiliated to social security
- •Age > 10 years
排除标准
- •Subject under legal protection
- •Subject who do not consent to the research
- •for the optional skin biopsy only: clinically significant coagulation abnormalities or anticoagulant treatment
结局指标
主要结局
Modification of antiparkinsonian treatment doses
时间窗: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Modification of antiparkinsonian treatment during follow-up will be measured as levodopa equivalent daily doses
Motor and non-motor complications
时间窗: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Occurence of motor (dyskinesia or motor fluctuations) or non-motor (dementia, dysautonomia, behavioral or psychiatric disorders, sleep disorders, falls, ...) complication
Disease progression
时间窗: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Hoehn and Yahr score change
次要结局
- Predictive factorsof PD progression: motor or non motor symptoms(through the end of follow-up in the cohort, at least 2 years, and average of 5 years)
- Clusters of patients with similar genetic and disease progression profiles(through the end of follow-up in the cohort, at least 2 years, and average of 5 years)
- Predictive factors of PD progression: brain imaging markers(through the end of follow-up in the cohort, at least 2 years, and average of 5 years)
- Genetic mutations associated with familal forms of PD(through study completion, 15 years)
- Predictive factors of PD progression: genetic variants(through the end of follow-up in the cohort, at least 2 years, and average of 5 years)
- Clusters of patients with similar disease progression profiles(through the end of follow-up in the cohort, at least 2 years, and average of 5 years)