ANCILLARY STUDY No. 3 TO RIPH C16-56: THE NS-PARK COHORT AIMED AT IDENTIFYING BIOMARKERS FOR PARKINSON'S DISEASE
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Biomarkers associated with PD progression
研究概览
简要总结
The goal of this clinical study is to identify biomarkers associated with Parkinson's disease (PD) progression in PD patients, participants at-risk of developing PD (e.g., a person who does not have the disease but carrying a mutation known to be related to the disease or a person with a prodromal form as iRBD for example), as well as healthy volunteers. The working hypothesis of this study is that patients with Parkinson's disease can be stratified into etiological subgroups through the integration of omics data. Combining molecular signatures with longitudinal clinical and phenotypic data from the NS-PARK cohort will enable the development of disease progression models grounded in the pathophysiological mechanisms of Parkinson's disease. Researchers will compare the data with those from healthy volunteers to determine whether the findings are specific to PD, as some biomarkers may reflect broader processes related to neurodegeneration, aging, or comorbidities.
In this ancillary study, in addition to the NS-PARK cohort assessments, participants will be proposed to do, during one visit:
- A lumbar puncture
- A blood draw
- A urine collection
- An olfactory test
- A more detailed neuropsychological assessment
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENT GROUP -Enrolled in the NS-PARK cohort in the Parkinson's disease patient group, with sample collection for genetic analysis.
- •AT-RISK GROUP
- •Enrolled in the at-risk group of the NS-PARK cohort, with sample collection for genetic analysis, in accordance with the NS-PARK cohort criteria, i.e.: Individual related to a patient with Parkinson's disease; And/or
- •Unaffected individual carrying a mutation in a gene known to be involved in Parkinson's disease; And/or
- •Individual presenting a prodromal form of the disease (e.g., idiopathic REM sleep behaviour disorder [iRBD]).
- •CONTROL GROUP (healthy volunteers)
- •Individual matched for age and sex with the patient included in this study;
- •No neurological disease or symptoms, as determined by the neurologist during the clinical interview, and no known history of neurological disease or symptoms.
- •FOR ALL GROUPS
- •Adult individual;
- •Affiliated with a social security scheme or entitled to benefits under such a scheme;
- •Negative blood or urine pregnancy test prior to inclusion for women of childbearing potential;
- •Having provided written, free and informed consent to participate in this research.
排除标准
- •Individuals under judicial protection (sauvegarde de justice);
- •Pregnant or breastfeeding women;
- •Individuals under guardianship or curatorship;
- •Known contraindication to lumbar puncture (as defined in the protocol).
研究组 & 干预措施
At-risk
Individuals at-risk of developing Parkinson's disease enrolled in the NS-PARK cohort: individuals who are related to a patient with PD, unaffected carriers of a mutation in a gene known to be associated with PD, or individuals with prodromal features of the disease such as isolated REM sleep behavior disorder (RBD).
干预措施: lumbar puncture (Procedure)
Controls
Healthy volunteers
干预措施: lumbar puncture (Procedure)
Patients
Patients from the NS-PARK cohort, carrying or not mutation in a gene known to be associated to PD
干预措施: lumbar puncture (Procedure)
结局指标
主要结局
Biomarkers associated with PD progression
时间窗: At inclusion
Biomarker levels measured in biological fluids
次要结局
未报告次要终点