Study of the Relationship Between the Presence of Anti-AChR Antibodies in the Cerebrospinal Fluid and the Presence of Neurocognitive Disorder in Myasthenic and Alzheimers's Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The ratio of the number of myasthenic patients with NS-NCD that may be related to myasthenia-related central nervous system damage to the total number of myasthenic patients with CND from all causes combined.
研究概览
简要总结
The purpose of the study is to evaluate if there is a specific association between the presence of anti Rach antibodies in the CSF and the presence of a cogntive disorder in myasthenic patients. Moreover the investigator wants to study if there is a link between the presence of Anti RACH antibodies in myasthenia and Alzheimers's disease.
For that, the investigator will recruit myasthenic patient with cognitive disorder that has undergo a diagnostic process including lombar punction for memory trouble in Nice memory center as well as Alzheimer's patient having go through the same process.
The study will consist in one additionnal blood draw. Anti RACH antibodies will be analyzed in historical CSF stored in biocollection and serum collected for the study.
LCS of healthy control will also be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For patient with myasthenia :
- •adult person,
- •Diagnosis of anti-AChR positive autoimmune myasthenia gravis, confirmed by clinical and biological data, and categorized in class I to IV according to the Myasthenia Gravis Foundation of America (MGFA) classification,
- •Mild or major neurocognitive disorder (DSM-5 criterion) having benefited from a diagnosis at the CMRR with CSF biomarker dosage and agreement to bio-collect residual CSF,
- •Agreeing to sign the free and informed consent,
- •Affiliate or beneficiary of a social security system.
- •For patient with Alzheimer Disease :
- •adult person,
- •Mild or major neurocognitive disorder (DSM-5 criterion) having benefited from a diagnosis at the CMRR with CSF biomarker dosage and agreement to bio-collect residual CSF,
- •Neurocognitive disorder only linked to Alzheimer's disease (IWG-2 criterion): typical or atypical clinical form with biomarkers of Alzheimer's disease in the CSF;
- •Agreeing to sign the free and informed consent,
- •Affiliate or beneficiary of a social security system.
- •For healty control :
- •absence of memory complaint,
- •absence of neurocognitive disorder,
- •Having agreed to carry out analyzes as part of research, on these CSF samples stored in the biobank of the Institute of Translational Neurology in Münster (Germany)
排除标准
- •For patient with myasthenia :
- •Person who does not have sufficient command of the French language to understand, read and write, to take neuropsychological tests;
- •Need to use the routine complementary CSF tube to carry out additional diagnostic explorations as part of routine care,
- •Vulnerable people are defined in articles L1121-5 to -8 ( Pregnant women, parturients and breastfeeding mothers, persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent under articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of article L. 1121-8, and persons admitted to a health or social establishment for purposes other than research/Adults who are subject to a legal protection measure or who are unable to express their consent.),
- •For patient with Alzheimer Disease :
- •1) vulnerable people are defined in articles L1121-5 to -8 ( Pregnant women, parturients and breastfeeding mothers, persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent under articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of article L. 1121-8, and persons admitted to a health or social establishment for purposes other than research/Adults who are subject to a legal protection measure or who are unable to express their consent.)
研究组 & 干预措施
Adults with Myasthenia
干预措施: Adults with Myasthenia (Procedure)
Adults with Alzheimer's disease
干预措施: Adults with Alzheimer's disease (Procedure)
healthy volonteer
干预措施: Healhty controls (Other)
结局指标
主要结局
The ratio of the number of myasthenic patients with NS-NCD that may be related to myasthenia-related central nervous system damage to the total number of myasthenic patients with CND from all causes combined.
时间窗: at day 0
次要结局
- Measurement of RACH antibodies in serum(at day 0)
- Measurement of RACH antibodies in cerebrospinal liquid(at day 0)