Identification of New Biomarkers Useful to Define the Course of Multiple Sclerosis and Study of the Mechanisms That Promote Synaptic Damage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Identification of predictive biomarkers of SM using an ex vivo chimeric model
研究概览
简要总结
A prospective and retrospective cohort study of about five years will be performed on blood and cerebrospinal fluid samples taken for diagnostic reasons from recruited patients within the Neuromed Neurology Unit. Subjects with other chronic neurodegenerative diseases such as Amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD) and Parkinson's disease (PD), and healthy subjects subjected to blood sampling and / or lumbar puncture for clinical reasons will be recruited As control groups.
详细描述
Blood and cerebrospinal fluid samples will be subjected to the procedures required for the isolation of the different components immediately after the withdrawal. Subsequently, the levels of microRNAs, cytokines, chemokines, cell growth factors, neuronal damage markers (tau, phosphorylated and truncated tau, neurofilaments) and mitochondrial (lactate) and free d-amino acids (Objective 1) will be determined. Furthermore, synaptic alterations will be evaluated in the ex vivo chimeric model of MS, using the patch-clamp technique (Objective 2). Genotyping studies will be conducted in order to identify single nucleotide polymorphisms (SNPs) in coding and / or regulating regions of genes (microRNAs or proteins) involved in alterations of the synaptic transmission of MS and its murine experimental model (i.e. SLC1A3, NGFB, PDGFA, etc.), which correlate with specific clinical parameters (i.e. EDSS, BREMS, disease progression index, MS type, disease activity, etc.) and with the levels of potential biomarkers identified
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients (age between 18 and 65 years)
- •Diagnosis of MS in accordance with McDonald's (2010 rev) criteria,
- •EDSS between 0 and 5.5 (included),
- •Patients able to provide informed consent to participation in the study
排除标准
- •Inability to provide informed written consent
- •Altered basal blood count
- •Pregnancy or lactation
- •Contraindications for the execution of magnetic resonance imaging with gadolinium
- •Significant clinical conditions in addition to SM or other chronic neurodegenerative diseases including latent viral infections
结局指标
主要结局
Identification of predictive biomarkers of SM using an ex vivo chimeric model
时间窗: September 01 2020
CSF concentrations of: neurofilaments, beta amyloid, tau protein, inflammatory cytokines and microRNAs
次要结局
- Identification of new therapeutic targets in MS.(September 01 2020)
研究者
Mario Stampanoni Bassi
Principal Investigator
Neuromed IRCCS