跳至主要内容
临床试验/NCT00978536
NCT00978536终止不适用

A Monocenter, Cross-sectional Study to Compare Different Type of Cognitive Impairment in Multiple Sclerosis Patients and Cerebrospinal Fluid Biomarkers (Beta Amyloid, Total Tau Protein and Tau-phosphorylated Protein).

Nantes University Hospital2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
29
试验地点
2
主要终点
The aim of this pilot study is to measure the level of total tau, phosphorylated tau and amyloid peptide in the CSF in order to establish correlations between a profile ofCSF biomarkers and a type of cognitive impairment, cortical or subcortical.

研究概览

简要总结

In multiple sclerosis (MS) sub cortical cognitive impairments are frequently reported. Nevertheless, cortical cognitive troubles, with hippocampic memory troubles have been described. Besides inflammatory damage, early cortical and degenerative damage are well known. In neurodegenerative diseases, three biomarkers of the cerebro spinal fluid (CSF), reflecting lesional mechanisms, are measured: the beta amyloid peptide, the tau total protein, and the phospho tau protein. Preliminary studies shown increased level of tau in MS. No study compare cognitive impairment and biomarkers of CSF.The aim of this study is to measure in the CSF of MS patients these three biomarkers (beta amyloid peptide, tau total and phosphotau) in order to establish correlations between a profile of biomarkers and a pattern of cognitive troubles, cortical or subcortical.The possibility to show, in MS patients with memory hippocampic troubles, a profile of biomarkers closed from the one encountered in AD, could argue in support of the degenerative hypothesis in MS and lead to discuss the interest of the use of AD treatment in MS.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
17 Years 至 66 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Groups 1 and 2 -patients MS - EDSS<7
  • Group 3- patients with first clinical inflammatory symptom

排除标准

  • Pregnant or not taking contraceptive
  • Contraindication for lumbar puncture
  • Contraindication for NMR

结局指标

主要结局

The aim of this pilot study is to measure the level of total tau, phosphorylated tau and amyloid peptide in the CSF in order to establish correlations between a profile ofCSF biomarkers and a type of cognitive impairment, cortical or subcortical.

时间窗: 15 months

次要结局

  • To define clinical and paraclinical characteristics of MS patients with cortical cognitive dysfunction by a clinical and neuropsychological evaluation, a morphological (cerebral MRI) and a functional exam (cerebral scintigraphy).(15 Months)
  • To compare each biomarker individually between the three groups.(15 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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