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).

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Disseminated Sclerosis

Intervention / Treatment
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* Other: Cognitive impairment of multiple sclerosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Groups 1 and 2 -patients MS - EDSS<7 Group 3- patients with first clinical inflammatory symptom Exclusion Criteria: Pregnant or not taking contraceptive Contraindication for lumbar puncture Contraindication for NMR

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: group 1<br>MS with cortical cognitive troubles | Other: Cognitive impairment of multiple sclerosis<br>* Patients will get a lumbar puncture in order to measure the biomarkers in the CSF, a neuropsychological exam, an evaluation of the hippocampal volume by MRI and a cerebral scintigraphy.<br>|
| Other: group 2<br>MS with subcortical cognitive troubles | Other: Cognitive impairment of multiple sclerosis<br>* Patients will get a lumbar puncture in order to measure the biomarkers in the CSF, a neuropsychological exam, an evaluation of the hippocampal volume by MRI and a cerebral scintigraphy.<br>|
| Other: group 3<br>MS in the early stage of the disease when cognitive troubles are absent or inconspicuous | Other: Cognitive impairment of multiple sclerosis<br>* Patients will get a lumbar puncture in order to measure the biomarkers in the CSF, a neuropsychological exam, an evaluation of the hippocampal volume by MRI and a cerebral scintigraphy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare each biomarker individually between the three groups. |  | 15 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, cognitive deterioration, biomarkers, cerebrospinal fluid, Alzheimer disease