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).

Not Applicable

Terminated

• Conditions: Disseminated Sclerosis
• Interventions: Other: Cognitive impairment of multiple sclerosis

• Registration Number: NCT00978536
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-09-16
• Study First Submitted QC: 2009-09-16
• Study First Posted: 2009-09-17
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-27
• Last Update Posted: 2013-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	Cognitive impairment of multiple sclerosis	MS with cortical cognitive troubles
group 3	Cognitive impairment of multiple sclerosis	MS in the early stage of the disease when cognitive troubles are absent or inconspicuous
group 2	Cognitive impairment of multiple sclerosis	MS with subcortical cognitive troubles

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France