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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).

NCT ID: NCT00978536

Last Updated: 2013-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-11-30

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.

Detailed Description

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Conditions

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Disseminated Sclerosis

Keywords

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Multiple sclerosis cognitive deterioration biomarkers cerebrospinal fluid Alzheimer disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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group 1

MS with cortical cognitive troubles

Group Type OTHER

Cognitive impairment of multiple sclerosis

Intervention Type OTHER

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.

group 2

MS with subcortical cognitive troubles

Group Type OTHER

Cognitive impairment of multiple sclerosis

Intervention Type OTHER

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.

group 3

MS in the early stage of the disease when cognitive troubles are absent or inconspicuous

Group Type OTHER

Cognitive impairment of multiple sclerosis

Intervention Type OTHER

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.

Interventions

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Cognitive impairment of multiple sclerosis

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.

Intervention Type OTHER

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
Minimum Eligible Age

17 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Boutoleau-Bretonniere, Doctor

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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CHU de Nantes

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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08/11-K

Identifier Type: -

Identifier Source: org_study_id