Clinical trial NCT00978536: 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).
Official title: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Disseminated Sclerosis
Keywords: Multiple sclerosis
cognitive deterioration
biomarkers
cerebrospinal fluid
Alzheimer disease
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2009-09-17
Enrollment: 29
Sex: ALL
Minimum age (years): 17
Maximum age (years): 66
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 15 months
Secondary outcomes:
measure: To compare each biomarker individually between the three groups.
timeFrame: 15 months
measure: 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).
timeFrame: 15 Months
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Claire Boutoleau-Bretonniere, Doctor
role: PRINCIPAL_INVESTIGATOR
References: