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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).

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).

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00978536
Acronym
BioCogS
Enrollment
29
Registered
2009-09-17
Start date
2009-02-28
Completion date
2011-11-30
Last updated
2013-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disseminated Sclerosis

Keywords

Multiple sclerosis, cognitive deterioration, biomarkers, cerebrospinal fluid, Alzheimer disease

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.

Interventions

OTHERCognitive 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.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
17 Years to 66 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026