A Monocenter, Cross-sectional Study to Compare Different Type of Cogni
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).
What it found
The trial ended early for another reason (see below).
Reason given: Difficulties of recruitment in a randomization arm
This trial finished 15 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Cognitive impairment of multiple sclerosis
What it measured
Main measures
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
Blood or spinal fluid markersThinking and memory
Other measures (2)
To compare each biomarker individually between the three groups.
15 months
Blood or spinal fluid markersTo 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
MRI lesionsThinking and memory
Who could take part
MS (type not specified) · 17 to 66
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Feb 2009
Main results due
Nov 2011
Finished
Nov 2011