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).

Disseminated Sclerosis Clinical Trial

— BioCogS  

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).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00978536
• Other study ID #: 08/11-K
• Status: Terminated
• Phase: N/A
• First received: September 16, 2009
• Last updated: September 27, 2013
• Start date: February 2009
• Est. completion date: November 2011

Study information

• Verified date: September 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 66 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cognition Disorders
• Disseminated Sclerosis
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To compare each biomarker individually between the three groups.		15 months	No
Secondary	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	No