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). (BioCogS)

This study has been terminated.

(Difficulties of recruitment in a randomization arm)

Sponsor:

Information provided by (Responsible Party):

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT00978536

First received: September 16, 2009

Last updated: February 11, 2013

Last verified: February 2013

History of Changes

Purpose

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.

Condition	Intervention
Disseminated Sclerosis	Other: Cognitive impairment of multiple sclerosis

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label
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).

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome 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. [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare each biomarker individually between the three groups. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
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). [ Time Frame: 15 Months ] [ Designated as safety issue: No ]

Enrollment:	29
Study Start Date:	February 2009
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
group 1 MS with cortical cognitive troubles	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.
group 2 MS with subcortical cognitive troubles	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.
group 3 MS in the early stage of the disease when cognitive troubles are absent or inconspicuous	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.

Eligibility

Ages Eligible for Study:	17 Years to 66 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978536

Locations

France
CHU de Nantes
Nantes, France, 44093

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:

Claire Boutoleau-Bretonniere, Doctor

CHU de Nantes

More Information

No publications provided

Responsible Party:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00978536 History of Changes
Other Study ID Numbers:	08/11-K
Study First Received:	September 16, 2009
Last Updated:	February 11, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:

Multiple sclerosis
cognitive deterioration
biomarkers
cerebrospinal fluid
Alzheimer disease

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Cognition Disorders
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013

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