Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients (CogMS)
|Multiple Sclerosis||Other: Observational Cognitive assessments Other: noninterventional, cognitive testing in tysabri treated patients||Phase 4|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients|
- SDMT CogState battery [ Time Frame: 2 years ]Monthly cognitive assessments
|Study Start Date:||September 2011|
|Study Completion Date:||March 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
cognitive evolution, observational,MS
multiple sclerosis tysabri treated patients
Other: Observational Cognitive assessments
Other Name: Cognitive assessmentsOther: noninterventional, cognitive testing in tysabri treated patients
noninterventional, cognitive testing in Tysabri treated patients
Tysabri reduces the relapse frequency, slows progression and preserves cognitive function as compared to placebo as per the AFFIRM trial. The benefit on relapse rate and progression appears to be sustained in longer-term studies such as STRATA. In clinical practice however despite a stable condition on the Expanded Disability Status Scale (EDSS) patients often complain of cognitive deterioration. It has yet to be shown that Tysabri will prevent cognitive deterioration after more than 2 years of treatment.
The Symbol Digit Modalities Test (SDMT) is a sensitive and validated test of cognition in MS. CogState offers a standardized battery of cognitive tests frequently used in clinical research in the fields of dementia and Parkinson's disease. The CogState battery of tests consisting of the Detection test (processing speed), Identification test (attention), One Back test (working memory), International Shopping List test (verbal learning) and the Groton Maze Learning test (reasoning and problem solving) will further confirm and validate the results of the Symbol Digit Modalities Test(SDMT) in MS patients as well as examine other cognitive parameters.
Together the above tests done prospectively can assess the evolution of cognitive function in Tysabri treated MS patients over the longer term.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658384
|Gatineau, Quebec, Canada, J9J 0A5|
|Principal Investigator:||François H Jacques, MD||Clinique Neuro-Outaouais and Centre de Santé et de Services Sociaux de Gatineau, Hôpital de Hull|