Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients (CogMS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01658384|
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : March 31, 2015
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Other: Observational Cognitive assessments Other: 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.
|Study Type :||Observational|
|Actual Enrollment :||63 participants|
|Official Title:||Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||March 2015|
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
- SDMT CogState battery [ Time Frame: 2 years ]Monthly cognitive assessments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|