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Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients (CogMS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
CogState Ltd.
Information provided by (Responsible Party):
Clinique Neuro-Outaouais
ClinicalTrials.gov Identifier:
NCT01658384
First received: November 10, 2011
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

This study is designed to evaluate the effect of Tysabri on cognition in multiple sclerosis (MS) patients. During a period of 24 months, the study will assess the evolution of cognitive function in Tysabri treated MS patients using the Symbol Digit Modalities Test (SDMT) and the CogState battery of tests.


Condition Intervention Phase
Multiple Sclerosis
 Other: Observational Cognitive assessments
Other: noninterventional, cognitive testing in tysabri treated patients
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients

Resource links provided by NLM:

Drug Information available for: Natalizumab
U.S. FDA Resources

Further study details as provided by Clinique Neuro-Outaouais:

Primary Outcome Measures:
  • SDMT CogState battery [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Monthly cognitive assessments


Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
cognitive evolution, observational,MS
multiple sclerosis tysabri treated patients
 Other: Observational Cognitive assessments
Observational
Other Name: Cognitive assessments
Other: noninterventional, cognitive testing in tysabri treated patients
noninterventional, cognitive testing in Tysabri treated patients

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with multiple sclerosis who are receiving Tysabri per indication.

Criteria

Inclusion Criteria:

  • Patients with multiple sclerosis who are receiving Tysabri per indication and are willing and able to give an informed consent.

Exclusion Criteria:

  • Patients who are depressed as per the Beck depression questionnaire at screening or at any time during the study.
  • Patients with cognitive decline from causes other than MS.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658384

Locations
Canada, Quebec
Clinique Neuro-Outaouais
Gatineau, Quebec, Canada, J9J 0A5
Sponsors and Collaborators
Clinique Neuro-Outaouais
CogState Ltd.
Investigators
Principal Investigator: François H Jacques, MD Clinique Neuro-Outaouais and Centre de Santé et de Services Sociaux de Gatineau, Hôpital de Hull
  More Information

No publications provided

Responsible Party: Clinique Neuro-Outaouais
ClinicalTrials.gov Identifier: NCT01658384     History of Changes
Other Study ID Numbers: CNO-001
Study First Received: November 10, 2011
Last Updated: March 1, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013