Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients

NCT ID: NCT01658384

Last Updated: 2019-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-03-31

Brief Summary

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.

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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

cognitive evolution, observational,MS

multiple sclerosis tysabri treated patients

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CogState Ltd.

INDUSTRY

Sponsor Role: collaborator

Clinique Neuro-Outaouais

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François H Jacques, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Neuro-Outaouais

Locations

Clinique Neuro-Outaouais

Gatineau, Quebec, Canada

Countries

Canada

Other Identifiers

CNO-001

Identifier Type: -

Identifier Source: org_study_id