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Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients - A Three Year Extension

Information source: Clinique Neuro-Outaouais
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Observational Cognitive assessments (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Clinique Neuro-Outaouais

Official(s) and/or principal investigator(s):
Francois Jacques, MD, Principal Investigator, Affiliation: Clinique Neuro-Outaouais

Overall contact:
Chantal Paquette, BScN, Phone: 819-777-2500, Ext: 3, Email: chantal.paquette@neuro-outaouais.ca

Summary

This study is designed to demonstrate that Tysabri is effective in maintaining cognition in MS patients after 5 or more years of continuous treatment. During a second period of 36 months, the extension study will assess the evolution of cognitive function in Tysabri treated MS patients using the Symbol Digit Modalities Test (SDMT) and a CogState battery of tests.

Clinical Details

Official title: Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients - A Three Year Extension

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

SDMT

Cogstate Battery

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 EDSS patients often complain of cognitive deterioration. The investigators' preliminary results from the first pilot study have shown that cognition in Tysabri treated MS patients for two or more years, as measured by the SDMT or Cogstate battery is maintained, including the ability to learn. The investigators' final data will be presented at the American Academy of Neurology (AAN) in 2015. 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 SDMT in MS patients as well as examine other cognitive domains. The Beck Depression Inventory-II [Beck 1996] is a validated and well recognized clinical research tool for depression in the field of multiple sclerosis. Together the above tests done prospectively can assess the evolution of cognitive function in Tysabri treated MS patients over the longer term.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients who have completed the original study and are willing to continue into the

extension. Exclusion Criteria:

- Patients with cognitive decline from causes other than MS (i. e., PML, stroke, sleep

apnea, neurodegenerative disorders, brain tumors).

Locations and Contacts

Chantal Paquette, BScN, Phone: 819-777-2500, Ext: 3, Email: chantal.paquette@neuro-outaouais.ca

Clinique Neuro-Outaouais, Gatineau, Quebec J9J 0A5, Canada; Recruiting
Chantal Paquette, BScN, Phone: 819-777-2500, Ext: 3, Email: chantal.paquette@neuro-outaouais.ca
Additional Information

Starting date: December 2014
Last updated: August 6, 2015

Page last updated: August 23, 2015

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