Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

— CogMS  

Official title:

Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658384
• Other study ID #: CNO-001
• Status: Completed
• Start date: September 2011
• Est. completion date: March 2015

Study information

• Verified date: March 2019
• Source: Clinique Neuro-Outaouais
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Canada	Clinique Neuro-Outaouais	Gatineau	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Clinique Neuro-Outaouais	CogState Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SDMT CogState battery	Monthly cognitive assessments	2 years