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

Multiple Sclerosis Clinical Trial

— CogMS-Ext  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383550
• Other study ID #: CNO-002
• Status: Completed
• Phase: N/A
• First received: March 4, 2015
• Last updated: November 1, 2017
• Start date: December 2014
• Est. completion date: August 30, 2017

Study information

• Verified date: November 2017
• Source: Clinique Neuro-Outaouais
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Observational Cognitive assessments
Observational

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	Cognitive assessment	3 years
Primary	Cogstate Battery	Cognitive assessment	3 years