MedDataX Logo

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

NCT ID: NCT02383550

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Multiple Sclerosis Cognition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observational Cognitive assessments

Observational

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CogState Ltd.

INDUSTRY

Sponsor Role collaborator

Clinique Neuro-Outaouais

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Francois Jacques, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Neuro-Outaouais

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinique Neuro-Outaouais

Gatineau, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CNO-002

Identifier Type: -

Identifier Source: org_study_id