Multiple Sclerosis

Cognitive impairment affects 50-70% of Multiple Sclerosis (MS) patients and is noted as one of the most disabling aspects of the disease. As such, addressing cognitive impairment and decline is vital in the development of MS treatments.

Cogstate supports your team in these efforts by providing highly sensitive and reliable digital cognitive testing, as well as endpoint data quality support for conventional assessments, such as the BICAMS, MSFC, and PASAT. We have the expertise to help you answer key drug development questions.

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Improve Strategic Study Design 

The Cogstate team of cognitive scientists and statisticians have the expertise to advise your team on vital study considerations, help you answer key drug development questions, and reduce risk and uncertainty in your trial.

With access to thousands of cognitive data profiles—and from decades supporting drug development work—Cogstate can advise your team on endpoint selection, powering decisions, and interpretation of study results supportive of product efficacy, safety, and differentiating claims.

Implement Robust Endpoint Data Quality Programs  

From helping you establish rater qualification criteria, to tailored certification pathways that credit the experience of expert raters, to central monitoring programs that target clinician reviews where they’re needed most, Cogstate supports all aspects of rater training and endpoint data quality programs. Studies also benefit from our global network of 180 highly trained expert clinicians who provide assessment support in 40+ languages.

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Leverage Sensitive and Reliable Digital Tests 

Cogstate digital assessments provide rapid and reliable measurement of distinct domains affected by MS and enable you to capture a complete and nuanced picture of a subject’s cognitive state.

Cogstate tests are culture- and education-neutral and designed for repeated administration with minimal practice or learning effects, making them ideal for use in global clinical trials. Normative data is available for both clinical samples and healthy controls. Study teams can choose the tests that best suit their research questions. Each test has been used in drug trials.

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Sample Multiple Sclerosis Battery 

The tests included are a sample battery based on domains commonly impacted by MS. Final battery recommendations vary based on study needs.

Cogstate Tests:Detection Test
Identification Test
One Card Learning Test
One Back Test
Two Back Test
International Shopping List Test
Groton Maze Learning Test
Length:Between 5-40 minutes
(depending on the number of tests included in the battery)
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I-IV
Culture and Language Neutral:Yes

Case Study of MS Solutions in Action

 

Evaluating Cognitive Deterioration in MS Patients via Cogstate Digital Assessments

Cogstate supported safety assessment in a 24-month observational study of natalizumab in multiple sclerosis patients. 63 patients were treated and assessed prior to monthly infusions using a Cogstate battery and the Symbol Digit Modalities Test (SDMT). Using data from the Cogstate assessments, no patient showed evidence of sustained cognitive deterioration over the 24-month period. Data were relevant to ensuring long-term safety and sustained efficacy of treatment. (Gaudet D., et al., DOI: https://doi.org/10.1016/j.atherosclerosis.2021.06.789)

Wearable Sensors for a Complete Picture of Patient Functioning 

Cogstate’s strategic partners at ERT deliver a complete wearable precision motion sensor solution that provides meaningful and functional insights for sponsors and patients through the capture of digital biomarkers. When integrated with Cogstate’s clinical outcome assessments of cognition or ERT’s data capture solutions for cardiac safety, eCOA, digital patient, imaging, or respiratory, digital biomarkers provide a holistic story of how a disease and therapy impacts patient function.

How can we help you optimize the measurement of brain health?

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