Schizophrenia

Improving cognitive assessment and reducing burden for clinical trials in people with schizophrenia.

Cognitive dysfunction is a central feature of schizophrenia and leads to significant impacts on patient function and quality of life. As such, addressing cognitive impairment is a major unmet medical need in the development of therapies for people with schizophrenia.

Cogstate supports sponsors in these efforts by providing valid, sensitive, and reliable digital/computerized assessment that comprehensively evaluates cognitive domains of relevance to people with schizophrenia, while offering a significant reduction in patient and trial burden compared to other assessment tools.

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Optimize Clinical Outcome Assessment in Schizophrenia Clinical Trials

Cogstate’s team of scientific and operational experts deliver innovative technology, proven operational delivery models, and leading scientific support for digital cognitive assessments in schizophrenia trials.

Guidance to Select Validated, Fit-For-Purpose Assessment Approaches Relevant to Cognitive Impairment in Schizophrenia

Choosing appropriate endpoints and designing strategic protocols are important decisions in the planning phase that impact future study results. Cogstate’s team of scientists have the expertise to advise your team on vital study considerations, help you answer key drug development questions, and design trials with reduced risk and uncertainty.

Leverage Sensitive and Reliable Computerized Cognitive Batteries

Cogstate’s computerized batteries of highly sensitive tests provide rapid and reliable measurement of distinct cognitive domains affected by schizophrenia such as processing speed and attention. Tests can be grouped into customizable batteries for 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. Tests have high patient acceptability and reduce burden on patient and sites.

Full-Service Support for Digital Data Collection

In addition to accessing Cogstate’s valid, sensitive, and reliable computerized cognitive assessments, research teams receive full-service support for all aspects of study delivery from kick-off to final database lock. This includes online training and certification of test administrators, dedicated project managers to drive Cogstate study activities, secure and compliant data collection and storage, ongoing review and query handling by our data management team, statistical analysis and support for regulatory submissions and interactions.

Partnerships and Integrations with Leading eCOA Platforms

Cogstate provides science-driven support for the data collection and data quality monitoring of all types of clinical assessments by partnering our scientific and operational expertise with industry-leading eCOA providers to deliver enhanced electronic solutions for the full range of PROs, ClinROs, and PerfOs required in schizophrenia clinical trials.

Cogstate Schizophrenia Battery (CSB)

Cogstate’s computerized battery of rapid, reliable, simple, and sensitive tests measure the cognitive domains affected by schizophrenia and identified by the National Institute of Mental Health (NIMH) Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) project. These are: Speed of processing (Detection), Verbal learning (International shopping list), Working memory (One-back), Reasoning and problem solving (Groton maze), Visual learning (One-card learning), Social cognition (Social emotional cognition), Attention vigilance (Identification).

The key outcome measures from each test are combined to form a single total ‘global cognition’ score using an average of the standardized z-scores. The CSB global cognition score is intended to be used as a co-primary outcome measure of efficacy in clinical trials of new drug treatments for Cognitive Impairment Associated with Schizophrenia (CIAS).

Each Cogstate cognitive test has comparative/normative data available for both clinical samples and healthy controls. Tests maintain excellent reliability across repeated testing and cross-sectional research designs. The battery that Cogstate recommends for schizophrenia trials aligns to the domains identified by the MATRICS project.

Final battery recommendations may vary based on study needs.

Cogstate Tests in a Schizophrenia Battery Can Include:Detection Test
Identification Test
One Card Learning Test
One Back Test
Two Back Test
International Shopping List Test
Groton Maze Learning Test
Social-Emotional Cognition Test
Continuous Paired Associate Learning Test
Length:Approx. 40 minutes
(depending on tests selected)
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I-IV
Culture and Language Neutral:Yes

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Cogstate Schizophrenia Battery Meets MATRICS Guidelines

The April 2004 MATRICS/FDA/NIMH workshop was held to consider guidelines for the design of clinical trials of cognitive-enhancing drugs for people with schizophrenia. From this came the performance-based outcome (PerfO) assessment known as the MATRICS Consensus Cognitive Battery (MCCB).

The Cogstate Schizophrenia Battery (CSB) meets the same consensus requirements as the MCCB, and with significantly reduced patient and trial burden. The CSB is a fully computerized battery with substantially improved adaptability for different cultures and languages, as it uses largely language-free stimuli, proven sensitivity to intervention, and has an average administration time one-third of that for the MCCB (40 minutes vs 120 minutes).*

*Pietrzak et al. A comparison of the Cogstate Schizophrenia Battery and the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Battery in assessing cognitive impairment in chronic schizophrenia. J Clin Exp Neuropsychol. 2009

Decentralized Clinical Trials

We help bring the trial to the patient

As more clinical trials realize the potential of decentralization, Cogstate digital endpoints are enabling at-home, self-administered assessment and our remote rating services are enabling at-home clinician-administered assessment to drive both enhanced data quality as well as patient enrollment, engagement and retention.

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Solutions for Every Stage of Your Study Development

Cogstate’s clinical trial services, coupled with innovative operational approaches, advanced analytics, and scientific consulting, help research teams draw conclusions from study data faster and with more accuracy. Learn how we can support your study:

Scientific Consulting

Computerized Cognitive Assessment

Rater Training

Central Monitoring

Scale Management

Remote / At-home Testing

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

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