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 can provide your trial with valid, sensitive, and reliable digital assessments that evaluate 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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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.

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 digital 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

Leverage Sensitive and Reliable Digital Tests

Cogstate digital assessments provide rapid and reliable measurement of distinct domains affected by schizophrenia 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.

Sample Schizophrenia Battery

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

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

Case Study of Schizophrenia Solutions in Action

Phase 2 study of Encenicline for Cognitive Impairment Associated with Schizophrenia (CIAS)

A phase 2 study of Encenicline for Cognitive Impairment Associated with Schizophrenia (CIAS) was designed to assess and characterize treatment effect on cognition. A Cogstate digital battery was selected as the primary efficacy endpoint. Notable improvements in cognition were demonstrated for treatment vs placebo. (Keefe et al Neuropsychopharmacology (2015) 40, 3053-3060.)

Schizophrenia Featured Resources

Fact Sheet

Improving Cognitive Assessment and Reducing Burden for Clinical Trials in People with Schizophrenia

Webinar

Clinical Trials of Schizophrenia: Optimizing Patient Reported Outcomes and Performance Outcome Assessments

Poster

The Cogstate Schizophrenia Battery (CSB) as a Co-Primary Outcome for Trials in Cognitive Impairment Associated with Schizophrenia

Video

Selection of Peer Reviewed Publications in Schizophrenia

Efficacy and Safety of Lurasidone in Adolescents with Schizophrenia: A 6-Week, Randomized Placebo-Controlled Study

Journal: Journal of Child and Adolescent Psychopharmacology

Year Published: 2017

Phase 2 Trial of an Alpha-7 Nicotinic Receptor Agonist (TC-5619) in Negative and Cognitive Symptoms of Schizophrenia

Journal: Schizophrenia Bulletin

Year Published: 2015

Randomized, Double-Blind, Placebo-Controlled Study of Encenicline, an α7 Nicotinic Acetylcholine Receptor Agonist, as a Treatment for Cognitive Impairment in Schizophrenia

Journal: Neuropsychopharmacology

Year Published: 2015

Effect of lurasidone on neurocognitive performance in patients with schizophrenia: a short-term placebo- and active-controlled study followed by a 6-month double-blind extension

Journal: European Neuropsychopharmacology

Year Published: 2013

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

Journal: Journal of Clinical and Experimental Neuropsychology

Year Published: 2009

All Publications

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.

Improve Strategic Study Design

Cogstate Schizophrenia Battery Meets MATRICS Guidelines

Leverage Sensitive and Reliable Digital Tests

Sample Schizophrenia Battery

Case Study of Schizophrenia Solutions in Action

Schizophrenia Featured Resources

Improving Cognitive Assessment and Reducing Burden for Clinical Trials in People with Schizophrenia

Clinical Trials of Schizophrenia: Optimizing Patient Reported Outcomes and Performance Outcome Assessments

The Cogstate Schizophrenia Battery (CSB) as a Co-Primary Outcome for Trials in Cognitive Impairment Associated with Schizophrenia

Clinical Trials for Cognitive Impairment Associated with Schizophrenia - Cogstate Battery

Study Shows Similar Symptom Profile in Ketamine Dependence with Persistent Psychosis and Schizophrenia

Increasing the Precision of Cognitive Endpoints in Schizophrenia Clinical Trials

Selection of Peer Reviewed Publications in Schizophrenia

Efficacy and Safety of Lurasidone in Adolescents with Schizophrenia: A 6-Week, Randomized Placebo-Controlled Study

Phase 2 Trial of an Alpha-7 Nicotinic Receptor Agonist (TC-5619) in Negative and Cognitive Symptoms of Schizophrenia

Randomized, Double-Blind, Placebo-Controlled Study of Encenicline, an α7 Nicotinic Acetylcholine Receptor Agonist, as a Treatment for Cognitive Impairment in Schizophrenia

Effect of lurasidone on neurocognitive performance in patients with schizophrenia: a short-term placebo- and active-controlled study followed by a 6-month double-blind extension

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

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