When considering impacts on the central nervous system (CNS), the side-effects of drugs in development are often evaluated through the assessment of their effects on specific aspects of cognition, such as attention, memory and executive function.
While this approach is obvious for drugs designed to influence CNS function — such as those used in psychiatry or neurology — it can be applied for drugs where CNS effects may be indirect. Decisions about CNS effects of drugs made in early-phase studies define adverse effects as the presence of a drug- or dose-related decline in cognition. This manifests as a decline from a pre-drug cognitive test performance hours or days after dosing. Compared to early-phase trials, the use of cognition to guide decisions about drug safety in late-phase trials conducted within a regulatory context is less understood and worth exploring.
In this webinar, the expert speakers will consider three use cases where American and European Regulatory authorities required sponsors to demonstrate the CNS safety of their drugs:
- The first use-case considers how cognition was used to reassure regulators and clinicians about the CNS safety of esketamine (SPARVATO) for use in adults with treatment-resistant depression
- The second use-case considers how cognition was used to reassure regulators that the extension of the use of evolocumab (REPATHA) for the treatment of familial hypercholesteremia to children did not result in any disruption to neurodevelopment
- The third use-case considers how cognition was used as the primary safety endpoint in a study designed to demonstrate that treatment of chronic heart failure with sacubitril and valsartan (ENTRESTO) did not lead patients to develop Alzheimer’s disease as neprilysin inhibition also promoted amyloid accumulation
Each of these use cases demonstrates how detection of change — or stability — in cognition over months or years of drug treatment is a valid, efficient and effective method for communicating information to patients, clinicians and regulators about the CNS safety of new drugs.
Register for this webinar today to explore how cognitive assessment plays a critical role in demonstrating CNS safety in drug development.
Speaker

Paul Maruff, PhD, Chief Innovation Officer, Cogstate
Professor Paul Maruff is one of the founders of Cogstate and served as Chief Science Officer before taking on the role of Chief Innovation Officer. He is a neuropsychologist with expertise in the identification and measurement of subtle behavioral and cognitive dysfunction.
Paul’s research integrates conventional and computerized neuropsychological testing with cognitive neuroscientific methods to guide decision-making in drug development and clinical medicine. Paul remains an active researcher. He is the appointed Professor at the Florey Institute for Neuroscience and Mental Health and the current Clinical Co-Chair of the Australian Imaging Biomarkers and Lifestyle (AIBL) study.
Paul has published over 450 research articles in international peer-reviewed scientific journals and has co-authored 15 book chapters.
Who Should Attend?
This webinar will appeal to Executives, Directors, Scientists and Managers from pharma, biotech and CROs responsible for safety considerations in clinical trials as well as those in the following fields:
- Research and development
- Clinical operations
- Clinical science
- Outcomes research
- Outsourcing and procurement
- Project management
- Clinical trial planning and optimization
- Medical affairs
What You Will Learn
Attendees will learn about:
- Considerations for the use of cognition to guide decision about drug safety in late-phase trials
- Examples demonstrating how detection of change in cognition is a valid method for communicating CNS safety of new drugs
- Importance of using appropriate tools to measure cognitive safety in early and late phase development
Xtalks Partner
Cogstate
Cogstate Ltd (ASX:CGS) is a leading science and technology solutions provider dedicated to optimizing the measurement of cognition in clinical trials, academic research and healthcare. Cogstate provides enabling technologies and professional services for higher quality neuropsychological assessments and is a pioneer in commercializing rapid, reliable and highly sensitive computerized cognitive tests. Cogstate customers include the world’s leading biopharmaceutical companies; elite sporting organizations and military; physicians and patients; renowned academic institutions and public-private partnerships. For more information, please visit www.cogstate.com.
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