Disruption to normal sleep/wake cycles, whether by disease, disorders, injuries of the central nervous system (CNS) or by the drugs used to treat these, can result in substantial disability and increased morbidity and mortality. For clinical development teams, inconsistent terminology and limited alignment between subjective symptoms and objective cognitive data often make it difficult to interpret safety and efficacy findings in sleep and wakefulness trials. This webinar focuses on how cognition can be systematically measured and interpreted to improve clarity in these programs.
Cognitive symptoms are a consistent and important manifestation of disorders characterized by difficulty sleeping or staying awake. The webinar will examine how cognition is assessed using both subjective reports and standardized neuropsychological tests, and how these approaches can be integrated to generate reliable, decision-ready data. It will also address the common but problematic use of overlapping terms such as fatigue, drowsiness, sleepiness and sedation, and explain how clearer definitions improve the interpretation of trial outcomes.
In this webinar, Prof. Paul Maruff will utilize data to provide a framework for understanding the nature and magnitude of cognitive impairment that can occur in sleep medicine drug development. Drawing on data from patients with disrupted sleep–wake cycles, healthy adults administered sedative medicines and healthy adults undergoing sleep restriction, the session will clarify how cognitive changes can be quantified and distinguished from broader sleep-related symptoms. It will also examine how this framework can support endpoint selection, safety monitoring and efficacy evaluation across development phases.
WHAT YOU WILL LEARN
- The importance of measuring cognition in sleep medicine trials
- Considerations to understand the nature and magnitude of cognitive symptoms that can occur in adults with disorders of sleep or wakefulness
- How cognitive tests can be used to better inform decision-making on the safety and efficacy of novel and licensed drugs
Speakers
Paul Maruff, PhD
Chief Innovation Officer
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 behavioural and cognitive dysfunction. Paul’s research integrates conventional and computerized neuropsychological testing with cognitive neuroscientific methods to guide decision making in drug development and in clinical medicine.
He has worked extensively on method to identify subtle neurocognitive impairment, and to assess the efficacy of pharmacological treatment, in Alzheimer’s disease, mild cognitive impairment and the HIV dementia complex. He has extended this approach to identify cognitive dysfunction, and monitor treatment efficacy in psychiatric diseases such as schizophrenia, obsessive-compulsive disorder and depression in adults, attention deficit disorder, developmental dyspraxia and substance abuse in children.
Paul remains an active researcher. He is appointed Professor at the Florey Institute for Neuroscience and Mental Health. He is currently clinical co-chair of the Australian Imaging Biomakers and Lifestyle (AIBL) study. Paul has published over 450 research articles in international peer-reviewed scientific journals, and has co-authored 15 book chapters.
