Leveraging Cognitive Measures in Clinical Trials

This webinar will discuss the assessment of cognitive function throughout the development of drugs for both CNS and non-CNS indications. It will include a discussion of methodological considerations for the design of clinical trials and approaches to the analysis and interpretation of cognitive outcome measures for the evaluation of both drug efficacy and safety.

Key Discussion Points:

• What do we mean by cognition?
• Why monitor cognition in drug development?
• How do we measure cognition?
• The current regulatory landscape
• Desirable characteristics of cognitive assessment tools
• The CANTAB Connect touchscreen cloud-based platform
• Future developments in cognitive assessment

Cognition refers to a range of mental processes relating to the acquisition, storage, manipulation, and retrieval of information. Cognitive functioning is critical for day-to-day life, governing our thoughts and actions. It allows us to understand information about the world around us and interact safely with our environment. Cognition can be separated into multiple distinct functions, dependent on particular brain circuits and neuromodulators. Computerized cognitive tests have been developed and validated for the objective measurement of distinct cognitive abilities, such as working memory, inhibition, cognitive flexibility, and executive planning that map to particular brain regions. The accurate measurement of specific aspects of cognitive function is essential for the evaluation of the efficacy of new medications being developed to treat some of our most feared and devastating medical conditions such as Alzheimer’s disease, depression, schizophrenia and ADHD. The ability to test, measure and monitor cognitive performance over time opens up the opportunity for patients to be identified earlier and more accurately, the evaluation of new treatments faster and more efficiently, and to improve decision making throughout the development process.

Cognitive impairment is increasingly recognized as an important potential side effect of medication. For example, several recent epidemiological studies have highlighted that use of commonly-used drugs with anticholinergic activity is associated with poor cognitive performance, mild cognitive impairment or even a diagnosis of dementia. However, despite concerns voiced by physicians, regulators and consumers, many drug development programs do not incorporate objective and sensitive cognitive assessments as part of the clinical characterization and decision-making process. In addition, many common medical conditions, both CNS and non-CNS disorders, including for example cardiovascular disease and diabetes, have associated cognitive deficits as part their underlying disease etiology. These cognitive deficits themselves represent important therapeutic targets, as drugs being developed to treat the disease process may also demonstrate reversal of the cognitive impairment. It is also important to consider that any drug that crosses the blood-brain barrier (BBB) can produce cognitive effects that can interfere with everyday functioning. This includes drugs for both CNS and non-CNS indications (e.g. cardiovascular drugs; including statins, diabetes, oncology, HIV, pain, antihistamines, anticonvulsants and antimuscarinics). Common disease states, environmental toxins, certain medications and the aging process itself can compromise the integrity of the BBB. It is therefore of critical importance for drug makers to monitor cognitive function throughout the drug development process and to consider the impact of their target patient populations, comorbid medical conditions and concomitant drug treatments in assessing the safety and risk profile of their drugs. This presentation will also discuss methodological considerations for cognitive assessment in clinical trials and approaches to the analysis and interpretation of cognitive outcome measures.

Viewers of the webinar will leave with a firm understanding of how current state-of-the-art cognitive assessment technology can be incorporated into the clinical development process to facilitate early decision making, evaluate cognitive efficacy, profile safety and tolerability and satisfy regulatory requirements in an increasingly challenging and competitive pharmaceutical landscape.

Speaker

Kenton Zavitz, PhD, Director of Clinical Affairs, Cambridge Cognition

Kenton has over 16 years of biotechnology and Pharmaceutical experience with involvement in all aspects of the industry from drug discovery and clinical development through to pre-commercialization. Prior to joining Cambridge Cognition, Kenton served as Chief Scientific Officer for biotech Zocere Inc. where he worked on developing a neuroprotectant drug designed to combat brain injury resulting from stroke. He currently serves on the Scientific Advisory Board for Exonate Limited, a start-up founded in 2013 at the University of Nottingham. From 1998 to 2012, Kenton worked at Myriad Pharmaceuticals, Inc. in Salt Lake City and served in a variety of roles including Senior Director of Clinical Affairs, Chief Scientist of the tarenflurbil clinical development program (an investigational drug for the treatment of Alzheimer’s disease, developed through Phase 3), Director of Neurodegeneration Therapeutics Discovery and Director of Strategic In-licensing and Scientific Evaluation. Kenton received his PhD in Biochemistry and Molecular Biology from The Sloan-Kettering Division of the Weill Cornell Graduate School of Medical Sciences in New York City. He was a Postdoctoral Fellow at the UCLA School of Medicine and was awarded fellowships from the Leukemia Society of America and the Jane Coffin Childs Memorial Fund for Medical Research.

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