SOURCE: Xtalks

Xtalks Webinars

October 20, 2015 07:30 ET

Leveraging Cognitive Measures in Clinical Trials

TORONTO, ON--(Marketwired - October 20, 2015) - On Friday, October 30, 2015, Xtalks will host a complimentary webinar discussing the assessment of cognitive function throughout the development of drugs for both CNS and non-CNS indications. The featured speaker, Dr. Kenton Zavitz, Director of Clinical Affairs at Cambridge Cognition will examine 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.

To register or learn more about this one-hour complimentary webinar visit: Leveraging Cognitive Measures in Clinical Trials

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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