Using Cognition to Guide Decisions on the Safety and Tolerability of Drugs in Clinical Development, A New Webinar Hosted by Xtalks

09:00 EDT 8 Jul 2019 | PR Web

Assessing cognition is an important facet of drug development, particularly if there are adverse CNS effects that could impact a person’s quality of life or neurodevelopment. In applying cognitive tests to clinical studies, it is important to ensure the appropriate outcome measures are selected and the assessments are sensitive and valid. In this free webinar, learn about what to consider when assessing cognition to guide decision-making about the safety and tolerability of an experimental drug.

TORONTO (PRWEB) July 08, 2019

In clinical trials, changes in performance on cognitive tests can provide a sensitive index of the impact of a drug on the central nervous system (CNS). In such trials, the detection of decline in specific aspects of cognition, or in cognition in general, is important for making decisions about target engagement, maximum tolerated dose and pharmacodynamic profile. Observations of drug-related cognitive decline can also indicate areas for concern with clinical use, such as the potential effects on activities of daily living or the ability to operate a motor vehicle. In children, drug-related cognitive decline can indicate the potential for influence on neurodevelopment.

Applying cognitive tests in different experimental designs can provide unique information to guide decision-making in drug dosage studies. As well, they can help elucidate the potential for additive or synergistic effects in drug-drug and drug-alcohol interaction trials. In later development and post-approval, the assessment of cognition can inform the presence of deleterious effects in the context of long-term follow-up and in larger, more representative samples.

In conducting such studies, it is important to derive distinct outcome measures for separate cognitive domains and ensure performance on these tests should remain stable with multiple assessments over short and long retest periods. Most importantly, the sensitivity of cognitive tests to pharmacological interventions is critical. Sponsors need to consider all of these elements when assessing cognition as an output of safety and tolerability of an experimental drug.

Join Cogstate experts Dr. Paul Maruff, Chief Science Officer and Dr. Chris Edgar, Senior Vice President of Clinical Science in a live webinar on Wednesday, July 24, 2019 at 11am EDT (3pm GMT/UK) to learn about:

  • Clear specification of relevant objectives related to cognition
  • An understanding of how the data collected will be applied
  • How elements of trial design will influence these determinations
  • Careful selection of an appropriate battery of tests

For more information or to register for this event, visit Using Cognition to Guide Decisions on the Safety and Tolerability of Drugs in Clinical Development.


Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device 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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