In this webinar, the expert speaker 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.
Join Paul Maruff, PhD, Chief Innovation Officer, Cogstate, for the live webinar on Wednesday, November 20, 2024, at 11am EST (4pm GMT).
For more information, or to register for this event, visit Utilizing the Measurement of Cognition to Determine Drug Safety in Late Phase Clinical Trials.
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