2024 - Utilizing the Measurement of Cognition to Determine Drug Safety in Late Phase Clinical Trials

When considering impacts on the central nervous system (CNS), the side-effects of drugs in development are often evaluated through the assessment of their effects on specific aspects of cognition, such as attention, memory and executive function.
While this approach is obvious for drugs designed to influence CNS function — such as those used in psychiatry or neurology — it can be applied for drugs where CNS effects may be indirect. Decisions about CNS effects of drugs made in early-phase studies define adverse effects as the presence of a drug- or dose-related decline in cognition. This manifests as a decline from a pre-drug cognitive test performance hours or days after dosing. Compared to early-phase trials, the use of cognition to guide decisions about drug safety in late-phase trials conducted within a regulatory context is less understood and worth exploring.
In this webinar, the expert speakers 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.
Keywords: Clinical Trials, Drug Development, Cognition, Clinical Research, CRO, Pharmacovigilance, Central Nervous System, Therapeutic Areas, CNS, CNS Trials, Safety, CNS Drug Development, Late Phase Trials