This webinar discussed the assessment of cognitive function throughout the development of drugs for both CNS and non-CNS indications. It included 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

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

Key discussion points included:

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

Cognitive impairment is increasingly recognised 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 aetiology. 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 ageing 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.