Application of Cognitive Test Outcomes for Clinical Drug Development

Cognitive tests are objective measures of task performance providing insights into the potential of drug treatments to impact patient function/activities of daily living. Such tests can be useful tools in all phases of clinical drug development. In early development, prior to phase 3, cognitive tests can be used to assess pharmacodynamics and identify potential efficacy and/or safety and tolerability signals. These data can be informative for go/no-go decision-making as part of a package of evidence that the drug is well tolerated, or that supports a proposed mechanism of action, or that provides early signals of efficacy. In phase 3 pivotal trials, cognitive tests can be employed as clinical outcome assessments (COAs) to confirm evidence of clinical benefit. For each of these contexts of use, it is important to establish their practicality/utility, validity, reliability, and ability to detect change, thus ensuring they are fit-for-purpose.