Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration

Cognitive assessment has long been a key efficacy measure in clinical trials of indications such as Alzheimer’s disease (AD). In the past few years, the use of cognitive efficacy measures has been extended to indications including Schizophrenia, Depression and Lewy body Dementias. The use of cognitive assessment has also been extended to the assessment of safety, especially in cardiology. Cognitive assessment has been employed with variable success and a hallmark of failed examples has been the use of tests with poor reliability, validity and sensitivity. 

The emergence of blood-based biomarkers (BBBM) for the detection of the early changes of AD has been a pivotal moment in dementia research. Early studies have shown that these BBBM have a high degree of sensitivity and specificity for identifying early changes of AD before the clinical signs such as memory loss are apparent. Existing studies have been undertaken using large research cohorts, so the impact of these BBBMs may have in the real-world is still unknown. Despite this, BBBMs pave the way for early diagnosis and better recruitment into clinical trials. 

In this webinar, as well as exploring the emerging blood-based biomarker breakthrough, we will review examples of both successful and failed case studies. We will conclude with recommendations for cognitive test selection and its successful integration into clinical drug trials.

This is an excellent opportunity to hear from two renowned cognition experts and gain a better understanding on the selection and successful integration of cognitive testing and blood-based biomarkers into therapeutic development programmes.