Innovation in clinical trials in brain health: Computerised assessment and remote clinical trials

Abstract

New clinical trials in brain health require innovative methodologies for targeted recruitment and longitudinal assessment. Professor Anne Corbett outlines how her team’s PROTECT portfolio can overcome challenges in trials of cognitive health interventions, offering solutions for intelligent trial design. After decades of relative inactivity, there is currently a growing interest and investment in novel interventions for cognitive and mental health conditions. This is particularly true for trials in cognitive impairment and early dementia. This health area has previously been considered too high-risk and challenging, with failed trials and difficulty in recruiting target groups leading to widespread demotivation for trials in this area. However, a new generation of disease-modifying treatments for Alzheimer’s Disease is in the pipeline, with immunotherapy lecanemab receiving FDA approval in 2023 and donanemab currently under review. (1) These successes have reinvigorated development in Alzheimer’s and dementia drug discovery programmes, and larger numbers of trials are anticipated in the coming years.