Alzheimer’s disease (AD) is a devastating neurodegenerative disease that progresses to impact every dimension of a patient’s life. With no cure and limited options to manage symptoms, research is underway to develop drugs that impact the most burdensome aspects of AD: memory problems and the ability to function independently.
Many clinical trials in drug development assess these aspects of health by measuring cognitive and physical function. However, current approaches are reliant on self-report, burdensome to patients, and not representative of real-world function. To ensure that new therapies address the needs of patients with AD, drug development tools (DDTs) that comprehensively capture aspects of daily living that matter to patients are paramount.
Digital clinical measures have the potential to address the limitations of currently available evidence-generation tools by directly measuring how patients feel and function in real-world environments with wearable and connected technologies. Such technologies can be deployed remotely, passively, and continuously to enable a new class of patient-centric endpoints aligned with the FDA’s Patient-Focused Drug Development initiatives. Real-world digital clinical measures that capture the dynamic day-to-day variation of disease manifestation are a departure from the status quo and have the potential to substantially advance drug development in AD and improve patient care.
This poster focuses on the opportunities for digital clinical measures in AD drug development. Specifically, we summarize what is known regarding the meaningful aspects of health in AD, describe the limitations of current DDTs, and highlight how novel digital clinical measures can address existing gaps and capture everyday patient functioning.