Outcomes for Regulatory Approval in Geriatrics: Embracing Loss of Mobility and Mobility Disability as Clinically Meaningful Therapeutic Indications

Excerpt

Advancing chronological age is accompanied by well described declines in motor function across virtually all species (1, 2). In humans, declines in motor function are mechanistically linked to the loss of mobility, evident in the inability to rise from a chair, walk a defined distance, and climb stairs. The loss of mobility is significant and prevalent amongst older adults and central to the loss of independence in multiple activities of daily living (ADL) and instrumental activities of daily living (IADL), including ambulating, toileting, transferring, shopping, and housekeeping (3‐6). Moreover, mobility disability, operationalized as the inability to walk 400 meters or ¼ of a mile, affects approximately 20% of community dwelling adults over 65 years and is associated with multi-morbidity, increased health care costs and utilization, and mortality (7‐10). …