Advances in Alzheimer’s Disease Therapeutics: A Global Perspective

Abstract

Alzheimer’s disease (AD) therapeutics are advancing at a rapid rate. After a 17-year hiatus with no new drugs approved worldwide, there have been approvals of disease modifying agents in 2021 and 2023 by the US Food and Drug Administration (FDA) and an additional agent is under review by the FDA. Lecanemab is approved in the US, China, and South Korea and is under review by many other countries. Widespread availability of anti-amyloid monoclonal antibodies is likely over the next few years. Appropriate use of these agents requires substantial healthcare infrastructure to ensure patient benefit and safety. Administration of monoclonal antibodies in countries where healthcare systems are less robust is challenging. Advances in the global treatment of Alzheimer’s disease require an improved understanding of the neurobiology of Alzheimer’s disease; the development of drugs that are accessible, efficacious, and safe; the creation of international clinical trial infrastructure to recruit more representative populations; education strategies to ensure the correct use of new drugs by clinicians; and implementation approaches that are culturally appropriate to inform patients about the availability of treatment and their proper use. Conduct of clinical trials and development of clinical trial site networks has many advantages including education about AD and clinical trials, learning strategies to rigorously generate robust clinical data, patient education opportunities, revenue generation, recruitment of diverse global populations, and interactions with biotechnology companies with improved collaboration and understanding of industry-based careers. Drug development for Alzheimer’s disease addresses a global problem and requires a globalsolution.