Design and Conduct of Trials in Alzheimer’s Disease Following the Impending Approvals of Disease-Modifying

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After nearly two decades of negative studies, two amyloid-lowering drugs have recently received accelerated approval for Alzheimer’s Disease (AD) by the FDA, and one of these drugs is likely to receive full approval by July 2023. Submissions have also been made to regulatory authorities in Asia and Europe, and it is possible there will be global approval by the end of 2023, or early 2024. Notably, these drugs go beyond symptom management and appear to directly affect the disease pathology. Given the long dearth of new approvals and the shift from symptomatic treatment to disease modification, the clinical trial landscape will need to undergo substantial change when one or more of these drugs receives full approval. To help sponsors and other stakeholders successfully navigate this new potential environment, several concepts and considerations are reviewed in this article.


Vice President, Project Management, Neuroscience

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