There has been a renewed interest in clinical trials of drugs to treat early Alzheimer’s disease, owing partially to recent advances in the understanding of pathophysiological processes that occur well before the emergence of clinical symptoms. Henry J. Riordan and Natalia E. Drosopoulou at Worldwide Clinical Trials reveal to the readers how the Food and Drug Administration (FDA) has responded to this shift and recently issued draft guidance to assist sponsor companies in the development of drugs for the treatment of the stages of sporadic Alzheimer’s disease.