The Department of Health and Human Services, through the National Institutes of Health (NIH), announces the Alzheimer's Drug-Development Program (U01 Clinical Trial Optional) aimed at funding the preclinical and early-stage clinical development of novel drug candidates for Alzheimer's disease (AD). This program invites applications for activities encompassing medicinal chemistry, pharmacokinetics, formulation development, and initial clinical testing. The goal is to address the growing public health challenge of AD, which currently affects 6.7 million people in the U.S. The funding opportunity encourages innovative research by supporting two project stages—Early Stage for optimizing drug properties and Late Stage for advancing to IND-enabling studies and Phase I trials. Eligible applicants include various organizations, from higher education institutions to private organizations, with a budget cap of $1.5 million annually. The application process necessitates adherence to rigorous guidelines set by NIH to ensure valid and reproducible research outcomes. Key dates for application submissions begin in January 2025, with an expected expiration date for the opportunity in November 2027. This program ultimately seeks to catalyze effective therapeutic advancements for AD, promoting inclusive and diverse participation in clinical research.