Utilizing MCID for evaluating clinical relevance of AD therapeutic interventions.

ABSTRACT: With the recent approval of disease-modifying treatments for mild cognitive impairment (MCI) and mild Alzheimer's disease (AD) by the United States Food and Drug Administration (FDA), Medicines and Healthcare products Regulatory Agency (MHRA), European Medicine Agency's Committee for Medicinal Products for Human Use (EMA/CHMP) entities, there is a growing sense of urgency and renewed efforts to reassess and understand what constitutes a clinically meaningful benefit in the context of new treatments for AD care, despite the discordance between regulatory entities in regulatory decision-making. While the concept of minimal clinically important difference (MCID) was introduced many years ago, there remains an ongoing debate about how best to evaluate and define clinical benefit in the context

SUBMITTER: Hamilton JL 

PROVIDER: S-EPMC12322313 | biostudies-literature | 2025 Jul-Sep

REPOSITORIES: biostudies-literature