Regulatory aspects of mild cognitive impairment: toward a harmonized perspective

The development of the concept of mild cognitive impairment (MCI) and its practical application have been intimately tied to attempts to produce therapeutic agents. Understanding the regulatory environment and determining the way in which it can be influenced are critical to the development of drugs and their eventual approval. In this article, we review some of the current challenges surrounding the concept of MCI relevant to drug development, summarize activities in various regions of the world, and conclude with some suggested next steps and an alternative framing for approving drugs for MCI and related conditions.