Document Type
Article
Publication Date
4-1-2022
Abstract
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.
Keywords
Alzheimer's disease, drug regulation, ethics, harmonization, mild cognitive impairment
Language
English
Publication Title
Dialogues in Clinical Neuroscience
Rights
© 2004 LLS. This is an open access article under the CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/3.0/), which permits non-commercial distribution and reproduction in any medium, provided the original work is properly cited.
Recommended Citation
Whitehouse, P. J. (2004). Regulatory aspects of mild cognitive impairment: toward a harmonized perspective. Dialogues in Clinical Neuroscience, 6(4), 409–414. https://doi.org/10.31887/DCNS.2004.6.4/pwhitehouse
Manuscript Version
Final Publisher Version