Development of Nanomedicines for the Treatment of Alzheimer’s Disease: Raison d’être, Strategies, Challenges and Regulatory Aspects

Alzheimer’s disease (AD) is a chronic neurodegenerative disorder characterized by progressive loss of memory. Presently, AD is challenging to treat with current drug therapy as their delivery to the brain is restricted by the presence of the blood-brain barrier. Nanomedicines, due to their size, high surface volume ratio, and ease of tailoring drug release characteristics, showed their potential to treat AD. The nanotechnology-based formulations for brain targeting are expected to enter the market in the near future. So, regulatory frameworks are required to ensure the quality, safety, and effectiveness of the nanomedicines to treat AD. In this review, we discuss different strategies, in-vitro blood-brain permeation models, in-vivo permeation assessment, and regulatory aspects for the development of nanomedicine to treat AD.