Development of monoclonal antibody therapeutics for alzheimer's disease

Background: In a previous review article in the Taiwanese Journal of Psychiatry (Takeda and Tagami: Taiwanese J. Psychiatry 2020; 34: 152-61), we gave the development status of drugs for Alzheimer's disease, presented a relatively pessimistic view, and highlighted the difficulties in their development. Methods: Since I have witnessed some encouraging development of monoclonal antibody therapeutics against Alzheimer's disease, I have decided to contribute this article. I reviewed new data from published journals and from internal reports of pharmaceutical companies. I have also offered some explanations and comments. Results: In 2021, I saw promising clinical trial results reporting the use of aducanumab, a monoclonal antibody treatment against amyloid β protein, and the U.S. Food and Drug Administration (FDA) announced a decision for expedited approval of aducanumab. But the results of aducanumab's phase III clinical trials were considered by some to be insufficient for the approval, and the FDA's decision was controversial. The European and Japanese regulatory authorities did not approve aducanumab. In September 2022, however, more promising results were announced from Phase III clinical trials of another monoclonal antibody, lecanemab. Conclusion: In this review, I have recounted the state of the arts of drugs for treating dementia and highlighted remarkable recent progress in the development of monoclonal antibody therapeutics for Alzheimer's disease.