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A Japanese registry for optimizing the safe use of anti-amyloid therapies for Alzheimer’s disease in Japan

Nature Aging volume 5, pages 1917–1919 (2025)Cite this article

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The Japanese regulatory authority has approved the clinical use of anti-amyloid-β (Aβ) immunotherapy for Alzheimer’s disease. This Correspondence highlights the launch of the Japanese Registry for Alzheimer’s Disease-Modifying Therapies, which aims to ensure safety and maximize the optimal risk–benefit balance through integrating a real-world database of adverse events, post-marketing surveillance, APOE genotyping and biomarker research.

Lecanemab, an anti-Aβ-antibody drug for Alzheimer’s disease, received accelerated approval in the USA on 6 January 2023 and was submitted for approval in Japan on 16 January. On 6 July, the US Food and Drug Administration granted full approval for lecanemab. Later that year, the Pharmaceuticals and Medical Devices Agency (PMDA) — the Japanese regulatory authority — approved the clinical use of lecanemab, which was listed in the national health insurance and made available for clinical use on 20 December 2023.

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Fig. 1: Research structure for the Japanese Registry for Alzheimer’s Disease-Modifying Therapies.

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Acknowledgements

The author thanks Eisai for providing information on the clinical use of lecanemab in Japan, and R. Ihara, T. Ikeuchi, H. Nakamura, Y. Niimi and other members of the research group and the registry administrative office at the NCNP for their dedication to the Japanese Registry for Alzheimer’s Disease-Modifying Therapies project. The author is supported by the Japanese Agency for Medical Research and Development (AMED), grant number JP23dk0207068.

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Authors and Affiliations

  1. National Center of Neurology and Psychiatry, Tokyo, Japan

    Takeshi Iwatsubo

  2. Department of Dementia Inclusion and Therapeutics, The University of Tokyo Hospital, Tokyo, Japan

    Takeshi Iwatsubo

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  1. Takeshi Iwatsubo
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Correspondence to Takeshi Iwatsubo.

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The author has received consultancy and/or speakers fees from Eisai, Eli-Lilly and Company, Fujirebio and Fujifilm.

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Nature Aging thanks Jonathan Schott, Serge Gauthier, and the other, anonymous, reviewer(s) for their contribution to the peer review of this work.

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Iwatsubo, T. A Japanese registry for optimizing the safe use of anti-amyloid therapies for Alzheimer’s disease in Japan. Nat Aging 5, 1917–1919 (2025). https://doi.org/10.1038/s43587-025-00980-5

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