Mechanism of action and clinical trial results of Lecanemab (Leqembi® 200 mg, 500 mg for Intravenous Infusion), a novel treatment for Alzheimer’s disease
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Lecanemab is a humanized monoclonal antibody directed against human soluble amyloid-β aggregates. It was developed for the treatment of early Alzheimer's disease (mild cognitive impairment or mild dementia stage of Alzheimer's disease). Among the amyloid-β (Aβ) involved in Alzheimer's disease, Lecanemab selectively binds to the highly neurotoxic Aβ protofibrils, and is thought to reduce Aβ protofibrils and amyloid plaques (Aβ plaques) in the brain. The efficacy and safety of Lecanemab in early Alzheimer's disease were investigated in an international Phase II placebo-controlled study (Study 201) and an international Phase III placebo-controlled study (Study 301). Both studies included Japanese subjects. Lecanemab was given accelerated approval in the United States in January 2023, followed by traditional approval in July 2023. In Japan, it was approved for "control of the progression of mild cognitive impairment or mild dementia stage of Alzheimer's disease" in September 2023, and was added to the NHI drug price list in December 2023.
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There is insufficient safety or efficacy information on starting lecanemab treatment sooner or later than in the conducted studies.
“There is insufficient safety or efficacy information on starting treatment sooner or later than in the conducted studies [137,138,139].”
From Recent Advances in Therapeutics for the Treatment of Alzheimer’s Disease (2024) · cites this paper as [138]
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- Authors
- Niidome, T., Ishikawa, Y., Ogawa, T., Nakagawa, M., & Nakamura, Y.
- Affiliations
- Eisai (Japan) (JP)
- Venue
- Folia Pharmacologica Japonica
- Publisher
- Japanese Pharmacological Society
- Published
- 2024-05-01
- Volume
- 159
- Issue
- 3
- Pages
- 173-181
- ISSN
- 0015-5691 (ISSN-L)
- 1347-8397
- OpenAlex
- W4396517053
- Cited by
- 14
- References
- 15
- Citations by year
- 2026: 6 · 2025: 7 · 2024: 1
- FWCI
- 3.98
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Folia Pharmacologica Japonica (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Pharmacology › Cholinesterase and Neurodegenerative Diseases
- Keywords
- lecanemab, Alzheimer's disease, amyloid-beta protofibrils, amyloid plaques, humanized monoclonal antibody, early Alzheimer's disease, mild cognitive impairment, mild dementia, mechanism of action, drug approval, drug safety and efficacy, Japanese patients
- MeSH terms
- Alzheimer Disease, Clinical Trials as Topic, Humans, Infusions, Intravenous, Amyloid beta-Peptides, Antibodies, Monoclonal, Humanized
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