Novel anti-amyloid-beta (Aβ) monoclonal antibody lecanemab for Alzheimer’s disease: A systematic review
Open accessAbstract
BACKGROUND: Lecanemab is the latest monoclonal antibody that targets beta-amyloid approved exclusively for treatment of Alzheimer's disease with mild cognitive impairment or mild dementia. This article aims to provide a systematic review of the efficacy, and safety of lecanemab in slowing clinical decline in Alzheimer's disease. METHODS: A comprehensive search of various databases, including the National Institute of Health clinical trials registry, PubMed, and the Cochrane library, was conducted until July 2023 using the keywords lecanemab, BAN2401, and Alzheimer's disease. Additionally, conference abstracts listed in the Cochrane database (including Embase) and drug information from the US Food and Drug Administration (FDA) label were examined. Only clinical trials published in the English language were considered. In total, 107 articles were retrieved, and after thorough evaluation, three randomized, double-blind, multicenter clinical trials involving 2729 participants were included in the analysis. RESULTS: The FDA approved lecanemab for Alzheimer's disease in January 2023 which acts as a novel disease-modifying anti-amyloid-beta (Aβ) human monoclonal antibody and is administered intravenously. Based on the clinical trials included in this review, lecanemab was found efficacious in reducing the accumulation of beta-amyloid and slowing down the cognitive decline and it was well tolerated. Lecanemab had a statistically significant change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB), Alzheimer's Disease Composite Score (ADCOMS), Alzheimer's Disease Assessment Scale (ADAScog14), Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL), and reductions in brain amyloid burden. The most common treatment-emergent adverse events were headache, infusion-related reactions, and Amyloid related imaging abnormalities-edema. CONCLUSIONS: Lecanemab therapy led to a substantial decrease in amyloid plaques and a noticeable slowing of clinical decline. The findings suggest a meaningful connection between the reduction in amyloid and the positive impact on patients' clinical outcomes, hinting at potential disease-modifying effects.
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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 [137]
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Cites
Lecanemab in early Alzheimer's disease
van Dyck, C. H., Swanson, C. J., Aisen, P., Bateman, R. J., Chen, C., Gee, M., Kanekiyo, M., Li, D., Reyderman, L., Cohen, S., et al. (2023) · New England Journal of Medicine · doi:10.1056/nejmoa2212948 · Cited by 5,678 · see citing works
Donanemab in Early Alzheimer’s Disease
Mintun, M. A., Lo, A. C., Duggan Evans, C., Wessels, A. M., Ardayfio, P. A., Andersen, S. W., Shcherbinin, S., Sparks, J., Sims, J. R., Brys, M., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2100708 · Cited by 1,728 · cited 1× · see citing works
“The success of lecanemab in delaying decline is commendable, especially when coupled with fi ndings from a Phase 2 trial of donanemab, 13 another anti-amyloid immunotherapy.”
BackgroundLecanemab: Appropriate Use Recommendations
Cummings, J., Apostolova, L., Rabinovici, G. D., Atri, A., Aisen, P., Greenberg, S., Hendrix, S., Selkoe, D., Weiner, M., Petersen, R. C., et al. (2023) · The Journal of Prevention of Alzheimer's Disease · doi:10.14283/jpad.2023.30 · Cited by 961 · see citing works
Swanson, C. J., Zhang, Y., Dhadda, S., Wang, J., Kaplow, J., Lai, R. Y. K., Lannfelt, L., Bradley, H., Rabe, M., Koyama, A., et al. (2021) · Alzheimer's Research & Therapy · doi:10.1186/s13195-021-00813-8 · Cited by 847 · see citing works
Logovinsky, V., Satlin, A., Lai, R. Y. K., Swanson, C. J., Kaplow, J. M., Osswald, G., Basun, H., & Lannfelt, L. (2016) · Alzheimer s Research & Therapy · doi:10.1186/s13195-016-0181-2 · Cited by 289 · see citing works
Lord, A., Gumucio, A., Englund, H., Sehlin, D., Sundquist, V. S., Söderberg, L., Möller, C., Gellerfors, P., Lannfelt, L., Pettersson, F. E., et al. (2009) · Neurobiology of Disease · doi:10.1016/j.nbd.2009.08.007 · Cited by 157 · see citing works
The Journal of Prevention of Alzheimer's Disease
(2021) · The Journal of Prevention of Alzheimer s Disease · doi:10.14283/jpad.2021.5 · Cited by 152 · see citing works
Lecanemab (BAN2401): an anti–beta-amyloid monoclonal antibody for the treatment of Alzheimer disease
Vitek, G., Decourt, B., & Sabbagh, M. N. (2023) · Expert Opinion on Investigational Drugs · doi:10.1080/13543784.2023.2178414 · Cited by 129 · see citing works
Söllvander, S., Ekholm-Pettersson, F., Brundin, R.-M., Westman, G., Kilander, L., Paulie, S., Lannfelt, L., & Sehlin, D. (2015) · Journal of Alzheimer’s Disease · doi:10.3233/jad-150236 · Cited by 60 · see citing works
Lecanemab reduces brain amyloid-β and delays cognitive worsening
Knopman, D. S. (2023) · Cell Reports Medicine · doi:10.1016/j.xcrm.2023.100982 · Cited by 31 · see citing works
Monoclonal Antibody Treatments for Alzheimer's Disease: Aducanumab and Lecanemab
Chowdhury, S. (2023) · Discoveries · doi:10.15190/d.2023.12 · Cited by 25 · see citing works
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Research works printed but not linked: 1
- [7]Lannfelt L Söderberg L Laudon H, et al. BAN2401 shows stronger binding to soluble aggregated amyloid-beta species than aducanumab. InBioArctic poster presentation. Alzheimer’s Association International Conference 2019; 14– 18.
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Recent Advances in Therapeutics for the Treatment of Alzheimer’s Disease
Thawabteh, A. M., Ghanem, A. W., AbuMadi, S., Thaher, D., Jaghama, W., Karaman, D., & Karaman, R. (2024) · Molecules · doi:10.3390/molecules29215131 · Cited by 56 · see citing works
“There is insufficient safety or efficacy information on starting treatment sooner or later than in the conducted studies [137–139].”
Background
- Authors
- Chowdhury, S., & Chowdhury, N. S.
- Affiliations
- Dhaka Medical College and Hospital (BD)
- Dinajpur Medical College (BD)
- Corresponding author
- Chowdhury, Selia
- ORCID
- Chowdhury, Selia
- Venue
- International Journal of Immunopathology and Pharmacology
- Publisher
- SAGE Publications
- Published
- 2023-01
- Volume
- 37
- Pages
- 3946320231209839-3946320231209839
- ISSN
- 0394-6320 (ISSN-L)
- 2058-7384
- PMC
- PMC10617290
- OpenAlex
- W4388014093
- Cited by
- 76
- References
- 11
- Citations by year
- 2026: 19 · 2025: 34 · 2024: 23
- FWCI
- 2.71
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- International Journal of Immunopathology and Pharmacology (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- 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, anti-amyloid beta monoclonal antibody, amyloid plaques, disease-modifying therapy, cognitive decline, mild cognitive impairment, mild dementia, treatment safety, adverse events, brain amyloid burden
- MeSH terms
- Activities of Daily Living, Alzheimer Disease, Antibodies, Monoclonal, Humans, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Amyloid beta-Peptides, Antibodies, Monoclonal, Humanized
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