Advance in Lecanemab therapy for Alzheimer's disease

doi:10.3969/j.issn.1672-6731.2026.02.010

Abstract

Abstract: Deposition of amyloid β-protein(Aβ) in the brain is a key pathogenesis and early change in Alzheimer's disease(AD). Clearing Aβ through anti-Aβ monoclonal antibody drugs is an important strategy for disease-modifying thrapy(DMT). Lecanemab is the first approved anti-Aβ monoclonal antibody durg for early therapy, and growing evidence has shown that Lecanemab could clear Aβ deposition and slow progress of AD. This article systematically summarizes the evidence for Lecanemab in treating AD, the results of the early-phase clinical studies, the phase Ⅲ clinical trials, open label extension(OLE) trials and long-term follow-up data, and ongoing clinical research, with the aim of providing clinical guidance on the safety, efficacy and applicability of AD treatment.

Key words: Alzheimer disease, Amyloid beta-peptides, Antibodies,monoclonal,humanized, Drug therapy, Review

摘要： 脑组织β-淀粉样蛋白（Aβ）沉积是阿尔茨海默病发病的关键环节和早期病理学特征，抗Aβ单克隆抗体药物清除Aβ是阿尔茨海默病疾病修饰治疗的重要策略。仑卡奈单抗可以有效清除脑组织Aβ沉积，延缓疾病进展，是国际上首个正式批准上市的抗Aβ单克隆抗体药物。本文总结仑卡奈单抗治疗阿尔茨海默病的早期临床研究、Ⅲ期临床试验、开放标签长期治疗研究、长期随访数据及正在进行的临床研究，旨在为临床提供阿尔茨海默病治疗的安全性、有效性及适用性指导。

关键词: 阿尔茨海默病, 淀粉样β肽类, 抗体,单克隆,人, 药物疗法, 综述

CLC Number:

R743

QIANG Qi-qi, LIU Pei-jie, CUI Si-meng, QU Qiu-min. Advance in Lecanemab therapy for Alzheimer's disease[J]. Chinese Journal of Contemporary Neurology and Neurosurgery, 2026, 26(2): 188-193.

强琪琦, 刘佩杰, 崔思萌, 屈秋民. 仑卡奈单抗治疗阿尔茨海默病临床研究进展[J]. 中国现代神经疾病杂志, 2026, 26(2): 188-193.

/ / Recommend / Download Citations

URL: https://journal11.magtechjournal.com/cjcnn/EN/10.3969/j.issn.1672-6731.2026.02.010

https://journal11.magtechjournal.com/cjcnn/EN/Y2026/V26/I2/188

References

[1] Scheltens P, De Strooper B, Kivipelto M, Holstege H, Chételat G, Teunissen CE, Cummings J, van der Flier WM.Alzheimer's disease[J]. Lancet, 2021, 397:1577-1590.
[2] Jucker M, Walker LC.Alzheimer's disease:from immunotherapy to immunoprevention[J]. Cell, 2023, 186:4260-4270.
[3] Tucker S, Möller C, Tegerstedt K, Lord A, Laudon H, Sjödahl J, Söderberg L, Spens E, Sahlin C, Waara ER, Satlin A, Gellerfors P, Osswald G, Lannfelt L.The murine version of BAN2401(mAb158) selectively reduces amyloid-β protofibrils in brain and cerebrospinal fluid of tg-ArcSwe mice[J]. J Alzheimers Dis, 2015, 43:575-588.
[4] Lord A, Gumucio A, Englund H, Sehlin D, Sundquist VS, Söderberg L, Möller C, Gellerfors P, Lannfelt L, Pettersson FE, Nilsson LN.An amyloid-beta protofibril-selective antibody prevents amyloid formation in a mouse model of Alzheimer's disease[J]. Neurobiol Dis, 2009, 36:425-434.
[5] Larkin HD.Lecanemab gains FDA approval for early Alzheimer disease[J]. JAMA, 2023, 329:363.
[6] Logovinsky V, Satlin A, Lai R, Swanson C, Kaplow J, Osswald G, Basun H, Lannfelt L.Safety and tolerability of BAN2401:a clinical study in Alzheimer's disease with a protofibril selective Aβ antibody[J]. Alzheimers Res Ther, 2016, 8:14.
[7] Swanson CJ, Zhang Y, Dhadda S, Wang J, Kaplow J, Lai RYK, Lannfelt L, Bradley H, Rabe M, Koyama A, Reyderman L, Berry DA, Berry S, Gordon R, Kramer LD, Cummings JL.Arandomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Aβprotofibril antibody[J]. Alzheimers Res Ther, 2021, 13:80.
[8] Dhadda S, Kanekiyo M, Li D, Swanson CJ, Irizarry M, Berry S, Kramer LD, Berry DA.Consistency of efficacy results across various clinical measures and statistical methods in the lecanemab phase 2 trial of early Alzheimer's disease[J]. Alzheimers Res Ther, 2022, 14:182.
[9] Tahami Monfared AA, Tafazzoli A, Ye W, Chavan A, Zhang Q.Long-term health outcomes of lecanemab in patients with early Alzheimer's disease using simulation modeling[J]. Neurol Ther, 2022, 11:863-880.
[10] Honig LS, Barakos J, Dhadda S, Kanekiyo M, Reyderman L, Irizarry M, Kramer LD, Swanson CJ, Sabbagh M.ARIA in patients treated with lecanemab (BAN2401) in a phase 2 study in early Alzheimer's disease[J]. Alzheimers Dement (NY), 2023, 9:e12377.
[11] van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, Kanekiyo M, Li D, Reyderman L, Cohen S, Froelich L, Katayama S, Sabbagh M, Vellas B, Watson D, Dhadda S, Irizarry M, Kramer LD, Iwatsubo T.Lecanemab in early Alzheimer's disease[J]. N Engl J Med, 2023, 388:9-21.
[12] Chen C, Katayama S, Lee JH, Lee JY, Nakagawa M, Torii K, Ogawa T, Dash A, Irizarry M, Dhadda S, Kanekiyo M, Hersch S, Iwatsubo T.Clarity AD:Asian regional analysis of a phaseⅢtrial of lecanemab in early Alzheimer's disease[J]. J Prev Alzheimers Dis, 2025, 12:100160.
[13] van Dyck CH, Sperling RA, Dhadda S, Li D, Hersch S, Irizarry MC, Kramer LD.Is there evidence for a continued benefit for long-term Lecanemab treatment:a benefit/risk update from longterm efficacy, safety and biomarker data[J]. Alzheimers Dement, 2025, 20(S6):e092094.
[14] van Dyck CH, Sperling R, Johnson K, Dhadda S, Kanekiyo M, Li D, Gee M, Hersch S, Irizarry M, Kramer L.Long-term safety and efficacy of lecanemab in early Alzheimer's disease:results from the clarity AD open-label extension study[J]. Alzheimers Dement, 2025, 21:e70905.
[15] van Dyck CH, Li D, Kanekiyo M, Dhadda S, Hersch S, Gee M, Irizarry MC, Kramer LD.The Lecanemab Clarity AD open-label extension in early Alzheimer's disease:initial findings from the48-month analysis[J]. Alzheimers Dement, 2025, 21(S7):e108905.
[16] Watson D, Neam M, Stafford M, Bouchard C, Ranney V, Werner S.Transitioning from clinical trial to clinical practice for long-term lecanemab treatment in early Alzheimer's disease:perspectives from an Alzheimer's disease treatment center[J]. JPrev Alzheimers Dis, 2025, 12:30-31.
[17] Cummings J, Apostolova L, Rabinovici GD, Atri A, Aisen P, Greenberg S, Hendrix S, Selkoe D, Weiner M, Petersen RC, Salloway S.Lecanemab:appropriate use recommendations[J]. JPrev Alzheimers Dis, 2023, 10:362-377.
[18] Liu YH, Bu XL, Liang CR, Wang YR, Zhang T, Jiao SS, Zeng F, Yao XQ, Zhou HD, Deng J, Wang YJ.An N-terminal antibody promotes the transformation of amyloid fibrils into oligomers and enhances the neurotoxicity of amyloid-beta:the dust-raising effec[tJ]. J Neuroinflammation, 2015, 12:153.
[19] Albertini G, Zielonka M, Cuypers ML, Snellinx A, Xu C, Poovathingal S, Wojno M, Davie K, van Lieshout V, Craessaerts K, Wolfs L, Pasciuto E, Jaspers T, HorréK, Serneels L, Fiers M, Dewilde M, De Strooper B.The Alzheimer's therapeutic Lecanemab attenuates Aβ pathology by inducing an amyloidclearing program in microglia[J]. Nat Neurosci, 2026, 29:100-110.
[20] Neurologist Branch, Chinese Medical Doctor Association;The Expert Group for Expert Consensus on Disease-Modifying Therapy for Alzheimer's Disease.Expert consensus on diseasemodifying therapy for Alzheimer's disease (2025 edition)[J]. Zhonghua Yi Xue Za Zhi, 2025, 105:1492-1502[.中国医师协会神经内科医师分会, 阿尔茨海默病疾病修饰治疗专家共识制订专家组.阿尔茨海默病疾病修饰治疗专家共识(2025版)[J]. 中华医学杂志, 2025, 105:1492-1502.]
[21] Reyderman L, Willis BA, Penner N, Charil A, Dhadda S, Hersch S, Irizarry MC, Kramer LD.How does the latest clinical pharmacology data&modeling support continued Lecanemab dosing[J]?Alzheimers Dement, 2024, 20(S6):e092091.
[22] Hayato S, Rawal S, Takenaka O, Landry I, Boyd P, Aluri J, Willis BA, Swanson CJ, Yasuda S, Hussein Z, Reyderman L.Subcutaneous dose selection of Lecanemab for treatment of subjects with early Alzheimer's disease (EAD)[J]. Alzheimers Dement, 2022, 18(S10):e069429.
[23] Willis BA, Penner N, Rawal S, Aluri J, Reyderman L.Subcutaneous (SC) lecanemab is predicted to achieve comparable efficacy and improved safety compared to LecanemabⅣin early Alzheimer's disease (AD)[J]. Alzheimers Dement, 2023, 19(S24):e082852.
[24] Irizarry M, Reyderman L, Hersch S, Gee M, Doherty T, Penner N, Patten A, Dhadda S, Kramer LD.Safety profile of a subcutaneous lecanemab formulation[C] //Clinical Trials on Alzheimer's Disease.18thClinical Trials on Alzheimer's Disease(CTAD), San Diego, 2025.Auzeville-Tolosane:Serdi Publisher, 2025:14-15.
[25] Liu S, Fan S, Gan J, Liao W, Chen Q, Li X, Zhang J, Chen X, Ji Y.Caregivers'perspectives on lecanemab use for Alzheimer's disease:a national survey in China[J]. Alzheimers Dement, 2025, 21:e70680.
[26] Rafii MS, Sperling RA, Donohue MC, Zhou J, Roberts C, Irizarry MC, Dhadda S, Sethuraman G, Kramer LD, Swanson CJ, Li D, Krause S, Rissman RA, Walter S, Raman R, Johnson KA, Aisen PS.The AHEAD 3-45 Study:design of a prevention trial for Alzheimer's disease[J]. Alzheimers Dement, 2023, 19:1227-1233.
[27] Goate A, Chartier-Harlin MC, Mullan M, Brown J, Crawford F, Fidani L, Giuffra L, Haynes A, Irving N, James L, Mant R, Newton P, Rooke K, Roques P, Talbot C, Pericak-Vance M, Roses A, Williamson R, Rossor M, Owen M, Hardy J.Segregation of a missense mutation in the amyloid precursor protein gene with familial Alzheimer's disease[J]. Nature, 1991, 349:704-706.

Please choose a citation manager

Content to export