Recent treatment approaches for Alzheimer’s disease with monoclonal antibodies targeting amyloid-β

Elif Asena Çulcu; Şeniz Demiryürek; Abdullah Tuncay Demiryürek

Review Article

Year 2023, Volume: 1 Issue: 3, 150 - 166, 31.12.2023

Elif Asena Çulcu Şeniz Demiryürek Abdullah Tuncay Demiryürek

Abstract

References

2022 Alzheimer's disease facts and figures. (2022). Alzheimer's & dementia: the journal of the Alzheimer's Association, 18(4), 700–789. https://doi.org/10.1002/alz.12638
Arslantaş, D., et al. (2009). Prevalence of dementia and associated risk factors in Middle Anatolia, Turkey. Journal of clinical neuroscience: official journal of the Neurosurgical Society of Australasia, 16(11), 1455–1459. https://doi.org/10.1016/j.jocn.2009.03.033
Bali, J., et al. (2012). Role of genes linked to sporadic Alzheimer's disease risk in the production of β-amyloid peptides. Proceedings of the National Academy of Sciences of the United States of America, 109(38), 15307–15311. https://doi.org/10.1073/pnas.1201632109
Bao, W., et al. (2021). PET neuroimaging of Alzheimer's disease: Radiotracers and their utility in clinical research. Frontiers in aging neuroscience, 13, 624330. https://doi.org/10.3389/fnagi.2021.624330
Bateman, R. J., et al. (2022). Gantenerumab: an anti-amyloid monoclonal antibody with potential disease-modifying effects in early Alzheimer's disease. Alzheimer's research & therapy, 14(1), 178. https://doi.org/10.1186/s13195-022-01110-8
Blennow, K., et al. (2012). Effect of immunotherapy with bapineuzumab on cerebrospinal fluid biomarker levels in patients with mild to moderate Alzheimer disease. Archives of neurology, 69(8), 1002–1010. https://doi.org/10.1001/archneurol.2012.90
Brockmann, R., et al. (2023). Impacts of FDA approval and Medicare restriction on antiamyloid therapies for Alzheimer's disease: patient outcomes, healthcare costs, and drug development. Lancet regional health. Americas, 20, 100467. https://doi.org/10.1016/j.lana.2023.100467
Budd Haeberlein, S., et al. (2022). Two randomized phase 3 studies of aducanumab in early Alzheimer's disease. The journal of prevention of Alzheimer's disease, 9(2), 197–210. https://doi.org/10.14283/jpad.2022.30
Busche, M. A., & Hyman, B. T. (2020). Synergy between amyloid-β and tau in Alzheimer's disease. Nature neuroscience, 23(10), 1183–1193. https://doi.org/10.1038/s41593-020-0687-6
Chételat, G., et al. (2020). Amyloid-PET and 18F-FDG-PET in the diagnostic investigation of Alzheimer's disease and other dementias. The Lancet. Neurology, 19(11), 951–962. https://doi.org/10.1016/S1474-4422(20)30314-8
Chételat, G., et al. (2012). Relationship between memory performance and β-amyloid deposition at different stages of Alzheimer's disease. Neuro-degenerative diseases, 10(1-4), 141–144. https://doi.org/10.1159/000334295
Cohen, S., et al. (2023). Lecanemab Clarity AD: Quality-of-Life Results from a Randomized, Double-Blind Phase 3 Trial in Early Alzheimer's Disease. The Journal of Prevention of Alzheimer's disease, 10(4), 771–777. https://doi.org/10.14283/jpad.2023.123
Cummings J. (2023). Anti-Amyloid monoclonal antibodies are transformative treatments that redefine Alzheimer's disease therapeutics. Drugs, 83(7), 569–576. https://doi.org/10.1007/s40265-023-01858-9
Cummings, J., et al. (2023). Alzheimer's disease drug development pipeline: 2023. Alzheimer's & dementia (New York, N. Y.), 9(2), e12385. https://doi.org/10.1002/trc2.12385
Delnomdedieu, M., et al. (2016). First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer's disease. Alzheimer's research & therapy, 8(1), 12. https://doi.org/10.1186/s13195-016-0177-y
Dhillon S. (2021). Aducanumab: First Approval. Drugs, 81(12), 1437–1443. https://doi.org/10.1007/s40265-021-01569-z
Doggrell S. A. (2018). Grasping at straws: the failure of solanezumab to modify mild Alzheimer's disease. Expert opinion on biological therapy, 18(12), 1189–1192. https://doi.org/10.1080/14712598.2018.1543397
Doody, R. S., et al. (2014). Phase 3 trials of solanezumab for mild-to-moderate Alzheimer's disease. The New England journal of medicine, 370(4), 311–321. https://doi.org/10.1056/NEJMoa1312889
Folch, J., et al. (2018). Memantine for the treatment of dementia: A review on its current and future applications. Journal of Alzheimer's disease: JAD, 62(3), 1223–1240. https://doi.org/10.3233/JAD-170672
Fotuhi, S. N., et al. (2020). Memory-related process in physiological status and Alzheimer's disease. Molecular biology reports, 47(6), 4651–4657. https://doi.org/10.1007/s11033-020-05438-y
Fu, H. J., et al. (2010). Amyloid-beta immunotherapy for Alzheimer's disease. CNS & neurological disorders drug targets, 9(2), 197–206. https://doi.org/10.2174/187152710791012017
Gao, Y., et al. (2023). Safety Analysis of Bapineuzumab in the treatment of mild to moderate Alzheimer's disease: A systematic review and meta-analysis. Combinatorial chemistry & high throughput screening, 10.2174/1386207326666230419095813. Advance online publication. https://doi.org/10.2174/1386207326666230419095813
GBD 2019 Dementia Forecasting Collaborators (2022). Estimation of the global prevalence of dementia in 2019 and forecasted prevalence in 2050: an analysis for the Global Burden of Disease Study 2019. The Lancet. Public health, 7(2), e105–e125. https://doi.org/10.1016/S2468-2667(21)00249-8
Grossberg, G. T., et al. (2019). Present algorithms and future treatments for Alzheimer's disease. Journal of Alzheimer's disease: JAD, 67(4), 1157–1171. https://doi.org/10.3233/JAD-180903
Gurvit, H., et al. (2008). The prevalence of dementia in an urban Turkish population. American journal of Alzheimer's disease and other dementias, 23(1), 67–76. https://doi.org/10.1177/1533317507310570
Haake, A., et al. (2020). An update on the utility and safety of cholinesterase inhibitors for the treatment of Alzheimer's disease. Expert opinion on drug safety, 19(2), 147–157. https://doi.org/10.1080/14740338.2020.1721456
Haddad, H. W., et al. (2022). Aducanumab, a novel anti-amyloid monoclonal antibody, for the treatment of Alzheimer's disease: A comprehensive review. Health psychology research, 10(1), 31925. https://doi.org/10.52965/001c.31925
Hao, Y., et al. (2023). Effectiveness and safety of monoclonal antibodies against amyloid-beta vis-à-vis placebo in mild or moderate Alzheimer's disease. Frontiers in neurology, 14, 1147757. https://doi.org/10.3389/fneur.2023.1147757
Holdridge, K. C., et al. (2023). Targeting amyloid β in Alzheimer's disease: Meta-analysis of low-dose solanezumab in Alzheimer's disease with mild dementia studies. Alzheimer's & dementia : the journal of the Alzheimer's Association, 10.1002/alz.13031. Advance online publication. https://doi.org/10.1002/alz.13031
Khan, S., Barve, K. H., & Kumar, M. S. (2020). Recent advancements in pathogenesis, diagnostics and treatment of Alzheimer's disease. Current neuropharmacology, 18(11), 1106–1125. https://doi.org/10.2174/1570159X18666200528142429
Klein, G., et al. (2019). Gantenerumab reduces amyloid-β plaques in patients with prodromal to moderate Alzheimer's disease: a PET substudy interim analysis. Alzheimer's research & therapy, 11(1), 101. https://doi.org/10.1186/s13195-019-0559-z
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Landen, J. W., et al. (2017a). Multiple-dose ponezumab for mild-to-moderate Alzheimer's disease: Safety and efficacy. Alzheimer's & dementia (New York, N. Y.), 3(3), 339–347. https://doi.org/10.1016/j.trci.2017.04.003
Landen, J. W., et al. (2017b). Ponezumab in mild-to-moderate Alzheimer's disease: Randomized phase II PET-PIB study. Alzheimer's & dementia (New York, N. Y.), 3(3), 393–401. https://doi.org/10.1016/j.trci.2017.05.003
Lane, C. A., Hardy, J., & Schott, J. M. (2018). Alzheimer's disease. European journal of neurology, 25(1), 59–70. https://doi.org/10.1111/ene.13439
Leurent, C., et al. (2019). Immunotherapy with ponezumab for probable cerebral amyloid angiopathy. Annals of clinical and translational neurology, 6(4), 795-806. https://doi.org/10.1002/acn3.761
Lilly News Release (2023). Lilly's donanemab significantly slowed cognitive and functional decline in phase 3 study of early Alzheimer's disease. https://investor.lilly.com/news-releases/news-release-details/lillys-donanemab-significantly-slowed-cognitive-and-functional (Accessed on 24 December 2023)
Majidazar, R., et al. (2022). Pharmacotherapy of Alzheimer's disease: an overview of systematic reviews. European journal of clinical pharmacology, 78(10), 1567–1587. https://doi.org/10.1007/s00228-022-03363-6
McDade, E., et al. (2022). Lecanemab in patients with early Alzheimer's disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study. Alzheimer's research & therapy, 14(1), 191. https://doi.org/10.1186/s13195-022-01124-2
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Ostrowitzki, S., et al. (2022). Evaluating the safety and efficacy of crenezumab vs placebo in adults with early Alzheimer disease: Two phase 3 randomized placebo-controlled trials. JAMA neurology, 79(11), 1113–1121. https://doi.org/10.1001/jamaneurol.2022.2909
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Recent treatment approaches for Alzheimer’s disease with monoclonal antibodies targeting amyloid-β

Year 2023, Volume: 1 Issue: 3, 150 - 166, 31.12.2023

Elif Asena Çulcu Şeniz Demiryürek Abdullah Tuncay Demiryürek

Abstract

Alzheimer’s disease (AD) is the most common neurodegenerative disease in aging, with a complex etiology. AD is associated with amyloid-β and tau protein accumulation. Although it has been a focus of research for decades, there is no effective treatment for AD. Currently used memantine and acetylcholinesterase inhibitors (donepezil, galantamine, and rivastigmine) can only slightly reduce symptoms of AD progression. These drugs are not curative and have no clear beneficial effects on the main pathological processes of the AD. In the last decade, many monoclonal antibodies targeting amyloid-β and tau proteins have been developed. Two anti-amyloid-β monoclonal antibodies, aducanumab and lecanemab, have been granted accelerated approvals by the FDA for the treatment of AD. These breakthrough agents constitute the first disease-modifying therapies for AD that can slow the inevitable progression of AD. However, monoclonal antibodies have side effects and, patients must be carefully monitored for the occurrence of amyloid-related imaging abnormalities and infusion reactions. Despite potential harms associated with these immunotherapies, there is still hope that the early onset of AD with the administration of an accurately adjusted dose of these antibodies could provide cognitive and functional benefits.

Keywords

Alzheimer’s disease, immunotherapy, amyloid-β, aducanumab, lecanemab

References

2022 Alzheimer's disease facts and figures. (2022). Alzheimer's & dementia: the journal of the Alzheimer's Association, 18(4), 700–789. https://doi.org/10.1002/alz.12638
Arslantaş, D., et al. (2009). Prevalence of dementia and associated risk factors in Middle Anatolia, Turkey. Journal of clinical neuroscience: official journal of the Neurosurgical Society of Australasia, 16(11), 1455–1459. https://doi.org/10.1016/j.jocn.2009.03.033
Bali, J., et al. (2012). Role of genes linked to sporadic Alzheimer's disease risk in the production of β-amyloid peptides. Proceedings of the National Academy of Sciences of the United States of America, 109(38), 15307–15311. https://doi.org/10.1073/pnas.1201632109
Bao, W., et al. (2021). PET neuroimaging of Alzheimer's disease: Radiotracers and their utility in clinical research. Frontiers in aging neuroscience, 13, 624330. https://doi.org/10.3389/fnagi.2021.624330
Bateman, R. J., et al. (2022). Gantenerumab: an anti-amyloid monoclonal antibody with potential disease-modifying effects in early Alzheimer's disease. Alzheimer's research & therapy, 14(1), 178. https://doi.org/10.1186/s13195-022-01110-8
Blennow, K., et al. (2012). Effect of immunotherapy with bapineuzumab on cerebrospinal fluid biomarker levels in patients with mild to moderate Alzheimer disease. Archives of neurology, 69(8), 1002–1010. https://doi.org/10.1001/archneurol.2012.90
Brockmann, R., et al. (2023). Impacts of FDA approval and Medicare restriction on antiamyloid therapies for Alzheimer's disease: patient outcomes, healthcare costs, and drug development. Lancet regional health. Americas, 20, 100467. https://doi.org/10.1016/j.lana.2023.100467
Budd Haeberlein, S., et al. (2022). Two randomized phase 3 studies of aducanumab in early Alzheimer's disease. The journal of prevention of Alzheimer's disease, 9(2), 197–210. https://doi.org/10.14283/jpad.2022.30
Busche, M. A., & Hyman, B. T. (2020). Synergy between amyloid-β and tau in Alzheimer's disease. Nature neuroscience, 23(10), 1183–1193. https://doi.org/10.1038/s41593-020-0687-6
Chételat, G., et al. (2020). Amyloid-PET and 18F-FDG-PET in the diagnostic investigation of Alzheimer's disease and other dementias. The Lancet. Neurology, 19(11), 951–962. https://doi.org/10.1016/S1474-4422(20)30314-8
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Cohen, S., et al. (2023). Lecanemab Clarity AD: Quality-of-Life Results from a Randomized, Double-Blind Phase 3 Trial in Early Alzheimer's Disease. The Journal of Prevention of Alzheimer's disease, 10(4), 771–777. https://doi.org/10.14283/jpad.2023.123
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Cummings, J., et al. (2023). Alzheimer's disease drug development pipeline: 2023. Alzheimer's & dementia (New York, N. Y.), 9(2), e12385. https://doi.org/10.1002/trc2.12385
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Dhillon S. (2021). Aducanumab: First Approval. Drugs, 81(12), 1437–1443. https://doi.org/10.1007/s40265-021-01569-z
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Fu, H. J., et al. (2010). Amyloid-beta immunotherapy for Alzheimer's disease. CNS & neurological disorders drug targets, 9(2), 197–206. https://doi.org/10.2174/187152710791012017
Gao, Y., et al. (2023). Safety Analysis of Bapineuzumab in the treatment of mild to moderate Alzheimer's disease: A systematic review and meta-analysis. Combinatorial chemistry & high throughput screening, 10.2174/1386207326666230419095813. Advance online publication. https://doi.org/10.2174/1386207326666230419095813
GBD 2019 Dementia Forecasting Collaborators (2022). Estimation of the global prevalence of dementia in 2019 and forecasted prevalence in 2050: an analysis for the Global Burden of Disease Study 2019. The Lancet. Public health, 7(2), e105–e125. https://doi.org/10.1016/S2468-2667(21)00249-8
Grossberg, G. T., et al. (2019). Present algorithms and future treatments for Alzheimer's disease. Journal of Alzheimer's disease: JAD, 67(4), 1157–1171. https://doi.org/10.3233/JAD-180903
Gurvit, H., et al. (2008). The prevalence of dementia in an urban Turkish population. American journal of Alzheimer's disease and other dementias, 23(1), 67–76. https://doi.org/10.1177/1533317507310570
Haake, A., et al. (2020). An update on the utility and safety of cholinesterase inhibitors for the treatment of Alzheimer's disease. Expert opinion on drug safety, 19(2), 147–157. https://doi.org/10.1080/14740338.2020.1721456
Haddad, H. W., et al. (2022). Aducanumab, a novel anti-amyloid monoclonal antibody, for the treatment of Alzheimer's disease: A comprehensive review. Health psychology research, 10(1), 31925. https://doi.org/10.52965/001c.31925
Hao, Y., et al. (2023). Effectiveness and safety of monoclonal antibodies against amyloid-beta vis-à-vis placebo in mild or moderate Alzheimer's disease. Frontiers in neurology, 14, 1147757. https://doi.org/10.3389/fneur.2023.1147757
Holdridge, K. C., et al. (2023). Targeting amyloid β in Alzheimer's disease: Meta-analysis of low-dose solanezumab in Alzheimer's disease with mild dementia studies. Alzheimer's & dementia : the journal of the Alzheimer's Association, 10.1002/alz.13031. Advance online publication. https://doi.org/10.1002/alz.13031
Khan, S., Barve, K. H., & Kumar, M. S. (2020). Recent advancements in pathogenesis, diagnostics and treatment of Alzheimer's disease. Current neuropharmacology, 18(11), 1106–1125. https://doi.org/10.2174/1570159X18666200528142429
Klein, G., et al. (2019). Gantenerumab reduces amyloid-β plaques in patients with prodromal to moderate Alzheimer's disease: a PET substudy interim analysis. Alzheimer's research & therapy, 11(1), 101. https://doi.org/10.1186/s13195-019-0559-z
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Leurent, C., et al. (2019). Immunotherapy with ponezumab for probable cerebral amyloid angiopathy. Annals of clinical and translational neurology, 6(4), 795-806. https://doi.org/10.1002/acn3.761
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Majidazar, R., et al. (2022). Pharmacotherapy of Alzheimer's disease: an overview of systematic reviews. European journal of clinical pharmacology, 78(10), 1567–1587. https://doi.org/10.1007/s00228-022-03363-6
McDade, E., et al. (2022). Lecanemab in patients with early Alzheimer's disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study. Alzheimer's research & therapy, 14(1), 191. https://doi.org/10.1186/s13195-022-01124-2
Olivares, D., et al. (2012). N-methyl D-aspartate (NMDA) receptor antagonists and memantine treatment for Alzheimer's disease, vascular dementia and Parkinson's disease. Current Alzheimer research, 9(6), 746–758. https://doi.org/10.2174/156720512801322564
Ostrowitzki, S., et al. (2022). Evaluating the safety and efficacy of crenezumab vs placebo in adults with early Alzheimer disease: Two phase 3 randomized placebo-controlled trials. JAMA neurology, 79(11), 1113–1121. https://doi.org/10.1001/jamaneurol.2022.2909
Ostrowitzki, S., et al. (2017). A phase III randomized trial of gantenerumab in prodromal Alzheimer's disease. Alzheimer's research & therapy, 9(1), 95. https://doi.org/10.1186/s13195-017-0318-y
Pradier, L., et al. (2018). SAR228810: an antibody for protofibrillar amyloid β peptide designed to reduce the risk of amyloid-related imaging abnormalities (ARIA). Alzheimer's research & therapy, 10(1), 117. https://doi.org/10.1186/s13195-018-0447-y
Rafii, M. S., et al. (2023). The AHEAD 3-45 Study: Design of a prevention trial for Alzheimer's disease. Alzheimer's & dementia: the journal of the Alzheimer's Association, 19(4), 1227–1233. https://doi.org/10.1002/alz.12748
Rashad, A., et al. (2022). Donanemab for Alzheimer's disease: A systematic review of clinical trials. Healthcare (Basel, Switzerland), 11(1), 32. https://doi.org/10.3390/healthcare11010032
Revi M. (2020). Alzheimer's disease therapeutic approaches. Advances in experimental medicine and biology, 1195, 105–116. https://doi.org/10.1007/978-3-030-32633-3_15
Rofo, F., et al. (2021). Novel multivalent design of a monoclonal antibody improves binding strength to soluble aggregates of amyloid beta. Translational neurodegeneration, 10(1), 38. https://doi.org/10.1186/s40035-021-00258-x
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Details

Primary Language	English
Subjects	Medical Pharmacology
Journal Section	Reviews
Authors	Elif Asena Çulcu 0000-0001-5044-9592 Şeniz Demiryürek 0000-0003-4762-4745 Abdullah Tuncay Demiryürek 0000-0002-9994-8541
Early Pub Date	December 29, 2023
Publication Date	December 31, 2023
Published in Issue	Year 2023 Volume: 1 Issue: 3

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APA	Çulcu, E. A., Demiryürek, Ş., & Demiryürek, A. T. (2023). Recent treatment approaches for Alzheimer’s disease with monoclonal antibodies targeting amyloid-β. Recent Trends in Pharmacology, 1(3), 150-166.

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