Year 2023,
Volume: 1 Issue: 3, 150 - 166, 31.12.2023
Elif Asena Çulcu
,
Şeniz Demiryürek
,
Abdullah Tuncay Demiryürek
References
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- 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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- 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
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- 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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- 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)
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- 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
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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.
References
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- 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
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- 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
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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
- 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
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- 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
- Knopman, D. S., et al. (2021). Alzheimer disease. Nature reviews. Disease primers, 7(1), 33. https://doi.org/10.1038/s41572-021-00269-y
- König, T., & Stögmann, E. (2021). Genetics of Alzheimer's disease. Genetik der Alzheimer-Demenz. Wiener medizinische Wochenschrift (1946), 171(11-12), 249–256. https://doi.org/10.1007/s10354-021-00819-9
- 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
- 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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