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A resurrection of aducanumab for Alzheimer's disease
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“since it is known that the Aβ plaques act as a driver of AD pathology63 and the accumulation Aβ plaques in the brain initiates a complex multicellular neurodegenerative process.”
From Interferon signaling modulates Down syndrome-associated Alzheimer’s disease pathology in a mouse model (2025) · cites this paper as [66]
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“Aducanumab (Biogen/Eisai) is a human monoclonal antibody targeting amyloid β fibrils and soluble oligomers [645].”
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“It is tempting to speculate that antibody binding to amyloid plaques would modulate these glial responses, which would complicate the interpretation of the outcome of clinical trials as these cellular effects might be different between different antibodies (Gallardo and Holtzman, 2017; Schneider, 2020).”
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“Although Biogen (manufacturer) claims that the positive results of the EMERGE trial were driven by greater exposure to a higher dose in the larger dataset, the effect could just as likely be due to greater worsening in the placebo group (Schneider, 2020).”
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“Recently, the significant results demonstrated the modest but greatest efficacy in a phase III trial by aducanumab, supplying important Aβ validation as a therapeutic target (Schneider, 2020).”
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“However, most clinical trials have not been able to meet their primary objectives (Egan et al., 2019; Honig et al., 2018) with an exception of Aducanumab (Biogen) which was able to meet pre-defined end points, when administered at a high dose (Schneider, 2020).”
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“In fact, it was only in the high dose intervention arm of the Aducanumab EMERGE trial that clinical benefit was found, suggesting the need of higher accumulated doses of the antibody to compensate for the low penetrance (Schneider, 2020; Leinenga et al., 2021).”
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“Despite this, by the first quarter of 2019 the Aducanumab ENGAGE (NTC02484547) and EMERGE (NTC02477800) trials were halted as a result of futility analysis (Schneider, 2020).”
BackgroundGLP-1 and Underlying Beneficial Actions in Alzheimer’s Disease, Hypertension, and NASH
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Background“Aducanumab” making a comeback in Alzheimer’s disease: An old wine in a new bottle
Behl, T., Kaur, I., Sehgal, A., Singh, S., Sharma, N., Makeen, H. A., Albratty, M., Alhazmi, H. A., Felemban, S. G., Alsubayiel, A. M., et al. (2022) · Biomedicine & Pharmacotherapy · doi:10.1016/j.biopha.2022.112746 · Cited by 50
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BackgroundMetabolic disorder in Alzheimer’s disease
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“It is still under dilemma with the data analysis and marketing policy (Mullard 2019; Schneider 2020).”
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“The amyloid cascade hypothesis of AD is supported by the efficacy of the anti-Ab antibody aducanumab in reducing Ab plaque formation, as demonstrated in a phase 3 clinical trial (Tolar et al., 2019; Schneider, 2020).”
MethodKoh, S.-H., Kwon, H. S., Choi, S. H., Jeong, J. H., Na, H. R., Lee, C. N., Yang, Y., Lee, A. Y., Lee, J.-H., Park, K. W., et al. (2021) · Alzheimer's Research & Therapy · doi:10.1186/s13195-021-00803-w · Cited by 39
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Microtechnologies for single-cell and spatial multi-omics
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“…can be applied to study the impact of amyloid plaques and tau tangles on neurodegenerative processes in Alzheimer’s disease 29,30 , revealing molecular, inflammation-linked changes in the cells around amyloid plaques 29 , which might act as triggers or drivers of Alzheimer’s disease 31–34 .”
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“This has led to contention as many believe there is not enough evidence to conclude aducanumab is sufficiently efficacious (Howard and Liu, 2020; Schneider, 2020; Knopman et al., 2021).”
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“Despite the fact that recent results with an immunotherapy clinical trial using aducanumab targeting aggregated forms of Aβ have been encouraging and could prove efficacious [32], this clearly suggests that when structural modifications are found in the brain due to accumulation of abnormal proteins, the proposed trea…”
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Stem Cells: Innovative Therapeutic Options for Neurodegenerative Diseases?
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“On 7 June 2021, Food and Drug Administration (FDA) approved Aduhelm (aducanumab) [67], a human IgG1 anti-Aβ monoclonal antibody claiming to reduce, in a dose-and time dependent manner, β-amyloid plaques in AD patients, as assessed by Positron Emission Tomography (PET) studies [68].”
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“…from aducanumab, a human monoclonal antibody selectively binding to Aβ fibrils and soluble oligomers, which in October 2019, after a reanalysis of the phase 3 studies, originally discounted after a futility analysis reporting no clinical advantage, showed some significant results (Schneider, 2020).”
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“The EMERGE and ENGAGE trials ceased early and underwent post hoc analysis of further trial data [25,27].”
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“therapeutic AD antibodies: an Aducanumab analogue (anti-Aβ antibody, commercially known as AduhelmTM) [34, 35], and RNF5, an anti-Tau antibody, which has recently been shown to be efficient in reducing p-Tau levels in an animal model with Tau pathology [36].”
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“All cortical brain areas studied have shown Aducanumab to dramatically reduce amyloid, despite ongoing doubts about its therapeutic usefulness [89,90].”
BackgroundInsulin Resistance as a Common Link Between Current Alzheimer’s Disease Hypotheses
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“However, after Bio-gen’s request, the U.S. Food and Drug Administration (FDA) approved a re-dosing study [72, 73].”
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“The FDA just recently approved aducanumab, a monoclonal antibody treatment for AD, despite mixed results in early clinical trials [15].”
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The Protective A673T Mutation of Amyloid Precursor Protein (APP) in Alzheimer’s Disease
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“Food and Drug Administration (FDA) in October 2019, selectively targets aggregated Aβ [69, 70].”
BackgroundEvidence for aggregation-independent, PrP C -mediated Aβ cellular internalization
Foley, A. R., Roseman, G. P., Chan, K., Smart, A., Finn, T. S., Yang, K., Lokey, R. S., Millhauser, G. L., & Raskatov, J. A. (2020) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.2009238117 · Cited by 38
“S. Jin et al., Amyloid-β(1-42) aggregation initiates its cellular uptake and cytotoxicity.”
BackgroundInfluentialBrain metastasis models: What should we aim to achieve better treatments?
Masmudi‐Martín, M., Zhu, L., Sánchez‐Navarro, M., Priego, N., Casanova-Acebes, M., Ruiz‐Rodado, V., Giralt, E., & Valiente, M. (2020) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2020.12.002 · Cited by 27
Li, K., Qu, H., Ma, M., Xia, C., Cai, M., Han, F., Zhang, Q., Gu, X., & Ma, Q. (2022) · Frontiers in Aging Neuroscience · doi:10.3389/fnagi.2022.816043 · Cited by 24
“The new drug aducanumab, which has recently been approved by the Food and Drug Administration (FDA) for the treatment of AD, targets to clear Aβ plaques in the brain (Sevigny et al., 2016; Schneider, 2020) and improve the cognitive function of AD patients.”
BackgroundSoluble Amyloid-β Consumption in Alzheimer’s Disease
Espay, A. J., Sturchio, A., Schneider, L. S., & Ezzat, K. (2021) · Journal of Alzheimer s Disease · doi:10.3233/jad-210415 · Cited by 46
“4 carriers [8].”
Self-citationAlzheimer Disease Clinical Trials Targeting Amyloid
Reiss, A. B., Montufar, N., DeLeon, J. R., Pinkhasov, A., Gomolin, I. H., Glass, A. D., Arain, H. A., & Stecker, M. M. (2021) · The Neurologist · doi:10.1097/nrl.0000000000000320 · Cited by 27
Stimulating myelin restoration with BDNF: a promising therapeutic approach for Alzheimer's disease
Zota, I., Chanoumidou, K., Gravanis, A., & Charalampopoulos, I. (2024) · Frontiers in Cellular Neuroscience · doi:10.3389/fncel.2024.1422130 · Cited by 25
“The first FDA-approved drug for AD targets the A β peptide, but it has sparked controversy among experts (Howard and Liu, 2020; Schneider, 2020; Knopman et al., 2021).”
BackgroundBlood Biomarkers for the Diagnosis of Neurodegenerative Dementia: A Systematic Review
Santos, F., Cabreira, V., Rocha, S., & Massano, J. (2023) · Journal of Geriatric Psychiatry and Neurology · doi:10.1177/08919887221141651 · Cited by 24
Chen, W. N., Chin, K. W., Tang, K. S., Agatonović-Kuštrin, S., & Yeong, K. Y. (2023) · Journal of Herbal Medicine · doi:10.1016/j.hermed.2023.100696 · Cited by 32
“Aducanumab is a monoclonal antibody that selectively binds to human B-cell clones triggered by neo-epitopes present in pathological Aβ aggregates, resulting in the reduction of brain Aβ plaques (Schneider, 2020; Sevigny et al., 2016).”
Predicting Amyloid Positivity in Cognitively Unimpaired Older Adults
Petersen, K. K., Lipton, R. B., Grober, E., Davatzikos, C. A., Sperling, R. A., & Ezzati, A. (2022) · Neurology · doi:10.1212/wnl.0000000000200553 · Cited by 24
“Aducanumab, a human monoclonal antibody that selectively targets aggregated Aβ, was recently approved by the US Food and Drug Administration for the treatment of AD in mild disease stage.(6) Due to the associated costs and access limitations, obtaining amyloid imaging or CSF studies from all at-risk individuals is not…”
BackgroundThe current landscape in Alzheimer’s disease research and drug discovery
Devenish, S. R. A. (2020) · Drug Discovery Today · doi:10.1016/j.drudis.2020.04.002 · Cited by 28
Drug Discovery and Development Targeting Dementia
Zagórska, A., Czopek, A., Fryc, M., Jaromin, A., & Boyd, B. J. (2023) · Pharmaceuticals · doi:10.3390/ph16020151 · Cited by 29
Shen, Z. J., Fu, Y. B., Hou, J. L., Lin, L. N., Wang, X. Y., Li, C., & Yang, Y. (2022) · Chinese Medicine · doi:10.1186/s13020-022-00698-1 · Cited by 27
“Moreover, almost all drugs targeting a single target or single process, such as solanezumab, bapineuzumab and aducanumab, have not shown significant efficacy [24, 25].”
Bloomingdale, P., Yadav, D. B., Sugam, J. A., Grauer, S. M., Smith, B. E., Antonenko, S. V., Judo, M., Azadi, G., & Yee, K. L. (2022) · Frontiers in Pharmacology · doi:10.3389/fphar.2022.867457 · Cited by 25
“One argument for this discrepancy is that patients in the positive trial received greater exposures of aducanumab (Schneider, 2020).”
ResultRoh, H. W., Kim, N., Lee, D. A., Cheong, J. Y., Seo, S. W., Choi, S. H., Kim, E., Cho, S. H., Kim, B. C., Kim, S. Y., et al. (2022) · Psychiatry Investigation · doi:10.30773/pi.2021.0335 · Cited by 21
Orchestration of antiviral responses within the infected central nervous system
Pavlou, A., Mulenge, F., Gern, O. L., Busker, L. M., Greimel, E., Waltl, I., & Kalinke, U. (2024) · Cellular and Molecular Immunology · doi:10.1038/s41423-024-01181-7 · Cited by 24
“Although microglia display a stereotypically activated response to β -amyloid (A β ) [192, 206, 207], little is known about the relationship between amyloid plaques and the neurodegenerative process [208 – 210].”
BackgroundRudolph, J., Rueckel, J., Döpfert, J., Ling, W. X., Opalka, J., Brem, C., Hesse, N., Ingenerf, M., Koliogiannis, V., Solyanik, O., et al. (2024) · Alzheimer s & Dementia Diagnosis Assessment & Disease Monitoring · doi:10.1002/dad2.70037 · Cited by 14
“8,9 16 Automated brain volumetry based on three-dimensional magnetic resonance imaging (MRI) has long been established 17–19 but has not yet been included in routine radiological reporting of MRI scans of dementia patients.”
Wei, Y.-D., Chen, X.-X., Yang, L., Gao, X., Xia, Q., Qi, C., & Ge, J. (2022) · Neurochemistry International · doi:10.1016/j.neuint.2022.105385 · Cited by 23
Parums, D. V. (2021) · PubMed Central · doi:10.12659/msm.934077 · Cited by 17
“Post-approval trials are awaited to support any clinical benefit and determine which patients may benefit, other than patients with mild cognitive impairment [16,18].”
BackgroundMethodAlzheimer's Disease: Many Failed Trials, So Where Do We Go from Here?
Reiss, A. B., Glass, A. D., Wısnıewskı, T., Wolozin, B. L., Gomolin, I. H., Pinkhasov, A., Leon, J. D., & Stecker, M. M. (2020) · Journal of Investigative Medicine · doi:10.1136/jim-2020-001297 · Cited by 26
Wasielewska, J. M., Chaves, J. C. S., Cabral-da-Silva, M. C., Pecoraro, M., Viljoen, S. J., Nguyen, T. H., Bella, V. L., Oikari, L. E., Ooi, L., & White, A. R. (2024) · Fluids and Barriers of the CNS · doi:10.1186/s12987-024-00565-1 · Cited by 22
Metadata
- Authors
- Schneider, L.
- Corresponding author
- Schneider, Lon
- ORCID
- Schneider, Lon
- Venue
- The Lancet Neurology
- Publisher
- Elsevier BV
- Published
- 2020-02
- Volume
- 19
- Issue
- 2
- Pages
- 111-112
- ISSN
- 1474-4422 (ISSN-L)
- OpenAlex
- W2992893037
- Cited by
- 286
- References
- 0
- Citations by year
- 2026: 5 · 2025: 18 · 2024: 27 · 2023: 45 · 2022: 55 · 2021: 76 · 2020: 59
- FWCI
- 32.86
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Lancet Neurology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Life Sciences › Neuroscience › Neurology › Neuroinflammation and Neurodegeneration Mechanisms
- Keywords
- aducanumab, Alzheimer's disease, anti-amyloid antibodies, Biogen, data reanalysis, anti-amyloid therapy
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