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Evaluation of Aducanumab for Alzheimer Disease: Scientific Evidence and Regulatory Review Involving Efficacy, Safety, and Futility
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“Recent breakthroughs with the detection of specific phosphorylated tau fragments in blood, some with apparent high specificity for early AD, are opening new perspectives in this regard 97 .”
From The amyloid hypothesis in Alzheimer disease: new insights from new therapeutics (2022) · cites this paper as [97]
In the citing paper
“Aducanumab, a monoclonal antibody against Aβ aggregates, has obtained the FDA’s approval as an Alzheimer’s drug for its ability to reduce the level of Aβ plaques in patients with early AD or mild cognitive impairment (MCI).46–48”
From Amyloid β-based therapy for Alzheimer’s disease: Challenges, successes and future (2023) · cites this paper as [47]
In the citing paper
“So far, two antibody-based drugs aducanumab and lecanemab have been approved by the FDA”
From Amyloid β-based therapy for Alzheimer’s disease: Challenges, successes and future (2023) · cites this paper as [47]
In the citing paper
“Aducanumab is the first FDA-approved therapy for Alzheimer’s.47,48”
From Amyloid β-based therapy for Alzheimer’s disease: Challenges, successes and future (2023) · cites this paper as [47]
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The antibody aducanumab reduces Aβ plaques in Alzheimer’s disease
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“In June 2021, aducanumab was approved by the FDA for medical use.(47,48) However, it is considered controversial due to the lack of sufficient evidence to support its efficacy.”
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Sadleir, K. R., Gómez, K., Edwards, A. E., Patel, A. J., Ley, M. L., Khatri, A. W., Guo, J., Mahesh, S., Watkins, E. A., Popović, J., et al. (2025) · Acta Neuropathologica · doi:10.1007/s00401-025-02888-1 · Cited by 18
Schmid, J. C., Frey, K., Scheiner, M., Garzón, J. F. G., Stafforst, L., Fricke, J., Schuppe, M., Schiewe, H., Zeeck, A., Weber, T., et al. (2021) · Angewandte Chemie International Edition · doi:10.1002/anie.202106802 · Cited by 15
Metadata
- Authors
- Alexander, G. C., Emerson, S., & Kesselheim, A. S.
- Affiliations
- Johns Hopkins University (US)
- University of Washington (US)
- Brigham and Women's Hospital (US)
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2021-05-04
- Volume
- 325
- Issue
- 17
- Pages
- 1717
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W3149600507
- Cited by
- 240
- References
- 4
- Citations by year
- 2026: 25 · 2025: 24 · 2024: 41 · 2023: 37 · 2022: 59 · 2021: 54
- FWCI
- 30.46
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (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, amyloid-beta, anti-amyloid therapy, drug efficacy, clinical trials
- MeSH terms
- Alzheimer Disease, Humans, United States, United States Food and Drug Administration, Randomized Controlled Trials as Topic, Treatment Failure, Drug Approval, Medical Futility, Antibodies, Monoclonal, Humanized
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