Aducanumab for the treatment of Alzheimer’s disease: A systematic review
Open accessAbstract
Aducanumab is a novel disease-modifying anti-amyloid-beta (Aβ) human monoclonal antibody specifically targeted to the pathophysiology of Alzheimer's disease (AD). It was granted for treating AD in June 2021 by the United States Food and Drug Administration. We systematically analyzed available trials to evaluate the efficacy and safety of aducanumab treating AD. We followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines. We conducted an extensive literature search using the electronic databases MEDLINE through PubMed, EMBASE, Cochrane, Web of Science, and Scopus for suitable studies on aducanumab. We considered human clinical trials of aducanumab, assessing its efficacy and adverse effects in treating AD, excluding any experimental animal studies. We included three randomised controlled trials. Studies reported that aducanumab reduced brain amyloid-beta plaques in a time- and dose-dependent manner (dose-response, P < 0.05) and a slowed decline in cognition (22% reduction) in the high-dose treated group, difference of -0.39 versus placebo in Clinical Dementia Rating Scale Sum Boxes (95% CI, -0.69 to -0.09; P = 0.012) along with a reduced amyloid positron emission tomography standard uptake value ratio score (P < 0.001) and plasma p181-tau (phosphorylated tau) level. Amyloid-related imaging abnormality was reported as a serious adverse event and was profound in high-dose treated group (425/1029 in 10 mg/kg). Aducanumab has been reported to affect two main pathophysiologic hallmarks (Aβ and tau) of AD. We suggest future studies addressing aducanumab's efficacy and safety to confirm that the benefit of this drug outweighs the risk.
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Reduction in amyloid-beta brain plaques and encouraging clinical outcomes in one of two pivotal Phase III trials were factors cited for aducanumab's expedited approval.
“The reduction in amyloid-beta brain plaques, a purported surrogate endpoint that indicates the “progression” of AD, and the encouraging clinical outcomes in one of the two pivotal Phase III trials were two of the factors cited for aducanumab’s expedited approval [130,134,135,136].”
From Recent Advances in Therapeutics for the Treatment of Alzheimer’s Disease (2024) · cites this paper as [130]
Aducanumab is the first disease-modifying medication for AD, a recombinant monoclonal antibody targeting amyloid beta specifically, and functions by lowering amyloid deposits or brain plaques.
“The first disease-modifying medication for AD is a recombinant monoclonal antibody called aducanumab, also known by the brand name Aduhelm. It targets amyloid beta specifically [37]. It functions by lowering the quantity of amyloid deposits or brain plaques [130,131].”
From Recent Advances in Therapeutics for the Treatment of Alzheimer’s Disease (2024) · cites this paper as [130]
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- Authors
- Rahman, A., Hossen, M. A., Chowdhury, M. F. I., Bari, S., Tamanna, N., Sultana, S. S., Haque, S. N., Al Masud, A., & Saif‐Ur‐Rahman, K. M.
- Affiliations
- Satkhira Medical College (BD)
- Sheikh Sayera Khatun Medical College Gopalganj Bangladesh
- Sylhet MAG Osmani Medical College (BD)
- University of Barishal (BD)
- Rangpur Medical College (BD)
- Southern Medical College Chittagong Bangladesh
- Dhaka Medical College and Hospital (BD)
- St Louis University Hospital St. Louis Missouri USA
- Ollscoil na Gaillimhe – University of Galway (IE)
- Corresponding author
- Saif‐Ur‐Rahman, K.M.
- Venue
- Psychogeriatrics
- Publisher
- Wiley
- Published
- 2023-02-12
- Volume
- 23
- Issue
- 3
- Pages
- 512-522
- ISSN
- 1346-3500 (ISSN-L)
- 1479-8301
- PMC
- PMC11578022
- OpenAlex
- W4320179487
- Cited by
- 104
- References
- 13
- Citations by year
- 2026: 21 · 2025: 31 · 2024: 35 · 2023: 17
- FWCI
- 3.75
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Psychogeriatrics (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Health Research Board (ESI-2021-001)
- Irish Research eLibrary
- Topics
- Health Sciences › Medicine › Physiology › 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 beta monoclonal antibody, amyloid plaques, disease-modifying therapy, cognitive decline, amyloid PET, phosphorylated tau, adverse events, treatment efficacy and safety
- MeSH terms
- Alzheimer Disease, Animals, Humans, Tomography, X-Ray Computed, Amyloid beta-Peptides, Antibodies, Monoclonal, Humanized
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