Abstract
Background Aducanumab, a new monoclonal antibody that targets β-amyloid aggregates, has been granted conditional approval by the U.S. FDA for treatment of mild Alzheimer's disease (AD). The approval of this drug without a confirmed significant clinical impact has resulted in several debates. Objective In this narrative review, aducanumab approval-related controversy, the drug's pharmacokinetics and pharmacodynamic characteristics, evidence from the efficacy and safety trials of aducanumab, implications of the drug approval, and the future directions in the management of patients with AD are summarized. Methods Using relevant keywords, Google Scholar, Web of Science, and MEDLINE databases and manufacturer's website were searched. Results Infusion of aducanumab at a higher dose resulted in a modest slowing of cognitive decline among patients with mild cognitive impairment or early-onset AD dementia. The drug however can cause amyloid-related imaging abnormalities. Due to modest impact on cognition, the use of this drug by patients with AD will most likely be limited. The manufacturer is required to run an extended phase IIIb trial to verify the benefit of this drug. Access to therapy requires a careful selection of patients and periodic monitoring to ensure the optimal use of the drug. Conclusion Despite the limitations, aducanumab is the first disease-modifying therapy approved for the treatment of AD. Aducanumab addresses a part of the pathogenesis of AD; therefore, drugs that can act on multiple targets are needed. In addition, the search for preventive strategies, validated plasma-based assays, and newer drugs for AD, which are effective, safe, convenient, and affordable, is vital.
Highlights
Alzheimer’s disease (AD) is one of the most prevalent neurodegenerative diseases resulting in progressive cognitive decline
Aggregates of β-amyloid protein peptides and neurofibrillary tangles (NFT) which damage the neurons are thought to be linked with the pathogenesis of AD [3]
Aducanumab at a high dose has the potential to slow down the cognitive decline linked with Alzheimer’s in patients with early-onset disease
Summary
Alzheimer’s disease (AD) is one of the most prevalent neurodegenerative diseases resulting in progressive cognitive decline. Aducanumab, a new monoclonal antibody that targets β-amyloid aggregates, has been granted conditional approval by the U.S FDA for treatment of mild Alzheimer’s disease (AD). The approval of this drug without a confirmed significant clinical impact has resulted in several debates. In this narrative review, aducanumab approval-related controversy, the drug’s pharmacokinetics and pharmacodynamic characteristics, evidence from the efficacy and safety trials of aducanumab, implications of the drug approval, and the future directions in the management of patients with AD are summarized. Infusion of aducanumab at a higher dose resulted in a modest slowing of cognitive decline among patients with mild cognitive impairment or early-onset AD dementia. Due to modest impact on cognition, the use of this drug by patients with AD will most likely be limited. The search for preventive strategies, validated plasma-based assays, and newer drugs for AD, which are effective, safe, convenient, and affordable, is vital
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