Aducanumab as treatment for Alzheimer’s disease: major breakthrough or improvident?

Brouwershaven, Tim van (2021) Aducanumab as treatment for Alzheimer’s disease: major breakthrough or improvident? Master's Thesis / Essay, Biomedical Sciences.

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Abstract

Alzheimer’s Disease (AD) is characterized by the deposition of amyloid-β (Aβ) plaques and neurofibrillary tangles in the brain, leading to neurodegeneration and synaptic dysfunction. So far, antibody-based immunotherapy against Aβ deposition has been unsuccessful. A breakthrough was reached earlier this year, when the U.S. Food and Drug Administration (FDA) granted an accelerated approval to Biogen’s monoclonal antibody aducanumab to be used in the treatment of AD. The decision led to a lot controversy and several members of the FDAs independent advisory panel resigned over the approval. Here the decision is investigated by looking at both preclinical and clinical studies, targeting mechanisms, adverse effects and future perspectives of several monoclonal antibodies (mAbs), including aducanumab, bapineuzumab, solanezumab, crenezumab & gantenerumab. Despite promising results on reduction of Aβ-levels after administration of different mAbs, clinical endpoints on phase III trials are yet to be found. After reanalysis of two phase III trials using aducanumab ENGAGE & EMERGE a significant benefit was reported only in EMERGE. Amyloid-related imaging abnormalities (ARIA) were not uncommon adverse effects after administration of aducanumab. Due to the failure of robust clinical evidence aducanumab has shown on the treatment in AD, the FDA approval remains highly questionable. It is arguable whether the FDA based the approval on promising results or if the incentive is mainly economic

Item Type:	Thesis (Master's Thesis / Essay)
Supervisor name:	Eisel, U.L.M.
Degree programme:	Biomedical Sciences
Thesis type:	Master's Thesis / Essay
Language:	English
Date Deposited:	13 Dec 2021 15:12
Last Modified:	13 Dec 2021 15:12
URI:	https://fse.studenttheses.ub.rug.nl/id/eprint/26369

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