Joel Petch|Daniel Bressington
Aducanumab for Alzheimer’s disease: The never?ending story that nurses should know
Medway School of Pharmacy|Charles Darwin University
nursing openvolume 8 issue 4 p 15241526 editorialopen access aducanumab alzheimers disease neverending story nurses know joel petch orcidorg0000000233680909 kent medway medical school canterbury uksearch papers authordaniel bressington corresponding author danielbressingtoncdueduau orcidorg0000000309512208 college nursing midwifery charles darwin university casuarina nt australia correspondence daniel bressington college nursing midwifery charles darwin university ellengowan drive casuarina nt 0810 australia email danielbressingtoncdueduausearch papers author joel petch orcidorg0000000233680909 kent medway medical school canterbury uksearch papers authordaniel bressington corresponding author danielbressingtoncdueduau orcidorg0000000309512208 college nursing midwifery charles darwin university casuarina nt australia correspondence daniel bressington college nursing midwifery charles darwin university ellengowan drive casuarina nt 0810 australia email danielbressingtoncdueduausearch papers author first published 07 april 2021 httpsdoiorg101002nop2878aboutsectionspdf toolsrequest permissionexport citationadd favoritestrack citation shareshare give accessshare full text accessshare fulltext accessplease review terms conditions use check box share fulltext version articlei read accept wiley online library terms conditions useshareable linkuse link share fulltext version article friends colleagues learn morecopy url share linkshare onemailfacebooktwitterlinked inredditwechat october 2019 american pharmaceutical company biogen stated intention apply us food drug administration fda candidate drug aducanumab licenced therapeutic agent treatment alzheimers disease ad approved aducanumab would become first new medication licenced specifically treatment ad past decade approval us may precipitant approval elsewhere predictably potential advent new drug ad resulted considerable excitement amongst general population healthcare professionals ad charities alike alzheimers research uk 2019 enthusiasm understandable aducanumab posited medication reduce brain amyloid accumulations reduce clinical decline seen ad biogen 2019a wang holtzman 2020 currently viewed progressive irreversible neurodegenerative condition cerebral atrophy cognitive decline loss functionality individual wang holtzman 2020 currently approved evidencebased pharmacological agents ad include acetylcholinesterase inhibitors donepezil galantamine glutamatergic antagonist memantine bnf 2021 important distinction make presently approved medications considered slow progression ad whereas aducanumab stated reverse pathological process associated clinical decline way clearance extracellular amyloid beta plaques observed within ad carroll 2020 aducanumab really reverse features reduce cognitive decline would revolutionary treatment whilst surface sounds positive advance significant potential decision biogen pursue fda approval raised concerns carroll 2020 aducanumab highaffinity fully human igg1 monoclonal antibody actually new drug first produced neurimmune licence sold biogen 2007 neurimmune 2020 several earlier studies exploring aducanumab within treatment ad failed demonstrate efficacy compared placebo apparent lack response aducanumab within clinical trials led biogens phase three trials discontinued early 2019 biogen 2019a despite discontinuing trials biogen undertook retrospective data trawl appeared uncover incorrect analysis earlier study leading biogen claim original trial dose small one twophase three clinical trials emerge trial actually reduce clinical decline patients early ad biogen 2019b statement success appeared conflicted earlier disclosure highlighting trial need prespecified end point confusion abounds new analysis data reported observed statistically significant reduction clinical decline early ad patients claimed greater exposure high dose aducanumab primary driver apparent positive results biogen 2019a following biogens announcement seek fda approval declared without full disclosure supporting data timeindependent analyses undertaken following public presentation data 5th december 2020 data split opinion regard potential efficacy ad protocol amendments initiated midstudy 2017 proving problematic many reviewing data conflict whether data presented true reflection objective transparent trial remains palpable indeed uk alzheimers society 2019 alzheimers research uk 2019 state possible determine whether aducanumab effective yet us alzheimers association currently strongly advocating approval fda alzheimers association 2020 even stating delay undertake additional clarifying trials would acceptable ad charities influence hopes people living dementia carers many healthcare professionals could argued advocating fda approval may providing higher level optimism perhaps realistic given important role many charitable organisations paramount importance public aware conflicting messages emanating two wellknown ad charities permit objective discussions based evidence currently still awaiting decision fda whether approve aducanumab clinical practice decision due made march 2021 delayed 7 june 2021 delay following fda request additional data biogen provided viewed context fda advisory committee met november 2020 raised significant concerns questioning effectiveness aducanumab outcome advisory committee appeared suggest application would rejected panel voting approving aducanumab despite noteworthy fda obliged follow committees advice bowman rogers 2020 interestingly peaks troughs optimism candidate drug reflected biogens stock market status wider perspective could argue exciting renewed scientific pharmaceutical interest within area ad something appears reduced recent years perhaps due complexity ad pathophysiology aducanumab may indeed turn first medication removes extracellular accumulations amyloid beta others may follow include donanemab gantenerumab amongst others renewed life within candidate drugs following apparent positive findings related aducanumab adams 2021 however inescapable reality ad pathophysiology highly complex demonstrated still considering accumulation amyloid beta target aducanumab candidate drugs continues poorly associated levels cognition clearance amyloid appear commensurate improvement cognition ackley et al 2021 might mean mental health care nursing practice 2021 beyond well much depends upon fda decision approval along decisions made regulatory organisations worldwide best medication may available although would based upon current data set may prudent scrutinise data ask beneficial may considerations also time many economies regressed sarscov2 pandemic future health spending undertaken critically important current psychopharmacological interventions remain affordable options good evidence base efficacy mildmoderate ad medications augmented comprehensive personcentred psychosocial interventions skilled nursing input must remain centre therapeutic interventions approval costly new medication potentially dubious effectiveness could jeopardise care packages evidenced increase quality life diagnosis ad could argued situation may illustrate broader issue pharmaceutical companies influence treatment hopes circumstance also demonstrates recommendations respected charities may well primary source health literacy information general public based preliminary findings peerreviewed subject usual checks balances scientific publishing process could adverse effect quality life living diagnosis dementia families summary availability new medications reduce accumulations amyloid beta ad exciting prospect potential treatment development great interest stakeholders likely become topic discussion within clinical meetings nurses work people live mildmoderate ad carers however nurses need know clearance amyloid necessary improve cognition ad evidence effectiveness aducanumab remains unclear despite strong support us alzheimers association currently best evidencebased treatment approaches involve personcentred psychosocial interventions combined acetylcholinesterase inhibitors memantine conflict interest daniel bressington associate editor nursing open conflicts interest authors author contributions authors contributed equally meet least one icmje criteria authorship httpwwwicmjeorgrecommendations approved final version ethical approval ethical approval required editorial open research data availability statement data sharing applicable new data generated references ackley f zimmerman c brenowitz w tchetgen e j gold l manly j j mayeda e r filshtein j power c elahi f brickman glymou 2021 effect reductions amyloid levels cognitive change randomized trials instrumental variable metaanalysis bmj 372 n156 httpsdoiorg101136bmjn156crossrefpubmedgoogle scholar adams b 2021 lilly hails alzheimers win donanemab boasting significant slowing decline online available httpswwwfiercebiotechcombiotechlillyhailsalzheimerswindonanemabboastingsignificantslowingdecline online 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