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Cited by 316Alzheimer's disease research and treatmentsDementia and Cognitive Impairment ResearchIntracerebral and Subarachnoid Hemorrhage Research

Aducanumab: Appropriate Use Recommendations

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Cummings, Jeffrey, Aisen, P., Apostolova, L.G., Atri, A., Salloway, S., Weiner, M.·2021·The Journal of Prevention of Alzheimer's Disease
DOI 10.14283/jpad.2021.41PMC PMC8835345
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Abstract

Aducanumab has been approved by the US Food and Drug Administration for treatment of Alzheimer's disease (AD). Clinicians require guidance on the appropriate use of this new therapy. An Expert Panel was assembled to construct Appropriate Use Recommendations based on the participant populations, conduct of the pivotal trials of aducanumab, updated Prescribing Information, and expert consensus. Aducanumab is an amyloid-targeting monoclonal antibody delivered by monthly intravenous infusions. The pivotal trials included patients with early AD (mild cognitive impairment due to AD and mild AD dementia) who had confirmed brain amyloid using amyloid positron tomography. The Expert Panel recommends that use of aducanumab be restricted to this population in which efficacy and safety have been studied. Aducanumab is titrated to a dose of 10 mg/kg over a 6-month period. The Expert Panel recommends that the aducanumab be titrated to the highest dose to maximize the opportunity for efficacy. Aducanumab can substantially increase the incidence of amyloid-related imaging abnormalities (ARIA) with brain effusion or hemorrhage. Dose interruption or treatment discontinuation is recommended for symptomatic ARIA and for moderate-severe ARIA. The Expert Panel recommends MRIs prior to initiating therapy, during the titration of the drug, and at any time the patient has symptoms suggestive of ARIA. Recommendations are made for measures less cumbersome than those used in trials for the assessment of effectiveness in the practice setting. The Expert Panel emphasized the critical importance of engaging in a process of patient-centered informed decision-making that includes comprehensive discussions and clear communication with the patient and care partner regarding the requirements for therapy, the expected outcome of therapy, potential risks and side effects, and the required safety monitoring, as well as uncertainties regarding individual responses and benefits.

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  • Anti-amyloid monoclonal antibodies currently require confirmation of amyloid-β pathology from PET or CSF before initiating therapy.

    “Currently, anti-amyloid monoclonal antibodies require the confirmation of amyloid-β pathology from PET or CSF before initiating therapy45,46.”

    From Diagnosis of Alzheimer's disease using plasma biomarkers adjusted to clinical probability (2024) · cites this paper as [46]

    The ‘Appropriate Patient’ section (page not specified in our copy) recommends confirming amyloid pathology by PET or CSF before treating patients with aducanumab. It does not establish a requirement for anti-amyloid monoclonal antibodies as a class, so the citing sentence is broader than this source supports. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

  • Plasma biomarkers may have an important role in reducing the patient burden associated with the initiation of anti-amyloid-β therapies for AD.

    “Plasma biomarkers may therefore have an important role in reducing the patient burden associated with the initiation of anti-amyloid-β therapies for AD, which at present require biomarker confirmation with PET or CSF, as well as serial magnetic resonance imaging to monitor for adverse events45,46.”

    From Diagnosis of Alzheimer's disease using plasma biomarkers adjusted to clinical probability (2024) · cites this paper as [46]

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References 90 · Cited by 316

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Authors
Cummings, J., Aisen, P., Apostolova, L. G., Atri, A., Salloway, S., & Weiner, M.
Affiliations
  • University of Nevada, Las Vegas (US)
  • University of Southern California (US)
  • Indiana University Indianapolis (US)
  • Harvard University (US)
  • Brown University (US)
  • University of California, San Francisco (US)
Corresponding author
Cummings, Jeffrey
ORCID
Venue
The Journal of Prevention of Alzheimer's Disease
Publisher
Elsevier BV
Published
2021-10
Volume
8
Issue
4
Pages
398-410
ISSN
2274-5807 (ISSN-L)
DOI
10.14283/jpad.2021.41
PMC
PMC8835345
OpenAlex
W3191999594
Cited by
316
References
90
Citations by year
2026: 26 · 2025: 44 · 2024: 76 · 2023: 59 · 2022: 92 · 2021: 19
FWCI
38.65
Type
journal article
Language
en
Open access
Licence
Locations
  • The Journal of Prevention of Alzheimer s Disease (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion, cc-by)
  • IUScholarWorks (Indiana University) (submittedVersion)
  • eScholarship (California Digital Library) (submittedVersion, cc-by)
  • Purdue University Indianapolis (Indiana University) (submittedVersion)
Funders
  • Foundation for the National Institutes of Health (R35AG71476, U01NS093334, P20GM109025, P30 AG010133, R01AG053798, R01 AG057739)
  • Alzheimer's Association (P30 AG010133)
  • Eli Lilly and Company (P20GM109025)
  • Biogen (P20GM109025)
  • University of Southern California (P20GM109025)
  • Patient-Centered Outcomes Research Institute
  • BioClinica (P20GM109025)
  • Sunovion
  • Buck Institute for Research on Aging
  • Eisai (P20GM109025)
  • Novo Nordisk
  • Shionogi
  • H. Lundbeck A/S (P20GM109025)
  • Grifols
  • Nestec
  • National Institutes of Health (RD005665)
  • Genentech (P20GM109025)
  • Allergan
  • National Institute on Aging (AG010133, P30AG010133, U01AG057195, NIA U01 AG057195, R01AG053798, P20AG068053, NIA P30 AG010133, R01AG057739, P30AG019610, R35AG71476, P30AG072976, P30AG072980, R35AG071476)
  • National Institute of General Medical Sciences (NIA R35AG71476, P20GM109025)
  • National Institute of Neurological Disorders and Stroke (U01NS093334)
Topics
  • Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Health Sciences › Medicine › Neurology › Intracerebral and Subarachnoid Hemorrhage Research
Keywords
aducanumab, Alzheimer's disease, amyloid-related imaging abnormalities, amyloid PET, dose titration, mild cognitive impairment, early Alzheimer's disease, treatment discontinuation, safety monitoring
MeSH terms
Alzheimer Disease, Amyloid, Humans, Infusions, Intravenous, Magnetic Resonance Imaging, United States, Guidelines as Topic, Antibodies, Monoclonal, Humanized, Drug-Related Side Effects and Adverse Reactions

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