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Lecanemab: Appropriate Use Recommendations
Open accessAbstract
Lecanemab (Leqembi®) is approved in the United States for the treatment of Alzheimer's disease (AD) to be initiated in early AD (mild cognitive impairment [MCI] due to AD or mild AD dementia) with confirmed brain amyloid pathology. Appropriate Use Recommendations (AURs) are intended to help guide the introduction of new therapies into real-world clinical practice. Community dwelling patients with AD differ from those participating in clinical trials. Administration of lecanemab at clinical trial sites by individuals experienced with monoclonal antibody therapy also differs from the community clinic-based administration of lecanemab. These AURs use clinical trial data as well as research and care information regarding AD to help clinicians administer lecanemab with optimal safety and opportunity for effectiveness. Safety and efficacy of lecanemab are known only for patients like those participating in the phase 2 and phase 3 lecanemab trials, and these AURs adhere closely to the inclusion and exclusion criteria of the trials. Adverse events may occur with lecanemab including amyloid related imaging abnormalities (ARIA) and infusion reactions. Monitoring guidelines for these events are detailed in this AUR. Most ARIA with lecanemab is asymptomatic, but a few cases are serious or, very rarely, fatal. Microhemorrhages and rare macrohemorrhages may occur in patients receiving lecanemab. Anticoagulation increases the risk of hemorrhage, and the AUR recommends that patients requiring anticoagulants not receive lecanemab until more data regarding this interaction are available. Patients who are apolipoprotein E ε4 (APOE4) gene carriers, especially APOE4 homozygotes, are at higher risk for ARIA, and the AUR recommends APOE genotyping to better inform risk discussions with patients who are lecanemab candidates. Clinician and institutional preparedness are mandatory for use of lecanemab, and protocols for management of serious events should be developed and implemented. Communication between clinicians and therapy candidates or those on therapy is a key element of good clinical practice for the use of lecanemab. Patients and their care partners must understand the potential benefits, the potential harms, and the monitoring requirements for treatment with this agent. Culture-specific communication and building of trust between clinicians and patients are the foundation for successful use of lecanemab.
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“Lecanemab has a boxed warning for serious and symptomatic ARIA and requires testing for APOE ε4 prior to initiation as homozygosity increases risk.(510)”
From Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission (2024) · cites this paper as [510]
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“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 [45]
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“For example, although patients with early-stage AD may be candidates for anti-amyloid therapies15–17, the coexistence of pathology from other etiologies, such as VD, can increase the risk of amyloid-related imaging abnormalities18.”
From AI-based differential diagnosis of dementia etiologies on multimodal data (2024) · cites this paper as [15]
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“The risk of developing these potentially serious adverse effects is higher in APOEε4 carriers, particularly homozygotes, and current recommendations are that patients are genotyped for APOE before starting these therapies to offer a balanced benefit–risk discussion190.”
From Multifaceted roles of APOE in Alzheimer disease (2024) · cites this paper as [190]
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“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 [45]
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“Individuals with two copies of the APOE‐e4 gene are at increased risk of developing ARIA.”
From 2024 Alzheimer's disease facts and figures (2024) · cites this paper as [59]
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“Accordingly, ApoE genotyping is now increasingly considered an important component of the pre-treatment work-up for anti-amyloid therapies [5, 8, 11, 12].”
From Plasma ApoE proteotyping for ApoE ε4 stratification in the anti-amyloid therapies era (2026) · cites this paper as [11]
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Metadata
- Authors
- Cummings, J., Apostolova, L., Rabinovici, G. D., Atri, A., Aisen, P., Greenberg, S., Hendrix, S., Selkoe, D., Weiner, M., Petersen, R. C., & Salloway, S.
- Affiliations
- Indiana University Indianapolis (US)
- University of California, San Francisco (US)
- Banner Health (US)
- University of Southern California (US)
- Harvard University (US)
- Brigham and Women's Hospital (US)
- Mayo Clinic (US)
- Brown University (US)
- Venue
- The Journal of Prevention of Alzheimer's Disease
- Publisher
- Elsevier BV
- Published
- 2023-09
- Volume
- 10
- Issue
- 3
- Pages
- 362-377
- ISSN
- 2274-5807 (ISSN-L)
- PMC
- PMC10313141
- OpenAlex
- W4360591479
- Cited by
- 961
- References
- 62
- Citations by year
- 2026: 335 · 2025: 305 · 2024: 249 · 2023: 71
- FWCI
- 170.48
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- The Journal of Prevention of Alzheimer s Disease (publishedVersion, cc-by)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion, cc-by)
- eScholarship (California Digital Library) (submittedVersion, cc-by)
- IUScholarWorks (Indiana University) (submittedVersion)
- Funders
- Foundation for the National Institutes of Health (R35AG71476, U01NS093334, P20GM109025, P30AG072959, P30 AG010133, R01AG053798, R01 AG057739)
- Alzheimer's Association (P30 AG010133)
- Alzheimer's Drug Discovery Foundation (P20GM109025)
- Eli Lilly and Company (P20GM109025)
- Biogen (P20GM109025)
- University of Southern California (P20GM109025)
- Patient-Centered Outcomes Research Institute
- Alnylam Pharmaceuticals
- BioClinica (P20GM109025)
- Sunovion
- Buck Institute for Research on Aging
- Prothena
- University of Oxford
- Eisai (P20GM109025)
- Novo Nordisk
- Shionogi
- H. Lundbeck A/S (P20GM109025)
- Grifols
- Nestec
- National Institutes of Health (RD005665)
- Genentech (P20GM109025)
- Allergan
- Avid Radiopharmaceuticals
- National Institute on Aging (AG010133, P30AG010133, U01AG057195, NIA U01 AG057195, R01AG053798, P20AG068053, NIA P30 AG010133, R01AG057739, R35AG71476, P30AG072959, P30AG072980, R35AG071476)
- National Institute of General Medical Sciences (P20GM109025)
- National Institute of Neurological Disorders and Stroke (U01NS093334)
- Topics
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Pharmacology (medical) › Cholinesterase and Neurodegenerative Diseases
- Keywords
- lecanemab, Alzheimer's disease, amyloid-related imaging abnormalities, amyloid plaques, mild cognitive impairment, early Alzheimer's disease, bleeding risk, anticoagulation, infusion reactions, monoclonal antibody therapy, caregiver-patient communication, clinical preparedness
- MeSH terms
- Alzheimer Disease, Amyloid, Antibodies, Monoclonal, Humans, Apolipoprotein E4, Antibodies, Monoclonal, Humanized
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