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Review
. 2025 Mar;12(3):100068.
doi: 10.1016/j.tjpad.2025.100068. Epub 2025 Jan 31.

Use of lecanemab and donanemab in the Canadian healthcare system: Evidence, challenges, and areas for future research

Eric E Smith  1 , Natalie A Phillips  2 , Howard H Feldman  3 , Michael Borrie  4 , Aravind Ganesh  5 , Alexandre Henri-Bhargava  6 , Philippe Desmarais  7 , Andrew Frank  8 , AmanPreet Badhwar  9 , Laura Barlow  10 , Robert Bartha  4 , Sarah Best  4 , Jennifer Bethell  11 , Jaspreet Bhangu  4 , Sandra E Black  12 , Christian Bocti  13 , Susan E Bronskill  14 , Amer M Burhan  15 , Frederic Calon  16 , Richard Camicioli  17 , Barry Campbell  18 , D Louis Collins  19 , Mahsa Dadar  19 , Mari L DeMarco  20 , Simon Ducharme  21 , Simon Duchesne  22 , Gillian Einstein  23 , John D Fisk  24 , Jodie R Gawryluk  25 , Linda Grossman  26 , Zahinoor Ismail  5 , Inbal Itzhak  27 , Manish Joshi  5 , Arthur Harrison  26 , Edeltraut Kröger  28 , Sanjeev Kumar  23 , Robert Laforce  22 , Krista L Lanctot  29 , Meghan Lau  26 , Linda Lee  30 , Mario Masellis  31 , Fadi Massoud  32 , Sara B Mitchell  23 , Manuel Montero-Odasso  33 , Karen Myers Barnett  26 , Haakon B Nygaard  10 , Stephen H Pasternak  34 , Jody Peters  26 , M Natasha Rajah  35 , Julie M Robillard  10 , Ken Rockwood  24 , Pedro Rosa-Neto  19 , Dallas P Seitz  5 , Jean-Paul Soucy  19 , Shanna C Trenaman  36 , Cheryl L Wellington  37 , Aicha Zadem  13 , Howard Chertkow  38 ; Canadian Consortium on Neurodegeneration in Aging Investigators
Affiliations
Review

Use of lecanemab and donanemab in the Canadian healthcare system: Evidence, challenges, and areas for future research

Eric E Smith et al. J Prev Alzheimers Dis. 2025 Mar.

Abstract

Lecanemab and donanemab are monoclonal antibody therapies that remove amyloid-beta from the brain. They are the first therapies that alter a fundamental mechanism, amyloid-beta deposition, in Alzheimer disease (AD). To inform Canadian decisions on approval and use of these drugs, the Canadian Consortium on Neurodegeneration in Aging commissioned Work Groups to review evidence on the efficacy and safety of these new therapies, as well as their projected impacts on Canadian dementia systems of care. We included persons with lived experience with Alzheimer disease in the discussion about the benefits and harms. Our review of the trial publications found high quality evidence of statistically significant group differences, but also recognized that there are mixed views on the clinical relevance of the observed differences and the value of therapy for individual patients. The drugs are intended for persons with early AD, at a stage of mild cognitive impairment or mild dementia. If patients are treated, then confirmation of AD by positron emission tomography or cerebrospinal fluid analysis and monitoring for risk of amyloid-related imaging abnormalities was recommended, as done in the clinical trials, although it would strain Canadian resource capacity. More data are needed to determine the size of the potentially eligible treatment population in Canada.

Keywords: Alzheimerʼs disease; Clinical trials; Donanemab; Lecanemab.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Howard Cherkow reports financial support was provided by Canadian Institutes of Health Research. Howard Chertkow reports financial support was provided by Alberta Prion Research Institute. Howard Chertkow reports financial support was provided by Alberta Innovates. Howard Chertkow reports financial support was provided by Alzheimer Research UK. Alzheimer Society of Canada reports financial support was provided by Alzheimer Society of Canada. Alzheimer Society of Canada reports financial support was provided by Brain Canada Foundation. Howard Chertkow reports financial support was provided by Canadian Nurses Foundation. Howard Chertkow reports financial support was provided by Eli Lilly and Company. Howard Chertkow reports financial support was provided by Quebec Health Research Fund. Howard Chertkow reports financial support was provided by Hypertension Canada. Howard Chertkow reports financial support was provided by Michael Smith Foundation for Health Research. Howard Chertkow reports financial support was provided by New Brunswick Health Research Foundation. Howard Chertkow reports financial support was provided by Nova Scotia Health Research Foundation. Howard Chertkow reports financial support was provided by Ontario Brain Institute. Howard Chertkow reports financial support was provided by Pfizer Canada Inc. Howard Chertkow reports financial support was provided by Robin and Barry Picov Family Foundation. Howard Chertkow reports financial support was provided by Sanofi. Howard Chertkow reports financial support was provided by Saskatchewan Health Research Foundation. AmanPreet Badhwar reports a grant from the Alzheimer Society of Canada, paid to her institution. Laura Barlow reports no disclosures. Robert Bartha reports no disclosures. Sarah Best reports honoraria from Eisai pharmaceuticals, paid to her. Jennifer Bethell reports no disclosures. Jaspreet Bhangu reports a contract from Eisai for site PI, paid to his institution; consulting for Eisai, unpaid; and consulting for Eli Lilly, paid to him. Sandra Black reports contracts with Genentech, Optina, Roche, Eli Lilly, Eisai/Biogen Idec, Novo Nordisk, Lilly Avid, and ICON, paid to her institution; grants from the Ontario Brain Institute, CIHR, Leducq Foundation, Heart and Stroke Foundation of Canada, NIH, Alzheimers Drug Discovery Foundation, Brain Canada, Weston Brain Institute, Canadian Partnership for Stroke Recovery, Canadian Foundation for Innovation, Focused Ultrasound Foundation, Alzheimers Association US, Queens University, Compute Canada Resources for Research Groups, CANARIE, and Networks of Centres of Excellence of Canada, paid to her institution; consulting for Novo Nordisk, Eisai, Eli Lilly, Roche, and Cpd network, paid to her; consulting for DSR: Diagnosis, Solutions & Results Inc., Conference Board Canada, World Dementia Council, University of Rochester Contribution to the Mission and Scientific Leadership of the Small Vessel VCID Biomarker Validation Consortium, National Institute of Neurological Disorders and Stroke, and Ontario Dementia Care Alliance (ODCA), paid to her institution; honoraria from Biogen, Roche, and Eisai, paid to her; and honoraria from Roche, unpaid. Christian Bocti reports stock in Imeka. Michael Borrie reports consulting for Eisai, Eli Lilly, Biogen, and Hoffmann-La Roche, paid to him; and contracts with Eisai, Eli Lilly, Biogen, Hoffmann-La Roche, and Alector, paid to his institution. Susan Bronskill reports grants from the Alzheimer Society of Canada, Brain Canada Foundation, Evaluative Clinical Sciences Research Platform of Sunnybrook Research Institute, Canadian Consortium on Neurodegeneration in Aging (CCNA), Canadian Institutes of Health Research, and Ontario Brain Institute, paid to her institution; and a contract with the Public Health Agency of Canada, paid to her institution. Amer Burhan reports a contract with the Toronto Memory Program (Headland Research), paid to him; consulting for Eisai, Avanir, Otsuka-Lundbeck, Boehringer-Ingelheim, and Roche Pharma, paid to him; and grants from the National Institute of Aging, Brain Canada Foundation, Alzheimer Drug Discovery Foundation, National Research Council, Weston Foundation, and Canada Institute for Health Research, paid to his institution. Frederic Calon reports meeting expenses from Eli Lilly, paid to him. Richard Camicioli reports grants from the Canadian Institutes of Health Research, National Institute of Health, Weston Foundation, paid to him; and support for attending meetings from Parkinson Canada, Canadian Movement Disorders Group, and the Canadian Consortium on Neurodegeneration in Aging, paid to him; and advisory boards for Ambroxal trial and Parkinson Canada, unpaid. Barry Campbell reports no disclosures. Howard Chertkow reports contracts as site PI for clinical trials with Hoffmann-La Roche Limited, TauRx, Eli Lilly Corp., Anavex Life Sciences, Alector LLC, Biogen MA Inc., IntelGenX Corp., and Immunocal, paid to his institution; and consulting for Eisai, Biogen, and Lilly Inc. in Canada, paid to his institution. D. Louis Collins reports no disclosures. Mahsa Dadar reports no disclosures. Mari DeMarco reports consulting for Roche and Eisai, paid to her; honoraria from Roche, paid to her; and a grant from Roche, paid to her institution. Philippe Desmarais reports consulting for Eisai, paid to him. Simon Ducharme reports contracts for clinical trials with Biogen, Janssen, Novo Nordisk, Alnylam, Passage Bio, and Innodem Neurosciences, paid to his institution; consulting for QuRALIS, Eisai, and Eli Lilly, paid to him; honoraria from Eisai, paid to him; and participation in a Data Safety Monitoring Board or Advisory Board for Aviado Bio and IntelGenX, paid to him. Simon Duchesne reports stock or stock options for True Positive Medical Devices Inc., paid to him; honoraria from Novo Nordisk, paid to him; and travel expenses from Eisai, paid to him. Gillian Einstein reports no disclosures. Howard Feldman reports consulting for Eisai Inc., Biogen, LuMind, and Novo Nordisk, paid to his institution; grants from Allyx Therapeutics, Vivoryon Therapeutics, Biohaven Pharmaceuticals, and LuMind Foundation, paid to his institution; royalties from the University of British Columbia, paid to him; a patent held by the University of British Columbia, paid to him; consulting for Axon Neuroscience, Arrowhead Pharmaceuticals, and Biosplice Therapeutics, paid to his institution; support for attending meetings or travel from Novo Nordisk Inc., Royal Society of Canada, Translating Research in Elder Care (TREC), and the Association for Frontotemporal Dementia (AFTD), with payments made to his institution; participation in a Data Safety Monitoring Board or Advisory Board for the Tau Consortium and Janssen Research & Development LLC, paid to his institution; and philanthropic support from the Epstein Family Alzheimers Research Collaboration, paid to his institution. John Fisk reports no disclosures. Andrew Frank reports consulting for Eli Lilly Canada, Eisai Canada, and Novo Nordisk, paid to him. Aravind Ganesh reports grants from the Alzheimer Society of Canada and Alzheimer Society of Alberta and Northwest Territories, paid to his institution; and consulting for Biogen and Eisai, paid to him. Jodie Gawryluk reports no disclosures. Linda Grossman reports no disclosures. Arthur Harrison reports no disclosures. Alexandre Henri-Bhargava reports consulting for Eisai Canada and Eli Lilly, paid to him; contracts for clinical trials with Novo Nordisk, Cerevel, Anavex, IntelGenX, and Green Valley (Shanghai), paid to his institution; honoraria from the Canadian Coalition for Seniors Mental Health, paid to him; leadership in the Consortium of Canadian Centres for Clinical Cognitive Research and the Canadian Neurological Society, unpaid; and other financial or non-financial interests through the Neil and Susan Manning Cognitive Health Initiative, paid to his institution. Zahinoor Ismail reports consulting for CADTH, Eisai, Lilly, Lundbeck, Novo Nordisk, Otsuka, and Roche, paid to him. Inbal Itzhak reports no disclosures. Manish Joshi reports consulting for Eisai, Biogen, Eli Lilly, and Clario, paid to him. Edeltraut Kröger reports no disclosures. Sanjeev Kumar reports no disclosures. Robert Laforce reports consulting for Eisai and Eli Lilly, paid to him. Krista Lanctot reports grants from the Canadian Institutes of Health Research, Alzheimers Drug Discovery Foundation, Weston Foundation, Alzheimers Association (US), and Pooler Charitable Fund, paid to her institution; contracts with Cerevel and BioXcel, paid to her institution; consulting for Boehringer Ingelheim, Bright Minds, Bristol Myers Squibb, Cerevel, Eisai Co. Ltd, Exciva, Ironshore Pharmaceuticals, Kondor Pharma, H Lundbeck A/S, Novo Nordisk, and Praxis Therapeutics, paid to her; honoraria from Novo Nordisk, H Lundbeck, and Eisai, paid to her; support for attending meetings or travel from H Lundbeck and Eisai, paid to her institution; participation in a Data Safety Monitoring Board or advisory board for the PAS-MCI Study, unpaid; leadership in the American Association of Geriatric Psychiatry, unpaid; and receipt of equipment, materials, drugs, gifts, or services from PBG, paid to her institution. Meghan Lau reports no disclosures. Linda Lee reports consulting for Eisai, Lilly, Novo Nordisk, Lundbeck, and Roche, paid to her. Mario Masellis reports grants from the Canadian Institutes of Health Research, Weston Brain Institute, Ontario Brain Institute, Washington University, Women's Brain Health Initiative, Brain Canada, and EU Joint Program for Neurodegenerative Disease Research, paid to him; contracts for clinical trials with Roche and Alector, paid to his institution; consulting fees from Ionis, Alector, Biogen Canada, Wave Life Science, Eisai Canada, and Novo Nordisk Canada, paid to him; royalties from the Henry Stewart Talks, paid to him; honoraria from MINT Memory Clinics and ECHO Dementia Series, paid to him; and membership in Scientific Advisory Boards of the Alzheimer's Society Canada and Parkinson Canada, unpaid. Fadi Massoud reports honoraria from Astellas and Pfizer, paid to him; and consulting for Eisai and Novo Nordisk, paid to him. Sara Mitchell reports consulting for Eisai, paid to her; honoraria from Eisai and Eli Lilly, paid to her; support for attending meetings or travel from Eli Lilly, paid to her; and leadership in the Novo Nordisk Advisory Board, paid to her. Manuel Montero-Odasso reports no disclosures. Karen Myers Barnett reports no disclosures. Haakon Nygaard reports consulting for Eisai, paid to him; and participation in advisory boards for Biogen and Hoffmann-La Roche, paid to him. Stephen Pasternak reports a grant from Zywie Bio LLC and the Weston Foundation, paid to his institution; site investigator for contracts with Cassava and AriBio, paid to his institution; consulting for Eisai, unpaid; an advisory board role for Zywie Bio LLC, unpaid; stock in Zywie Bio LLC; a patent through Zywie Bio LLC, unpaid; and leadership in the C5R Board, unpaid. Jody Peters reports no disclosures. Natalie Phillips reports no disclosures. M. Natasha Rajah reports no disclosures. Julie Robillard reports no disclosures. Kenneth Rockwood reports royalties from The Clinical Frailty Scale and the Pictorial Fit-Frail Scale, paid to his institution; honoraria from the Burnaby Family Practice, Chinese Medical Association, University of Nebraska-Omaha, the Australia New Zealand Society of Geriatric Medicine, the Atria Institute, University of British Columbia, McMaster University, and Fraser Health Authority, paid to him; a US patent application submitted for Electronic Goal Attainment Scaling (patent number US20230402138A1); consulting for EIP Pharma Inc., the ADMET-2 advisory board (Johns Hopkins), and the Wake Forest University Medical School Centre advisory board, unpaid; advisory board roles with Ardea Outcomes, Danone, Hollister, INmune, Novartis, Takeda, and Nutricia, unpaid. Pedro Rosa-Neto reports no disclosures. Dallas Seitz reports a grant from the University Health Foundation - Alberta Roche Collaboration in Health, Alzheimers Association, and Alzheimer Society of Canada, paid to his institution; honoraria from the Canadian Coalition for Seniors Mental Health, Alberta Health Services, and Recovery Alberta, paid to him; and leadership on the Board of Directors for the Alzheimer Society of Alberta and Northwest Territories, unpaid. Eric Smith reports grants from the Canadian Institutes of Health Research, Weston Family Foundation, and Weston Brain Institute, paid to his institution; contracts for clinical trials from Biogen, paid to his institution; contracts with Sense Diagnostics and SFJ Pharmaceuticals, paid to his institution; royalties from UpToDate and UTI Limited Partnership, paid to him; consulting for Eisai, Eli Lilly, and Alnylam, unpaid; and participation in a Data Safety and Monitoring Board for NINDS, paid to him. Jean-Paul Soucy reports grants from the Weston Foundation and Canadian Institutes of Health Research, paid to his institution; a contract with Charles River, paid to his institution; and consulting for Biogen, paid to him. Shanna Trenaman reports being a patient advisor for a Delphi panel developing best practices for antipsychotic use in long-term care, unpaid. Cheryl Wellington reports grants from the Heart and Stroke Foundation of Canada, BrightFocus Foundation, and Cure Alzheimer Fund, paid to her institution. Aicha Zadem reports no disclosures. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Design of the CLARITY-AD (Lecanemab) and TRAILBLAZER-ALZ2 (Donanemab) Clinical Trials In TRAILBLAZER-ALZ 2, participants on donanemab crossed over to the placebo arm at 24 weeks or 52 weeks if the amyloid-PET was <11 Centiloids on any single PET scan or ≥11 but <25 Centiloids on 2 consecutive PET scans. CMB, cerebral microbleed; cSS, cortical superficial siderosis; CSF, cerebrospinal fluid; MMSE, Folstein Mini-Mental State Examination; MRI, magnetic resonance imaging; PET, positron emission tomography; WAIS-IV LMII, Wechsler Adult Intelligence Scale IV Logical Memory II test; Wks, weeks.
See this image and copyright information in PMC

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