Use of lecanemab and donanemab in the Canadian healthcare system: Evidence, challenges, and areas for future research
Authors: Smith EE, Phillips NA, Feldman HH, Borrie M, Ganesh A, Henri-Bhargava A, Desmarais P, Frank A, Badhwar A, Barlow L, Bartha R, Best S, Bethell J, Bhangu J, Black SE, Bocti C, Bronskill SE, Burhan AM, Calon F, Camicioli R, Campbell B, Collins DL, Dadar M, DeMarco ML, Ducharme S, Duchesne S, Einstein G, Fisk JD, Gawryluk JR, Grossman L, Ismail Z, Itzhak I, Joshi M, Harrison A, Kroger E, Kumar S, Laforce R, Lanctot KL, Lau M, Lee L, Masellis M, Massoud F, Mitchell SB, Montero-Odasso M, Myers Barnett K, Nygaard HB, Pasternak SH, Peters J, Rajah MN, Robillard JM, Rockwood K, Rosa-Neto P, Seitz DP, Soucy JP, Trenaman SC, Wellington CL, Zadem A, Chertkow H
Affiliations
1 University of Calgary, Canada. Electronic address: eesmith@ucalgary.ca.
2 Concordia University, Canada.
3 Alzheimer's Disease Cooperative Study, Department of Neurosciences, University of California, San Diego, United States.
4 Western University, Canada.
5 University of Calgary, Canada.
6 University of British Columbia, University of Victoria, Island Health, Canada.
7 Centre Hospitalier de l'Université de Montréal, Canada.
8 Bruyère Health Research Institute and University of Ottawa, Canada.
9 Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Université de Montreal, Canada.
10 University of British Columbia, Canada.
11 KITE Research Institute, Toronto Rehabilitation Institute - University Health Network, University of Toronto, Canada.
12 Sunnybrook Research Institute, Canada.
13 Université de Sherbrooke, Canada.
14 Institute for Clinical Evaluative Sciences (ICES), Canada.
15 Ontario Shores Centre and University of Toronto, Canada.
16 Université Laval (Faculté de pharmacie), Canada.
17 University of Alberta, Canada.
18 University of Manitoba, Canada.
19 McGill University, Canada.
20 Providence Health Care, University of British Columbia, Canada.
21 McGill University - Douglas Institute, Canada.
22 Laval University, Canada.
23 University of Toronto, Canada.
24 Dalhousie University, Canada.
25 University of Victoria, Canada.
26 Person with lived experience, Canada.
27 Lady Davis Institute for Medical Research, Canada.
28 Université Laval, Canada.
29 Sunnybrook Health Sciences Centre, Canada.
30 McMaster University, Canada.
31 Division of Neurology, Department of Medicine, Sunnybrook Health Sciences Centre, Hurvitz Brain Sciences Program, Sunnybrook Research Institute, University of Toronto, Canada.
32 Centre Hospitalier Charles LeMoyne / University of Sherbrooke, Canada.
33 Department of Medicine and Epidemiology and Biostatistics, Western University, Canada.
34 Western University, Parkwood Institute, Canada.
35 Toronto Metropolitan University, Canada.
36 Dalhousie University and Nova Scotia Health, Canada.
37 Department of Pathology and Laboratory Medicine, University of British Columbia, Canada.
38 Rotman Research Institute, Baycrest Centre, Canada.
Description
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: Alzheimerʼ; s disease; Clinical trials; Donanemab; Lecanemab;
Links
PubMed: https://pubmed.ncbi.nlm.nih.gov/39893139/
DOI: 10.1016/j.tjpad.2025.100068