Lecanemab for early Alzheimer’s disease: Appropriate use recommendations from the French federation of memory clinics
The Journal of Prevention of Alzheimer's Disease. 2025-02-01; : 100094
DOI: 10.1016/j.tjpad.2025.100094
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Villain N(1), Planche V(2), Lilamand M(3), Cordonnier C(4), Soto-Martin M(5),
Mollion H(6), Bombois S(7), Delrieu J(5); French Federation of Memory Clinics
Work Group on Anti-Amyloid Immunotherapies.
Author information:
(1)Sorbonne Université, INSERM U1127, CNRS 7225, Institut du Cerveau – ICM,
Paris, France; AP-HP Sorbonne Université, Hôpital Pitié-Salpêtrière, Department
of Neurology, Institute of Memory and Alzheimer’s Disease, Paris, France.
Electronic address: .
(2)Univ. Bordeaux, CNRS, UMR 5293, Institut des Maladies Neurodégénératives,
F-33000 Bordeaux, France; Centre Mémoire Ressources Recherches, Pôle de
Neurosciences Cliniques, CHU de Bordeaux, F-33000 Bordeaux, France.
(3)Université Paris Cité, INSERM UMR S-1144, Paris, France; AP-HP. Nord
Université Paris Cité Department of Geriatrics and Cognitive Neurology Center,
Lariboisière-Fernand Widal Hospital, Paris, France.
(4)Univ. Lille, Inserm, CHU Lille, U1172 – LilNCog – Lille Neuroscience &
Cognition, F-59000 Lille, France.
(5)Maintain Aging Research team, CERPOP, INSERM UMR 1295, Universite Paul
Sabatier, Toulouse, France; Centre Mémoire Ressources Recherches de Toulouse,
Pôle Gériatrie, Cité de la santé, Toulouse CHU, Toulouse, France.
(6)Centre Mémoire Ressources Recherches de Lyon – Hôpital Neurologique –
Hospices Civils de Lyon – F 69677 BRON cedex, France.
(7)AP-HP Sorbonne Université, Hôpital Pitié-Salpêtrière, Department of
Neurology, Institute of Memory and Alzheimer’s Disease, Paris, France.
Lecanemab, a monoclonal antibody targeting β-amyloid protofibrils, has shown
promising results in a Phase III clinical trial for the treatment of early
stages of Alzheimer’s disease (AD) and has been approved by the European
Medicines Agency. An Early Market Authorization could be submitted to the French
regulatory agencies, potentially allowing for the drug’s use in clinical
practice in France in 2025. To guide French clinicians in administering
lecanemab in a standardized way, the French Federation of Memory Clinics has
developed appropriate use recommendations for lecanemab that highlight relevant
questions established to ensure an optimal risk-benefit ratio. The
recommendations emphasize that lecanemab treatment requires a comprehensive
individualized evaluation of the risk-benefit ratio, which should occur in
multidisciplinary meetings. When approved, the guidelines support the use of
blood biomarkers, proposing specific cutoffs for patients eligible for lecanemab
under restricted conditions. In addition to the European Medicines Agency
restrictions in patients on anticoagulants, and APOE4 homozygotes, the
guidelines recommend against lecanemab treatment for patients with high
amyloid-related hemorrhagic risk such as probable cerebral amyloid angiopathy
(Boston criteria v1.5) until further data become available. Additionally, we
recommend that MRI monitoring be started before the third infusion to account
for early Amyloid Related Imaging Abnormalities (ARIA) occurring on lecanemab.
It is recommended to establish a specific clinical care pathway with protocols
for patients with ARIA, with trained physicians and radiologists with expertise
in neurological emergency and intensive care. Finally, a discontinuation
protocol based on dementia severity assessment after 18 months of lecanemab
treatment is suggested. Access to lecanemab requires a personalized biological
and genetic diagnosis of AD, which is currently not necessary in most cases.
Therefore, the healthcare system must rapidly adjust to new diagnostic
procedures and treatment delivery to ensure equal access for all individuals.
Copyright © 2025 The Author(s). Published by Elsevier Masson SAS.. All rights
reserved.
DOI: 10.1016/j.tjpad.2025.100094
PMID: 40011173
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: Independent of this work, NV
received research support from Fondation Bettencourt-Schueller, Fondation
Servier, Union Nationale pour les Intérêts de la Médecine (UNIM), Fondation
Claude Pompidou, Fondation Alzheimer and Fondation pour la Recherche sur
l’Alzheimer; travel grant from the Movement Disorders Society, Merz-Pharma, UCB
Pharma, and GE Healthcare SAS; is an unpaid local principal investigator or
sub-investigator in NCT04241068 and NCT05310071 (aducanumab, Biogen),
NCT05399888 (BIIB080, Biogen), NCT03352557 (gosuranemab, Biogen), NCT05463731
(remternetug, Eli-Lilly), NCT04592341 (gantenerumab, Roche), NCT03887455
(lecanemab, Eisai), NCT03828747 and NCT03289143 (semorinemab, Roche),
NCT04619420 (JNJ-63,733,657, Janssen – Johnson & Johnson), NCT04374136 (AL001,
Alector), NCT04592874 (AL002, Alector), NCT04867616 (bepranemab, UCB Pharma),
NCT04777396 and NCT04777409 (semaglutide, Novo Nordisk), NCT05469360 (NIO752,
Novartis), is an unpaid national coordinator for NCT05564169 (masitinib,
ABScience), NCT (AD04, ADvantage Therapeutics GmbH); has given unpaid lectures
in symposia organized by Eisai and the Servier Foundation; has been an unpaid
expert for Janssen – Johnson & Johnson. During the past 3 years, VP was a local
unpaid investigator or sub-investigator for clinical trials granted by
NovoNordisk, Biogen, Janssen and Alector. Outside this work, he received
consultant fees for MRI studies in animals from Motac Neuroscience Ltd and
research grants from the Fondation Recherche Alzheimer, Fondation PSP-France and
from the Agence Nationale de la Recherche. During the past 3 years, ML has the
following disclosures: 1. Unpaid activities: Investigator or co-investigator for
studies by Bayer and Bristol-Myers Squibb laboratories; Participation in the
Eisai Symposium on Behavioural Neurology 2023. 2. Paid activities: Consultant
for a brochure on Alzheimer’s disease Eisai 2024. CC received personal fees from
Bayer (international steering committee member of RCT dedicated to stroke),
Biogen (international steering committee member of RCT dedicated to stroke),
Boehringer-Ingelheim (board), Novartis (board), Amgen (board), Op2lysis (board).
She is Associate Editor of the Stroke Journal. She is a member of data safety
monitoring boards (FIVhema, Univ Caen & BLITZ, APHP; unpaid). Her institution
receives grant fundings from the ANR, PHRC and France 2030. MS has served on
advisory boards/consultancies Acadia, Otsuka, Avanir, Medesis Pharma, Servier,
Eisai, Roche, Biogen, Lilly and Ethypharm. During the past 3 years, HM has the
following disclosures: 1. Unpaid activities: principal investigator or
co-investigator in therapeutic trials for the following pharmaceutical groups:
NovoNordisk, Biogen, TauRx Pharmaceuticals, Green Valley Pharmaceuticals, EISAI,
Roche, Genentech, Lundbeck, Boehringer-Ingelheim, Sanofi, UCB; participation in
an EISAI board meeting. 2. Paid activities: EISAI meeting, EISAI regional board,
EISAI symposium. 3. Miscellaneous benefits (transport, meals, etc.): Biogen
(2022), EISAI (2022, 2023). During the past 3 years, SB was a local unpaid
investigator or sub-investigator for clinical trials granted by Biogen, Roche,
Eisai, Eli Lilly, Janssen, Johnson & Johnson, Alector, NovoNordisk, UCB-pharma,
Genentech, AB science, Novartis, and GlaxoSmithKline. She received fees from
Biogen for a symposium (2021), outside the scope of the submitted work. She
received non-personal fees from GE-Healthcare (2023) and Eli-Lilly (2024).
During the past 3 years, JD has received payment/honoraria from Biogen
(presentation for Biogen in 2021); and has served as consultant for Roche France
in 2020–2022, Eisai France in 2023–2024 and Lilly France in 2024 with personal
compensation. He is an investigator in clinical trial sponsored by Regenlife
(NCT05926011) and served as consultant and/or SAB member for Regenlife but
received no personal compensation.