The science does not yet support regulatory approval of amyloid‐targeting therapies for Alzheimer’s disease based solely on biomarker evidence
Alzheimer's & Dementia. 2025-04-01; 21(4):
DOI: 10.1002/alz.70068
Lire sur PubMed
Planche V(1)(2), Schindler S(3), Knopman DS(4), Frisoni G(5), Galasko D(6),
Grill JD(7), Schneider L(8), Karlawish J(9), Villain N(10)(11).
Author information:
(1)Univ. Bordeaux, CNRS, Institut des Maladies Neurodégénératives, Bordeaux,
France.
(2)Pôle de Neurosciences Cliniques, Centre Mémoire de Ressources et de
Recherche, CHU de Bordeaux, Bordeaux, France.
(3)Department of Neurology, Washington University in St. Louis, St. Louis,
Missouri, USA.
(4)Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.
(5)Memory Center, Department of Rehabilitation and Geriatrics, University
Hospitals and University of Geneva, Geneva, Switzerland.
(6)Department of Neurosciences, UC San Diego, La Jolla, California, USA.
(7)Institute for Memory Impairments and Neurological Disorders, Department of
Psychiatry and Human Behavior, Department of Neurobiology and Behavior,
University of California Irvine, Irvine, California, USA.
(8)Keck School of Medicine of the University of Southern California, Los
Angeles, California, USA.
(9)University of Pennsylvania, Perelman School of Medicine, Penn Memory Center,
Philadelphia, Pennsylvania, USA.
(10)Sorbonne Université, INSERM U1127, CNRS 7225, Institut du Cerveau – ICM,
Paris, France.
(11)Department of Neurology, Institute of Memory and Alzheimer’s Disease, AP-HP
Sorbonne Université, Pitié-Salpêtrière Hospital, Paris, France.
DOI: 10.1002/alz.70068
PMCID: PMC12004391
PMID: 40243238
Conflict of interest statement: Author disclosures are available in the
Supporting information. During the past 3 years, Dr. Planche was a local unpaid
investigator or sub‐investigator for clinical trials granted by NovoNordisk,
Biogen, TauRx Pharmaceuticals, Janssen, Green Valley Pharmaceuticals, and
Alector. He received consultant fees for animal studies from Motac Neuroscience
Ltd, outside the submitted work. He received grants from the Agence Nationale de
la Recherche, Fondation Recherche Alzheimer and Fondation PSP France. Dr.
Schindler has served on scientific advisory boards on biomarker testing and
education for Eisai and Novo Nordisk and has received speaking fees for
presentations on biomarker testing from Eisai, Eli Lilly, and Novo Nordisk. Dr.
Knopman serves on Data Safety Monitoring Boards for (1) the Dominantly Inherited
Alzheimer Network Treatment Unit study for which he receives personal
compensation; (2) a study of nicorandil for the treatment of hippocampal
sclerosis of aging sponsored by the University of Kentucky (no compensation);
(3) a study of varenicline in Parkinson disease sponsored by the University of
Michigan (no compensation); and (4) a study of lamotrigine for mild cognitive
impairment sponsored by Johns Hopkins (no compensation). He was a site
investigator in clinical trials sponsored by Biogen, Lilly Pharmaceuticals and
the University of Southern California, and is currently a site investigator in a
trial in frontotemporal degeneration with Alector. He has served as a consultant
for Roche, Biovie, Linus Health, and Alzeca Biosciences but receives no personal
compensation from any of the sponsors. Dr. Frisoni has received funding through
the Private Foundation of Geneva University Hospitals from: A.P.R.A.
– Association Suisse pour la Recherche sur la Maladie d’Alzheimer, Genève;
Fondation Segré, Genève; Ivan Pictet, Genève; Race Against Dementia Foundation,
London, UK; Fondation Child Care, Genève; Fondation Edmond J. Safra, Genève;
Fondation Minkoff, Genève; Fondazione Agusta, Lugano; McCall Macbain Foundation,
Canada; Nicole et René Keller, Genève; Fondation AETAS, Genève; has received
funding through the University of Geneva or Geneva University Hospitals: for
IISSs from ROCHE Pharmaceuticals OM Pharma EISAI Pharmaceuticals Biogen
Pharmaceuticals and Novo Nordisk; has received funding for competitive research
projects from: H2020, Innovative Medicines Initiative (IMI), IMI2, Swiss
National Science Foundation, and VELUX Foundation; has received consulting fees
from: Biogen, Diadem, Roche; has received payment or honoraria for lectures,
presentations, speakers bureaus, manuscript writing, or educational events from:
Biogen, Roche, Novo Nordisk, GE HealthCare. Dr. Galasko has served as a
consultant for Eisai, Inc. Dr. Grill reports research support from NIA,
Alzheimer’s Association, BrightFocus Foundation, Biogen, Eli Lilly, Genentech,
and Eisai. He has consulted for SiteRx. He receives personal income for
editorial service to Alzheimer’s & Dementia and has received travel support from
the Alzheimer’s Association. Within a 48 months time frame, Dr. Schneider
reports grants from NIH R01 AG054434 (Delivery of Essential Fatty Acids to the
Brain in Alzheimer’s disease), P30 AG066530 (USC ADRC), R01 AG062687, R01
AG051346, R01 AG055444, P01 AG02350, R01 AG053267 (DIAN‐TU), R01 AG074983 (Aβ
and tau vaccines), R01 AG063826, State of California CADC 15‐10291; grants and
personal fees from Eli Lilly/Avid, grants and personal fees from
Roche/Genentech; grants/contracts from Eisai, Biogen, and Biohaven; grants from
Washington University, St. Louis/ NIA DIAN‐TU, grants from UC San Diego ADCS,
personal fees from Neurim, Ltd (Israel), Cognition Therapeutics, Corium,
Immunobrain Checkpoint, Ltd (Israel), Alpha‐cognition, BioVie, Lexeo,
Lighthouse, AC Immune (Suisse), Athira, GW Research (UK, Jazz, USA), Merck,
Otsuka (USA), Pharmatrophix, Linus Health, Lundbeck, Novo Nordisk, Muna
(Denmark), Ono Ltd, Vivli.org, outside the submitted work; and from The Della
Martin Foundation endowment. In the past 12 months or coming 12 months, Dr.
Karlawish has or will receive compensation from Linus Health (scientific
advisory board) and Biogen (consultation). Independent of this work, Dr. Villain
received research support from Fondation Bettencourt‐Schueller, Fondation
Servier, Union Nationale pour les Intérêts de la Médecine (UNIM), Fondation
Claude Pompidou, Fondation Alzheimer, Banque Publique d’Investissement 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), NCT04592341 (gantenerumab, Roche), NCT03887455 (lecanemab, Eisai),
NCT03828747, and NCT03289143 (semorinemab, Roche), NCT04619420 (JNJ‐63733657,
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