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. 2025 Sep;12(8):100259.
doi: 10.1016/j.tjpad.2025.100259. Epub 2025 Jul 9.

Comment by European Alzheimer's Disease Consortium (EADC) investigators on the negative recommendation of the CHMP on the marketing authorization of donanemab for early Alzheimer' s disease

Affiliations

Comment by European Alzheimer's Disease Consortium (EADC) investigators on the negative recommendation of the CHMP on the marketing authorization of donanemab for early Alzheimer' s disease

Frank Jessen et al. J Prev Alzheimers Dis. 2025 Sep.
No abstract available

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Conflict of interest statement

Declaration of competing interest Frank Jessen: FJ has received grants from Roche Pharma and Roche Diagnostics; FJ has received consulting fees from Eli Lilly and Eisai; FJ has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Eli Lilly and Eisai; FJ has received payment for expert testimony from Eli Lilly and Eisai; FJ is Chairman of the EADC. Javier Arbizu: JA has received research funding paid to University of Navarre Clinic from Siemens Healthineers, GE Healthcare, and PET tracer from Life Molecular Imaging; consultancy fees from Novartis and Eli Lilly; and received speaker honoraria from Biogen, Novartis, Life Molecular Imaging, Roche, Novo Nordisk, Siemens Healthineers, GE Healthcare, Zambon. Mercé Boada: MB has received consulting fees from Grifols, Araclon Biotech, Roche, Biogen, Lilly, Merck, Zambon, Novo Nordisk; MB has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Roche, Biogen, Grifols, Nutricia, Araclon Biotech, Servier, Novo Nordisk; MB participated in Data Safety Monitoring Board or Advisory of Board Grifols, Roche, Lilly, Araclon Biotech, Merck, Zambon, Biogen, Novo Nordisk, Bioiberica, Eisai, Servier, Schwabe Pharma, Lighthouse Pharma. Mircea Balasa: No COI. Karim Bennys has received grants to his institution from Acadia Pharmaceuticals, Alzheon Inc., Araclon Biotech S.L., AstraZeneca, Biogen, Bristol Myers Squibb, Eisai Inc., Eli Lilly, Genentech, Inc., GlaxoSmithKline, Hoffmann- La Roche, INmune Bio Inc., Janssen Research & Development, Medesis Parma, Merck Sharp & Dohme, Nestlé, Novartis Pharmaceuticals, Novo Nordisk, TauRx Therapeutics Ltd, UCB Biopharma. Marina Boban has received grants from 4BrainFlames project, EU fund Research (managed by institution), Croatian Science Foundation Research (managed by institution). Katharina Bürger: Honoraria from Eisai Germany, Lilly Germany, Roche; Travel support by Lilly Germany and Novo Nordisk. Andrea Chincarin: No COI. Annachiara Cagnin, AC received speaker honoraria from: PIAM, Eisai, GE, Lilly, Novo Nordisk, Roche. Peter Paul De Deyn: consulted for Eisai, Biogen, and Perha Pharmaceuticals. Emrah Düzel: Co-Founder and interim-CEO of neotiv, honoraria for advisory work talks from Roche, Lilly, Eisai, Biogen. Sebastiaan Engelborghs: SE has received consulting fees from Biogen, Eisai (paid to institution), Icometrix (paid to institution), Janssen, Eli Lilly, Novartis (paid to institution). SE holds patent EP3452830B1 for an assay for the diagnosis of a neurological disease (licensed to ADX Neurosciences NV & Euroimmun Medizinische Labordiagnostika AG). SE is a member of SMB/SAB for EU-H2020 project RECAGE (unpaid) and of the DSMB of PRImus-AD (unpaid). Michael Ewers: ME received research funding from Eli Lilly. Lieza G. Exalto: PI at Brain Research Center, however not involved in lecanumab nor donanemab clinical trials. Wiesje M. van der Flier: WF has been an invited speaker at Biogen MA Inc, Danone, Eisai, WebMD Neurology (Medscape), Novo Nordisk, Springer Healthcare, European Brain Council. WF is consultant to Oxford Health Policy Forum CIC, Roche, Biogen MA Inc, Eisai, Eli-Lilly, Owkin France. WF participated in advisory boards of Biogen MA Inc, Roche, and Eli Lilly. WF is member of the steering committee of phase 3 EVOKE/EVOKE+ studies (Novo Nordisk). WF is member of the steering committee op phase 3 Trontinemab study (Roche). All funding is paid to her institution. WF is member of the steering committee of PAVE, and Think Brain Health. WF is chair of the Scientific Leadership Group of InRAD. WF was associate editor of Alzheimer, Research & Therapy in 2020/2021. WF is associate editor at Brain. WF is member of Supervisory Board (Raad van Toezicht) Trimbos Instituut. Juan Fortea: JF reported serving on the advisory boards, adjudication committees, or speaker honoraria from AC Immune, Adamed, Alzheon, Biogen, Eisai, Esteve, Fujirebio, Ionis, Laboratorios Carnot, Life Molecular Imaging, Lilly, Lundbeck, Novo Nordisk, Perha, Roche, Zambón, Spanish Neurological Society, T21 Research Society, Lumind foundation, Jérôme-Lejeune Foundation, Alzheimer’s Association, National Institutes of Health USA, and Instituto de Salud Carlos III. JF reports holding a patent for markers of synaptopathy in neurodegenerative disease (licensed to ADx, EPI8382175.0). No other competing interests were reported. Kristian Steen Frederiksen: KF has participated in advisory boards/consulted for Novo Nordisk, Roche Diagnostics, Eisai/Bioarctic, Eli Lilly (paid to institution), honoraria for lectures from Eisai/Bioarctic, Nono Nordisk, Eli Lilly (paid to institution), Editor-in-Chief, Alzheimer´s Research & Therapy (Personal renumeration form Springer Nature). Giovanni B Frisoni: GBF 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. He has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from: Biogen, Roche, Novo Nordisk, GE HealthCare. All through institution. Lutz Frölich: Honoraria from Biogen, BioVie, Eisai, Eli Lilly, FOMF, Araclon/Grifols, Janssen Cilag, Medical Tribune, Medfora, Neurimmune, Noselab, Novo Nordisk, Roche, TauRX, Schwabe, StreamUp, Avanir/Otsuka, PharmatrophiX, Charité Berlin, Neuroscios, Vivoryon; Research support: Roche. Alejandro J. Garza-Martinez: No COI. Timo Grimmer: TG reported receiving consulting fees from Acumen, Advantage Ther, Alector, Anavex, Biogen, BMS; Cogthera, Eisai, Eli Lilly, Functional Neuromod., Grifols, Janssen, Neurimmune, Noselab, Novo Nordisk, Roche Diagnostics, and Roche Pharma; lecture fees from Anavex, Cogthera, Eisai, Eli Lilly, FEO, Grifols, Pfizer, Roche Pharma, Schwabe, and Synlab; and has received grants to his institution from Biogen, Eisai and Eli Lilly. Bernard Hanseeuw: consulted for Eisai, Biogen, and Roche. Jakub Hort: consulted for Eisai, Biogen, Roche and Eli Lilly, speakers honoraria from Eli Lilly, Schwabe, stock options in Alzheon. Adrian Ivanoiu: No COI. Patrick G Kehoe: has received Research Grants from BRACE, Alzheimer’s Brain Banks UK, the Bright Focus Foundation and R01AG074258 NIH (NIA); Payments made to the Institution for Biomedical related research projects on post mortem brain tissue unrelated to these drugs. Sean P Kennelly: SPK has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Roche, Novo Nordisk, Eisai, Biogen and Nutricia; SPK has received support for attending meetings and/or travel from Roche and Nutricia. Silke Kern: SK has served at scientific advisory boards, speaker and / or as consultant for Roche, Eli Lilly, Geras Solutions, Optoceutics, Biogen, Eisai, Merry Life, Triolab, Novo Nordisk and Bioarctic. Stefan Klöppel: SK has received various research grants but not related data reported; SK has received consulting fees from OM Pharma (Participantion dementia summit), SK has received payment or honoraria for lectures from OM Pharma (personal payment); participation on Advisory boards 2023: Advisory Board Alzheimer's Disease - Eisai Switzerland 2024: Advisory Board Rexulti AA – Lundbeck 2025: Advisory Board Alzheimer’s Disease- Eisai (personal payment). Lenka Krajčovičová: No COI. Milica G. Kramberger: MGK has received consulting fees from Lilly; MGKhas received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Lilly; MGK has participated in a Data Safety Monitoring Board or Advisory Board for Lilly. Bernadette McGuinness: has received consulting fees from Biogen, Lilly, Eisai (payment made personally); has received payment or honoraria for Chair for Lilly sponsored event at British Geriatrics Society meeting 2024 (payment made personally). Patrizia Mecocci: PM has received grants or contracts from HORIZON-JU-RIA Program AD-Riddle, Horizon 2020 Lethe; PM has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Piam, Angelini, Epitech; PM has participated in a Data Safety Monitoring Board or Advisory Board Primus; PM is Treasurer Italian Academy of Geriatrics, Member Board of Directors SIGOT. Timo Jan Oberstein: TJO received lecture honoraria from: Biogen, Lilly, Siemens Healthineers. Pierre-Jean Ousset: has received consulting fees from Eli Lilly’s, EISAI’s, International Board and national board. Claire Paquet: CP has received consulting fees from Eli Lilly’s, EISAI’s, Roche’s, Novo Nordisk’s, UCB’s International Board and national board; CP has received payment or honoraria for lectures for Eli Lilly and EISAI; CP has received payment for expert testimony from Eli Lilly (national testimony with patient in April 2025). Robert Perneczky: RP has received honoraria for advisory boards and speaker engagements from Roche, EISAI, Eli Lilly, Biogen, Janssen-Cilag, Astra Zeneca, Schwabe, Grifols, Novo Nordisk and Tabuk. Fabrizio Piazza: Consulting fees, advisory board fees, and educational activities, paid to the University of Milano Bicocca, with Alnylam Pharmaceuticals, Roche, Biogen, Alector, Lilly, Araclon, Eisai. FP is the inventor, without ownership, of the amyloid-beta antibody ultrasensitive assay. Domenico Plantone: DP received travel reimbursments from Fujirebio Italia srl. Innocenzo Rainero: IR has recevied consulting honoraria from Eli Lilly. Guillaume Sacco: has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from EISAI and Biogen, has received support for attending meetings and/or travel from Biogen and BMS. Eric Salmon: Advisory Board for Biogen, Eisai, Will Pharma. Isabel Santana: IS has received funding through the University of Coimbra: for IISSs from FCT (National Agency for Research), ROCHE Pharmaceuticals OM Pharma Biogen Pharmaceuticals . She has received payment or honoraria for lectures, presentations, speakers or bureaus, from: Biogen, Lilly, EISAI, Novo Nordisk. Nikolaos Scarmeas: Novo Nordisk - Local PI of recruiting site for multinational, multicenter industry sponsored phase III treatment trial for Alzheimer's disease - funding to institution. Anja Schneider: Research Grant from Eisai (2020-2023), SAB for Biogen CELIA study, received honoraria from Eisai and Biogen. Jonathan M Schott: JMS has received research funding and PET tracer from AVID Radiopharmaceuticals (a wholly owned subsidiary of Eli Lilly) and Alliance Medical; has consulted for Roche, Eli Lilly, Biogen, MSD and GE; and received royalties from Oxford University Press and Henry Stewart Talks. He is an NIHR Senior Investigator and Chief Medical Officer for Alzheimer’s Research UK. Eino Solje: E. Solje has served on the advisory board of Novartis, EISAI, Lilly and Roche, served as a consult for Novo Nordisk, BioaArctic, EISAI, Lilly and Roche and received honoraria from for lectures from Lundbeck, BioaArctic and Roche and travel support from Lilly. Elka Stefanova: ES has received grants from AACSFD-17–533520, IGPCC-B-1262787, National Grant Republic of Serbia (451–03–66/2024-03/200110) (payment made to the institution); ES has received support for attending meetings and/or travel from Teva, Goodwil Pharma, Krka (payment made to the institution). Elisabeth Stögmann`s institution (Medical University of Vienna, Austria) received financial support by research grants for research in AD: Eisai, EU Horizon 2020, Austrian Research Promotion Agency). Elisabeth Stögmann`s institution (Medical University of Vienna, Austria) received financial support for participation in clinical trials from Biogen, Novo Nordisk and Roche Diagnostics. Elisabeth Stögmann received honoraria (consultations, lectures, speakers bureaus, educational events, advisory boards) from pharmaceutical companies: Biogen, Roche, Novo Nordisk, Eisai, Novartis, Sanofi and Lilly. Elisabeth Stögmann held leadership in scientific societies: Austrian Alzheimer Association. Mélanie Strauss: consulted for Eisai. Stanislav Sutovsky No COI. Gunhild Waldemar: GW reported no conflicts of interest. Bengt Winblad: BW serves as member of Scientific Advisory Boards (SABs) for Alzinova, Axon Neuroscience, Artery Therapeutics, Phanes Biotech and is a member of the DSMB for Primus-AD. BW has stocks in Artery Therapeutics and AlzeCure.

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