Efficacy assessment of an active tau immunotherapy in Alzheimer's disease patients with amyloid and tau pathology: a post hoc analysis of the "ADAMANT" randomised, placebo-controlled, double-blind, multi-centre, phase 2 clinical trial.

"Declaration of interests Nick Cullen received personal fees from AXON Neuroscience SE. All authors affiliated with AXON NEUROSCIENCE SE or one of its subsidiaries received salary from their respective companies. Jozef Hanes, Eva Kontsekova, and Branislav Kovacech report patents with AXON Neuroscience R&D Services SE. Petr Novak received payments from F. Hoffmann-La Roche AG. The investigators’ institutions received reimbursement on a per-patient per-visit basis. Duygu Tosun’s institution received payments from AXON Neuroscience for image processing, and payments to the institution from Siemens Medical Solutions USA, Inc., Takeda Pharmaceutical Company Ltd., DOD WW81XWH-19-1-0669, NIH/NIA U19AG024904, NIH/NIA U01AG068057, NIH/NIA U24AG074855, NIH/NIA R01AG058676. Reinhold Schmidt has received personal fees and honoraria for image analyses from AXON NEUROSCIENCE. Stefan Ropele reports no conflict of interest. Bengt Winblad reports personal fees for taking part in Scientific Advisory Board meetings and Data Safety Management Board meetings from AXON NEUROSCIENCE, and from Alzinova DSMB and Artery TX SAB. Dr. Feldman reports a service agreement between Axon Neuroscience and UCSD for consulting and travel with all payments to UCSD and no personal funds received. Other activities to report include: grant funding from Annovis (QR Pharma), Vivoryon (Probiodrug), AC Immune, and LuMind; service agreements for consulting activities with LuMind, Genentech (DSMB), Roche/Banner (DMC), Tau Consortium (SAB), Samus Therapeutics, Biosplice Therapeutics, Novo Nordisk Inc., Janssen Research & Development LLC, and Arrowhead Pharmaceuticals with no personal funds received and all payments to UCSD. He also reports a philanthropic donation to UCSD from the Epstein Family Alzheimer's Disease Collaboration for therapeutic research in AD."

"The clinical trial and the present analysis were wholly financed by AXON NEUROSCIENCE SE."

"The approving ethics committees and approval numbers are as follows: Austria–Ethikkommission der Medizinischen Universität Graz, 28-092 ex 15/16; Czech Republic–Eticka komise Fakultni nemocnice v Motole, EK-1747/15; Germany–Ethik-Kommission II der Universität Heidelberg Universitätsklinikum Mannheim, 2016-001F-MA; Poland–Komisja Bioetyczna przy Bydgoskiej Izbie Lekarskiej, 20/2016; Romania–Comisia Nationala de Bioetica a Medicamentului si a Dispozitivelor Medicale, 159S/21.12.2015; Slovakia–Etická komisia Univerzitnej nemocnice L. Pasteura Košice, EK/15/09; Slovenia–Komisja Republike Slovenije za medicinsko etiko, 0120-307/2016-12; Sweden–Regionala etikprövningsnämnden i Stockholm 2015/2263-31/4. The study is registered under EudraCT 2015-000630-30 and NCT02579252. The EudraCT is the primary record."