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Authors
Klein, Gregory
Delmar, Paul
Voyle, Nicola
Rehal, Sunita
Hofmann, Carsten
Abi-Saab, Danielle
Andjelkovic, Mirjana
Ristic, Smiljana
Wang, Guoqiao
Bateman, Randall
Kerchner, Geoffrey A.
Baudler, Monika
Fontoura, Paulo
Doody, Rachelle
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Funding
Funding for this research was provided by:
F. Hoffmann-La Roche (n/a)
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Article History
Received: 24 July 2019
Accepted: 19 November 2019
First Online: 12 December 2019
Ethics approval and consent to participate
: The study protocol was approved by the respective institutional review boards prior to participant recruitment and was conducted in accordance with US Food and Drug Administration regulations, International Council on Harmonization E6 Guideline for Good Clinical Practice, and applicable local, state, federal, and country laws.
: Not applicable
: GK, PD, SRi, CH, DA-S, MA, MB, and PF are full-time employees of F. Hoffmann-La Roche Ltd. GK, CH, DA-S are shareholders in F. Hoffmann-La Roche Ltd. SRe and NV are full-time employees of Roche Products Ltd. RD is a full-time employee and shareholder in F. Hoffmann-La Roche Ltd. and Genentech Inc. GW is the statistician for the DIAN-TU study and has no competing interests to disclose. RB is a principal investigator of a therapeutic trial evaluating investigational drugs. Washington University is also the regulatory sponsor for this trial. Funding for DIAN-TU clinical trials includes the National Institute on Aging of the National Institutes of Health, Alzheimer’s Association, Eli Lilly and Co, F. Hoffmann-La Roche Ltd. and Genentech, Inc., Janssen, Avid Radiopharmaceuticals, GHR Foundation, and an anonymous foundation. Washington University and Dr. David Holtzman, Department Head of Neurology at Washington University School of Medicine, may receive royalty income for the investigational drug, solanezumab, which is being tested in the DIAN-TU trial and was developed by Dr. Holtzman and licensed by Washington University to Eli Lilly & Company. RB also receives research funding from the DIAN-TU Pharma Consortium (AbbVie, Biogen, Eisai, Eli Lilly and Co/Avid Radiopharmaceuticals, F. Hoffmann-La Roche Ltd. and Genentech, Inc., Janssen, and United Neuroscience); and has received honoraria from Janssen, Pfizer, and F. Hoffmann-La Roche Ltd. as a speaker, Eisai as a consultant, and from Merck, F. Hoffmann-La Roche Ltd., and Pfizer as an Advisory Board member.
