Accepted for Publication: October 3, 2019.
Published Online: November 25, 2019. doi:10.1001/jamaneurol.2019.3988
Correction: This article was corrected on July 13, 2020, to fix the mean data reported for lanabecestat 20 mg vs placebo in DAYBREAK-ALZ.
Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License. © 2019 Wessels AM et al. JAMA Neurology.
Corresponding Author: John R. Sims, MD, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285 (sims_john_r@lilly.com).
Author Contributions: Drs Wessels and Tariot contributed equally to this work as co–first authors. Dr Sims had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Wessels, Tariot, Zimmer, Downing, Willis, Shering, Sims.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Wessels, Zimmer, Selzler, Willis.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Andersen, Landry, Willis, Barker, Schumi.
Administrative, technical, or material support: Wessels, Zimmer, Selzler, Bragg, Downing, Willis, Shering, Sims.
Supervision: Wessels, Tariot, Zimmer, Mullen, Shering, Matthews, Sims.
Conflict of Interest Disclosures: Drs Wessels, Zimmer, Selzler, Krull, Downing, Willis, Shcherbinin, Matthews, and Sims; Ms Bragg; and Messrs Andersen and Landry reported being full-time employees and minor shareholders of Eli Lilly and Company. Dr Tariot reported receiving personal fees from AbbVie, AC Immune, Acadia, Auspex, Boehringer Ingelheim, Chase Pharmaceuticals, Corium, Eisai, GliaCure, INSYS Therapeutics, Pfizer, and T3D; receiving grants and personal fees from AstraZeneca, Avanir, Biogen, Eli Lilly and Company, H. Lundbeck A/S, Merck and Company, Roche, and Takeda; receiving grants from Amgen, Avid, GE Healthcare, Genentech, Novartis, National Institute on Aging, and Arizona Department of Health Services; owning stock options in Adamas; and being a contributor on a patent owned by the University of Rochester. Drs Mullen, Barker, Schumi, and Shering reported being employees of AstraZeneca, which holds the intellectual property for lanabecestat, and being minor shareholders of AstraZeneca. Drs Barker, Schumi, and Shering reported having a lanabecestat patent held by AstraZeneca pending and issued. Dr Stern reported receiving personal fees from Eli Lilly and Company and Biogen, receiving grants from Avid Radiopharmaceuticals (a subsidiary of Eli Lilly and Company), and receiving royalties for published neuropsychological tests from Psychological Assessment Resources, Inc. Dr Vellas reported being a member of scientific boards for Otsuka, Eli Lilly and Company, Nestlé, MSD, Biogen, Roche, Accera, and Arcadia and receiving research grants from AbbVie, Eli Lilly and Company, Lundbeck, MSD, AstraZeneca, Nestlé, and Novartis. Dr Cohen reported receiving grants from Eli Lilly and Company to her research site for execution of lanabecestat clinical trials, receiving consultancy payments from Eli Lilly and Company for her participation in the lanabecestat steering committee, and receiving grants from Merck. Dr Boada reported receiving fees or consulting compensation from Servier, Roche, Eli Lilly and Company, Avid, Bayer, Elan, Janssen, Neuroptix, and Sanofi; receiving fees for lectures from Eli Lilly and Company, Nutricia, Roche, Schwabe Farma Ibérica SLU, Araclon, Esteve, Grifols, Janssen, Novartis, Piramal Imaging Limited, Pfizer-Wyett, and Servier; receiving fees for being part of the advisory board of Eli Lilly and Company and Schwabe Farma Ibérica SLU; and receiving grants or research funding from AbbVie, Araclon, Biogen Research Limited, Bioiberica, Grifols, Eli Lilly and Company, Merck Sharp & Dohme, Merck Inc, Kyowa Hakko Kirin, Servier, Nutricia SRL, Oryzon Genomics, Piramal Imaging Limited, Roche Pharma SA, and Schwabe Farma Ibérica SLU. No other disclosures were reported.
Funding/Support: Eli Lilly and Company and AstraZeneca provided the funding for the study.
Role of the Funder/Sponsor: Eli Lilly and Company was responsible for data collection, monitoring, and statistical analyses. AstraZeneca was responsible for manufacturing investigational product and matching placebo. AstraZeneca participated in the study designs, and both companies interpreted the data and reviewed the manuscript. All final content decisions were made by the authors.
Data Sharing Statement: See Supplement 3.
Additional Contributions: Patricia Bennett, MS, a full-time employee of Eli Lilly and Company, contributed to the data analyses. Writing support was provided by Sriram Govindan, PhD, and Rohit Bhandari, PhD (both full-time employees of Eli Lilly Services India Private Limited). None were compensated for their contributions. We thank all patients, site employees, investigators, vendor partners, employees, and former employees of Eli Lilly and Company and AstraZeneca.
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