Protocol for a seamless phase 2A-phase 2B randomized double-blind placebo-controlled trial to evaluate the safety and efficacy of benfotiamine in patients with early Alzheimer’s disease (BenfoTeam)

• Howard H. Feldman ,

  Contributed equally to this work with: Howard H. Feldman, José A. Luchsinger, Gary E. Gibson

  Roles Conceptualization, Funding acquisition, Investigation, Methodology, Writing – original draft, Writing – review & editing

  * E-mail: howardfeldman@health.ucsd.edu

  Affiliations Department of Neurosciences, University of California San Diego, La Jolla, California, United States of America, Alzheimer’s Disease Cooperative Study, University of California San Diego, La Jolla, California, United States of America, Shiley-Marcos Alzheimer’s Disease Research Center, La Jolla, California, United States of America

  https://orcid.org/0000-0002-9258-4538

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• José A. Luchsinger ,

  Contributed equally to this work with: Howard H. Feldman, José A. Luchsinger, Gary E. Gibson

  Roles Conceptualization, Funding acquisition, Investigation, Methodology, Writing – review & editing

  Affiliation Columbia University Irving Medical Center, New York, New York, United States of America

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• Gabriel C. Léger,

  Roles Writing – review & editing

  Affiliations Department of Neurosciences, University of California San Diego, La Jolla, California, United States of America, Alzheimer’s Disease Cooperative Study, University of California San Diego, La Jolla, California, United States of America

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• Curtis Taylor,

  Roles Writing – review & editing

  Affiliations Department of Neurosciences, University of California San Diego, La Jolla, California, United States of America, Alzheimer’s Disease Cooperative Study, University of California San Diego, La Jolla, California, United States of America

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• Diane M. Jacobs,

  Roles Methodology, Writing – review & editing

  Affiliations Department of Neurosciences, University of California San Diego, La Jolla, California, United States of America, Alzheimer’s Disease Cooperative Study, University of California San Diego, La Jolla, California, United States of America, Shiley-Marcos Alzheimer’s Disease Research Center, La Jolla, California, United States of America

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• David P. Salmon,

  Roles Methodology, Writing – review & editing

  Affiliations Department of Neurosciences, University of California San Diego, La Jolla, California, United States of America, Alzheimer’s Disease Cooperative Study, University of California San Diego, La Jolla, California, United States of America, Shiley-Marcos Alzheimer’s Disease Research Center, La Jolla, California, United States of America

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• Steven D. Edland,

  Roles Methodology, Writing – review & editing

  Affiliations Department of Neurosciences, University of California San Diego, La Jolla, California, United States of America, Alzheimer’s Disease Cooperative Study, University of California San Diego, La Jolla, California, United States of America, Shiley-Marcos Alzheimer’s Disease Research Center, La Jolla, California, United States of America

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• Karen Messer,

  Roles Methodology, Writing – review & editing

  Affiliations Department of Neurosciences, University of California San Diego, La Jolla, California, United States of America, Alzheimer’s Disease Cooperative Study, University of California San Diego, La Jolla, California, United States of America

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• Carolyn Revta,

  Roles Project administration, Writing – review & editing

  Affiliations Department of Neurosciences, University of California San Diego, La Jolla, California, United States of America, Alzheimer’s Disease Cooperative Study, University of California San Diego, La Jolla, California, United States of America

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• Sarah A. Flowers,

  Roles Methodology, Writing – review & editing

  Affiliation University of Virginia, Charlottesville, Virginia, United States of America

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• Kerry S. Jones,

  Roles Methodology, Writing – review & editing

  Affiliation Nutritional Biomarker Laboratory, MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom

  https://orcid.org/0000-0002-7380-9797

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• Albert Koulman,

  Roles Methodology, Writing – review & editing

  Affiliation Nutritional Biomarker Laboratory, MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom

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• Kevin E. Yarasheski,

  Roles Methodology, Writing – review & editing

  Affiliation C2N Diagnostics, St. Louis, Missouri, United States of America

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• Philip B. Verghese,

  Roles Methodology, Writing – review & editing

  Affiliation C2N Diagnostics, St. Louis, Missouri, United States of America

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• Venky Venkatesh,

  Roles Methodology, Writing – review & editing

  Affiliation C2N Diagnostics, St. Louis, Missouri, United States of America

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• Henrik Zetterberg,

  Roles Methodology, Writing – review & editing

  Affiliations Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden, Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden, Department of Neurodegenerative Disease, UCL Institute of Neurology, Queen Square, London, United Kingdom, UK Dementia Research Institute at UCL, London, United Kingdom, Hong Kong Center for Neurodegenerative Diseases, Clear Water Bay, Hong Kong, China, Wisconsin Alzheimer’s Disease Research Center, University of Wisconsin School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, United States of America

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• January Durant,

  Roles Writing – original draft, Writing – review & editing

  Affiliations Department of Neurosciences, University of California San Diego, La Jolla, California, United States of America, Alzheimer’s Disease Cooperative Study, University of California San Diego, La Jolla, California, United States of America

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• Jody-Lynn Lupo,

  Roles Writing – original draft, Writing – review & editing

  Affiliations Department of Neurosciences, University of California San Diego, La Jolla, California, United States of America, Alzheimer’s Disease Cooperative Study, University of California San Diego, La Jolla, California, United States of America

  https://orcid.org/0000-0002-9323-5727

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• Gary E. Gibson ,

  Contributed equally to this work with: Howard H. Feldman, José A. Luchsinger, Gary E. Gibson

  Roles Conceptualization, Funding acquisition, Investigation, Methodology, Writing – review & editing

  Affiliation Burke Neurological Institute, Weill Cornell Medicine, White Plains, New York, United States of America

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•  [ ... ],
• for the ADCS BenfoTeam Study Group

  ¶Membership of the ADCS BenfoTeam Study Group is provided in the Acknowledgments

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