Journal article
Trial of solanezumab for mild dementia due to Alzheimer's disease
LS Honig, B Vellas, M Woodward, M Boada, R Bullock, M Borrie, K Hager, N Andreasen, E Scarpini, H Liu-Seifert, M Case, RA Dean, A Hake, K Sundell, VP Hoffmann, C Carlson, R Khanna, M Mintun, R DeMattos, KJ Selzler Show all
New England Journal of Medicine | Published : 2018
Abstract
BACKGROUND Alzheimer's disease is characterized by amyloid-beta (Aβ) plaques and neurofibrillary tangles. The humanized monoclonal antibody solanezumab was designed to increase the clearance from the brain of soluble Aβ, peptides that may lead to toxic effects in the synapses and precede the deposition of fibrillary amyloid. METHODS We conducted a double-blind, placebo-controlled, phase 3 trial involving patients with mild dementia due to Alzheimer's disease, defined as a Mini-Mental State Examination (MMSE) score of 20 to 26 (on a scale from 0 to 30, with higher scores indicating better cognition) and with amyloid deposition shown by means of florbetapir positron-emission tomography or Aβ1-..
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Awarded by Bristol-Myers Squibb
Funding Acknowledgements
Supported by Eli Lilly.Dr. Honig reports receiving grant support and consulting fees from Bristol-Myers Squibb, Eisai, Forum Pharmaceuticals, and Lundbeck, grant support and travel support from Eli Lilly, consulting fees from Fujirebio, and grant support from AbbVie, AstraZeneca, Axovant, Biogen, C2N Diagnostics, Genentech, Janssen-Johnson & Johnson, Merck, Pfizer, Roche, TauRx, and vTv Therapeutics; Dr. Vellas, receiving grant support from AbbVie, Pierre Fabre, Regeneron, AstraZeneca, LPG Systems, and Alzheon, grant support and consulting fees from Eli Lilly, Lundbeck, MSD, Otsuka, Roche, Sanofi, and Nestle, and consulting fees from Biogen, Transition Therapeutics, and Takeda Pharmaceutical; Dr. Woodward, receiving grant and travel support and consulting fees from Cognition Therapeutics (CogRx), Nutricia, Merck, Eli Lilly, and Lundbeck, consulting fees and travel support from Seqirus, and grant support from Bristol-Myers Squibb, Eisai, Forum Pharmaceuticals, AbbVie, AstraZeneca, Axovant, Biogen, Buck Institute for Research on Aging, Servier, Sanofi, Genentech, Janssen-Johnson & Johnson, Pfizer, Roche, Prana Biotechnology, Takeda Pharmaceutical-Zinfandel Pharmaceuticals, Novartis, TauRx, and vTv Therapeutics; Dr. Boada, receiving consulting fees, lecture fees, and grant support from Araclon Biotech and Grifols, consulting fees and grant support from Eli Lilly, MSD, Nutricia, and Roche, lecture fees and grant support from Krka, consulting fees and lecture fees from Dr. Willmar Schwabe Pharmaceuticals, consulting fees from AstraZeneca, Janssen, Kyowa Hakko Kirin, and Servier, and grant support from Piramal, Biogen, Fundacio La Caixa, and Bioiberica; Dr. Bullock, serving on an advisory board for Eli Lilly; Dr. Borrie, receiving consulting fees and fees for serving on an advisory board from Eli Lilly and Roche, consulting fees from Mediti Pharma, and grant support from Bristol-Myers Squibb, Eisai, Forum Pharmaceuticals, Lundbeck, Biogen, Genentech, Janssen-Johnson & Johnson, Merck, and Pfizer; Dr. Scarpini, receiving fees for serving on an advisory board for Eli Lilly; Dr. Liu-Seifert, Mr. Case, Dr. Hake, Dr. Khanna, and Dr. Selzler, being employed by and being shareholders in Eli Lilly; Dr. Dean, Ms. Sundell, Dr. Poole Hoffmann, Dr. Carlson, and Dr. Siemers, being formerly employed by and holding stock in Eli Lilly; Dr. Mintun, being employed by Eli Lilly and Avid Radiopharmaceuticals; and Dr. DeMattos, being employed by Eli Lilly and holding a patent (U.S. patent number, 7195761 B2) for humanized antibodies that sequester amyloid-beta peptide, for which no royalties have been received. No other potential conflict of interest relevant to this article was reported.