Novel Statistically-Derived Composite Measures for Assessing the Efficacy of Disease-Modifying Therapies in Prodromal Alzheimer's Disease Trials: An AIBL Study
Samantha C Burnham, Nandini Raghavan, William Wilson, David Baker, Michael T Ropacki, Gerald Novak, David Ames, Kathryn Ellis, Ralph N Martins, Paul Maruff, Colin L Masters, Gary Romano, Christopher C Rowe, Greg Savage, S Lance Macaulay, Vaibhav A Narayan
Journal of Alzheimer's Disease | IOS PRESS | Published : 2015
BACKGROUND: There is a growing consensus that disease-modifying therapies must be given at the prodromal or preclinical stages of Alzheimer's disease (AD) to be effective. A major unmet need is to develop and validate sensitive measures to track disease progression in these populations. OBJECTIVE: To generate novel statistically-derived composites from standard scores, which have increased sensitivity in the assessment of change from baseline in prodromal AD. METHODS: An empirically based method was employed to generate domain specific, global, and cognitive-functional novel composites. The novel composites were compared and contrasted with each other, as well as standard scores for their ab..View full abstract
Awarded by Alzheimer's Disease Neuroimaging Initiative (ADNI) (National Institutes of Health)
Awarded by DOD ADNI (Department of Defense)
Awarded by NATIONAL INSTITUTE ON AGING
AIBL: Core funding for the study was provided by the CSIRO Flagship Collaboration Fund and the Science and Industry Endowment Fund (SIEF) in partnership with Florey Institute of Neuroscience and Mental Health, Edith Cowan University (ECU), Alzheimer's Australia (AA), National Ageing Research Institute (NARI), Austin Health, CogState Ltd., Hollywood Private Hospital, Sir Charles Gardner Hospital. The study also receives funding from the National Health and Medical Research Council (NHMRC), the Dementia Collaborative Research Centres program (DCRC), The McCusker Alzheimer's Research Foundation and Operational Infrastructure Support from the Government of Victoria. AIBL has also received funding from industry to support the cohort including Pfizer, GE, Merck and Janssen.Data collection and sharing for this project was funded by the Alzheimer's Disease Neuroimaging Initiative (ADNI) (National Institutes of Health Grant U01 AG024904) and DOD ADNI (Department of Defense award number W81XWH-12-2-0012). ADNI is funded by the National Institute on Aging, the National Institute of Biomedical Imaging and Bioengineering, and through generous contributions from the following: Alzheimer's Association; Alzheimer's Drug Discovery Foundation; Araclon Biotech; BioClinica, Inc.; Biogen Idec Inc.; Bristol-Myers Squibb Company; Eisai Inc.; Elan Pharmaceuticals, Inc.; Eli Lilly and Company; EuroImmun; F. Hoffmann-La Roche Ltd and its affiliated company Genentech, Inc.; Fujirebio; GE Healthcare; IXICO Ltd.; Janssen Alzheimer Immunotherapy Research & Development, LLC.; Johnson & Johnson Pharmaceutical Research & Development LLC.; Medpace, Inc.; Merck & Co., Inc.; Meso Scale Diagnostics, LLC.; NeuroRx Research; Neurotrack Technologies; Novartis Pharmaceuticals Corporation; Pfizer Inc.; Piramal Imaging; Servier; Synarc Inc.; and Takeda Pharmaceutical Company. The Canadian Institutes Health Research is providing funds to support ADNI clinical sites in Canada. Private sector contributions are facilitated by the Foundation for the National Institutes of Health (http://www.fnih.org). The grantee organization is the Northern California Institute for Research and Education, and the study is coordinated by the Alzheimer's Disease Cooperative Study at the University of California, San Diego. ADNI data are disseminated by the Laboratory for Neuro Imaging at the University of Southern California.