@article{d3f4c707af7b4944b0f9ef971721b45e,
title = "Rationale for use of the Clinical Dementia Rating Sum of Boxes as a primary outcome measure for Alzheimer's disease clinical trials",
abstract = "Background: We used the database of the Alzheimer's Disease Neuroimaging Initiative (ADNI) to explore the psychometric properties of the Clinical Dementia Rating Sum of Boxes (CDR-SB) to consider its utility as an outcome measure for clinical trials in early and mild, as well as later, stages of Alzheimer's disease (AD). Methods: We assessed internal consistency, structural validity, convergent validity, and 2-year internal and external responsiveness of the CDR-SB using data from 382 subjects with early or mild AD at entry into the ADNI study. Results: The CDR-SB assesses both cognitive and functional domains of AD disability. Mean scores declined nearly linearly; CDR-SB cognitive and functional subsums contributed equally to total scores at both very mild (early) and mild stages of the disease. Conclusions: The CDR-SB has psychometric properties that make it attractive as a primary outcome measure that comprehensively assesses both cognitive and functional disability in AD patients. It may prove particularly useful for studies in early, predementia stages of AD.",
keywords = "ADNI, Alzheimer's disease, Clinical trials, Mild cognitive impairment, Outcome measures",
author = "Cedarbaum, {Jesse M.} and Mark Jaros and Chito Hernandez and Nicola Coley and Sandrine Andrieu and Michael Grundman and Bruno Vellas",
note = "Funding Information: ADNI: Data used in the preparation of this article were obtained from the ADNI database ( www.loni.ucla.edu/ADNI ). As such, the investigators within the ADNI contributed to the design and implementation of ADNI and/or provided data but did not participate in analysis or writing of this report. ADNI investigators include (complete listing available at http://www.loni.ucla.edu/ADNI/Collaboration/ADNI_Manuscript_Citations.pdf ). The principal investigator of this initiative is Michael W. Weiner, MD, VA Medical Center and University of California, San Francisco, CA. Subjects have been recruited from more than 50 sites across the United States and Canada. The Foundation for the National Institutes of Health ( www.fnih.org ) coordinates the private sector participation in the ADNI public–private partnership that was begun by the National Institute on Aging and supported by the National Institutes of Health. Corporate contributions have been provided to the Foundation for the National Institutes of Health by Abbott, AstraZeneca AB, Bayer Schering PharmaAG, Bristol-Myers Squibb, Eisai Global Clinical Development, Elan Corporation, Genentech, GE Healthcare, GlaxoSmithKline, Innogenetics, Johnson & Johnson, Eli Lilly and Co., Merck & Co. Inc., Novartis AG, Pfizer Inc., F. Hoffmann-LaRoche, Schering-Plough, Synarc Inc., and Wyeth, as well as nonprofit partners, the Alzheimer's Association and the Institute for the Study of Aging.",
year = "2013",
month = feb,
doi = "10.1016/j.jalz.2011.11.002",
language = "English",
volume = "9",
pages = "S45--S55",
journal = "Alzheimer's and Dementia",
issn = "1552-5260",
publisher = "John Wiley and Sons Inc.",
number = "1 SUPPL.",
}