{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T22:09:15Z","timestamp":1790633355357,"version":"4.1.0"},"reference-count":33,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2011,7,11]],"date-time":"2011-07-11T00:00:00Z","timestamp":1310342400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"French Ministry of Health","award":["PHRC 98-47 N"],"award-info":[{"award-number":["PHRC 98-47 N"]}]},{"name":"French Ministry of Health","award":["PHRC 18-05"],"award-info":[{"award-number":["PHRC 18-05"]}]},{"name":"CIFRE","award":["2007\/189"],"award-info":[{"award-number":["2007\/189"]}]},{"name":"Ipsen Pharma and the French National Association of Technical Research"}],"content-domain":{"domain":["alz-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Alzheimer's &amp;amp; Dementia"],"published-print":{"date-parts":[[2011,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Clinical measures continue to be used as primary endpoints for disease\u2010modifying trials for Alzheimer's disease (AD). Currently, two co\u2010primary endpoints must be specified, which measure cognitive and functional impairments. Generally, the Alzheimer's Disease Assessment Scale\u2010Cognitive Subscale (ADAS\u2010Cog) is one of the co\u2010primary endpoints, but high variability in this measure results in large sample sizes. We evaluated the psychometric properties of the Clinical Dementia Rating\u2010Sum of Boxes (CDR\u2010SB) to assess its suitability as a single primary endpoint as an alternative to the traditional co\u2010primary approach.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Internal consistency, structural and convergent validity, and 2\u2010year internal and external responsiveness of the CDR\u2010SB were assessed in 667 very mild to moderate (global Clinical Dementia Rating, 0.5\u20132) AD patients from the REAL.FR (R\u00e9seau sur la Maladie d'Alzheimer Fran\u00e7ais) study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The CDR\u2010SB showed good internal consistency (Cronbach's alpha = 0.88), and acceptable structural (separate \u201ccognitive\u201d and \u201cfunctional\u201d factors) and convergent validity. Variability in mean changes over time was low, leading to excellent internal responsiveness (effect size = 1.2; standardized response mean = 1.17 at 2 years) and smaller sample sizes as compared with the ADAS\u2010Cog. External responsiveness was acceptable when compared with \u201cclinically meaningful\u201d changes on the Activities of Daily Living scale but only borderline acceptable when compared with the ADAS\u2010Cog and Instrumental Activities of Daily Living. Levels of missing data and floor\/ceiling effects were low.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The CDR\u2010SB measures cognitive and functional impairment simultaneously, and has excellent 2\u2010year internal responsiveness. This makes it a promising candidate as a sole primary endpoint for AD trials, although more work is required to determine the clinical relevance of CDR\u2010SB changes, and its usefulness as an endpoint at other disease stages.<\/jats:p><\/jats:sec>","DOI":"10.1016\/j.jalz.2011.01.005","type":"journal-article","created":{"date-parts":[[2011,7,15]],"date-time":"2011-07-15T05:05:55Z","timestamp":1310706355000},"page":"602","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":93,"title":["Suitability of the Clinical Dementia Rating\u2010Sum of Boxes as a single primary endpoint for Alzheimer's disease trials"],"prefix":"10.1002","volume":"7","author":[{"given":"Nicola","family":"Coley","sequence":"first","affiliation":[{"name":"INSERM U558\u2014University of Toulouse III F\u201031073 Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandrine","family":"Andrieu","sequence":"additional","affiliation":[{"name":"INSERM U558\u2014University of Toulouse III F\u201031073 Toulouse France"},{"name":"Department of Epidemiology and Public Health CHU Toulouse Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Jaros","sequence":"additional","affiliation":[{"name":"Elan Pharmaceuticals South San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Weiner","sequence":"additional","affiliation":[{"name":"Department of Veterans Affairs Medical Center University of California San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jesse","family":"Cedarbaum","sequence":"additional","affiliation":[{"name":"Elan Pharmaceuticals South San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Vellas","sequence":"additional","affiliation":[{"name":"INSERM U558\u2014University of Toulouse III F\u201031073 Toulouse France"},{"name":"Department of Geriatric Medicine Alzheimer Centre, CHU Toulouse Gerontopole Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2011,7,11]]},"reference":[{"key":"e_1_2_8_2_2","unstructured":"EMEA Committee for Medicinal Products for Human Use (CHMP).Guideline on medicinal products for the treatment of Alzheimer's disease and other dementias. 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