Suitability of the Clinical Dementia Rating-Sum of Boxes as a single primary endpoint for Alzheimer’s disease trials

Clinical measures continue to be used as primary endpoints for disease‐modifying trials for Alzheimer's disease (AD). Currently, two co‐primary endpoints must be specified, which measure cognitive and functional impairments. Generally, the Alzheimer's Disease Assessment Scale‐Cognitive Subscale (ADAS‐Cog) is one of the co‐primary endpoints, but high variability in this measure results in large sample sizes. We evaluated the psychometric properties of the Clinical Dementia Rating‐Sum of Boxes (CDR‐SB) to assess its suitability as a single primary endpoint as an alternative to the traditional co‐primary approach.

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