Subsets of a large cognitive battery better power clinical trials on early stage Alzheimer's disease

大型认知测试套件的子集能更好地支持早期阿尔茨海默病临床试验。

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Abstract

BACKGROUND/AIMS: Cognitive batteries routinely used by the Alzheimer's disease (AD) research community may contain items that are uninformative for tracking disease progression to power clinical trials on early stage AD. We aim to identify the subsets of the most informative items from an existing cognitive battery to better power clinical trials on early AD. METHODS: Longitudinal change in item scores from the battery was associated with the onset of mild cognitive impairment (MCI) in 1,513 elderly individuals. Items whose longitudinal changes were correlated with the onset of MCI were selected as informative for tracking the early cognitive progression. RESULTS: 226 items in the battery were annually assessed over a follow-up of up to 13 years. Changes of item scores over time from 187 items were significantly correlated with the onset of MCI. For clinical trials on preclinical AD and on MCI, informative items permit smaller or similar sample sizes as compared to the entire battery, whereas uninformative items require much larger sample sizes. CONCLUSIONS: Longitudinal changes in item scores from about 17% of items in the cognitive battery are uninformative for tracking early disease progression. Clinical trials on early AD can be better powered using informative items rather than the entire battery.

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