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Statistical modeling can be used to find the best weighted combination of items for measuring progression in a given population.
Because there are no validated biomarkers in AD, it is important to seek out clinical outcomes that are also sensitive for measuring progression in these very early stages of disease.
Neuropsychological cognitive testing items are optimal for measuring progression in pre-MCI populations, and current research is exploring the best ways to combine these items into a composite cognitive score with maximum responsiveness.
Instead, the focus will be on describing the methods for identifying populations and the methods for developing new clinical composites for measuring progression in MCI and pre-MCI populations in support of clinical trial design decisions.
Because this field is rich in reliable and validated neuropsychological tests (including cognitive outcomes that measure many different cognitive domains and outcomes that measure function and global changes), the focus should be on improving responsiveness as the primary challenge in measuring progression in MCI and pre-MCI populations.
In this study, we described a new scoring methodology for the ADAS-Cog called the ADAS-CogIRT, which addresses several major limitations of the current scoring methodology and significantly improves the sensitivity of the ADAS-Cog in measuring progression in cognitive impairment in clinical trials.
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A formal measure of TTCW has emerged as an attractive composite endpoint that measures progression in PAH.
Different weighting of ADAS-cog items in order to minimize the impact of these less sensitive items or even eliminate these items from the scale results in a cognitive composite with improved sensitivity in measuring progression over time in MCI subjects [ 19].
The proposed scoring methodology significantly improves the sensitivity of the ADAS-Cog in measuring progression of cognitive impairment in clinical trials focused in the mild-to-moderate Alzheimer's disease stage.
However, several concerns have been raised recently regarding its sensitivity in measuring progression of cognitive impairment in clinical trials [ 2– 5].
As a result, the ADAS-Cog is limited in measuring progression of cognitive impairment over the course of disease progression.
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