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- W2897050989 abstract "Despite significant advances in our understanding of Alzheimer's disease (AD) etiology, large-scale clinical drug trials continue to fail. This might partly stem from early phase trials producing spurious results due to small biased patient samples and clinical endpoints that lack sensitivity to drug treatment effects. Many conventional clinical endpoints perform disparately across disease stages, produce high variability and small effect sizes and are burdensome to patients and sites and expensive to implement in larger clinical trials. Taking a holistic approach to assessing CNS function by incorporating more direct physiological measures that are clinically relevant and can be applied more frequently may result in better detection of true treatment effects. There is great anticipation that digital technology will enable improved assessments of CNS function and result in more informative clinical trials. Exciting new technologies are rapidly emerging and numerous research efforts focus on advancing these technologies for drug development. However, it is not clear how to evaluate these technologies or how to use them to derive new digital endpoints that can more effectively detect treatment effects in AD. We have designed an experimental clinical study development plan for advancing promising digital endpoints. Here we describe the plans for a non-interventional methodological study in preclinical to mild AD and a novel scorecard to determine the success or failure of each endpoint. The primary objectives are a) to test the feasibility of a range of novel digital endpoints and b) to compare them head-to-head vs. conventional endpoints. The digital technologies selected for this study include computerized and digitized cognitive testing, dual tasking paradigms, gait and eye motor tracking, as well as novel EEG methods. This study pilots a novel scorecard for evaluating digital endpoints and will help identify endpoints worth advancing further. There is an urgent need for methods to identify improved efficacy endpoints. Stringent and predefined decision making tools are needed to evaluate the growing influx of novel digital endpoints. More informative digital endpoints may result in more efficient Phase 2 trials in AD and stronger confidence when it comes to advancing new investigational drugs to Phase 2b/3." @default.
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- W2897050989 date "2018-07-01" @default.
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- W2897050989 title "P4‐339: THE MEDIA STUDY: A NOVEL METHOD FOR EVALUATING DIGITAL ENDPOINTS IN ALZHEIMER'S DISEASE" @default.
- W2897050989 doi "https://doi.org/10.1016/j.jalz.2018.07.162" @default.
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