ArticleJournal of Alzheimer's disease reports
Comparison between treatment-placebo difference and saved time measures to assess treatment effect in Alzheimer's disease.
Article in Journal of Alzheimer's disease reports. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
3 authors.
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Abstract
Background: The estimated treatment-placebo difference from fitted statistical models is often used to evaluate the treatment effect. In addition, we may use time saving as an alternative measure to assess the treatment benefit to patients. Two methods were developed to estimate saved time based on the placebo or treatment disease progression curve. Objective: In this article, we are interested in comparing the performance of the traditional model and saved time measures with regards to the statistical hypothesis testing. Methods: By mimicking data from the Phase 2 and 3 donanemab trials, we studied three different treatment disease progression trajectories. Results: The traditional treatment-placebo difference model often has higher statistical power values than the saved time methods when sample size is small to medium. As sample size goes up, saved time methods have similar statistical power and they could be more powerful than the traditional model in some cases. Conclusions: Saved time methods may be considered in future Alzheimer's disease trials to improve the efficiency in drug discovery.
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