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Lecanemab for Patients With Early Alzheimer Disease

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Key Points Question The US Food and Drug Administration has promoted innovation in clinical trial design via the bayesian approach; does that make clinical trials more efficient? Findings In this… Click to show full abstract

Key Points Question The US Food and Drug Administration has promoted innovation in clinical trial design via the bayesian approach; does that make clinical trials more efficient? Findings In this bayesian analysis of a randomized trial, the bayesian design assigned most patients to better performing doses. Appropriately accounting for missing data our analyses found that the most effective dose of lecanemab nearly doubles efficacy at 18 months relative to placebo in comparison with restricting to patients who completed follow-up. Meaning These results suggest that innovations associated with using the bayesian approach improve the efficiency of drug development and the accuracy of clinical trials, even when there is substantial data missingness.

Keywords: patients early; alzheimer disease; lecanemab patients; early alzheimer

Journal Title: JAMA Network Open
Year Published: 2023

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