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Article type: Research Article
Authors: Costa, Tommasoa; b; * | Cauda, Francoa; b
Affiliations: [a] GCS-fMRI, Koelliker Hospital and Department of Psychology, University of Turin, Turin, Italy | [b] FOCUS Lab, Department of Psychology, University of Turin, Turin, Italy
Correspondence: [*] Correspondence to: Tommaso Costa, Department of Psychology, Via Verdi 10, 10124 Turin, Italy. Tel.: +39 011 670 39 24; E-mail: tommaso.costa@unito.it.
Abstract: Background:In December 2019, in light of additional blinded data, Biogen claimed efficacy of the drug Aducanumab (ADU). Objective:We conducted a reanalysis of the phase III ADU summary statistics, focusing in particular on the Clinical Dementia Rating-Sum of Boxes. Methods:We used a Bayesian framework to mitigate the problems of the null-hypothesis significance testing framework. In particular, we used Bayes Factor (BF) to analyze the summary statistics. The BF is the comparison of how well two hypotheses predict the data. Results:Our results showed that the evidence for ADU efficacy is very low. The results show that the only data with a BF value in favor of the alternative hypothesis (i.e., drug efficacy) is the high-dose condition in the EMERGE trial. However, the obtained BF falls within the range of values considered anecdotal, meaning a low level of evidence. Conclusion:We provide a clearer interpretation of the results of the clinical trials based on the Bayesian framework, as this may be useful for future development and research in the field.
Keywords: Alzheimer’s disease, bayesian statistics, clinical trial, drugs
DOI: 10.3233/JAD-220132
Journal: Journal of Alzheimer's Disease, vol. 87, no. 3, pp. 1009-1012, 2022
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