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Updated: Sep 27, 2025

Basics of Multivariate Analysis in Neuroimaging Data
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A Bayesian Reanalysis of the Phase III Aducanumab (ADU) Trial

Tommaso Costa1,2, Franco Cauda1,2

  • 1GCS-fMRI, Koelliker Hospital and Department of Psychology, University of Turin, Turin, Italy.

Journal of Alzheimer'S Disease : JAD
|April 11, 2022
PubMed

Insights

Evidence for Aducanumab (ADU) efficacy in Alzheimer's disease is very low. A Bayesian reanalysis of Phase III trial data found only anecdotal evidence supporting drug effectiveness.

Area of Science:

  • Neuroscience
  • Clinical Trials
  • Biostatistics

Background:

  • Biogen claimed Aducanumab (ADU) efficacy based on blinded data in December 2019.
  • ADU is a drug investigated for Alzheimer's disease treatment.

Purpose of the Study:

  • To reanalyze Phase III Aducanumab (ADU) trial summary statistics.
  • To focus on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) for efficacy assessment.
  • To apply a Bayesian framework for a more robust interpretation of trial results.

Main Methods:

  • Reanalysis of Phase III ADU trial summary statistics.
  • Utilized a Bayesian framework to address limitations of null-hypothesis significance testing.
  • Employed Bayes Factor (BF) for analyzing summary statistics and comparing hypothesis prediction of data.

Main Results:

  • The overall evidence for ADU efficacy was found to be very low.
  • Only the high-dose EMERGE trial data showed a BF value favoring the alternative hypothesis (drug efficacy).
  • The BF value for the high-dose EMERGE trial was in the anecdotal range, indicating low evidence.

Conclusions:

  • The Bayesian reanalysis provides a clearer interpretation of Aducanumab clinical trial results.
  • The findings suggest limited evidence for ADU's effectiveness in Alzheimer's disease.
  • This Bayesian approach may inform future drug development and research in neurodegenerative diseases.
Abstract

Keywords:
Alzheimer’s diseasebayesian statisticsclinical trialdrugs

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