Representativeness of Participants Eligible to Be Enrolled in Clinical Trials of Aducanumab for Alzheimer Disease Compared With Medicare Beneficiaries With Alzheimer Disease and Mild Cognitive Impairment

JAMA. 2021 Oct 26;326(16):1627-1629. doi: 10.1001/jama.2021.15286.


This study evaluates whether patients enrolled in trials of aducanumab, EMERGE and ENGAGE, were representative of patients with dementia enrolled in Medicare by estimating the proportions of Medicare beneficiaries with Alzheimer disease (AD) or mild cognitive impairment (MCI) who would have been excluded from these trials.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Alzheimer Disease / drug therapy*
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Clinical Trials, Phase III as Topic
  • Cognitive Dysfunction / drug therapy*
  • Contraindications, Drug
  • Drug Approval
  • Early Termination of Clinical Trials*
  • Female
  • Humans
  • Insurance Claim Review / statistics & numerical data
  • Male
  • Medicare / statistics & numerical data*
  • Middle Aged
  • Patient Selection
  • United States
  • United States Food and Drug Administration


  • Antibodies, Monoclonal, Humanized
  • aducanumab