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

This analysis found 92.2% of patients with Alzheimer disease (AD) and related disorders, 91% with AD and 85.5% with mild cognitive impairment met at least one exclusion criteria for the EMERGE and ENGAGE clinical trials of aducanumab; most commonly due to CV disease.

SPS commentary:

The authors report that most patients met multiple exclusion criteria, including 77.4% of patients with Alzheimer disease and related disorders and 64.4% with mild cognitive impairment. They say these findings are concerning considering the broad FDA labelling for aducanumab; the increased risk of vascular oedema and haemorrhages observed in the clinical trials are likely to be higher in populations ineligible for the trials, particularly in those with prior stroke or chronic conditions treated with antiplatelets or anticoagulants.

Journal of the American Medical Association