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

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

Timothy S Anderson  1 , John Z Ayanian  2   3 , Jeffrey Souza  4 , Bruce E Landon  4
Affiliations

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

Timothy S Anderson et al. JAMA. .

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Anderson reported receiving grants from the National Institute on Aging (NIA) during the conduct of the study and personal fees from Alosa Health and grants from the American College of Cardiology and Boston Claude D. Pepper Older Americans Independence Center outside the submitted work. Dr Ayanian reported receiving grants from the NIA during the conduct of the study and grants from the National Library of Medicine, Michigan Department of Health and Human Services, and Merck Foundation; personal fees from The JAMA Network, the New England Journal of Medicine, Harvard University, University of Massachusetts Medical School, and University of Chicago; and nonfinancial support from the National Academy of Medicine, the National Institutes of Health, and AcademyHealth outside the submitted work. Dr Landon reported receiving grants from the NIA during the conduct of the study. No other disclosures were reported.

Figures

Figure.
Figure.. Prevalence of Aducanumab Trial Exclusion Criteria Among Medicare Beneficiaries With Alzheimer Disease and Mild Cognitive Impairment
ADRDs indicates Alzheimer disease and related disorders; AD, Alzheimer disease; and MCI, mild cognitive impairment.
See this image and copyright information in PMC

References

    1. Alexander GC, Emerson S, Kesselheim AS. Evaluation of aducanumab for Alzheimer disease: scientific evidence and regulatory review involving efficacy, safety, and futility. JAMA. 2021;325(17):1717-1718. doi:10.1001/jama.2021.3854 - DOI - PubMed
    1. Centers for Medicare & Medicaid Services . Chronic Conditions Data Warehouse. Accessed July 10, 2021. https://www2.ccwdata.org/web/guest/condition-categories
    1. ClinicalTrials.gov . 221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer’s Disease (EMERGE). Accessed July 10, 2021. https://clinicaltrials.gov/ct2/show/NCT02484547
    1. ClinicalTrials.gov . 221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer’s Disease (ENGAGE). Accessed July 10, 2021. https://clinicaltrials.gov/ct2/show/NCT02477800
    1. US Food and Drug Administration. Aducanumab (marketed as Aduhelm) information. Accessed July 14, 2021. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-an...

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