Demographic data supporting FDA authorization of AI devices for Alzheimer disease and related dementias

JAMA

2025-07-30

(Press-News.org) About The Study: Transparency of evidence supporting Food and Drug Administration (FDA) authorization of artificial intelligence (AI)- and machine learning -based devices for Alzheimer disease and related dementias was limited, precluding effective evaluation of training and validation dataset representativeness. Disease status (i.e., dementia type and distribution), age, and sex were reported for fewer than half of devices, while race and ethnicity data were rarely disclosed, raising uncertainty about real-world generalizability and clinical accuracy in intended populations.

Corresponding Author: To contact the corresponding author, Ravi Gupta, MD, MSHP, email ravigupta@jhmi.edu.

To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/

(doi:10.1001/jama.2025.12779)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.

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Media advisory: This study is being presented at the Alzheimer’s Association International Conference.

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Demographic data supporting FDA authorization of AI devices for Alzheimer disease and related dementias

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