JAMA : the journal of the American Medical Association
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Comment Observational Study
Blood Biomarkers to Detect Alzheimer Disease in Primary Care and Secondary Care.
An accurate blood test for Alzheimer disease (AD) could streamline the diagnostic workup and treatment of AD. ⋯ The APS2 and percentage of p-tau217 alone had high diagnostic accuracy for identifying AD among individuals with cognitive symptoms in primary and secondary care using predefined cutoff values. Future studies should evaluate how the use of blood tests for these biomarkers influences clinical care.
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Comment
Changes in Alzheimer Disease Blood Biomarkers and Associations With Incident All-Cause Dementia.
Plasma biomarkers show promise for identifying Alzheimer disease (AD) neuropathology and neurodegeneration, but additional examination among diverse populations and throughout the life course is needed. ⋯ Plasma biomarkers of AD neuropathology, neuronal injury, and astrogliosis increase with age and are associated with known dementia risk factors. AD-specific biomarkers' association with dementia starts in midlife whereas late-life measures of AD, neuronal injury, and astrogliosis biomarkers are all associated with dementia.
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Advances in artificial intelligence (AI) must be matched by efforts to better understand and evaluate how AI performs across health care and biomedicine as well as develop appropriate regulatory frameworks. This Special Communication reviews the history of the US Food and Drug Administration's (FDA) regulation of AI; presents potential uses of AI in medical product development, clinical research, and clinical care; and presents concepts that merit consideration as the regulatory system adapts to AI's unique challenges. ⋯ Strong oversight by the FDA protects the long-term success of industries by focusing on evaluation to advance regulated technologies that improve health. The FDA will continue to play a central role in ensuring safe, effective, and trustworthy AI tools to improve the lives of patients and clinicians alike. However, all involved entities will need to attend to AI with the rigor this transformative technology merits.