Recommendations for the Clinical Implementation of Blood-Based Biomarker Testing for Alzheimer Disease Published

The Global CEO Initiative on Alzheimer’s Disease (CEOi), an organization of business leaders who are working to address care for Alzheimer disease (AD), has announced the publication of 2 articles in the journal Alzheimer’s & Dementia. The articles provide recommendations for the effective integration of blood-based biomarker (BBM) testing into clinical practice to enhance the accuracy and time efficiency of AD diagnosis. The publications result from the efforts of the CEOi BBM Workgroup, a body of over 90 experts and leaders in health care, academia, policy, nonprofits, industry, business, and patient advocacy.

The recommendations presented in both articles were developed after the launch of the BBM Workgroup in 2022, based on a systematic literature review that identified barriers, facilitators, and ethical considerations for implementing BBM tests for AD in the primary and secondary care settings.

In the first article, “Considerations for widespread implementation of blood-based biomarkers of Alzheimer’s disease,” the authors present 3 considerations for implementing BBM testing into clinical practice for AD care:

• An obstacle to the widespread adoption of BBM testing is the lack of consistent recommendations for the assessment of cognitive impairment in primary care.
• Health care provider (HCP) education is necessary for determining the predictive value of BBM tests across the patient population.
• A lack of substantial evidence limits the interpretation of BBM test results within diverse populations.

The authors also present 2 ethical considerations regarding confidentiality and a patient’s right to know their results.

In the second article, “Recommendations for clinical implementation of blood-based biomarkers for Alzheimer's disease,” the authors provide a pathway for BBM testing for use as a triaging tool when determining eligibility for disease-modifying therapy (DMT) in symptomatic individuals with cognitive concerns.

“These recommendations set a standardized approach for incorporating blood-based biomarkers (BBMs) within the Alzheimer's diagnostic pathway by providing clear guidance on their application and interpretation, ensuring their effective and ethical use,” said Chi Udeh-Momoh, PhD, Assistant Professor of epidemiology and prevention at Wake Forest University School of Medicine. “As demand for accurate diagnosis increases with the availability of disease-modifying therapies and a growing dementia population, these guidelines could enhance early detection and access to essential treatments for those who need them most.”

The 2 published articles are:

• Mielke MM, Anderson M, Ashford JW, et al. Considerations for widespread implementation of blood-based biomarkers of Alzheimer's disease. Alzheimers Dement. 2024;1-7. doi: 10.1002/alz.14150
• Mielke MM, Anderson M, Ashford JW, et al. Recommendations for clinical implementation of blood-based biomarkers for Alzheimer's disease. Alzheimers Dement. 2024; 1-9. doi: 10.1002/alz.14184