Draft revision of Alzheimer’s diagnostic criteria includes blood-based biomarkers

A draft proposal for new Alzheimer’s disease diagnostic criteria incorporates blood-based biomarkers, whose utility, relatively low cost and performance have made them a promising new tool in AD detection.

According to a release from the Alzheimer’s Association, the proposed guidelines are a revision of the 2018 National Institute on Aging-Alzheimer’s Association Alzheimer’s research framework and were presented to attendees at the 2023 Alzheimer’s Association International Conference in Amsterdam.

“Care has to evolve with the science,” Maria C. Carrillo, PhD, the association’s chief science officer, said in the release. “Our understanding of Alzheimer’s disease has advanced, in particular our understanding of biomarkers, and this needs to be reflected in how we describe and diagnose the disease.”

Early last year, the Alzheimer’s Association convened a steering committee to spearhead the framework’s revision, led by Clifford R. Jack Jr., MD, consultant and professor of radiology at the Mayo Clinic.

Three main principles guided their effort:

• No disease-targeted therapies received regulatory approval in 2018, but several have in the interim.
• In 2018, biomarkers were based on either cerebrospinal fluid assays or imaging, but in the last 5 years, plasma-based biomarkers have been developed and clinically validated.
• Research has since demonstrated that imaging and fluid biomarkers within a category are not equivalent for many use cases.

To date, some biomarkers included in the proposal have not been conclusively tested in broadly representative populations. Continued analysis among underrepresented groups continues to be paramount, as the need for more representative cohorts is a cornerstone position of the Alzheimer’s Association.

The new guidelines will be available for public comment for 30 days on the Alzheimer's Association AAIC website.

“We look forward to input from the scientific and clinical community on these proposed revisions,” Carrillo said in the release.

Reference:

• NIA-AA revised clinical guidelines for Alzheimer’s. https://aaic.alz.org/nia-aa.asp. Published July 16, 2023. Accessed July 18, 2023.