• Head-to-head study examined which blood tests most accurately detected amyloid plaques and other Alzheimer’s-related measures.
• Some blood tests had accuracy similar to cerebrospinal fluid tests in detecting amyloid plaques and could eliminate the need for an invasive spinal tap or expensive brain scan in many patients.
• Widespread clinical use of blood tests could lead to more accurate diagnoses of people with cognitive impairment and more efficiently identify who may benefit from Alzheimer’s treatments.

A new study, developed and launched by the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium, found some blood tests are accurate enough that they are suitable for clinical use and could replace spinal taps and brain scans in many patients with cognitive impairment. The study compared the accuracy of leading commercial blood tests in detecting amyloid plaques, a characteristic feature of Alzheimer’s.

Some blood tests recently have been shown to identify the telltale brain changes of Alzheimer’s disease as accurately as established, more invasive methods, such as brain scans and cerebrospinal fluid tests. Yet, their widespread use in clinical practice has been limited by a lack of robust data validating their accuracy.

The study results will be presented in an oral session at the Alzheimer’s Association International Conference (AAIC) in Philadelphia. The detailed study findings are available on the MedRxiv pre-print server.

“The recent approvals of new anti-amyloid drugs—and the many treatments being studied in clinical trials—underscore the pressing need for more accessible, less invasive testing for early detection of Alzheimer’s,” said Julie Gerberding, MD, MPH, President and CEO of the FNIH. “This collaborative research effort has resulted in a rich dataset that is freely available to the scientific community and moves us closer to our goal—accelerating the development of Alzheimer’s diagnostic tools and therapeutic options for the millions of people who suffer from this disease.”

The study confirmed that some blood tests have accuracy similar to established cerebrospinal fluid tests, which require a spinal tap, in determining the presence of amyloid plaques as measured by positron emission tomography (PET) scans. The project team evaluated commercially available tests developed by ALZpath, C₂N Diagnostics, Fujirebio Diagnostics, Janssen, Quanterix, and Roche Diagnostics. Using blood samples from the Alzheimer’s Disease Neuroimaging Initiative (ADNI), the team assessed the ability of these tests to accurately detect amyloid plaques and tau tangles, decrease in brain volume, and clinical dementia symptoms.

The study also offered further confirmation that blood tests measuring levels of the protein p-tau217 are the most accurate in determining the presence and amount of amyloid plaques. In addition to their use in clinical diagnosis, the Alzheimer’s blood tests could speed future drug development by helping researchers select the optimal participants for clinical trials.

“Many Alzheimer’s blood tests are now clinically available. Some are highly accurate, while others are little better than flipping a coin. Doctors need to know which tests can be trusted,” said Suzanne Schindler, MD, PhD, a clinical neurologist and the Fluid Biomarker Core Leader at Washington University School of Medicine in St. Louis, and a member of the FNIH project team. “This study generated an incredible dataset that is easily accessible to researchers, who can scrutinize our findings and also answer many more questions about blood tests for Alzheimer’s.”

An important goal of current research is evaluating whether certain treatments may prevent or slow the onset of cognitive decline in patients with early Alzheimer’s brain changes. The FNIH study found that some blood tests accurately detected low levels of brain amyloid in people without cognitive impairment, and the FNIH project team is performing additional analyses to evaluate how well these blood tests can predict the progression of Alzheimer’s disease over time, including the likelihood of pre-symptomatic individuals eventually developing cognitive symptoms.

Data from this study are available via ADNI for investigators interested in further studying the performance of these tests as well as evaluating other scientific questions, such as the effects of age, sex, genetics, medical conditions, race, and the social determinants of health on amyloid pathology.

AAIC Presentation Details

“Head-to-head evaluation of leading blood tests for amyloid pathology,” presented by Dr. Kellen Petersen on Tuesday, July 30, at 2:28 p.m. EDT in 118 ABC, Developing Topics Session 2, Pennsylvania Convention Center, Philadelphia.

About the Biomarkers Consortium

The Foundation for the National Institutes of Health’s Biomarkers Consortium leads cross-sector efforts to validate and qualify biomarkers that accelerate the development of new therapeutics and health technologies. The core operations of the Biomarkers Consortium are supported through its contributing membership program, which includes the National Institutes of Health (NIH), the U.S. Food and Drug Administration, private industry, and not-for-profit organizations. For a list of partners supporting this study, see the project webpage.

About the Foundation for the National Institutes of Health

The Foundation for the National Institutes of Health (FNIH) builds public-private partnerships that connect leading biomedical scientists at the National Institutes of Health (NIH) with their counterparts in life sciences companies, academia, patient advocacy organizations, foundations, and regulatory agencies (including the Food and Drug Administration and European Medicines Agency). Through team science, the FNIH solves complex health challenges and accelerates breakthroughs for patients, regardless of who they are or what health threats they face. The FNIH contributes to the development of new therapies, diagnostics, and potential cures; advances global health and equity in care; and celebrates and helps train the next generations of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit fnih.org. Follow us on social media: LinkedIn, X, Facebook.

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"This collaborative research effort has resulted in a rich dataset... and moves us closer to our goal—accelerating the development of Alzheimer’s diagnostic tools and therapeutic options." — Julie Gerberding, MD, MPH