FNIH Biomarkers Consortium Announces Study Results Further Validating Blood Tests for Alzheimer’s Disease
July 28 2024 - 7:53AM
Business Wire
- 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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Melanie Doupé Gaiser Ruder Finn, on behalf of the FNIH
212-593-6459 Melanie.Gaiser@RuderFinn.com