A new blood test was proven to have “high accuracy” in determining the risk of Alzheimer’s, paving the path for a cheaper, easier alternative to current tests for the illness, according to recently published research.
The peer-reviewed study, published in the JAMA Network on Jan. 22, investigated the use of a test called “ALZpath pTau217 assay” to identify Alzheimer’s with a blood test. Currently, individuals have to undergo a spinal tap or brain scan to identify protein buildup like amyloid beta and tau in the brain, which would suggest the risk of Alzheimer’s. However, these can be expensive and oftentimes inaccessible. The study focused on a form of tau protein called p-tau217—a key biomarker of Alzheimer’s.
Researchers examined data from three independent clinical studies, which involved 786 participants in total. In all three datasets, the “ALZpath pTau217 assay” test displayed “high accuracy” when it came to identifying elevated amyloid beta and p-tau217 in the brains of the participants.
The new test had an accuracy rate of up to 97 percent in identifying tau and up to 96 percent accuracy in identifying amyloid beta.
The precision was found to be “comparable” to Cerebrospinal fluid (CSF) biomarker tests, now considered the most exact tests for Alzheimer’s.
However, unlike the “ALZpath pTau217 assay,” which only involves a simple blood test, CSF is significantly more invasive and requires a painful spinal tap procedure to be conducted. A spinal tap involves inserting a needle into the lower back to extract the cerebrospinal fluid surrounding the spine.
“ALZpath pTau217 assay” was also found to be a “superior” test compared to brain atrophy assessments to determine Alzheimer’s.
“In primary care, it is estimated that more than 50 percent of patients with cognitive impairment remain undiagnosed or incorrectly diagnosed because of the lack of accessible and cost-effective tools. Thus, blood biomarkers are set to revolutionize clinical care by providing objective biomarker-based information,” the study said.
“This study highlights the effectiveness of a commercially available plasma p-tau217 assay in identifying AD (Alzheimer’s) pathology. Our findings demonstrate the substantial reduction of confirmatory testing by approximately 80 percent.”
“ALZpath pTau217 assay” is a test developed by California-based biotech research firm ALZpath. In its funding disclosure, researchers revealed that the company provided materials for the study at no cost. The firm also reviewed the manuscript before it was submitted for publication. However, the business had “no role” in the design or conduct of the study, it said.
The authors declared multiple conflicts of interest. One researcher received advisory board fees from ALZpath while the study was conducted. A second researcher reported having equity in the company as well as a patent pending for the biotech firm.
A third researcher served as a consultant and on the advisory board of ALZpath, while a fourth researcher received advisory board fees. In addition, several more potential conflicts of interest and funding disclosures were also made in the study.
Cheaper and Easier
ALZpath claims that its Alzheimer’s blood test is two to three times cheaper than CSF tests requiring spinal taps.
The recent study is “an instrumental finding in blood-based biomarkers for Alzheimer’s, paving the way for the clinical use of the ALZpath pTau 217 assay,” said study co-authors Professors Kaj Blennow and Henrik Zetterberg from the University of Gothenburg, according to a Jan. 22 press release.
The company stated that its “ALZpath pTau217 assay” will be available for clinical use starting in late January.
“This diagnostic capability offers increasingly vital aid in medical management and treatment decisions for Alzheimer’s, especially as new disease-modifying treatments become more accessible,” said Dr. Andreas Jeromin, ALZpath’s chief scientific officer.
In an interview with CNN, Nicholas Ashton, a professor of neurochemistry at the University of Gothenburg in Sweden and an author of the study, said that the scientific community has known for some time that using blood tests to check tau or other markers could be used to determine the risk of Alzheimer’s.
“Now we are close to these tests being prime-time, and this study shows that,” he said. “What was impressive with these results is that the blood test was just as accurate as advanced testing like cerebrospinal fluid tests and brain scans at showing Alzheimer’s disease pathology in the brain.”
Changes related to Alzheimer’s can take place in the brain around 20 years before the onset of symptoms. As such, blood tests like the one from ALZpath can be used to diagnose a person experiencing early memory loss. They can also detect symptoms of the illness, Dr. Richard Isaacson, director of research at the Institute for Neurodegenerative Diseases in Florida, told the outlet.
“This is actually the test that has, at this time, among the best available evidence for being one single test for Alzheimer’s,” he said. “This study takes us one really powerful step closer to having that test, and the beauty of this study is it also looked at people before they had symptoms.”
Mr. Isaacson pointed out that people take cholesterol tests before they have a heart attack or stroke. As such, he believes the ALZpath test would be “best served” among people before they start showing cognitive symptoms of Alzheimer’s.
“Just like cholesterol tests, by following the pTau217 level over time, we can better understand how various therapies and lifestyle changes are working to keep Alzheimer’s under better control.”
ALZpath estimates its new blood test for Alzheimer’s could cost anywhere from $200 to $500.
According to data from the U.S. Centers for Disease Control and Prevention (CDC), as many as 5.8 million Americans were living with Alzheimer’s in 2020. By 2060, this number is projected to hit 14 million.
“The number of people living with the disease doubles every 5 years beyond age 65,” it said. “Younger people may get Alzheimer’s disease, but it is less common … Symptoms of the disease can first appear after age 60, and the risk increases with age.”
From The Epoch Times
