A new blood test that can diagnose Alzheimer’s disease 15 years before the disease appears will be available in the US within days.
Patients can order the $500 ALZpath Dx test through their doctor, which works by looking for a dangerous protein in the blood.
The test is not intended to be covered by health insurance because the test has not yet been recommended by an official US health agency.
But research has shown that the mail-in test is just as accurate – but much faster – than current gold standard methods, which require lengthy appointments and suction of fluid from the spinal cord.
Experts have heralded the Pap smear as a gamechanger, saying it will make diagnosing Alzheimer’s disease just as easy as ‘high cholesterol’.
A new blood test for Alzheimer’s disease is so simple. Experts say patients can expect results within ‘days’, instead of the years it currently takes to get a diagnosis (stock image)
But others have raised concerns about using the test to detect the disease in people without symptoms, saying many may have markers of the condition but never experience cognitive decline.
Dr. Andreas Jeromin, the chief scientific officer behind the test, told DailyMail.com: ‘Our goal, and we have achieved the first milestone with the launch of ALZpath Dx, is to provide access to diagnostic tests for Alzheimer’s disease.
‘This is really something that patients and doctors need and want, so we really want to make these tools available.
‘What doctors really need is a blood-based biomarker that can be easily drawn, possibly at home, and easily performed and the results returned to the doctor.’
Blood is drawn from patients by doctors before the samples are sent to the NeuroCode laboratory in Washington state, where hundreds of tests can be performed per day.
Discussions are also underway to conduct the testing at three to four other labs in the Midwest and East Coast.
Patients can order the tests through their doctors anywhere in the US.
The test – developed by California-based ALZpath – takes a few hours and the results are then sent back to a doctor. Blood samples can take days to arrive, depending on where in the US they are sent.
The test does not need to be approved by the Food and Drug Administration (FDA).
From 1906, when clinical psychiatrist Alois Alzheimer first reported a “severe disease of the cerebral cortex,” to the uncovering of the disease’s mechanisms in the 1980s and 1990s, to the recent “breakthrough” drug lecanemab, scientists have more than spent a century struggling with the A cruel disease that robs people of their knowledge and independence
About 6.7 million Americans suffer from Alzheimer’s disease, although this figure is expected to rise to 13 million by 2050
Changes in humor and increased swearing are all signs of Alzheimer’s disease and frontotemporal dementia (FTD), a form of dementia that causes problems with behavior and language. According to experts, poor parking and shabby clothes are also signs of the memory-robbing disease. Graphic shows: six signs of Alzheimer’s disease
Dr. Jeromin said they are developing plans to offer the test in hospitals, where it can be completed in as little as 30 minutes, but this would require FDA approval.
He said they have now started working with the FDA to approve this version of the test, but don’t expect it to be available before 2025 or 2026.
The test is currently intended for older adults who already have symptoms of Alzheimer’s disease or are concerned they may have the condition.
Dr. Jeromin said they are working on a separate version that will indicate how likely someone is to develop the debilitating disease.
Swedish researchers said the test works by analyzing levels of the blood biomarker p-tau217, which corresponds to the levels of tau and amyloid in the brain.
These proteins begin to build up in the brain ten to fifteen years before symptoms appear.
And they are thought to be responsible for Alzheimer’s disease because they can form lumps in the brain that are thought to disrupt communication between cells.
In a study in Sweden of 786 people, they found that the test was 97 percent accurate in predicting Alzheimer’s disease.
This is comparable to current, more expensive examinations, including spinal cord punctures, in which fluid is removed from the spinal column, and brain scans.
Experts say the new test will ‘revolutionise’ diagnosis and could have ‘huge implications’ for future treatments, speeding up diagnosis and clinical trials.
They were about 66 years old on average, the scientists said, and a third showed signs of memory loss.
Dr. Andreas Jeromin said the test would be available in the US within days
The scientists then grouped participants according to whether they were very likely or very unlikely to develop the condition.
About a fifth of participants were also placed in the middle and told they needed further tests – such as a spinal tap – to confirm their Alzheimer’s status.
The findings, published in the journal JAMA Neurology, show that the approach was 97 percent accurate.
Professor David Curtis, honorary professor at the UCL Genetics Institute in Britain, said the findings could have “huge implications” for the way Alzheimer’s disease is managed.
“Everyone over 50 could be routinely screened every few years, in much the same way they are now screened for high cholesterol,” he said.
‘It is possible that currently available treatments for Alzheimer’s disease would work better in people diagnosed early in this way.
‘However, I think the real hope is that better treatments can also be developed.
‘The combination of a simple screening test with an effective treatment for Alzheimer’s disease would have a dramatic impact for the individual and for society.’
About 6.7 million people in the United States suffer from Alzheimer’s disease, although this is expected to rise to more than 13 million by 2050.
The condition affects about six in ten people with dementia.
Memory problems, thinking and reasoning problems, and language problems are common early symptoms of the condition, which then worsen over time.