{"id":78268,"date":"2024-10-08T19:00:48","date_gmt":"2024-10-09T01:00:48","guid":{"rendered":"https:\/\/www.uchealth.org\/today\/?p=78268"},"modified":"2024-10-23T17:11:06","modified_gmt":"2024-10-23T23:11:06","slug":"new-blood-tests-for-alzheimers-may-allow-for-earlier-detection","status":"publish","type":"post","link":"https:\/\/www.uchealth.org\/today\/new-blood-tests-for-alzheimers-may-allow-for-earlier-detection\/","title":{"rendered":"New blood tests for Alzheimer\u2019s may allow for earlier detection of the terrible disease. But how much will Alzheimer’s blood tests cost, and who should get them?"},"content":{"rendered":"
<\/div>
\"Older
New blood tests can detect Alzheimer’s. But who should get them? Photo: Getty Images.<\/figcaption><\/figure>\n

For decades, there wasn\u2019t much good news to report about efforts to battle Alzheimer\u2019s disease, the neurodegenerative scourge that affects nearly 7 million people<\/a> in the United States. But that changed rapidly in the past year with progress on three fronts: the U.S. Food and Drug Administration’s approval of two new drugs<\/a> to slow progression of the disease; new information about the genetic roots of Alzheimer’s<\/a>; and encouraging recent results of a blood test that could improve early detection of Alzheimer’s.<\/p>\n

Alzheimer\u2019s Association researchers strongly touted<\/a> the promise of the new blood test, which measures levels of two key biomarkers tied to Alzheimer\u2019s disease. The organization’s leaders noted that blood tests generally could make Alzheimer\u2019s disease screening and diagnosis much more widely available and less expensive for patients. In turn, patients could begin treatment when the disease is still in its early stages. Blood tests could also help to boost the number of candidates who qualify for clinical trials of new treatments.

Keep up to date with the latest news on Alzheimer’s disease.<\/a><\/div>\n

To provide answers to your top questions about this encouraging news, we spoke with Dr. Tara Carlisle<\/a>, a behavioral neurologist and assistant professor of Neurology with the University of Colorado School of Medicine, who practices at the Advanced Therapy for Neurodegenerative Disorders Clinic, a space within the University of Colorado Neurobehavior and Memory Disorders Clinic<\/a> at the UCHealth Neurology Clinic \u2013 Central Park<\/a>.<\/p>\n

Carlisle explained that while the new developments related to blood tests for Alzheimer\u2019s disease are encouraging, they also raise important questions for both patients and providers.<\/p>\n

Is there a blood test available for Alzheimer\u2019s disease?<\/strong><\/h2>\n

Yes. In fact, several companies offer tests. They include Quest Diagnostics<\/a>, ALZPath, Inc.<\/a>, Roche Diagnostics<\/a> (developed with Eli Lilly Company), LabCorp<\/a>, and C2N Diagnostics<\/a>.<\/p>\n

What do the blood tests measure?<\/strong><\/h2>\n

That depends on the test. In general, the new blood tests detect levels of proteins that indicate risk for Alzheimer\u2019s disease, Carlisle said. For example, the AD-Detect test introduced by Quest Diagnostics in 2023<\/a> measures the ratio of beta-amyloid 42 and 40<\/a>. In Alzheimer\u2019s disease, amyloid inappropriately clumps together to create sticky plaques that affect the way brain cells function and degrade cognition.<\/p>\n

In April 2024, Quest announced<\/a> a new blood test that measures levels of p-tau217, another protein associated with Alzheimer\u2019s disease that forms tangles in the brain. The blood tests for p-tau217 can also predict whether amyloid plaques may be present, Carlisle said.<\/p>\n

The PrecivityAD2 test from C2N Diagnostics<\/a> measures both the beta-amyloid 42\/40 ratio and p-tau217 levels, Carlisle said.<\/p>\n

How accurate are the new blood tests for Alzehimer’s?<\/strong><\/h2>\n

The Precivity AD2 test is \u201cpretty accurate and specific,\u201d Carlisle said. In a study partially funded by the National Institutes of Health<\/a> that generated much attention, that blood test accurately predicted Alzheimer\u2019s disease in 88% to 92% of participants. The result compared favorably with the current \u201cgold standards\u201d for diagnosing Alzheimer\u2019s disease: lumbar punctures<\/a>, which are used to draw cerebrospinal fluid and analyze it for the presence of beta-amyloid and tau; and positron emission tomography (PET) scans<\/a>, which measure beta-amyloid in the brain but do not provide information about tau. The Precivity test was also significantly more accurate than clinical evaluations by providers in memory centers (73%) or primary care facilities (61%).<\/p>\n

The numbers should be viewed from a broad perspective, Carlisle cautioned. For example, the PrecivityAD2 study was conducted with Swedish patients. The National Institute on Aging<\/a> called for additional studies of more diverse populations. Many other factors can affect the accuracy of the tests, Carlisle added.<\/p>\n

\u201cThere are different groups that are developing different tests in different locations, but it is important to understand that some of the blood-based biomarkers might be affected not only by your own medical problems, but also by genetics, geographic location and other things,\u201d she said. \u201cJust because a test was developed in one location doesn\u2019t mean it\u2019s going to have the same sensitivity or specificity in another location. That is really important to highlight.\u201d<\/p>\n

How can I get a blood test for Alzheimer\u2019s disease?<\/strong><\/h2>\n

Access to the new blood tests for Alzheimer’s varies depending on the test. For example, the PrecivityAD2 test<\/a> is available only with a physician\u2019s order. An individual can get Quest\u2019s AD-Detect test for beta-amyloids without a doctor\u2019s order, Carlisle said. However, she added an important caveat.<\/p>\n

\u201cThis type of screening tool should only be used by physicians or other providers who really understand the value of the result,\u201d Carlisle said.<\/p>\n

Why should people be cautious about getting the blood tests without consulting with a doctor?<\/h2>\n

Test results and additional information may be helpful to some individuals and family members. But Carlisle warns people that the new blood tests for Alzheimer’s can return false negative or positive results. Plus, it’s vital to have help understanding and interpreting the results.<\/p>\n

\u201cIt\u2019s important to know what to do with the information and how to counsel the patient about it,\u201d Carlisle said.<\/p>\n

Experts at the Alzheimer\u2019s Association<\/a> bolster that view, saying, \u201cat this time, it is recommended that blood tests only be used by specialty care doctors who are seeing patients with memory complaints.\u201d<\/p>\n

Are the tests covered by insurance?<\/strong><\/h2>\n

No. None of the new blood tests for Alzheimer’s are fully approved by the Food and Drug Administration (FDA), and they are not currently covered by Medicare, Medicaid or private insurance, Carlisle said. For now, patients likely will have to pay out of pocket for any of the available tests. However, some tests, including the Elecsys pTau217<\/a> from Roche Diagnostics and the Simoa phospho-Tau 217<\/a> from AlzPath, have received \u201cbreakthrough device designations<\/a>\u201d from the FDA, which could speed their approval.<\/p>\n

How much should I expect to pay out of pocket for a blood test for Alzheimer\u2019s disease?<\/strong><\/h2>\n

The costs vary by hundreds of dollars, as this analysis<\/a> from early 2024 shows. The AD-Detect test lists for $399. The PrecivityAD2 test \u2014 which demonstrated promise in the clinical trial noted earlier \u2014 costs $1,450, Carlisle said. The manufacturer, C2N Diagnostics, offers patient assistance<\/a> to those who qualify, she added, \u201cbut that\u2019s still potentially a pretty high cost.\u201d<\/p>\n

How soon will the new blood tests for Alzheimer’s be widely available?<\/strong><\/h2>\n

Carlisle speculated that it could be 5 to 10 years before the new blood tests for Alzheimer’s are widely available. However, the move in dementia care toward early detection might speed that up. For example, the United States Preventive Services Task Force (USPSTF) does not formally recommend cognitive screening<\/a> for older patients, unless they express concerns about memory loss or other symptoms. Why? Because until recently, providers have had few options to treat people with Alzheimer\u2019s disease. But with the FDA approval of anti-amyloid therapies Leqembi (lecanemab)<\/a> and Kisunla (donanemab)<\/a>, that is changing, and USPSTF experts could convene again soon to review and modify their recommendations, Carlisle said.<\/p>\n

\u201cIn the future, I think we are going to start trying to identify patients sooner, which means you would have to do a universal screening,\u201d she said.<\/p>\n

Early screening for Alzheimer’s would start with a comprehensive battery of cognitive tests, \u201cbut perhaps the next step would be something like a biomarker test to understand how much we really need to be worried about (an individual\u2019s symptoms).\u201d<\/p>\n

I\u2019ve decided to pay for a blood test. What are some of the issues I should consider?<\/strong><\/h2>\n

First, any test for Alzheimer\u2019s disease should only be done if you are exhibiting measurable signs of cognitive impairment, such as memory problems, Carlisle said.<\/p>\n

\u201cThere are typical changes in thinking that occur with aging and medical problems, so it is important to have a medical provider involved,\u201d she stressed.<\/p>\n

Second, at least for now, a blood test can be used to screen for Alzheimer\u2019s disease, but these results are not yet considered a definitive diagnosis, Carlisle said.<\/p>\n

\u201cWe have no promises from insurance companies \u2014 including Medicare and Medicaid \u2014 whether or not a blood-based biomarker would be considered confirmation of Alzheimer\u2019s or if we would need to then do a gold standard (test),\u201d Carlisle said. \u201cIf you are doing a screening and then it\u2019s positive, we still have to do a lumbar puncture or an amyloid PET scan. That is something we have to consider.\u201d<\/p>\n

Third, not all Alzheimer\u2019s disease blood tests are the same. For example, tests that measure p-tau217 are generally more sensitive than those that measure the ratio of beta-amyloid 42 and 40 alone, Carlisle said. As she noted, the PrecivityAD2 test uses both measures.<\/p>\n

Isn\u2019t it worth it if a simple blood test can give me answers about my risk of getting Alzheimer\u2019s disease?<\/strong><\/h2>\n

There isn\u2019t a straightforward answer to whether it’s worth it for most people to take the new blood tests for Alzheimer’s so they can get answers about their risks for getting Alzheimer’s, Carlisle said.<\/p>\n

Even if a blood test reveals the amyloid and tau culprits of Alzheimer\u2019s disease, the findings do not predict how the condition will affect an individual, Carlisle said. A person should weigh the potential benefits of getting additional information against the potential harms \u2014 including anxiety and distress \u2014 that learning about signs of Alzheimer’s<\/a> could cause for individuals and loved ones, she said.<\/p>\n

Signs of cognitive decline may not be attributable to Alzheimer\u2019s disease, Carlisle noted.<\/p>\n

For example, an individual might experience memory loss with no clear start date that progresses slowly over time. In that case, \u201cthe suspicion for Alzheimer\u2019s is going to be higher,\u201d she said. \u201cBut that doesn\u2019t mean that (Alzheimer\u2019s) is actually the pathology that is causing the problem,\u201d Carlisle continued.<\/p>\n

For example, limbic-predominant age-related TDP-43 encephalopathy (LATE) causes short-term memory loss, thinking problems and other symptoms that mimic Alzheimer\u2019s disease. However, it is not associated with amyloid, but rather a defect in the TDP-43 protein that causes deposits in the brain that damage cognition. As of now, LATE can only be definitely diagnosed during an autopsy, she added.<\/p>\n

\u201cEven though a person in life and clinically looks like they have Alzheimer\u2019s disease, it\u2019s not always Alzheimer\u2019s disease,\u201d Carlisle said.<\/p>\n

OK. If I need a lumbar puncture to test for Alzheimer\u2019s disease, what does that entail? How painful, difficult or risky is a lumbar puncture?<\/strong><\/h2>\n

A lumbar puncture is a pretty standard procedure that generally takes about 30 minutes after the setup. Some people may be uncomfortable having a large needle inserted in the lower back, but the procedure generally is not painful. Providers draw cerebrospinal fluid, which \u201cbathes\u201d the spinal cord and the brain, she said.<\/p>\n

What can that cerebrospinal fluid tell us?<\/strong><\/h2>\n

It may contain low levels of beta-amyloid, which is a sign that the proteins are getting stuck in the brain, and\/or high levels of tau. In combination, these findings help to confirm a diagnosis of Alzheimer\u2019s disease, Carlisle said.<\/p>\n

The fluid may contain clues to other diseases that affect cognition. For example, it may reveal signs of inflammation, such as specific antibodies, like the anti-NMDA antibody. That antibody causes anti-NMDA receptor encephalitis<\/a>, which includes symptoms of cognitive decline, Carlisle said.<\/p>\n

Other tests of the fluid can help providers diagnose diseases like Creutzfeldt-Jakob disease<\/a> that also deteriorate memory and thinking, she noted. An alpha-synuclein seed test<\/a> of cerebrospinal fluid could also help to diagnose dementia with Lewy bodies<\/a> \u2013 another cause of cognitive impairment \u2013 but this test is not yet covered by insurance, Carlisle said.<\/p>\n

Are there advantages to a lumbar puncture over an amyloid PET scan in testing for Alzheimer\u2019s disease?<\/strong><\/h2>\n

Yes. A lumbar puncture can help to rule in or out autoimmune diseases, like anti-NMDA receptor encephalitis, or other neurodegenerative disorders, like Creutzfeldt-Jakob disease, mentioned above, Carlisle said. That\u2019s particularly important for younger people with early-onset cognitive decline because their risk of Alzheimer\u2019s disease is relatively low.<\/p>\n

For people considering the anti-amyloid therapies lecanemab and donanemab, Carlisle also prefers a lumbar puncture. \u201cThe amyloid PET scan tells me only about amyloid,\u201d she said. \u201cIt doesn\u2019t tell me anything about other markers we see in Alzheimer\u2019s disease, like tau.\u201d<\/p>\n

Carlisle added that in the two clinical trials that led to the approval of these drugs, people with higher levels of tau were less likely to respond to the treatments. \u201cThe information about tau can be helpful, but we can\u2019t get it with PET imaging,\u201d Carlisle said.<\/p>\n

In summary, how do you assess, as of today, blood tests to screen for Alzheimer\u2019s disease?<\/strong><\/h2>\n

\u201cMy best advice is that just because it might be easy to get one of these tests, it doesn\u2019t mean you will be able to interpret the results in a meaningful way,\u201d Carlisle said. \u201cI highly recommend that people talk to their primary care provider, and if there are concerns about their cognition, that they see a [neurology] and\/or dementia specialist in their area and determine what the proper workup would be.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

For decades, there wasn\u2019t much good news to report about efforts to battle Alzheimer\u2019s disease, the neurodegenerative scourge that affects nearly 7 million people in the United States. But that changed rapidly in the past year with progress on three fronts: the U.S. Food and Drug Administration’s approval of two new drugs to slow progression […]<\/p>\n","protected":false},"author":2143,"featured_media":78623,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[5,8],"tags":[708,185,184,9171],"class_list":["post-78268","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-innovative-care","category-news","tag-adults-65-plus","tag-alzheimers-care","tag-neurology","tag-senior-care"],"acf":[],"yoast_head":"\nNew blood tests for Alzheimer\u2019s may allow for earlier detection - UCHealth Today<\/title>\n<meta name=\"description\" content=\"A health care expert discusses new blood tests for Alzheimer\u2019s disease, including possible earlier detection, costs and who should get tested.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.uchealth.org\/today\/new-blood-tests-for-alzheimers-may-allow-for-earlier-detection\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New blood tests for Alzheimer\u2019s may allow for earlier detection of the terrible disease. 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