Blood Tests and a New Promising Drug for Alzheimer’s Are Here. Here’s What You Need to Know.

Q. I know Alzheimer’s research, diagnostic tools, and treatments have come a long way in the past few years, with several new options having been introduced. But, I’m curious — do any of these options really work or even show real promise?

A. Alzheimer’s disease research is at an important moment, with the emergence of blood tests that can detect the illness and the possible approval of new treatments, including a new drug awaiting FDA approval.

New Alzheimer’s Blood Test Shows Promise

The Centers for Disease Control and Prevention (CDC) estimate that Alzheimer’s disease affects 6.5 million people in the United States. In the past, brain autopsies were the only real way to know for sure whether someone had Alzheimer’s. Over the past several years, however, sophisticated tests such as spinal taps and specialized PET scans have become available — but they are invasive and costly and not routinely used for those reasons. As a result, Alzheimer’s is frequently misdiagnosed, especially in the early stages.

Now, simple blood tests have been designed to help doctors diagnose Alzheimer’s. In coming years, the blood tests could transform the way Alzheimer’s is researched, diagnosed, and treated, experts say.

Here’s what you should know:

• At least three tests — by C2N Diagnostics, Quest Diagnostics, and Quanterix — are available in most states outside clinical trials;
• Eli Lilly and Roche also have developed tests but for now are using them only in trials;
• The tests detect tiny amounts of abnormal proteins in the blood, including a sticky version called amyloid beta, to determine whether the hallmarks of Alzheimer’s are present in the brain;
• The tests are currently being used mostly in clinical trials and are expediting research;
• Few tests are being sold on the commercial market;
• These tests are designed to complement doctors’ assessments based on symptoms and other tests, not replace them;
• In regular patient care, doctors can prescribe the tests, but that happens infrequently because of a lack of effective treatments if the tests are positive;
• The tests, which cost hundreds of dollars or more, often are not covered by insurance;
• For now, none of the Alzheimer’s-specific tests are covered by Medicare, and private insurance coverage is patchy:
  • Quest, which charges $500, said some health plans are paying for its test, and that its test is for people with or without symptoms and the company relies on physicians to use their own discretion when ordering tests;
  • C2N charges $1,250 and offers financial assistance for eligible patients;
  • Quanterix said its test is much cheaper than amyloid PET scans, which can cost $5,000 or more;
  • Labcorp in July began offering a test for neurodegeneration that may occur because of head trauma or disease, including Alzheimer’s, and the company says its test is covered by Medicare.
• Some experts say much more research is needed before the new tests can be widely deployed, especially in primary-care settings;
• Others say there already is sufficient information on the accuracy of some tests;
• All agree that no single test is perfect, and physicians still should perform a complete clinical assessment;
• Many neurologists say it is a matter of time before the tests are adopted more widely, providing clarity for a disease that is difficult to diagnose and helping determine which patients should get new treatments — if federal regulators approve therapies now under review.

“If you had asked me five years ago if we would have a blood test that could reliably detect plaques and tangles in the brain, I would have said it was unlikely,” said Gil Rabinovici, a neurologist at the University of California at San Francisco. “I am glad I was wrong about that.”

Should the Tests be Used for People without Symptoms?

Scientists agree that the tests, which must be ordered by doctors, should be reserved for people with cognitive problems — persistent memory or logic issues, not just the occasional forgetfulness we all experience because of normal aging or stress.

Many researchers say it is too early to use the tests for people who do not have symptoms, because there isn’t adequate research involving that group, and there are scientific uncertainty and ethical questions involved.  Others believe that down the road, after more research is conducted, the blood tests might be used to alert people, even those without symptoms, that they have elevated amyloid and tau in their brains, putting them at risk for Alzheimer’s. Patients could start a preventive therapy early, if one exists, or they could pursue healthier lifestyles. Patients can also conduct legal planning earlier for themselves and their loved ones while they are still of sound mind and can make decisions for themselves.

Alzheimer’s Treatment Availability May Help Expedite Test Availability

Alzheimer’s treatments may be improving. Recently reported results showed that an experimental drug called lecanemab, by Japanese drugmaker Eisai and its U.S. partner, Biogen, worked to slow Alzheimer’s disease. It was the first therapy to do so in a well-run trial. The Food and Drug Administration could decide whether to approve the drug as soon as January 2023.

Here’s what you should know about lecanemab:

• A press statement released in September from Eisai and Biogen gave top-line results from a major clinical trial of lecanemab, given to nearly 2,000 people with early Alzheimer’s disease;
  • The therapy “slowed cognitive decline,” the statement said, raising hopes that a drug might provide “a clinically meaningful impact on cognition and function”;
• Lecanemab is not easy to administer — unlike pills and capsules, patients are required to attend a clinic for an intravenous infusion twice a month;
• The side effects call for extensive monitoring, requiring regular scans for brain swelling and bleeding;
• From the data released so far, some doctors warn that the benefits of the drug seem so small that patients may not even notice;
• Other researchers believe that any effect on Alzheimer’s deserves celebration, proving the disease can be beaten, or at least slowed down, and that it’s a start and a concrete foundation to build on;
• After 18 months, cognition declined 27 percent less in those who took the drug compared with those on a placebo;
• On a common dementia rating scale, which scores people from 0 to 18 on memory, problem-solving and other tasks, those on lecanemab performed only 0.45 points better. The result is statistically significant, but it may not mean much for individual patients;
• The FDA will rule on lecanemab in January 2023;
• If a new treatment is approved by the FDA and gains Medicare coverage, blood tests could play a key role in determining who might benefit.

Knowing Your Risk of Alzheimer’s Can Be Helpful

If you have concerns about memory or reasoning issues, you should talk to your family and your doctor. Even if new treatments for Alzheimer’s are not cleared, many experts say, it is important for patients to know their diagnoses so they can plan for the future.

“Knowing your risk can be a hugely positive motivator,” said Leslie M. Shaw, a pathologist and Alzheimer’s researcher at the University of Pennsylvania. “Make the changes we now know are important. Instead of being a classic couch potato, get off your duff and get going.”

“If people are having cognitive symptoms, they deserve to know their diagnosis,” said Howard Fillit, co-founder and chief science officer at the Alzheimer’s Drug Discovery Foundation, a nonprofit group that helps fund research into the disease. “If they test positive, they will get certainty. If they test negative, maybe they have depression or a different type of dementia that might be treated differently.”

Demetrius M. Maraganore, chairman of the neurology department at Tulane University School of Medicine, concurred, saying that knowing their diagnosis “will help (people) to flip the page and start focusing on acceptance and getting the support they need.”

If you or a loved one has symptoms of Alzheimer’s or have been diagnosed, be sure to read my many articles on the subject, including what to do if you are diagnosed with Alzheimer’s and information about other studies, diagnostic tools, and ways you can stave off Alzheimer’s and other forms of dementia.

Medicaid Asset Protection for Alzheimer’s and Other Forms of Dementia

Those with Alzheimer’s and their families face special legal and financial needs. At the Farr Law Firm, we help our clients ease the financial and emotional burden on those suffering from dementia and their loved ones. We help protect assets from the devastating expenses of long-term care in order to help our clients maintain utmost dignity, quality of life, and financial security by ensuring eligibility for critical government benefits such as Medicaid and Veterans Aid and Attendance. Please call us any time to make an appointment for an initial consultation:

Fairfax Alzheimer’s Planning: 703-691-1888
Fredericksburg Alzheimer’s Planning: 540-479-1435
Rockville Alzheimer’s Planning: 301-519-8041
DC Alzheimer’s Planning: 202-587-2797