Earlier this month, the FDA approved a new Alzheimer’s drug called Leqembi — the second of its kind to get a speedy approval. Clinical trials found that Leqembi (generic name: lecanemab) effectively slows down the progression of Alzheimer’s. This is big news; the first FDA-approved drug, known as Aduhelm, was not effective, according to expert advisers who reviewed the drug’s clinical trials. Also, the current Alzheimer’s drugs on the market only treat symptoms of the disease, not any of the underlying causes.
Despite the promising findings of the clinical trials, Leqembi has some downsides, including potentially serious side effects and a big price tag. To better understand the benefits, risks, and everything in between, read the answers to your FAQ’s below.
What does the new Alzheimer’s drug do?
In a series of randomized, controlled clinical trials, Leqembi targeted and reduced the buildup of amyloid plaque in the brains of Alzheimer’s patients, whereas a placebo did not. Leqembi also appeared to slow cognitive decline (the researchers conducted tests on memory and cognition on all the patients).
How long do the benefits last?
The clinical trials only lasted a year and half, per the The New York Times — so it’s unclear how long the positive effects of Leqembi will endure. However, the study participants experienced benefits for the full 18 months. In a News Wise press release, one doctor argued that even a short-term improvement of three months could be very valuable for patients suffering from the disease.
When will lecanemab be available?
Thanks to the FDA’s accelerated approval process for drugs that treat serious conditions, lecanemab is available now, and doctors may prescribe it based on a specific set of criteria. (The Leqembi website lists the guidelines that healthcare providers should follow before prescribing the drug to a patient.) However, The New York Times reported that some doctors are cautious about prescribing the drug to patients so soon. Also, experts agree that it will take time before the treatment is readily available to patients (a high cost is one of the primary barriers).
Who is a good candidate for Leqembi?
Leqembi is designed for patients with Alzheimer’s disease and not other forms of dementia, according to the News Wise press release. As such, doctors must first run tests to make sure the patient in question has Alzheimer’s, and that Alzheimer’s is causing a buildup of amyloid plaque proteins in the patient’s brain. (The drug treats these plaques, so if there isn’t a significant buildup of plaque, Leqembi might not be a good fit.) In addition, doctors should only approve the drug for Alzheimer’s patients with mild symptoms — not moderate to severe symptoms. (The clinical trials on Leqembi were conducted on patients with mild symptoms. Future research is needed before doctors can prescribe the drug to those with worse symptoms.)
Other factors for candidacy include: 1) the patient isn’t taking blood thinners; 2) the patient does not have existing brain bleeds, brain swelling, aneurysms, vascular malformation, brain tumors, or an uncontrolled bleeding disorder; 3) the patient does not have a gene called APOE4, which increases the risk of brain bleeding and swelling during treatment.
How can a person get approved for Leqembi?
If you are curious about Leqembi, talk to your doctor, geriatrician, neurologist, or psychiatrist. Your doctor must first conduct a diagnostic evaluation to make sure that Alzheimer’s is causing your mild dementia or cognitive impairment. If this is true, your doctor must then conduct genetic and diagnostic testing to make sure your brain contains abnormal clumps of amyloid plaques. Diagnostic tests will consist of either brain imaging or spinal fluid tests.
How do you take the drug?
Leqembi is given by IV infusion. An IV session lasts one hour, and healthcare providers schedule them once every two weeks. Providers must monitor patients during the sessions to make sure they don’t experience adverse reactions, like low blood pressure or difficulty breathing. (Experts told News Wise that these reactions can happen during any type of IV infusion.) On the fifth, seventh, and 14th infusions, the patient must receive an MRI. This is in accordance with FDA guidelines, so that healthcare providers can monitor for brain swelling or bleeding.
What are the downsides of the new Alzheimer’s drug?
As mentioned, Leqembi may come with serious side effects, including brain bleeding and brain swelling. Large brain bleeds, which were rare during clinical trials, could be fatal. Other downsides of the drug to consider include the time commitment of IV sessions, and the cost. Right now, diagnostic testing (like brain scans) are not automatically covered by insurance, and the current list price for Leqembi treatments is at a whopping $26,500 per year, as reported by The New York Times.
Furthermore, some experts are not convinced that Leqembi is effective enough. “From the perspective of a physician caring for Alzheimer’s patients, the difference between lecanemab and placebo is well below what is considered to be a clinically meaningful treatment effect,” Dr. Madhav Thambisetty, a neurologist and a senior investigator at the National Institute on Aging, told The Times.
While there are a lot of unknowns surrounding the drug, there is also a lot of promising data. At the very least, each new experimental treatment for Alzheimer’s disease brings us one step closer to a cure.
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