Leqembi, the New Alzheimer’s Drug: Everything to Know

The Food and Drug Administration (FDA) recently granted Leqembi (lecanemab) full approval for patients in the early stages of Alzheimer’s disease. In the clinical trials evaluating Leqembi, physicians and researchers from Washington University School of Medicine’s Charles F. and Joanne Knight Alzheimer Disease Research Center (Knight ADRC) in St. Louis enrolled participants with the most common form of Alzheimer’s disease, which occurs in people aged 65 and older.

The trials were overseen by Barbara Joy Snider, MD, PhD, a professor of neurology at Washington University. Physicians at Washington University and BJC HealthCare will begin offering Leqembi to eligible patients in August. Those interested in learning more about the medicine and who qualifies for it can phone 314-362-WELL (9355).

Snider answers the following questions regarding the drug:

What is the significance of the FDA’s approval of Leqembi?

Leqembi does not treat Alzheimer’s disease or improve memory or reasoning. However, it is the first medicine that has been demonstrated to reduce the advancement of Alzheimer’s disease among persons in the early stages of the condition. A big clinical trial of Leqembi in which Washington University’s Knight ADRC participated found that the medicine slowed memory and thinking decreases by around 30% over the course of 18 months of therapy.

How does Leqembi function?

It prevents the formation of amyloid plaques in the brain, which is a characteristic of Alzheimer’s disease and can impair memory and thinking. Clinical trials show that Leqembi eliminates amyloid plaques from the brain, which delays the progression of the disease.

Who is eligible for the medicine, and how is it administered?

Leqembi is intended for persons with moderate Alzheimer’s disease, which implies they have some difficulty with thinking and memory but not severe symptoms. Because the clinical studies only included patients with moderate disease, we don’t know if the medicine will benefit people with more severe memory loss or cognitive impairments. Every two weeks, the medication is administered by IV infusions at an infusion center.

Is it feasible that part of the research done at Washington University contributed to the development of a medicine like Leqembi?

The Knight ADRC has been conducting Alzheimer’s disease research for the past 40 years. Earlier studies conducted here, as well as studies conducted at other facilities, made the current medication trials possible. Overall, these earlier studies aided in the development of amyloid PET imaging scans, blood tests, and spinal fluid tests that allow us to determine who has Alzheimer’s disease in people who have symptoms, such as memory loss and cognitive decline, and who is at higher risk of the disease prior to the onset of symptoms. For many years, we’ve also headed the DIAN (Dominantly hereditary Alzheimer Network) project, a big multinational study of patients with hereditary forms of Alzheimer’s disease that is partly financed by the National Institutes of Health (NIH). Participants in this study have inherited gene mutations that almost guarantee they will get Alzheimer’s disease in their 30s, 40s, or 50s. The DIAN observational project is assisting in defining the natural history of Alzheimer’s disease in participants and establishing accurate biomarkers that follow disease development. The DIAN Trials Unit (DIAN-TU) is a therapeutic trial that seeks to determine whether it is feasible to prevent or delay the beginning of Alzheimer’s disease. This is the first trial to look at a combination of two Alzheimer’s drugs: an amyloid treatment that targets amyloid plaques and a drug that combats the development of the protein tau in the brain, which is associated to cognitive loss.

What proportion of Alzheimer’s patients might be eligible for the drug?

Around 15% to 20% of all Alzheimer’s patients have mild symptoms and will be suitable for the treatment. Our neurology specialists at Washington University’s Memory Diagnostic Center will assess individuals’ eligibility for the medicine. We’re collaborating with BJC HealthCare to make the medicine available to patients, who will receive it at BJC infusion centers. People who live in rural or underserved locations with limited access to specialty physicians and infusion clinics may find it more difficult to obtain Leqembi at first. Furthermore, patients must have access to advanced brain imaging to screen for side effects. We hope that these issues will resolve themselves over time.

What are the potential negative effects of Leqembi? And how common are they?

Some people are allergic to the infusion. That’s very frequent, but it’s usually very mild — things like feeling a little anxious or short of breath, but it’s usually only temporary. Although Leqembi has been demonstrated to be generally safe, clinical testing did uncover several potentially dangerous adverse effects. Small parts of the brain, for example, may become swelled as if wounded. We can occasionally see regions with little bleeding, known as microhemorrhages. These alterations, which can be visible on brain scans, can occur in approximately 25% of persons who get Leqembi. Most people who take the medicine are unaware that this has occurred because they have no symptoms, and the brain bleeding or swelling diminishes on its own. However, some patients may experience more severe effects such as headaches, disorientation, or even stroke-like symptoms. Brain swelling or hemorrhage might be deadly in extremely rare circumstances. As a result, the drug’s labeling carries a warning that the medication has the potential to cause serious and life-threatening consequences.

What is the price of Leqembi?

The annual cost of the medicine is projected to be $26,500. Medicare has stated that it will cover 80% of the medication’s cost, however there are additional fees. Determining eligibility may necessitate advanced PET imaging scans, which may not be reimbursed by Medicare. Follow-up MRI scans are also required once therapy begins to assess any side effects. Patients will benefit from coverage of 80% of the drug’s cost, but there will be out-of-pocket expenses as well.

We also don’t know how long a person must take the medicine. People in the clinical trial were on Leqembi for 18 months, but many of them in the experiment are still taking the drug, and some of the findings appear to imply that people perform better if they stay on the treatment longer. We’re still gathering data on the consequences of long-term treatment, which will help us establish how long the medicine will be effective.

Is it possible that a medicine like Leqembi could help prevent Alzheimer’s disease?

Yes. Our current understanding shows that the aggregation of the amyloid protein into amyloid plaques in the brain is one of the first anomalies that occurs in someone on the way to acquiring Alzheimer’s disease symptoms. As a result, it’s feasible that an anti-amyloid medicine, such as Leqembi, given very early in the illness process, before there are any memory problems, may be the most effective method to avoid things that happen later in the disease process, such as the start of memory problems and, eventually, dementia. The goal would be to treat with an anti-amyloid medication that may, perhaps, prevent the entire process at the outset of the disease, when amyloid pathology first appears. There is no indication that Leqembi will achieve all of that yet, but fresh research is pointing in that direction. For example, we are participating in the AHEAD research, which is testing Leqembi in adults who are at risk of developing Alzheimer’s disease but do not yet have symptoms.

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