Lecanemab Alzheimer’s Treatment Set for FDA Approval – Neuroscience News

Summary: Doctors are preparing to administer lecanemab, a promising new Alzheimer’s disease treatment nearing FDA approval.

This therapy, marketed as Leqembi, slows cognitive decline by extracting the amyloid protein from the brain, thereby reducing the accumulation of tau protein. Treatment, especially for patients with mild cognitive impairment or mild dementia in Alzheimer’s disease, involves a strict 18-month regimen, with the potential to slow cognitive decline by around six months.

However, their use requires careful patient screening because of risks such as brain bleeding and swelling.

Key Facts:

  1. Lecanemab works by pulling the amyloid protein, which interferes with brain function, from the brain, thereby reducing the accumulation of tau protein and moderately slowing cognitive decline.
  2. This treatment is designed for people with mild cognitive impairment or mild dementia due to Alzheimer’s disease. It’s not recommended for anyone with more severe dementia or people who are at risk of developing Alzheimer’s but display normal cognitive function.
  3. The treatment carries potential risks, including brain bleeding and swelling. Also, the process involves an intensive regimen of IV infusions and MRIs.

Source: Cedars Sinai Medical Center

The Cedars-Sinai patient care team is preparing to offer lecanemab, a new Alzheimer’s disease treatment that is expected to receive approval from the US Food and Drug Administration (FDA), to patients in the coming months.

“This is the most promising therapy for Alzheimer’s disease, but providing care to patients is far from simple,” says Sarah Kremen, MD, who leads the Alzheimer’s Disease Clinical Trials Program in the Department of Neurology at Cedars-Sinai.

It shows neurons.
Lecanemab, marketed under the brand name Leqembi, is not a perfect solution, but it is a positive step forward. Credits: Neuroscience News

“We want to make sure that potential patients understand the treatment process and the risks, and are clear about the kinds of real-world benefits it might bring.”

Lecanemab, marketed under the brand name Leqembi, isn’t a perfect solution, but it is a positive step forward, says Zaldy Tan, MD, MPH, medical director of the Jona Goldrich Center for Alzheimer’s and Memory Disorders in the Department of Neurology at Cedars-Sinai.

“More than 6 million people in the US are diagnosed with Alzheimer’s disease, and it is the most effective treatment we have,” said Tan. “We have to start somewhere.”

Kremen and Tan sat together Cedars-Sinai Newsroom to explain the screening and treatment process for patients interested in receiving lecanemab, as well as the risks and benefits.

How does lecanemab work–and how well?

Cream: Clinical trial data show that the treatment can significantly pull amyloid—a protein that forms plaque and impairs brain function—out of the brain.

Patients who received lecanemab during clinical trials also showed slight declines on tests of memory and functional abilities.

Lecanemab also appears to reduce the accumulation of the protein tau, which forms a tangle in the neurons of Alzheimer’s patients, particularly in the memory centers of the brain. Even so, treatment took 18 months and only slowed cognitive decline by about six months.

When should Cedars-Sinai start giving lecanemab to patients?

Tan: Cedars-Sinai hopes to start offering this treatment in the next few months. Our multidisciplinary team – including experts in cognitive testing, brain imaging, pharmaceuticals, infusion therapy and patient care coordination – have worked to create robust processes that will support patients from pre-treatment screening through follow-up care and account for any anticipated challenges that may be appeared by itself.

Who can be treated with lecanemab?

Cream: This treatment is designed for people who have mild cognitive impairment or mild dementia due to Alzheimer’s disease.

It is not for people with moderate or severe dementia, where their memory and other cognitive functions are so affected that they need to rely on others for help with daily living.

It’s also not for people who are at risk for Alzheimer’s disease but who have normal memory and thinking. This medication is not recommended for anyone who is taking blood thinners or who has significant brain bleeding, brain swelling, aneurysm, vascular malformation, brain tumor, or uncontrolled bleeding disorder.

What real-world benefits might the drug have for patients?

Tan: We don’t yet know how many people will get an observable benefit from this drug. We hope this will extend our patient’s ability to function, but that may just be a difference of three months delaying disease progression.

However, three more months of thinking better and participating in activities of daily living may mean something to some of our patients and their families as they deal with this condition.

What are the risks associated with treatment?

Cream: Risks include brain hemorrhage and brain swelling, which also applies to other similar Alzheimer’s disease treatments that have not been successful so far in clinical research trials.

The side effect we were most concerned about was massive brain hemorrhage, which is quite rare but can happen. So people need to be discussing this with an open eye, because we’re not going to be able to fully mitigate these risks.

What is the treatment process like?

Tan: The drug is given by IV infusion over one hour, every two weeks—so the time commitment is something to consider. And the patient needs to have an MRI before the fifth, seventh and 14thth IV drip, according to FDA guidelines, so that we can monitor brain swelling and brain bleeding.

We must also monitor infusion reactions, such as low blood pressure or difficulty breathing, which can occur during any type of IV infusion. We will monitor for three hours after the patient’s first dose, two hours after the second and third doses, and 30 minutes after the remaining doses for patients who do not have an infusion-related reaction.

What kind of pre-treatment testing does the patient need?

Cream: Patients will need a diagnostic evaluation to confirm that their dementia or cognitive impairment is caused by Alzheimer’s disease and nothing else. This evaluation may be performed by a primary care physician, geriatrician, neurologist or psychiatrist.

They will also need testing to confirm the presence of amyloid, which the drug is designed to treat. This can be done through special brain imaging — which isn’t widely available or covered by insurance — or through spinal fluid tests.

Patients also need genetic testing, as those with one or two copies of a gene called APOE4 are at increased risk of brain bleeding and swelling and need to take this into account when deciding whether to treat.

What costs are associated with treatment?

Tan: According to lecanemab’s manufacturer, Eisai, the drug alone will cost about $26,500 per year, and there are additional costs for pre-treatment testing and monitoring required during treatment.

The Center for Medicare & Medicaid Services has stated that if lecanemab receives full FDA approval, Medicare will cover treatment in an “appropriate setting”.

It’s still unclear whether Medicare or private insurers will cover testing and monitoring, and the cost to patients is uncertain.

About this Alzheimer’s disease research and neuropharmacology news

Author: Christina Elston
Source: Cedars Sinai Medical Center
Contact: Christina Elston – Cedars Sinai Medical Center
Picture: The image is credited to Neuroscience News

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