New Alzheimer’s Drug Approved in Great Britain

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The Medicines and Healthcare products Regulatory Agency (MHRA) approved the medicine lecanemab (LEQEMBI®) in Great Britain for the treatment of mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult patients that are apolipoprotein E ε4 (ApoE 4) heterozygotes or non-carriers.

Lecanemab is the first new Alzheimer’s drug to receive MHRA approval in more than 20 years, and the first in a new class of therapies, known as monoclonal antibodies, that can slow progression of disease, not just treat its symptoms.

Babak Tousi, M.D., neurogeriatrician for Cleveland Clinic, has been involved in the research of this drug through its phase 3 clinical trial and offers insight into how it works.

How does lecanemab work?

“To understand how lecanemab works, let’s start with how we believe Alzheimer’s disease begins. We understand there is abnormal accumulation of the protein amyloid in the brain, which develops into plaques. The thought has been if we can somehow interrupt this cycle or buildup of plaques in the brain, we can maybe change the trajectory of disease progression down the road. What lecanemab does is trigger the immune system to identify, interrupt and help clear up these plaques,” Dr. Tousi said.

Who is lecanemab for?

“This medication is approved for people at the very earliest stage of Alzheimer’s disease with confirmed amyloid pathology. This is someone who is still relatively independent but requires assistance for more complicated tasks, like managing medications or finances. It’s important to know this is not for everybody with Alzheimer’s disease or other types of dementia,” Dr. Tousi said.

What are the side effects?

“As with any medication, there are side effects. While rare, the one we are most concerned about is amyloid-related imaging abnormalities (ARIA), which involve fluid buildup or small brain bleeds detectable on a magnetic resonance imaging (MRI) scan. That’s why we periodically schedule MRI scans after infusions. If we suspect someone has an abnormality, we may pause treatment until it clears. Often, we can resume the medication," Dr. Tousi said.

Editor’s notes: Media assets (quotes, sound bites, b-roll) are available for use courtesy of Cleveland Clinic. Dr. Tousi is a paid scientific advisor for Eisai.

Other Frequently Asked Questions:

Who is lecanemab for?

It is for people in the earliest symptoms of Alzheimer’s disease with confirmed presence of the amyloid deposition in the brain, often called “plaques”, only one or no copies of the ApoE 4 gene. As with any medical treatment, appropriateness depends on a variety of factors.

Who is lecanemab not for?

Lecanemab is not for use in individuals in moderate or late stages of Alzheimer’s disease or in any dementia other than Alzheimer’s disease. Lecanemab is not for patients who have two copies of the ApoE 4 gene. Use of lecanemab is contraindicated in patients who are on anticoagulants (blood thinners, including warfarin) or have been diagnosed with cerebral amyloid angiopathy (CAA) on MRI, or people who have had a recent stroke or TIA (mini-stroke). Lecanemab should not be used in patients diagnosed with other conditions that cause cognitive impairment and dementia (i.e., Lewy body dementia, vascular dementia/stroke, frontotemporal dementia, Parkinson’s disease).

Is lecanemab used for those diagnosed with mild cognitive impairment?

If mild cognitive impairment is due to underlying Alzheimer’s disease and tests have confirmed the presence of amyloid deposits in the brain, then lecanemab may be a treatment option.

How do I know if lecanemab is right for me or my loved one?

Lecanemab is for people with mild symptoms caused by Alzheimer’s disease and who have had confirmation of Alzheimer’s disease with testing (amyloid PET scan or spinal fluid testing). Lecanemab will require a prescription and regular hospital visits for treatment and monitoring. As with any medical treatment, an individual’s suitability for lecanemab treatment will require a detailed medical review.

If you are concerned about Alzheimer’s disease, book a detailed clinical assessment with one of our expert neurologists, by calling 44 20 3423 7500. Our assessment will involve a detailed history and examination and appropriate tests will be arranged. If a diagnosis of Alzheimer’s disease is confirmed, your neurologist will explain the condition and discuss treatment options with you.

How does lecanemab work?

Lecanemab is a monoclonal antibody. In our bodies, antibodies “mark” or “label” molecules that need to be removed by the immune system. Normally, these are bacteria, viruses and toxins. Lecanemab is manufactured to stick to amyloid beta protein, enabling the immune system to gradually remove the protein from the brain. Lecanemab is delivered via infusion as a daycase patient in hospital – directly into the vein through a needle or catheter – every two weeks. The infusion itself takes around an hour.

Is lecanemab safe?

Like any medication, lecanemab also has side effects. The side effect seen most commonly during the studies was amyloid-related imaging abnormalities (ARIA) – removing of amyloid may cause leakiness of blood vessels and swelling in the brain or bleeding. Regular brain MRI (magnetic resonance imaging) scans are required during treatment with lecanemab to monitor any changes.

When will lecanemab be available at Cleveland Clinic London?

Managing the complexities of this new medication may delay its clinical use. We are currently working through our process for new drug approvals, no decision has been made at this time.