The Medicines and Healthcare Products Regulatory Agency has approved the medicines Donanemab (KISUNLA®) and Lecanemab (LEQEMBI®) for the treatment of mild cognitive impairment or mild dementia due to Alzheimer’s disease in some adults. (These medications are only for people who are apolipoprotein ε4 [ApoE 4] heterozygotes or non-carriers). These new Alzheimer’s drugs can slow the progression of Alzheimer’s disease, not just treat its symptoms.

We are now offering donanemab and lecanemab at Cleveland Clinic London. To make an enquiry about these services, please contact us at [email protected] / [email protected].

What does the approval of donanemab and lecanemab by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of Alzheimer’s disease mean?

It means that these new drugs are now available in the U.K. for certain people with Alzheimer’s. Specifically, regulators approved donanemab (KISUNLA® ) and lecanemab (LEQEMBI®) for the treatment of mild cognitive impairment or mild dementia due to Alzheimer’s disease in certain adults. To qualify for these drugs, you or your loved one must be diagnosed as an apolipoprotein ε4 (ApoE 4) heterozygote or non-carrier.

What do donanemab and lecanemab do?

They can slow the progression of Alzheimer’s disease, not just treat its symptoms. They are known as anti-amyloid therapies because they target a brain protein called amyloid. An abnormal buildup of amyloid protein is thought to be one of the key steps in the development of early Alzheimer’s.

In research, donanemab and lecanemab have been shown to gradually remove this abnormal amyloid protein from the brain. For people with the earliest symptoms of Alzheimer’s disease, removal of amyloid by these drugs appears to slow the progression of symptoms due to Alzheimer’s disease. Neither donanemab or lecanemab will completely stop or reverse Alzheimer’s disease.

Who are donanemab and lecanemab for?

These medicines are for certain people with the earliest symptoms of Alzheimer’s disease. To qualify, you or your loved one must have confirmed presence of the amyloid deposits in the brain, often called “plaques.” You must also have only one or no copies of the ApoE 4 gene. As with any medical treatment, appropriateness depends on a variety of factors.

Who are donanemab and lecanemab NOT for?

Donanemab and lecanemab are not for people in moderate or late stages of Alzheimer’s disease or with any dementia other than Alzheimer’s disease. These drugs are not for people who have two copies of the ApoE 4 gene.

These drugs are also not recommended (contraindicated) for people:

  • Taking anticoagulants (blood thinners, including warfarin)
  • Diagnosed by MRI with cerebral amyloid angiopathy (CAA)
  • Who have had a recent stroke or TIA (mini-stroke)

Donanemab and lecanemab also should not be used for people diagnosed with other conditions that cause cognitive impairment and dementia. This includes  Lewy body dementia, vascular dementia/stroke, frontotemporal dementia and Parkinson’s disease.

Are donanemab and lecanemab used for those diagnosed with mild cognitive impairment?

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

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

Donanemab and lecanemab are for people with mild symptoms caused by Alzheimer’s disease and who have had confirmation of Alzheimer’s disease with certain tests. This testing includes an amyloid PET scan or spinal fluid testing. To use them, you need a prescription and will need to make regular hospital visits for treatment and monitoring. As with any medical treatment, a person’s suitability for donanemab or lecanemab will require a detailed medical review.

If you are concerned about Alzheimer’s disease and if one of these treatments is right for you, please contact us at [email protected] / [email protected].

We’ll perform an assessment that will include a detailed history and examination. We’ll also arrange appropriate tests. If we confirm a diagnosis of Alzheimer’s disease, your neurologist will explain the condition and discuss treatment options with you (or you and your loved one).

How do donanemab and lecanemab work?

Both donanemab and lecanemab are monoclonal antibodies. Antibodies “mark” or “label” molecules in the body that the immune system needs to remove. Normally, these are bacteria, viruses and toxins. Anti-amyloid therapies are manufactured to stick to amyloid beta protein. Then, the immune system can gradually remove the protein from the brain.

You get both lecanemab and donanemab by infusion — directly into a vein through a needle or catheter. Lecanemab is given every two weeks. Donanemab is given monthly.

Are donanemab and lecanemab safe?

Like any medication, donanemab and lecanemab have side effects. In studies, the most common side effect was amyloid-related imaging abnormalities (ARIA). This means that the removal of amyloid may cause leakiness of blood vessels and swelling in the brain, or bleeding. So, you or your loved one will require regular brain MRI (magnetic resonance imaging) scans during treatment to monitor any changes.

Does Cleveland Clinic London administer donanemab and lecanemab to patients?

Yes, Cleveland Clinic London offers both donanemab and lecanemab to:

  • Current patients for the treatment of mild cognitive impairment
  • Qualified patients who have mild dementia due to Alzheimer’s disease and are apolipoprotein ε4(ApoE 4) heterozygotes or non-carriers.

They are offered in an outpatient setting. Some Cleveland Clinic locations in the U.S. (Ohio and Nevada) also offer lecanemab to patients.

I am a patient at Cleveland Clinic London. How can I be evaluated for donanemab or lecanemab?

You can check with your consultant/provider about donanemab or lecanemab at your next scheduled appointment. If you do not currently have an appointment scheduled, please contact us at [email protected] / [email protected]. You may also request more information from your provider about these drugs or another disease-modifying therapy for early-stage Alzheimer’s disease.

I am NOT a patient at Cleveland Clinic London. How can I be evaluated for donanemab or lecanemab?

If you are not currently a patient at Cleveland Clinic London but are interested in being evaluated for Alzheimer’s disease, please ask your current consultant to send a referral to Cleveland Clinic London. Then, you may contact us at [email protected] / [email protected].

I am a current patient at Cleveland Clinic London. Should I make an appointment to come in sooner?

If you have questions about donanemab or lecanemab prior to your next scheduled neurology appointment, please send your care team a message via MyChart.

Will this be covered by insurance?

Neither donanemab or lecanemab are currently covered by insurance in the U.K.

What is the cost of donanemab and lecanemab?

Donanemab and lecanemab are billable medications. We will provide you with the most accurate estimate of your costs. The original estimate may change based on adjustments to your treatment plan or the services you receive. If you have questions about your medical bill or would like to learn more about how to pay for your care, please call +44 20 3423 8900.

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