Information on Lecanemab Treatment for Patients and Families

The FDA has granted full approval of lecanemab (Leqembi®), an anti-amyloid antibody for the treatment of Alzheimer's disease in patients with mild cognitive impairment or mild dementia due to Alzheimer disease (AD).

Is lecanemab for everyone?

No. The FDA has set guidelines on who will be eligible to receive this treatment. Only people who meet these guidelines will be evaluated to see if it is appropriate for them. For safety reasons it is not appropriate for some people. The James E.C. Walker Memory Assessment and Management Program at UConn Health is following guidelines recommended by experts in the field.

How does lecanemab work? Will it improve my cognitive and functional abilities?

Lecanemab works by lowering the level of beta-amyloid protein in the brain. This approach doesn’t stops the disease process and does not improve cognitive symptoms or functional abilities. Rather, it slows the rate of cognitive and functional decline. In the Phase 3 research study, the group treated with lecanemab had slower decline on cognitive tests and activities of daily living than the group that received placebo (about 5 months slower decline over the 18 months of the trial). Not all experts agree on whether this is clinically significant. The benefit is likely different from person to person and at different stages of the disease.

Will insurance cover lecanemab? If so, what will be the cost to beneficiaries?

The Centers for Medicare and Medicaid Services (CMS) will provide coverage to Medicare beneficiaries if they are enrolled in an approved Alzheimer Patient Registry. UConn Health Memory Program staff will help register our patients after they have met all required criteria and testing. The medication costs approximately $26,500 a year. The exact cost to beneficiaries is not yet known and will vary with different insurance coverage plans. For example, individuals with Original Medicare will pay the standard 20% copay once they meet their Part B deductible. Patients with supplemental Medicare plans may have much of this deductible covered. Patients may also be responsible for some costs associated with infusions, MRI scans, medical appointments, and other aspects of treatment. Some private health insurance plans will cover lecanemab with prior authorization, but others have not yet provided details. UConn Health financial representatives will provide an estimate letter once the decision has been made to begin lecanemab treatment.

Why are patient registries needed?

Patient registries will collect information to help ensure appropriate patient selection and monitor the safety and benefits of this treatment. Patient outcomes and safety information will help us make decisions about who benefits most. Our center will help register eligible patients in the Centers for Medicare & Medicaid Services (CMS) as well as the Alzheimer's Association registries.

When and how can I receive lecanemab?

The UConn Pharmacy & Therapeutics Committee has added lecanemab to the UConn formulary so it will be available through our Infusion Center. UConn physicians will be instructed on how to refer patients with early dementia for evaluation to see if lecanemab is appropriate for them. The James E.C. Walker Memory Assessment Program, located at 21 South Road, Farmington, will be responsible for screening patients for lecanemab therapy, ordering the treatment and monitoring safety and outcomes for all UConn Health patients who receive lecanemab.

What tests and procedures are needed to determine whether I am eligible to receive lecanemab?

Your primary care doctor, neurologist, psychiatrist, or other referring provider must first evaluate you for cognitive changes and make a diagnosis of mild cognitive impairment due to AD or mild AD dementia That evaluation should include a basic mental and physical examination and lab tests for common causes of cognitive problems, within 6 months of the referral date, and an MRI of the brain within 12 months of referral. Your referring doctor should also confirm that you are not on a blood thinner (aspirin or clopidogrel (Plavix) is OK) or on medicines that suppress the immune system. You should not have any poorly controlled medical, neurological, or psychiatric condition in addition to AD.

After referral to the Memory Assessment Program, you may need additional testing:

  • To confirm that you have elevated brain amyloid, you may need a spinal tap to test the cerebrospinal fluid (CSF) for the presence of amyloid protein, or an amyloid positron emission tomography (PET) brain imaging scan which can show how much amyloid protein is in your brain.
  • We may also need to do a genetic test to find out what type(s) of the APOE gene you carry. This helps us understand your risk of potential side effects.

How will this new treatment be given?

Lecanemab is given through an intravenous (IV) needle in your arm every 2 weeks for at least 18 months. Each infusion lasts about 1 hour followed by post-infusion monitoring. The Memory Program will provide a schedule of your treatments. Infusions will be given in the Infusion Center on the 4th floor of the Outpatient Pavilion at UConn Health. In addition to infusion visits and regularly scheduled visits with referring providers, patients receiving lecanemab will have brain MRIs at 2 months, 3 months, and 6.5 months into treatment (plus additional MRIs as indicated) to look for any brain changes caused by the treatment.

What are possible side effects of lecanemab?

In the phase III study, only 2.8% of subjects had symptoms due to lecanemab. Most symptoms were mild and temporary including headache, confusion, dizziness, changes in vision, nausea, or difficulty walking. However, lecanemab can cause small areas of swelling or bleeding in the brain called amyloid related imaging abnormalities (ARIA). ARIA is usually asymptomatic and detected only by monitoring brain MRI scans. ARIA-related swelling occurred in 12.6% of subjects receiving lecanemab, and 8.4% of subjects had both swelling and bleeding, often without symptoms. Patients who develop ARIA will therefore need to be monitored with more frequent MRIs (usually monthly) until it resolves, usually within 6 months, and some patients may need to stop treatment.

Rarely, ARIA can cause larger areas of inflammation and/or bleeding in the brain, sometimes causing seizures, confusion or more severe symptoms. The risks of more severe ARIA leading to hospitalization are highest in people who have 2 copies of the APOE e4 gene. In the phase 3 study, symptomatic ARIA occurred in 9.2% of participants with 2 APOE4 genes, 1.7% of participants with 1 APOE4 gene, and 1.4% in participants who did not carry an APOE4 gene. The rates of serious symptomatic ARIA were 2.1% in participants with 2 APOE4 genes, 0.4% in participants with 1 APOE4 gene, and 0.7% in participants who did not carry an APOE4 gene. For this reason, the UConn Memory Program will not give lecanemab to patients who carry 2 copies of the APOE e4 gene.

Has anyone died from lecanemab?

In the first part of the lecanemab phase 3 trial that included 1795 participants over 18 months, 6 participants who received lecanemab and 7 of those receiving placebo died, which was not significantly different. In the open label extension of the study, where everybody received lecanemab, 3 participants (out of about 900) died from side effects thought to be due to lecanemab. Two of the deaths were related to brain hemorrhages (bleeding), one occurring in a participant on anticoagulation (a blood thinner), the other in a patient who had a stroke and received tissue plasminogen activator, a medication used to break down blood clots. The third death occurred in a patient with 2 APOE4 genes who developed symptomatic ARIA. To lower the risk of these complications, we will not give lecanemab to patients on anticoagulation. A key purpose of the screening MRI prior to treatment is to identify risk factors for bleeding such as microhemorrhages (tiny areas of bleeding) that would lead to a higher risk of serious ARIA. Also, APOE genotyping will allow us to identify patients with 2 copies of the APOE4 gene who are at higher risk for developing side effects and who will not be eligible to receive lecanemab at UConn.

Is lecanemab is effective for patients with early-onset AD? How about in racial and ethnic minorities?

The phase 3 study did not provide conclusive results about the effectiveness or side effects of lecanemab in these subgroups. Additional data from more subjects will be helpful to answer these important questions. This is one purpose of the registry noted above.

What will happen if I decide not to receive this treatment?

Whether to start treatment is a decision you should make with your family and your physician. We will continue to be a resource for you if you decide not to receive treatment. We will support you by answering your questions, and providing medical expertise and guidance as you weigh this new medication option.

Will I be eligible for lecanemab if I participated in a clinical trial investigating a different treatment for AD?

Prior participation in clinical therapeutic research studies will not make you ineligible to receive lecanemab, provided the other eligibility criteria are satisfied.

Can I enroll or continue in clinical research studies for AD if I am on lecanemab?

At present, most studies investigating potential new treatments for AD do not allow you to enroll if you are on lecanemab. This could change in the future. We recommend speaking with your current provider and/or contacting us if you have questions about whether lecanemab or a research study is the best option for you. If you are currently enrolled in a drug study or an observational study, please contact your research site about how treatment with lecanemab might affect your ongoing participation in the study.