Leqembi

Leqembi Overview:

Leqembi (lecanemab-irmb) is a treatment for early Alzheimer’s disease. It is used in people with mild cognitive impairment or mild dementia due to Alzheimer’s who have confirmed amyloid plaques in the brain. Leqembi is made by Eisai and Biogen and received full FDA approval in July 2023. It is one of the first treatments shown to slow the progression of Alzheimer’s disease, rather than only easing symptoms.

Understanding Leqembi:

Alzheimer’s disease is marked by a buildup of a protein called amyloid beta, which clumps together and forms plaques in the brain. Leqembi is a monoclonal antibody that binds to amyloid beta, especially the early, soluble clumps called protofibrils, and helps the body clear amyloid from the brain. Leqembi does not cure Alzheimer’s or reverse memory loss that has already occurred, but it can slow how quickly the disease progresses.

Unlocking Leqembi’s Potential:

FDA approval was based on the Phase 3 Clarity AD trial. Over 18 months, patients treated with Leqembi showed 27% less decline on a standard measure of memory, thinking, and daily function (CDR-SB) than patients given placebo, along with a marked reduction in brain amyloid. Leqembi is given by IV infusion in a clinic or infusion center. A subcutaneous autoinjector, Leqembi Iqlik, is also available for weekly injections at home after supervised starting doses.

Navigating Dosage and Administration:

• IV dose: Given by IV infusion over about one hour, once every 2 weeks.
• After 18 months: Patients may continue every 2 weeks or move to a maintenance schedule of once every 4 weeks.
• Subcutaneous option: Leqembi Iqlik is given as a weekly injection. The first doses are supervised by a healthcare provider before a patient or caregiver may give it at home.
• MRI monitoring: A brain MRI is done before starting treatment, then at about 1, 2, 3, and 6 months, to check for ARIA. Close clinical monitoring is recommended during the first 14 weeks.
• Monitoring during infusion: Patients are watched for infusion-related reactions during and after each infusion.

Preparing for Leqembi Treatment:

Before starting treatment, the care team will:

• Confirm the presence of amyloid plaques, usually with an amyloid PET scan or a spinal fluid test
• Obtain a recent baseline brain MRI
• Recommend ApoE e4 genetic testing, since people with two copies of this gene have a higher risk of ARIA
• Review current medications, especially blood thinners
• Discuss the expected benefits, risks, and monitoring schedule with the patient and caregivers

Leqembi Side Effects:

The most common side effects in clinical trials included:

• Infusion-related reactions, such as fever, chills, flu-like symptoms, nausea, or changes in blood pressure
• ARIA, often found on MRI without symptoms
• Headache
• Rash
• Nausea or vomiting

Leqembi carries a boxed warning for amyloid-related imaging abnormalities (ARIA). ARIA is temporary swelling (ARIA-E) or small areas of bleeding (ARIA-H) in the brain. It usually causes no symptoms and is found on routine MRI. When symptoms occur, they can include headache, confusion, dizziness, vision changes, nausea, or seizures. In rare cases, ARIA can be serious or life-threatening, and brain bleeds larger than 1 cm have occurred. The risk is higher in ApoE e4 homozygotes and may be higher in people taking blood thinners.

Patients and caregivers should report any new or worsening symptoms right away. Treatment may be paused or stopped depending on MRI findings and symptoms. Patients with a history of serious hypersensitivity to lecanemab or any of its ingredients should not receive Leqembi.

Empowering Alzheimer’s Care with Leqembi:

Leqembi gives people in the early stages of Alzheimer’s disease a way to slow progression by targeting amyloid, a root cause of the disease. With careful patient selection, a structured MRI monitoring schedule, and IV or subcutaneous dosing options, it can help patients preserve memory, independence, and quality of life for longer.