The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to consider accelerated approval for Lecanemab to treat Alzheimer’s disease.
Studies have shown removing beta-amyloid from the brain can reduce functional and cognitive decline in people with early Alzheimer’s. This is promising news for the millions of Americans suffering from the debilitating disease.
How Lecanemab Works
When beta-amyloid accumulates in plaques, it can contribute to tissue loss and cell death in parts of the brain essential to thinking, behavior, learning, and memory. Lecanemab targets and attaches itself to the beta-amyloid, signaling the immune system to attack.
Although the brain continues creating beta-amyloid, the drug reduces the amount of buildup. Other processes in the brain can operate more efficiently due to the removal of plaques.
Administration Method for Lecanemab
A doctor administers Lecanemab intravenously. Treatments occur during a 45 to 60-minute infusion every four weeks. Patients can undergo treatments at an infusion therapy center or a hospital. The medication reaches the brain most effectively by injecting it through an IV.
Common Side Effects of Lecanemab
The most common side effects of the new Alzheimer’s drug are falls, headaches, and amyloid-related imaging abnormalities (ARIA). An allergic reaction is another potential side effect.
Although ARIA is a common side effect, it typically doesn’t cause symptoms. However, it can be a serious problem. ARIA is temporary swelling in parts of the brain. Over time, the swelling can go down. Symptoms are unlikely, but the people who experience adverse effects have changes in vision, dizziness, confusion, headaches, and nausea.
Research Shows Slowed Cognitive Decline in Alzheimer’s Patients
Eisai, the Lecanemab manufacturer, developed the drug to slow the effects of cognitive decline in people in the early stages of Alzheimer’s. Initial data shows the drug has been successful during the late stages of clinical trials.
During the clinical trial, 1,795 participants received Lecanemab or a placebo every two weeks for eighteen months. A clinical dementia rating scale measured cognitive decline in each person. The scale focuses on six areas – memory, community affairs, problem-solving and judgment, personal care, hobbies and home, and orientation.
Eisai plans to present findings from the trial at an Alzheimer’s conference in November. The company also plans to submit the data from its trial to the FDA for approval by March. With the FDA’s agreement for accelerated approval, Eisai expects the agency to decide on conditional approval by early January.
Who Qualifies for the Alzheimer’s Drug?
People in Lecanemab studies were in the early stages of Alzheimer’s disease. Patients included those with mild cognitive impairment or mild dementia due to Alzheimer’s with evidence of amyloid plaque buildup in the brain.
Treatment seems most appropriate for individuals in stages of the disease studied in the clinical trials. However, effectiveness and safety data aren’t available for administering the drug in earlier or later stages of the disease.
Before prescribing the new medication, doctors must confirm the presence of beta-amyloid plaques in the brain. Medical providers can determine a patient’s eligibility with tests such as amyloid PET imaging or cerebrospinal fluid analysis.
Contact a Tampa Elder Law Attorney
If your loved one has Alzheimer’s, it is crucial to plan for their future medical care. You should contact us immediately to speak with an experienced Tampa elder law attorney. We can advise you about the available options for protecting your family member’s assets and preparing for necessary long-term care. To schedule an appointment at our Brandon law firm, simply call (813) 438-8503.