LEXINGTON, Ky. — The University of Kentucky is a site for the groundbreaking AHEAD study, the first-ever clinical trial to test the effect of a promising drug known as lecanemab. Just a few weeks ago, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway to treat Alzheimer’s disease. This represents an important advancement in the ongoing fight to treat Alzheimer’s disease effectively, and UK’s Sanders-Brown Center on Aging is at the forefront of the work.
The accelerated approval was based largely on the clear demonstration of removing the amyloid plaques from Alzheimer patients’ brains. It is not based on the clinical benefit associated with that. A traditional approval, which the drug maker Eisai is seeking, will consider that aspect of the trials.
Alzheimer’s disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans that slowly destroys memory and thinking skills. While the specific causes of Alzheimer’s are not fully known, it is characterized by changes in the brain, like amyloid beta plaques or tau tangles. These changes affect a person’s ability to remember and think.
“Could we see an extension of quality of life for years with this medicine? The current estimates are that if we get this medicine into people early enough and continue it, we will be able to add two and a half years of quality of life before they decline into what we traditionally all recognize as the more moderate and severe stages of Alzheimer’s disease,” Jicha said.
The FDA did acknowledge some side effects seen with this drug. The prescribing information includes a warning for amyloid-related imaging abnormalities (ARIA), which are known to occur with antibodies of this class. ARIA usually does not have symptoms, although serious and life-threatening events rarely may occur. ARIA most commonly presents as temporary swelling in areas of the brain that usually resolves over time and may be accompanied by small spots of bleeding in or on the brain’s surface.
However, some people may have headaches, confusion, dizziness, vision changes, nausea and seizure. Another warning for Leqembi is the risk of infusion-related reactions, such as flu-like symptoms, nausea, vomiting and changes in blood pressure. The most common side effects of Leqembi were infusion-related reactions, headache and ARIA. Studies on the side effects and how to combat them are currently underway. This work is also taking place at UK’s Sanders-Brown.
Jicha says this latest work and the promising discoveries provide him hope and hope for his fellow researchers, patients and their caregivers.
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