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 for the treatment of Alzheimer’s disease. This represents an important advancement in the ongoing fight to effectively treat Alzheimer’s disease, and UK’s Sanders-Brown Center on Aging is on the forefront of the work.
“The approval was accelerated, but it wasn't conditional. So, what that really means is that Alzheimer's disease itself is an unmet need. Diseases with unmet needs are ones that we don't have any medicines that are approved that can impact and change the disease itself. We have medicines for memory — that help with memory — but this new medicine actually removes the amyloid plaques from the brain,” said Greg Jicha, M.D., Ph.D., director of clinical trials at UK’s Sanders-Brown Center on Aging “That is such a breakthrough in an area of an unmet need that it had to be accelerated. Now, right now, accelerated approval does come with some caveats to it.”
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 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 an additional 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 surface of the brain, though some people may have symptoms such as headache, confusion, dizziness, vision changes, nausea and seizure. Another warning for Leqembi is for a risk of infusion-related reactions, with symptoms 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 looking at 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 are providing him hope, as well as hope for his fellow researchers, patients and their caregivers.
“For the first time, having a medication that we understand can fundamentally change the disease process is the first step and it’s a giant step,” said Jicha. “It tells us and teaches us all that we are on the path to the eventual cure for Alzheimer’s that we’re all looking for.”
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The AHEAD study is funded by the National Institutes of Health (NIH) and Eisai Inc., a U.S. subsidiary of Eisai Co. Ltd. (Headquarters: Tokyo), and seeks 1,165 participants from North America. The study has more than 100 study locations worldwide, including North America, Japan, Singapore, Australia and Europe.
To learn more about the AHEAD study, call 1-800-AHEAD-70 or to find a trial site location enrolling near you, visit www.AHEADstudy.org.
Learn more about enrolling in studies at UK’s Sanders-Brown Center on Aging here.
Research reported in this publication was supported by the National Institute on Aging of the National Institutes of Health under Award Numbers R01AG054029 and R01AG061848. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The AHEAD study (Clinical Trial number NCT04468659) received funding from NIH and from nongovernmental sources. This release discusses the investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.
MAY 25, 2023
MAY 24, 2023