January 6, 2023 – Today, as expected, the US Food and Drug Administration granted accelerated approval to lecanemab, a monoclonal antibody against the beta amyloid protein that accumulates in the brain of people with Alzheimer’s disease. Lecanemab was approved on the basis of the treatment’s demonstrated effect of lowering levels of brain amyloid, as measured by a type of brain scan known as positron emission tomography (PET) imaging. Lecanemab is now approved for the treatment of patients with mild cognitive impairment or mild dementia, and should be used in patients in whom that same amyloid PET brain scan (or measures…
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Elizabeth Head, PhD UCI MIND Faculty Member Elizabeth Head, PhD was featured in the Akron Beacon Journal: I recently interviewed Dr. Elizabeth Head, a neuropathology core co-investigator at the Alzheimer's Disease Research Center at University of California, Irvine. While she collaborates with researchers studying Alzheimer's in the general population, her research is focused specifically on the Down syndrome population. Her team and others are conducting longitudinal studies, in which volunteers with Down syndrome participate for many years, discovering relevant data that are the building blocks for future treatments. Read the full article here >
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Bells and Whistles. ACI-35.030 includes a phospho-tau peptide anchored to a liposomal bilayer, along with two adjuvants and a non-target T cell epitope to rally B cells to churn out antibodies against phospho-tau. The work of our faculty, researchers, and collaborators was highlighted in a recent Alzforum article on anti-tau vaccines. AC Immune updates Phase 1b/2 comparison of two anti-#tau vaccines. A liposomal vaccine prompted #antibody response against phospho-tau. Preclinical data bode well for another tau vaccine; first trial slated for next year. Read more >
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UCI MIND Director Joshua Grill, PhD is featured in and comments on Alzforum's report on "convincing and noteworthy" lecanemab results. The slightly larger effect on ADLs caught the interest of some scientists, since these can feel most important to participants. “ indicates that patients and families could benefit from slowing of observable functional worsening,” Joshua Grill of the University of California, Irvine, wrote to Alzforum (full comments below). Read his commentary here > Read the full article here > Diverging Trajectories. People on lecanemab worsened more slowly on the CDR-SB than did people on placebo, resulting in a quarter less progression…
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Message from the Director Dear Friends of UCI MIND, As the fall MIND Matters newsletter goes to print, many of us are preparing to travel to San Francisco for the annual Clinical Trials in Alzheimer’s Disease (CTAD) meeting, where we will hear important results from recently completed Phase 3 clinical trials of potential new therapies for Alzheimer’s disease (AD). This includes trials of lecanemab (page 1) as well as other treatments. The topline results for lecanemab announced by the trial sponsors are exciting and suggest that lecanemab may slow the progression of AD. The availability of treatments to slow the…
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Eat This, Not That! "According to a study performed by UCI MIND and presented at the American Association for the Advancement of Science, there's a connection between longevity and drinking a moderate amount of alcohol. (Let's stress the "moderate.") The research involved individuals 90+ years of age. In this particular study, participants who drank approximately two glasses of wine or beer were linked to an 18% decreased risk of early mortality. So sipping in moderation can be a good thing!" Learn more here > Learn about The 90+ Study here >
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“Alzheimer’s is the most important medical condition society faces and we need an army of citizen volunteers to participate in drug trials,” said UCI MIND’s Joshua Grill, with study leader Marina Ritchie. UCI MIND When the U.S. Food and Drug Administration gave controversial accelerated approval to the first Alzheimer’s drug in nearly 20 years, it had a surprising impact on attitudes about research into the disease. A survey by University of California, Irvine neuroscientists has found news coverage of the FDA’s decision made the public less willing to volunteer for Alzheimer’s pharmaceutical trials. The study was conducted by the UCI…
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Contributed by Joshua Grill, PhD On the opening night of the Clinical Trials for Alzheimer’s Disease (CTAD) meeting, a packed room was abuzz with excitement. The evening included five presentations related to the Phase 3 CLARITY-AD trial of lecanemab, a monoclonal antibody against the beta amyloid protein that builds up in the brain of a person with Alzheimer’s disease. The excitement and anticipation were palpable, since the sponsor of the trial, Eisai, had announced in September that the results were positive. The presentations were accompanied by the full publication of the results in the New England Journal of Medicine and coverage…
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Contributed by Joshua Grill, PhD and David Sultzer, MD An article in ScienceInsider, a news outlet published by Science magazine, reports on an unpublished case of a person who died after treatment with the monoclonal antibody lecanemab. There are two hallmarks of Alzheimer’s dementia: amyloid-beta protein deposits known as plaques, and tangles of a protein called tau, but several potential antibody therapies target just amyloid. KATERYNA KON/SCIENCE SOURCE Lecanemab is a promising investigational treatment, seemingly poised for FDA approval as a disease-modifying treatment for Alzheimer’s disease. Topline results were announced in September that indicated lecanemab had been shown to slow progression of…
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The actor Chris Hemsworth recently publicly disclosed that he learned that he carries two copies of the Alzheimer’s disease risk gene Apolipoprotein (APOE) e4 (https://www.goodmorningamerica.com/culture/story/chris-hemsworth-discovers-risk-alzheimers-disease-series-limitless-93442609). We’ve previously discussed direct-to-consumer genetic testing that includes the option for APOE testing on the UCI MIND blog (https://mind.uci.edu/fda-approves-23andme-limited-direct-consumer-genetic-risk-testing/). APOE is the strongest known genetic risk factor for Alzheimer’s disease. People who carry one or two copies of the e4 allele are at increased risk for Alzheimer’s disease, while people who carry the e2 allele are at lower risk (most people carry two copies of the e3 allele). But people with e4 don’t always develop…
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