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Controversial Alzheimer’s drug approval sparks surprising impact

By Carousel Slider, Commentary, In the News, 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 Institute for Memory Impairments and Neurological Disorders, known as UCI MIND. It appears in the Journal of Alzheimer’s Disease. (Link to abstract) The UCI team performed the survey in tandem with the FDA’s spring…

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CTAD Abuzz

By Commentary, In the News, UCI MIND

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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Are there new safety concerns for Lecanemab?

By Commentary, In the News, UCI MIND

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PhD and David Sultzer, MD An article in ScienceInsider, a news outlet published by Science magazine, reports on an unpublished case of a person who died after treatment with the monoclonal antibody lecanemab. 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 disease. The full data will be presented tomorrow at the Clinical Trials in Alzheimer’s Disease (CTAD) international conference. The presentation should include efficacy as well as safety data for lecanemab. As…

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Learning Alzheimer’s Risk

By Carousel Slider, In the News, UCI MIND

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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Topline results announced for Phase 3 trial of gantenerumab

By Commentary, In the News, UCI MIND

Contributed by Joshua Grill, PhD On November 14, Roche announced negative topline results for their GRADUATE program testing gantenerumab, a monoclonal antibody against the beta amyloid protein that accumulates in the brain of people with Alzheimer’s disease. The program included two phase 3 trials (GRADUATE 1 and GRADUATE 2). As with other recent trials, the studies included patients with “early Alzheimer’s disease,” including people with Mild Cognitive Impairment and mild dementia. The trials were large and lengthy, with 1965 participants (across the two studies) who were followed for 27 months. According to the press release, participants randomized to gantenerumab demonstrated…

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