UCI MIND

July 6, 2023—Today, the US Food and Drug Administration granted full approval to the drug lecanemab (brand name Leqembi®), a monoclonal antibody that has been demonstrated to lower levels of amyloid plaques in the brain and slow cognitive and functional decline in people living with Mild Cognitive Impairment and mild dementia due to Alzheimer’s disease. The approval is the first full approval of a new drug for Alzheimer’s disease in nearly 2 decades. The full, or traditional, approval is distinguished from “accelerated” approval, which lecanemab was also granted in January of this year. The full approval communicates that the agency…

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On June 9, The US Food and Drug Administration convened members of the updated Peripheral and Central Nervous System Drugs Advisory Committee to review the available data for lecanemab, the monoclonal antibody treatment for early Alzheimer’s disease developed by Eisai and Biogen. The members voted unanimously, 6-0, in favor of approval. Lecanemab was recently granted accelerated approval by FDA, based on demonstration that treatment with the infused medication could lower brain amyloid levels (https://mind.uci.edu/fda-grants-accelerated-approval-to-lecanemab/). Based on results from a large Phase 3 trial in which lecanemab demonstrated efficacy in slowing disease progression over 18-months (https://mind.uci.edu/eisai-and-biogen-announce-positive-phase-3-results-for-lecanemab/), the agency will now consider full…

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UCI MIND Director, Dr. Joshua Grill, named one of this year’s OC50 (50 people shaping the future of healthcare in Orange County) in the Orange County Business Journal.  Read the article here. [Subscription required, you can request an electronic copy of the article by sending an email to communications@uci.edu.]

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Masashi Kitazawa, Associate Professor of Environmental and Occupational Health, and his team found exposure to traffic-related air pollution led to memory loss and cognitive decline and triggered neurological pathways associated with the onset of Alzheimer’s disease. Read the article here.

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May 12, 2023–Brexpiprazole has now been approved by the FDA for the treatment of agitation in Alzheimer’s dementia.  Agitated behaviors are common in those with moderate or advanced Alzheimer’s dementia and these symptoms contribute substantially to caregiver burden, institutionalization, and faster cognitive decline.  Yesterday’s decision marks the first approval in the United States of a medication for these symptoms. The approval was based on the results of three 12-week treatment studies.  The studies collectively showed modest reduction in the frequency of specific agitated behaviors and lower severity on a clinician-rated measure.  In one of the studies, 56% of those treated…

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May 3, 2023–Eli Lilly and company announced today (https://investor.lilly.com/news-releases/news-release-details/lillys-donanemab-significantly-slowed-cognitive-and-functional) the positive topline results from their Phase 3 clinical trial of donanemab, a monoclonal antibody that rapidly lowers beta amyloid levels in the brain of people with Alzheimer’s disease. The release indicated that patients treated with donanemab experienced significantly slower cognitive and functional decline, compared to those receiving placebo, over 18 months. The primary outcome was a composite measure known as the integrated Alzheimer’s Disease Rating Scale (iADRS, a tool that borrows pieces of other instruments to look at elements key in early disease) and was reported as demonstrating a 35%…

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New number crunching from the Alzheimer’s Orange County estimates that the number of folks enduring this sort of heartbreak has essentially doubled since 2014 in the O.C. That’s a startling jump, from 84,000 to 164,000 people, which works out to about 5% of our total population. … “The new number is believable, especially if a difference from the previous estimate is the inclusion of mild cognitive impairment as a category,” said Dr. Joshua D. Grill, Professor of Neurobiology & Behavior and noted Alzheimer’s researcher at UC Irvine . “Orange County is ‘grayer’ than the rest of the country, so we do…

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