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From data to decision-making: the role of machine learning and digital twins in Alzheimer’s Disease

By Carousel Slider, Commentary, In the News
For patients experiencing cognitive decline due to Alzheimer’s Disease (AD), choosing the most appropriate treatment course at the right time is of great importance. A key element to these decisions is the careful consideration of the available scientific evidence, particularly from randomized clinical trials (RCTs) such as the recent lecanemab trial. Translating RCT results into patient-level decisions, however, can be challenging. This is because trial results tell us about the outcomes of groups rather than individuals. A doctor must judge how similar their patient is to the groups studied in trials. For AD, where patients vary widely in clinical presentations…
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Dr. Craig Stark takes UCI’s women’s health research to new heights with the Ann S. Bowers Women’s Brain Health Initiative

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As we celebrate Women's History Month this March, we also find ourselves at a historic moment in scientific inquiry for women’s health research. Today, nearly two-thirds of Americans with Alzheimer’s disease are women, but the underlying cause of this sex disparity is still poorly understood. For decades, research focusing on women's health has been inadequate, with a mere 0.5% of all neuroimaging studies conducted over the past 25 years focusing on women's health. The potential to reach new heights in our understanding of the brain, especially today in the era of “big data” and artificial intelligence, is promising, but requires…
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FDA delays decision on donanemab

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The FDA today announced that it will convene an advisory panel to review the data submitted to support potential approval of donanemab, a monoclonal antibody against the beta amyloid protein that demonstrated efficacy in early Alzheimer’s disease in a recent Phase 3 clinical trial. A positive decision to approve donanemab had been expected before the end of this month. Though data for donanemab’s ability to lower brain amyloid levels are convincing, the FDA had opted not to grant accelerated approval to the drug, citing limited safety data. This contrasted the agency’s decisions for two other amyloid-lowering drugs, aducanumab and lecanemab…
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MIND Matters | Quarterly Newsletter | Winter 2024

By Carousel Slider, Commentary, Community Events, COVID-19, In the News, Participants
Message from the Director Dear Friends of UCI MIND, Happy New Year! We hope that 2024 is off to a positive start for you. As we embark upon a new year, UCI MIND and the field of Alzheimer’s disease and related dementias (ADRD) research are abuzz with excitement about progress made and opportunities to further advance our field.  At the end of 2023, we held our annual signature fundraising event, the December to Remember Gala. We honored Lauren Miller Rogen and Seth Rogen, the founders of Hilarity for Charity (HFC) and our partners in a program to mentor and inspire…
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Is Preclinical Alzheimer’s Disease a Business Product?

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Amyloid PET scan The LA Times recently published a fairly negative appraisal of the construct of preclinical Alzheimer’s disease (AD). The article described the recent effort by an international committee to update diagnostic criteria that date back to 1984, updated in 2011 and again in 2018. The most recent updates have been presented at meetings and published online and have indeed been the source of debate and disagreement in the field. But the LA Times article goes quite a bit further, essentially asking if one particular aspect of the criteria—the definition of preclinical AD—exists mainly to benefit pharmaceutical and medical…
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Biogen terminates phase 4 efficacy study of aducanumab

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Jessica Rinaldi/The Boston Globe Biogen, the maker of aducanumab has announced that it will terminate the Phase 4 trial required by the FDA for aducanumab, the monoclonal antibody against beta amyloid that received accelerated approval in 2021. The company is also halting production of the compound and relinquishing ownership rights to the original developer, Neurimmune. Accelerated approval was based on the demonstration in multiple studies that treatment with aducanumab could lower brain amyloid in people with Alzheimer’s disease. But two Phase 3 trials gave contrasting results about aducanumab’s efficacy, preventing the FDA from granting full clinical approval for the medication.…
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New Alzheimer’s drugs bring hope. But not equally for all patients.

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The medications have not been widely tested in Black people with the disease, underscoring stark — and persistent — disparities Robert Williford, 67, receives a dose of Leqembi at Abington Neurological Associates in Abington, Pa. (Hannah Yoon for The Washington Post) ABINGTON, Pa. — Wrapped in a purple blanket, Robert Williford settles into a quiet corner of a bustling neurology clinic, an IV line delivering a colorless liquid into his left arm. The 67-year-old, who has early Alzheimer’s disease, is getting his initial dose of Leqembi. The drug is the first to clearly slow the fatal neurodegenerative ailment that afflicts 6.7…
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Studies on negative impacts of sleep deprivation continue to sleep on Blacks

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Black people know intrinsically about the myriad of life areas negatively impacted by the fact that the myth of white supremacy is baked into the foundations of all American institutions. But one area that doesn’t get enough attention is how racism robs Blacks of one of nature’s most powerful healing agents – sleep. Blacks have disproportionately higher rates of sleep disorders (sleep apnea, insomnia, more light and less deep sleep, delayed onset, more daytime sleepiness, and shorter sleep duration) compared to any other racial and ethnic groups in the U.S. These disparities are compounded by the fact that they contribute…
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Sound waves get Alzheimer’s drug past brain barrier, small study shows

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Scientists in an MRI control area plan a focused ultrasound treatment at West Virginia University's Rockefeller Neuroscience Institute. (Victor Finomore/WVU Rockefeller Neuroscience Institute/AP) In the first study of its kind in humans, researchers have discovered that it is safe to use sound waves fired into specific areas of the brain to open a protective barrier and clear the way for Alzheimer’s medications. The study, reported in the New England Journal of Medicine, involved just three patients, but it raises hope about the long-term potential of the treatment strategy known as focused ultrasound. Joshua Grill, professor of psychiatry and human behavior…
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Strategies and habits for a longer, healthier life

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93 colored candles on a cake are being lit. (Getty Images) TAMPA (BLOOM) – Join us as we explore strategies—from mindful living to emerging technologies—and discover how every choice can lead to a longer and healthier life. Welcome to the science of aging, where the pursuit of health and happiness is the entire goal. Lifestyle Habits for Longevity Avoiding Harmful Substances In the pursuit of a longer, healthier life, steering clear of harmful substances is an obvious decision. Dr. Claudia Kawas, a distinguished neurologist at the University of California, Irvine, sounds the alarm on two major culprits: smoking and excessive alcohol…
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UCI MIND director’s research on differences in trial eligibility by race and ethnicity is featured in Neurology Today

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Joshua Grill, Professor, Psychiatry & Human Behavior. photo: Steve Zylius/UCI UCI MIND Director, Dr. Joshua Grill, is quoted in Neurology Today for his work with colleagues at USC, Massachusetts General Hospital, Brigham and Women’s Hospital, and Eisai on racial and ethnic disparities in eligibility for Alzheimer's disease clinical trials. To read the article, click here.
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Celebrating What’s Right With Aging: Inside the Minds of Super Agers

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Some people in their 80s and 90s show shockingly little decline in their brainpower. Scientists are beginning to understand what makes them different and how the rest of us might benefit Mark Ross Studio / Getty You can find Vernon Smith hard at work at his computer by 7:30 each morning, cranking out 10 solid hours of writing and researching every day. His job is incredibly demanding — he is currently on the faculty of both the business and law schools at Chapman University. But the hard work pays off: Smith’s research is consistently ranked as the most-cited work produced…
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Researchers testing out drug for Alzheimer’s prevention

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More than 6 million Americans have Alzheimer's disease, and the CDC expects that number to double in the next three decades. Photo by: Manuel Balce Ceneta / AP The first drug fully approved by the FDA for Alzheimer’s has been on the market for 10 months. Now, researchers are looking at testing it to prevent Alzheimer's. A shot that could one day prevent Alzheimer's disease — that’s the potential future for lecanemab, or Leqembi. Researchers are studying to see if the drug can prevent the disease. "We hope make breakthroughs in discoveries that change our ability to help people in their…
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More good news from CMS

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On Friday October 13, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a formal change to their coverage policy for amyloid PET imaging. Previously, with limited exceptions, patients were required to be enrolled in a clinical study known as “Coverage with Evidence Determination” for the scan to be reimbursed. Now, that requirement has been removed and the door has been opened for more patients to get the scan and result in savings of thousands of dollars for patients and their families. In fact, patients may have the opportunity to receive multiple covered scans as part of their routine care…
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How Old is Too Old to Govern?

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Most Americans favor an age limit for the president and other politicians. But some ethicists and scientists argue that’s ageist and scientifically unsound. Photos via Wikimedia Commons (left: Joint Congressional Committee; right: Gage Skidmore) Barring a considerable shift in the political winds, the next US president will be either 82 or 78 years old on Inauguration Day. Meanwhile, Senate Minority Leader Mitch McConnell, who twice froze in front of cameras and was unable to speak for several agonizing moments, is 81. His Democratic counterpart, Majority Leader Chuck Schumer, is a comparative spring chicken at 72. Senator Dianne Feinstein died last month…
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The Secret to Living to 100? It’s Not Good Habits

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iStock Neurologist Dr. Claudia Kawas has been tracking the habits of the “oldest old,” those older than 90, in Southern California since 2003, as part of a study at the University of California, Irvine. She and a team of researchers have found links between longevity and even short amounts of exercise, social activities such as going to church, and modest caffeine and alcohol intake. Read the article here.
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Hispanic Americans are at higher risk of developing Alzheimer’s disease, research shows

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Hispanic people are 1.5 times more likely to develop Alzheimer's. ‘Our America: Unforgettable’The documentary special, produced by ABC Owned Television Stations in partnership with ABC News, takes a looks at alarming data on Alzheimer’s disease through a Hispanic and Latino lens. Nearly 7 million Americans live with Alzheimer's disease, an irreversible and devastating form of dementia that gradually breaks down memory and thinking skills. But not everyone is equally at risk. Hispanic people are 1.5 times more likely to develop Alzheimer's disease than white people, according to data from the Alzheimer's Association. "Our America: Unforgettable" is an hour-long special produced by ABC Owned…
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UCI Summer Institute Trains Undergraduates in Biostatistics and Data Science

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This summer, UC Irvine was again one of only 10 universities in the U.S. to host a free six-week program to train undergraduate students in the fundamentals of biostatistics, data science and computing. For the second year in a row, the Irvine Summer Institute in Biostatistics and Undergraduate Data Science (ISI-BUDS) brought students to UCI from across the nation and, as part of the training, offered hands-on experience conducting cutting-edge biomedical research. The ISI-BUDS Program Of the more than 150 applicants, 15 students were selected for the highly competitive program, which includes up to $500 in travel expenses, free housing,…
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OC Racism: Bad for Brain Health

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Whatever keeps the community up at night – or makes them pull the covers over their head to not face the day – probably won’t surface for years to come, but Dr. Karen Lincoln sees where it starts in the early stages through brain imaging. In and of itself, she said it’s not so much about sleep, but rather why advanced aging disproportionately impacts the Black community. Two of her landmark studies, Sleep Tight and Express Yourself, show how and why everyday discrimination and microaggressions are taking a dramatic toll on health. Earlier this year, Dr. Lincoln joined UCI faculty…
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Dianne Feinstein’s cause of death hasn’t been disclosed, but it likely wasn’t dementia

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Sen. Dianne Feinstein during a committee hearing in 2022. (J. Scott Applewhite / Associated Press) No cause of death has been disclosed for Dianne Feinstein, the longtime California senator who struggled with evident health problems in her final years before her death Friday. She was absent from the U.S. Senate for nearly three months earlier this year while recovering from a case of shingles that led to encephalitis, a rare complication that causes inflammation and swelling in the brain. She was briefly hospitalized in August after falling at her home and was often seen in a wheelchair in public. Indications that Feinstein, 90, was struggling with memory problems have…
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Consumers Can Now Buy a Blood Test to Evaluate Their Alzheimer Disease Risk, but Should They?

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iStock.com/ratthanan Consumers can order blood tests from the laboratory testing behemoth Quest Diagnostics to check their iron or vitamin D levels, learn whether they have a sexually transmitted disease, or determine whether their thyroid is functioning properly. And now, for $399, plus a $13 “physician service fee,” they can order a blood test that promises to help assess their risk of Alzheimer disease. In a press release, Quest Diagnostics noted that its AD-Detect Test for Alzheimer Disease is the first blood test available for consumers to purchase that measures a biomarker linked to the most common form of dementia. The test…
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Taking Medication For High Blood Pressure May Lower Your Dementia Risk

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Willie B. Thomas/Getty Images Treating high blood pressure in older adults reduces their risk of dementia, an analysis of previous research shows, providing more evidence that heart health and brain health are intimately connected. In a new meta-analysis, published Sept. 12 in JAMA Network Open, researchers found that older adults with untreated high blood pressure were 42% more likely to develop dementia during the study period compared to healthy older adults. This was true even among 70- and 80-year-olds. “The study suggests that successful treatment of hypertension might bring down the risk of developing dementia to the level of individuals with no hypertension,” said Dr. S.…
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Celebrating 2023 Lauds & Laurels Honoree Andrea Wasserman

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Dear Colleagues, I am thrilled to announce and celebrate four outstanding individuals who have been honored with Lauds & Laurels awards. These individuals have not only excelled in their respective fields but have also demonstrated exceptional dedication and a relentless pursuit of excellence. Dr. Tamera Hatfield, PhD, an alumna of our school, has been awarded the Distinguished Alumni award. Dr. Hatfield’s academic journey at the School of Biological Sciences and the UCI School of Medicine has culminated in her becoming a board-certified, fellowship-trained UCI Health obstetrician. Andrea Wasserman, the Chief Administrative Officer of the UC Irvine Institute for Memory Impairments…
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Early-stage trial for Parkinson’s disease therapy shows signs of promise

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Small trial of Bemdaneprocel, which aims to replace dopamine-producing neurons, raises hope for treatment The loss of dopamine-producing neurons with Parkinson’s causes symptoms including a tremor, slow movements and muscle stiffness. Photograph: David Davies/PA Scientists have reported early success in a trial of an experimental cell therapy for Parkinson’s disease, raising hope for patients. Bemdaneprocel therapy is at an early stage, and the year-long trial involved just 12 patients, but the positive outcome is viewed as significant after decades of setbacks in the hunt for an effective treatment. Developed by BlueRock therapeutics, a subsidiary of the pharmaceutical company Bayer, it…
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The Link Between Air Quality and Your Longevity

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Downtown Los Angeles seen in the hazy distance. Photo: Caroline Brehman/Zuma Press Smoggy air can hurt your health even after the smoke has cleared. But you can lower your risk. Some animal research suggests that fine particles can make their way into the brain, says Masashi Kitazawa, an associate professor of environmental and occupational health at the University of California, Irvine. He recently co-wrote a study that found that older mice who were exposed to polluted air were at an increased risk of developing Alzheimer’s disease than those who got purified air. Even the younger mice who were exposed to polluted…
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UC Irvine is part of $16 million effort to increase dementia research representation

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More Asian Americans, Native Hawaiians and Pacific Islanders sought for studies on aging UCI’s Joshua Grill is one of three principal investigators for the National Institute on Aging grant that will fund CARE 2.0. Steve Zylius / UCI August 2, 2023—With a $16 million grant from the National Institute on Aging, the University of California, San Francisco and the University of California, Irvine will work with community partners to improve the representation of Asian American, Native Hawaiian and Pacific Islander adults in research on aging, caregiving, and Alzheimer’s disease and related dementias. The new project builds on a previous effort…
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Direct to Consumer Blood Tests for Alzheimer’s Disease

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Quest Diagnostics recently announced the launch of a direct-to-consumer blood test to detect amyloid plaques in the brain. The test examines the ratio of Ab42/Ab40 in the plasma. Based on the Quest website, the test results are provided in numeric fashion, as well as based on categories of low, intermediate, and high risk of amyloid presence in the brain (with lower numbers on the plasma Ab ratio associated with higher likelihood of amyloid being present in the brain). As can be seen on the website, there is a high degree of overlap on test results among those with elevated compared…
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Insight: Promising new Alzheimer’s drugs may benefit whites more than Blacks

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Barrington and Vickie Riley pose at the Emory University Brain Health Center in Atlanta, Georgia, U.S., July 12, 2023. The Riley's, who have been married more than 35 years, participated in the Charlie and Harriet Shaffer Cognitive Empowerment Program. Barrington Riley has mild cognitive impairment. REUTERS/Alyssa Pointer Dr. Joshua Grill, a University of California, Irvine, Alzheimer's researcher, who collaborated with Eisai and other researchers to analyze two trials for Leqembi and two for an earlier anti-amyloid drug, also found that Black, Hispanic and Asian people were more likely to be screened out of clinical trials because the amount of amyloid…
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UC Irvine receives record $653 million in research funding for fiscal 2022-23

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From cutting-edge research on Alzheimer’s disease to an innovative effort to include environmental justice and community engagement in climate and sustainability science research and education, University of California, Irvine scholars, scientists and physicians are blazing new paths to help change the world. And their impact keeps growing. In fiscal 2022-23, which ended June 30, UCI received the most research funding in campus history: $653 million in grants and contracts. Awards from federal and state agencies, leading foundations and forward-thinking companies rose by 12.7 percent over the 2021-22 total of $580 million, reflecting strong support for UCI’s top-ranked faculty, first-rate facilities,…
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UCI MIND researchers awarded UCI ICTS 2023 Campus-Community Researcher Incubator Award

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UCI MIND researchers, Christian Salazar, PhD, MPH, and Maria Corona, PhD, have been awarded a UCI ICTS 2023 Campus-Community Researcher Incubator Award for their project, "Improving Knowledge and Awareness of Alzheimer's Disease and Related Dementias among Promotores in Santa Ana, California.”  The team will partner with the OC based, Latino Health Access to train and support community health workers, called promotores, to increase awareness of dementia in Hispanic and Latinx communities.
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Full A4 results presented at AAIC

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Results were presented on Monday from the first-of-its kind Anti-Amyloid treatment in Asymptomatic Alzheimer’s (A4) Study. The A4 was a more than 10-year project to conduct one of the first and largest “preclinical” Alzheimer’s disease clinical trials, testing a compound for potential disease-slowing properties before memory problems begin in a population deemed at risk based on an amyloid PET scan biomarker test. Unfortunately, the drug studied, solanezumab, did not slow memory worsening compared to placebo in this trial. This was surprising given the previous findings in which solanezumab had appeared to have very small but seemingly real effects in symptomatic…
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Full Donanemab results presented at AAIC

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Results were presented on Monday for TRAILBLAZER-ALZ-2, a registration trial of the monoclonal antibody donanemab, which was previously announced as positive. The data were highly convincing that donanemab has a significant effect of slowing disease progression in Alzheimer’s disease and almost certainly points to a full clinical approval for the drug by the FDA in the future. The primary analytic group under study in this TRAILBLAZER study (there are several different clinical trials of donanemab sponsored by Eil Lilly under the moniker of “TRAILBLAZER”) was patients with “low-to-medium tau burden,” assessed with a tau PET scan. Unlike the previous trial…
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Do reading, puzzles, and similar activities really stave off dementia?

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Can reading and similar activities help stave off dementia? Image credit: Simone Wave/Stocksy? MNT spoke with Dr. Karen D. Lincoln, a professor in the Department of Environmental and Occupational Health at the University of California, Irvine. She noted that while some evidence suggests that cognitive exercises like crossword puzzles or word games slow cognitive decline in those with mild cognitive impairment, the evidence is inconclusive. … “f you like to play dominoes, spades, or bid whist, you are actually engaging in healthy brain exercises,” she said. “Not necessarily because the games are very challenging and require good memory, but because the…
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FDA grants full approval to lecanemab (Leqembi)

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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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FDA Advisory Panel Votes in Favor of Full Approval for Lecanemab

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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. Based on results from a large Phase 3 trial in which lecanemab demonstrated efficacy in slowing disease progression over 18-months, the agency will now consider full approval for…
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UCI MIND faculty finds connection between air pollution from traffic and Alzheimer’s disease

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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. "Public and environmental regulatory agencies need to accelerate efforts to reduce particulate matter levels in order to reduce the risk of Alzheimer's disease and other serious health conditions," says Michael Kleinman. (Credit: Getty Images) Read the article here.
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And now, the FDA approves a medication for behavioral symptoms of Alzheimer’s disease

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David Sultzer, MD 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%…
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Positive topline results announced for TRAILBLAZER 3

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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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Dementia doubles in Orange County in less than a decade – UCI MIND Director weighs in

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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 . Joshua Grill, PhD “Orange County is ‘grayer’ than the rest of the country,…
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UCI MIND faculty named one of the top inspirational Black women in medicine

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UCI MIND faculty member and professor in the School of Public Health,  Karen D. Lincoln, PhD, MSW, MA, FGSA, is featured in Authority Magazine as being one of the top inspirational Black women in medicine. Read the full interview here To learn more about Dr. Lincoln's research to address health disparities in Black communities, visit her faculty profile or her website: Advocates for African American Elders Dr. Karen D. Lincoln  
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UCI MIND faculty featured, “Hope Dies Last”, wins Golden Mike Award

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OC World produced documentary "Hope Dies Last", featuring UCI MIND faculty members, Drs. Joshua Grill and Leslie Thompson, wins the Golden Mike Award for best documentary. "Hope Dies Last" creates a narrative around the impact of Alzheimer's disease on California communities and the stories of families who find hope in the darkest of times. The documentary, produced by OC World, was awarded Best Long Form Programming or Documentary at the 73rd Annual Golden Mike Awards. Read the full article here.    View the documentary here. https://youtu.be/wABhpdiZO0E
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