{"id":76701,"date":"2024-06-27T15:15:33","date_gmt":"2024-06-27T21:15:33","guid":{"rendered":"https:\/\/www.uchealth.org\/today\/?p=76701"},"modified":"2024-10-18T09:50:00","modified_gmt":"2024-10-18T15:50:00","slug":"first-patient-at-uchealth-receives-leqembi-new-treatment-for-alzheimers-disease","status":"publish","type":"post","link":"https:\/\/www.uchealth.org\/today\/first-patient-at-uchealth-receives-leqembi-new-treatment-for-alzheimers-disease\/","title":{"rendered":"First patient at UCHealth receives new treatment for Alzheimer\u2019s disease"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div><figure id=\"attachment_76704\" aria-describedby=\"caption-attachment-76704\" style=\"width: 480px\" class=\"wp-caption alignright\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-76704 size-full\" src=\"https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2024\/06\/27142507\/Leqembi-Treatment-2-Greg-and-Patty-web.webp\" alt=\"Greg with his wife Patty during the first Leqembi infusion. Photo courtesy of Patricia Young.\" width=\"480\" height=\"640\" \/><figcaption id=\"caption-attachment-76704\" class=\"wp-caption-text\">Greg with his wife Patty during the first Leqembi infusion. Photo courtesy of Patricia Young.<\/figcaption><\/figure>\n<p>The first UCHealth patient has received an infusion of the <a id=\"\" href=\"https:\/\/www.uchealth.org\/today\/how-well-does-leqembi-fight-alzheimers-first-fda-approved-alzheimers-drug\/\" target=\"_blank\" rel=\"noopener\">first drug approved by the FDA<\/a> to slow the progression of Alzheimer\u2019s disease.<\/p>\n<p>The generic name for the drug is lecanemab and the brand name is Leqembi.<\/p>\n<p>Greg Young, a 78-year-old from Larkspur, became the first UCHealth patient to receive Leqembi with his initial infusion on June 26.<\/p>\n<p>Greg and his wife, Patty, first bonded over their shared love of horses when they met 15 years ago and married a couple of years later. About six or seven years ago, Greg began noticing increased forgetfulness. His symptoms then worsened during the COVID-19 pandemic.<\/p>\n<p>\u201cAfter getting (COVID), his memory was not as sharp,\u201d Patty said. A standout incident occurred in the kitchen as they cooked together, which they like to do.<\/p>\n<p>\u201cHe forgot how to make a lemon-butter sauce for artichokes that we always have,\u201d Patty said. \u201cHe was the one who taught me how to make it.\u201d<\/p>\n<p>Patty also began noticing that Greg couldn\u2019t remember where plates and utensils went when he unloaded the dishwasher and at times, had trouble focusing on a task at hand.<\/p>\n<p>Greg eventually received an Alzheimer\u2019s diagnosis. Through his doctors, he soon learned about Leqembi and became the first patient to qualify for the new treatment.<\/p>\n<p>Greg and Patty know that Leqembi is not a cure for Alzheimer\u2019s, and doctors, patients and researchers still have much to learn about its effectiveness. Still, the Youngs felt it was worth trying.<\/p>\n<p>\u201cWe\u2019d rather try to do something,\u201d Greg said. \u201cIf we have good results, it helps the [Neurology] program, and it helps us. I hope it helps me feel fresher and keeps me steady.\u201d<\/p>\n<h2><strong>Setting up a safe system to provide Leqembi to patients who qualify<\/strong><\/h2>\n<p>While Leqembi received FDA approval last year after a phase 3 clinical trial of nearly 2,000 patients, it has taken several months for UCHealth experts to set up a safe system for patients to be properly screened and to receive the new infusions.<\/p>\n<p>The drug works through infusions that target beta-amyloid, the protein that builds up and creates sticky plaque in the brains of people with Alzheimer\u2019s disease. The trial demonstrated that it reduced cognitive and functional decline in those who took it, compared with a placebo.<div class=\"su-callout-box col-xs-12 col-sm-6 right\" style=\"background-color:#dce4e7; color:#2e3b44;\">Keep up to date with the <a href=\"https:\/\/www.uchealth.org\/today\/tag\/alzheimers-care\/\">latest news on Alzheimer&#8217;s disease.<\/a><\/div>\n<p>The 2023 FDA green light for Leqembi was cause for both celebration and caution at UCHealth. Systems had to be put in place to evaluate patients since the drug is not for everyone. Medical providers also needed to ensure there were adequate numbers of infusion chairs and staff to administer the drug, and develop measures to ensure patient safety.<\/p>\n<p>Dr. Victoria Pelak, professor of\u00a0<a id=\"\" href=\"https:\/\/medschool.cuanschutz.edu\/neurology\" target=\"_blank\" rel=\"noopener\">Neurology<\/a>\u00a0and\u00a0<a id=\"\" href=\"https:\/\/medschool.cuanschutz.edu\/ophthalmology\" target=\"_blank\" rel=\"noopener\">Ophthalmology<\/a>\u00a0at the\u00a0<a id=\"\" href=\"https:\/\/medschool.cuanschutz.edu\/\" target=\"_blank\" rel=\"noopener\">University of Colorado School of Medicine<\/a> on the Anschutz Medical Campus, summed up the challenges in an <a href=\"https:\/\/www.uchealth.org\/today\/how-well-does-leqembi-fight-alzheimers-first-fda-approved-alzheimers-drug\/\">interview<\/a> shortly after the FDA approval last summer.<\/p>\n<p>\u201cBecause of the risk and complexity of the diagnosis and the discussions of the drug\u2019s risks and benefits, we need strong protocols in place, not only for those who are eligible, but also to determine if someone is ineligible,\u201d Pelak said.<\/p>\n<h2><strong>Who is eligible for Leqembi, and how do patients get screened?<\/strong><\/h2>\n<p>Medical experts at UCHealth have spent the last year working to ensure that patients who receive Leqembi are those most likely to benefit from it and to minimize its safety risks.<\/p>\n<p>Job one is screening patients, said <a href=\"https:\/\/www.uchealth.org\/provider\/tara-carlisle-md\/\">Dr. Tara Carlisle<\/a>, a behavioral neurologist and assistant professor of Neurology with the University of Colorado School of Medicine. She sees candidates who wish to receive Leqembi at the University of Colorado clinic for Advanced Therapy for Neurodegenerative Disorder. It\u2019s part of the <a id=\"\" href=\"https:\/\/medschool.cuanschutz.edu\/alzheimer\/clinic\" target=\"_blank\" rel=\"noopener\">University of Colorado Neurobehavior and Memory Disorders Clinic<\/a> at the <a href=\"https:\/\/www.uchealth.org\/locations\/uchealth-neurology-clinic-central-park\/\">UCHealth Neurology Clinic \u2013 Central Park<\/a>.<\/p>\n<p>\u201cIn order to be eligible for Leqembi, a person needs to have cognitive impairment that is suspected to be due to underlying Alzheimer\u2019s disease,\u201d Carlisle said.<\/p>\n<figure id=\"attachment_76705\" aria-describedby=\"caption-attachment-76705\" style=\"width: 250px\" class=\"wp-caption alignright\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-76705\" src=\"https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2024\/06\/27142509\/Leqembi-Treatment-3-Tara-Carlisle-web.webp\" alt=\"Dr. Tara Carlisle, behavioral neurologist with the CU Advanced Therapy for Neurodegenerative Disorder Clinic, prescribes Leqembi treatment for Alzheimer\u2019s disease for patients who meet the requirements. Photo by the University of Colorado.\" width=\"250\" height=\"260\" \/><figcaption id=\"caption-attachment-76705\" class=\"wp-caption-text\">Dr. Tara Carlisle, behavioral neurologist with the University of Colorado Advanced Therapy for Neurodegenerative Disorder Clinic, prescribes Leqembi treatment for Alzheimer\u2019s disease for patients who meet the requirements. Photo by the University of Colorado.<\/figcaption><\/figure>\n<p>For those patients, clinic staffers then perform tests to confirm that a patient has Alzheimer\u2019s and determine how severe it is.<\/p>\n<p>The process begins with a lumbar puncture to look for evidence of amyloid and tau, which are the two proteins most closely associated with Alzheimer\u2019s disease. Less frequently, providers perform an <a id=\"\" href=\"https:\/\/www.cms.gov\/medicare\/coverage\/evidence\/amyloid-pet#:~:text=Amyloid%20PET%20imaging%20uses%20a,Vizamyl%E2%84%A2%20(flutemetamol%20F18).\" target=\"_blank\" rel=\"noopener\">amyloid PET brain scan<\/a> to detect signs of the proteins.<\/p>\n<p>Patients who are eligible for Leqembi must have mild cognitive impairment or mild dementia due to Alzheimer\u2019s disease. Those who have advanced to the moderate stage of Alzheimer\u2019s \u2014 meaning they need assistance with everyday activities \u2014 are not candidates for the drug, Carlisle said.<\/p>\n<p>Patients on drugs that suppress the immune system are excluded because Leqembi works by activating the immune system. Patients who take blood thinners also are not candidates because Leqembi was shown in clinical trials to increase the risk of <a id=\"\" href=\"https:\/\/www.ajronline.org\/doi\/full\/10.2214\/AJR.22.28461#:~:text=Amyloid%2Drelated%20imaging%20abnormalities%20(ARIA,for%20Alzheimer%20disease%20(AD).\" target=\"_blank\" rel=\"noopener\">amyloid-related imaging abnormalities<\/a>, or ARIAs, including brain swelling and bleeding. Patients get a baseline MRI on specific scanners to look for signs and risks of ARIAs, Carlisle added.<\/p>\n<h2><strong>The genetic factor in Leqembi treatment<\/strong><\/h2>\n<p>For those who are still candidates to receive Leqembi, the clinic recommends testing for the APOE4 gene, which is a <a id=\"\" href=\"https:\/\/www.nih.gov\/news-events\/nih-research-matters\/study-defines-major-genetic-form-alzheimer-s-disease\" target=\"_blank\" rel=\"noopener\">strong risk factor<\/a> for Alzheimer\u2019s disease in people with two copies. Carlisle explained that these individuals are doubly disadvantaged. They have a greater risk of brain bleeding and swelling, and a separate analysis from the phase 3 clinical trial of Leqembi showed that they were \u201cunlikely to get actual benefit from the drug,\u201d she said.<\/p>\n<p>\u201cWe\u2019re not requiring the genetic test,\u201d Carlisle added. \u201cBut as part of the counseling, we explain that there is a different benefit and risk profile, depending on if you have no copies, one copy or two copies of the APOE4 gene.\u201d<\/p>\n<p>For individuals with two copies, Carlisle said the clinic starts a \u201cshared decision-making conversation\u201d and will administer the Leqembi infusions with the understanding that they might need additional monitoring for brain bleeds and swelling.<\/p>\n<h2><strong>Space for Leqembi infusions<\/strong><\/h2>\n<p>As of early June, Carlisle said she had evaluated about two dozen patients with Alzheimer\u2019s and was averaging four new patients a week. At that time, two patients had made it to the \u201cfinal steps\u201d to receive the infusions, which will be administered every two weeks for 18 months in the <a href=\"https:\/\/www.uchealth.org\/locations\/uchealth-outpatient-infusion-center-anschutz\/\">UCHealth Outpatient Infusion Center<\/a> on the <a href=\"https:\/\/www.uchealth.org\/locations\/uchealth-at-university-of-colorado-anschutz-medical-campus\/\">Anschutz Medical Campus<\/a>, she said.<\/p>\n<p>Another infusion center in the Neurology Clinic at Central Park has been built, and providers will start scheduling patients soon, Carlisle added.<\/p>\n<h2><strong>Safety first for Leqembi infusions<\/strong><\/h2>\n<p>In addition to developing these patient-selection measures and creating the infrastructure for infusions, Carlisle said UCHealth spent considerable time crafting a \u201crobust safety protocol\u201d for patients who choose to receive Leqembi.<\/p>\n<figure id=\"attachment_76703\" aria-describedby=\"caption-attachment-76703\" style=\"width: 480px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-76703 size-full\" src=\"https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2024\/06\/27142503\/Leqembi-Treatment-1-Greg-Young-web.webp\" alt=\"Greg Young gets his first infusion of Leqembi at the UCHealth Outpatient Infusion Center on June 26. Young was also the first patient at UCHealth to receive the Leqembi infusion for his mild Alzheimer\u2019s disease. Photos courtesy of Patricia Young.\" width=\"480\" height=\"640\" \/><figcaption id=\"caption-attachment-76703\" class=\"wp-caption-text\">Greg Young gets his first infusion of Leqembi at the UCHealth Outpatient Infusion Center on June 26. Young was the first patient at UCHealth to receive the Leqembi infusion for his mild Alzheimer\u2019s disease. Photos courtesy of Patricia Young.<\/figcaption><\/figure>\n<p>\u201cThat\u2019s one of the reasons that we\u2019ve taken a little bit longer to get our program up and running,\u201d she said.<\/p>\n<p>As part of that work, Carlisle said she communicated with other centers, such as Brigham and Women\u2019s Hospital, Massachusetts General Hospital and University of California San Francisco Hospital, to learn about their patient safety measures.<\/p>\n<p>To monitor the risk of ARIAs, clinic managers worked closely with University of Colorado School of Medicine <a id=\"\" href=\"https:\/\/medschool.cuanschutz.edu\/radiology\/sections\/neuroradiology\" target=\"_blank\" rel=\"noopener\">neuroradiologists<\/a> to ensure they have the training to identify brain bleeding and swelling and that they follow <a id=\"\" href=\"https:\/\/www.asnr.org\/\" target=\"_blank\" rel=\"noopener\">American Society of Neuroradiology<\/a> guidelines for doing so, Carlisle said. The safety details extend to ensuring that a patient\u2019s follow-up brain scans are done on a similar scanner to avoid variations between manufacturers, she added.<\/p>\n<p>Patients will also be closely monitored during and after their infusions, Carlisle said: three hours after the first one and two hours each for the second and third treatments, to guard against \u201cdelayed infusion reactions,\u201d such as fever, chills and muscle aches that can be easily treated, or more serious problems. Following these initial infusions, Carlisle said her nurse infusion navigator will follow up with patients later that day to check on how they are doing.<\/p>\n<h2><strong>The long view of Leqembi\u2019s effectiveness<\/strong><\/h2>\n<p>For patients and providers, of course, the ultimate question is whether Leqembi actually works. Carlisle said her clinic is doing initial screenings of patients\u2019 thinking, memory and function. They will then follow up at six, 12 and 18 months.<\/p>\n<p>\u201cWe are trying to get an idea of their trajectory over time. How are they are doing, has their quality of life improved or worsened? We want to understand the impacts of this drug,\u201d she said.<\/p>\n<p>The testing and treatment time demands for Leqembi infusions are important considerations for patients to take into account, Carlisle said. \u201cYou basically become a full-time patient,\u201d she noted.<\/p>\n<h2><strong>They met through a love for horses and hope to keep enjoying their passions<\/strong><\/h2>\n<p>Greg and Patty hope that Leqembi infusions will allow them to continue enjoying riding horses, cooking together and enjoying beautiful mountain views from their home south of Denver.<\/p>\n<p>The couple met through a foxhunting group called the Arapahoe Hunt, which is based in Franktown. Greg is a lifelong resident of Douglas County and always has loved riding horses. He enjoyed a career selling and installing windows and doors. Patty, meanwhile, had worked for 42 years as a dental hygienist in the Denver area.<\/p>\n<p>She was busy administering her late brother\u2019s estate a little more than 15 years ago when an attorney assisting her with the work made a suggestion.<\/p>\n<p>\u201cHe told me, \u2018Patty, you need to get a life,\u2019\u201d she recalls.<\/p>\n<p>The attorney encouraged Patty to join the Arapahoe Hunt, which she\u2019d never heard of, to make some social connections. She gave it a try, met Greg, and began riding with the hounds, which Greg and Patty still do.<\/p>\n<h2><strong>Evaluation for Alzheimer\u2019s disease<\/strong><\/h2>\n<p>When Greg started to feel that his memory was slipping, he consulted with his primary care provider in Frisco, who administered some simple memory tests. The tests gave him enough trouble that Greg\u2019s doctor referred him to a neurologist for further evaluation, which indicated he had Alzheimer\u2019s disease. A follow-up test a year later showed his cognition had declined further.<\/p>\n<p>Greg found the news enlightening rather than depressing.<\/p>\n<p>\u201cIt explained a few things,\u201d he said. \u201cIt was nice to have a diagnosis.\u201d<\/p>\n<p>Greg\u2019s primary care provider told the Youngs about Leqembi, which had recently received FDA approval, and recommended that they contact UCHealth to inquire about receiving it. The Youngs eventually secured an appointment with <a href=\"https:\/\/www.uchealth.org\/provider\/samantha-holden-md\/\">Dr. Samantha Holden<\/a>, medical director of the University of Colorado Neurobehavior and Memory Disorders Clinic and an associate professor of Neurology at the University of Colorado School of Medicine. Holden has played a key role in helping UCHealth experts prepare to safely begin administering Leqembi.<\/p>\n<p>As soon as the clinic began screening patients for Leqembi, Greg went through the time-consuming but vital testing regimen that ultimately ended in approval for him to receive Leqembi.<\/p>\n<p>\u201cWe don\u2019t mind the time commitment,\u201d Patty said. \u201cIf it slows the progression of the disease, that\u2019s what we want.\u201d<\/p>\n<h2><strong>The promise and uncertainty of Alzheimer\u2019s disease and treatment<\/strong><\/h2>\n<p>While Greg and Patty still love their shared passions, Patty acknowledges that Alzheimer\u2019s disease already has changed their relationship a bit.<\/p>\n<p>\u201cI am the caregiver and have taken on more responsibility in making decisions and following through with things that need to be done,\u201d she said. \u201cIt\u2019s nothing that I can\u2019t handle, but there is anxiety. It is important for me to be patient and kind.\u201d<\/p>\n<p>Whether or not Leqembi gives Greg and Patty a few extra months of quality time together remains to be seen. For her part, Carlisle stresses that the drug\u2019s approval is just one important step in a much longer battle against Alzheimer\u2019s disease.<\/p>\n<p>For example, Leqembi targets only amyloids, which are but \u201cone piece of the pathology\u201d of the disease, Carlisle said. The drug does not affect tau, the cognition-deteriorating tangles in the brain. What happens to cognitive decline and disease progression in patients after 18 months of Leqembi treatment is also an open question.<\/p>\n<p>Still, Leqembi is \u201cthe first potentially disease-modifying drug for Alzheimer\u2019s\u201d after years of futile clinical studies, which raises hopes for future breakthroughs, Carlisle said. For example, an <a id=\"\" href=\"https:\/\/www.alz.org\/news\/2024\/fda-advisory-committee-donanemab-efficacy\" target=\"_blank\" rel=\"noopener\">FDA advisory panel<\/a> found in early June that <a id=\"\" href=\"https:\/\/www.drugs.com\/donanemab.html\" target=\"_blank\" rel=\"noopener\">donanemab<\/a>, another drug that targets beta-amyloid, was effective in slowing cognitive decline in people with mild Alzheimer\u2019s disease. If donanemab gains full FDA approval, patients who receive it would require infusions every four weeks, instead of two.<\/p>\n<p>\u201cWhat I am most optimistic about is what this means for the future of treating neurodegenerative disorders,\u201d Carlisle concluded.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The first UCHealth patient has received an infusion of the first drug approved by the FDA to slow the progression of Alzheimer\u2019s disease. The generic name for the drug is lecanemab and the brand name is Leqembi. Greg Young, a 78-year-old from Larkspur, became the first UCHealth patient to receive Leqembi with his initial infusion [&hellip;]<\/p>\n","protected":false},"author":2143,"featured_media":76704,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[8],"tags":[185,184],"class_list":["post-76701","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-alzheimers-care","tag-neurology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - 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