{"id":91907,"date":"2022-11-29T00:00:00","date_gmt":"2022-11-29T00:00:00","guid":{"rendered":"http:\/\/medgoo.com\/index.php\/2022\/11\/29\/second-death-in-trial-of-experimental-alzheimer-drug-raising-concerns\/"},"modified":"2022-12-01T00:30:00","modified_gmt":"2022-12-01T00:30:00","slug":"second-death-in-trial-of-experimental-alzheimer-drug-raising-concerns","status":"publish","type":"post","link":"https:\/\/medgoo.com\/index.php\/2022\/11\/29\/second-death-in-trial-of-experimental-alzheimer-drug-raising-concerns\/","title":{"rendered":"Second Death in Trial of Experimental Alzheimer Drug Raising Concerns"},"content":{"rendered":"<h3>\n<p>Doctors suspect that by stripping away amyloid deposits, lecanemab weakens blood vessels and leaves them vulnerable to bleeds<\/p>\n<\/h3>\n<p><b>By Physician\u2019s Briefing Staff HealthDay Reporter<\/b><\/p>\n<p><b><\/b><\/p>\n<p>TUESDAY, Nov. 29, 2022 (HealthDay News) &#8212; Two people have now died from brain hemorrhages that may be linked to an experimental drug for Alzheimer disease, calling into question the medication&#8217;s safety.<\/p>\n<p>A 65-year-old woman with early-stage Alzheimer disease recently died from a massive brain bleed that some researchers link to lecanemab, an antibody drug designed to bind to and remove amyloid-beta from the brain, according to a report published Nov. 27 in <em>Science Insider<\/em>.<\/p>\n<p>The woman suffered a stroke as well as a type of brain swelling and bleeding that has been previously seen with such antibodies, the report noted. Emergency physicians at Northwestern University Medical Center in Chicago treated the woman with a tissue plasminogen activator. She immediately had substantial bleeding throughout her brain&#8217;s outer layer.<\/p>\n<p>&#8220;As soon as they put it in her, it was like her body was on fire,&#8221; her husband told <em>Science Insider<\/em>. &#8220;She was screaming, and it took like eight people to hold her down. It was horrific.&#8221; The woman died a few days later, according to the case report.<\/p>\n<p>The death follows that of an 80-year-old man who was taking part in lecanemab&#8217;s phase 3 clinical trial. His death was linked to a possible interaction between the experimental drug and the blood thinner apixaban.<\/p>\n<p>Rudolph Castellani, M.D., a Northwestern neuropathologist who autopsied the woman, determined that she had amyloid deposits surrounding many of her brain&#8217;s blood vessels. The woman had been receiving biweekly infusions of lecanemab, which appears to have inflamed and weakened her blood vessels, Castellani said. These vessels then burst when exposed to a tissue plasminogen activator, something that can happen even in conventional stroke cases.<\/p>\n<p>The Japanese firm Eisai Co. is scheduled this week to provide the first detailed account of lecanemab&#8217;s phase 3 trial, which included about 1,800 people with signs of early Alzheimer disease. Eisai developed lecanemab with the Swedish firm BioArctic and sponsored the clinical trial with U.S. biotech company Biogen. A <a href=\"https:\/\/www.eisai.com\/news\/2022\/news202271.html\" target=\"_blank\" rel=\"noopener\">news release<\/a> issued by the company in September said people taking lecanemab had less amyloid and 27 percent less cognitive decline than people who received a placebo during an 18-month period.<\/p>\n<p>Eisai declined to comment on the woman&#8217;s case, <em>Science Insider<\/em> said. &#8220;All the available safety information indicates that lecanemab therapy is not associated with an increased risk of death overall or from any specific cause,&#8221; the company said in a <a href=\"https:\/\/www.eisai.com\/news\/2022\/pdf\/enews202283pdf.pdf\" target=\"_blank\" rel=\"noopener\">statement<\/a>.<\/p>\n<p><a href=\"https:\/\/www.science.org\/content\/article\/second-death-linked-potential-antibody-treatment-alzheimer-s-disease\" target=\"_blank\" rel=\"noopener\">More Information<\/a><\/p>\n<p><i><\/i><\/p>\n<p><i>Copyright \u00a9 2022 <a href=\"https:\/\/www.healthday.com\/\" target=\"_new\" rel=\"noopener\">HealthDay<\/a>. All rights reserved.<\/i><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Doctors suspect that by stripping away amyloid deposits, lecanemab weakens blood vessels and leaves them vulnerable to bleeds<\/p>\n","protected":false},"author":6,"featured_media":91986,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[11],"class_list":["post-91907","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-news"],"_links":{"self":[{"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/posts\/91907","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/comments?post=91907"}],"version-history":[{"count":1,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/posts\/91907\/revisions"}],"predecessor-version":[{"id":91985,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/posts\/91907\/revisions\/91985"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/media\/91986"}],"wp:attachment":[{"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/media?parent=91907"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/categories?post=91907"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/tags?post=91907"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}