{"id":8,"date":"2011-09-22T11:45:29","date_gmt":"2011-09-22T18:45:29","guid":{"rendered":"http:\/\/lsfisher.com\/wordpress\/?p=8"},"modified":"2011-09-22T12:54:09","modified_gmt":"2011-09-22T19:54:09","slug":"safety-first-new-clinical-trial-guidelines","status":"publish","type":"post","link":"http:\/\/lsfisher.com\/wordpress\/?p=8","title":{"rendered":"Safety First: New Clinical Trial Guidelines"},"content":{"rendered":"<p>Alzheimer\u2019s disease is the only disease in the top 10 causes of death without effective treatment or a cure. This can be shocking news for a newly diagnosed person. Not long after my 49-year-old husband was diagnosed with\u00a0dementia of the Alzheimer\u2019s type, we heard about a Phase III\u00a0<a href=\"http:\/\/www.nia.nih.gov\/Alzheimers\/publications\/trials-studies.htm\">clinical trial<\/a> for a new Alzheimer\u2019s drug. After agonizing about safety versus the possibility of a drug that might stave off the disease, we enrolled Jim in the study.<\/p>\n<p>We saw immediate advantages: free evaluations by the neurologist in charge of the study group, ongoing cognitive testing and, most important to us, the Alzheimer\u2019s study drug. It seemed like a win-win situation, until three weeks later nausea, diarrhea and general stomach distress set in. Later, we learned the study was terminated and the drug wasn\u2019t approved.<\/p>\n<p>Now, the Alzheimer\u2019s Association Research Roundtable working group and the U.S. Food and Drug Administration (FDA) have announced new safety recommendations for Phase I and II amyloid-lowering drug trials. Original FDA guidelines would have stalled the research process by eliminating participants with certain age-related brain changes. The\u00a0<a href=\"http:\/\/www.alz.org\/documents_custom\/final_aria_news_release_071211_alz-dem_jrnl.pdf\">new guidelines<\/a> are a compromise to allow more pre-existing brain conditions than the FDA originally allowed while closely monitoring any changes.<\/p>\n<p>Thankfully, Jim\u2019s side effects were minor, but everyone who enters a drug trial takes a chance on unexpected results. Families understand the urgency for effective treatment, but want safety to be a priority.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Alzheimer\u2019s disease is the only disease in the top 10 causes of death without effective treatment or a cure. This can be shocking news for a newly diagnosed person. Not long after my 49-year-old husband was diagnosed with\u00a0dementia of the &hellip; <a href=\"http:\/\/lsfisher.com\/wordpress\/?p=8\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-8","post","type-post","status-publish","format-standard","hentry","category-news"],"jetpack_featured_media_url":"","_links":{"self":[{"href":"http:\/\/lsfisher.com\/wordpress\/index.php?rest_route=\/wp\/v2\/posts\/8","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/lsfisher.com\/wordpress\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/lsfisher.com\/wordpress\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/lsfisher.com\/wordpress\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/lsfisher.com\/wordpress\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=8"}],"version-history":[{"count":3,"href":"http:\/\/lsfisher.com\/wordpress\/index.php?rest_route=\/wp\/v2\/posts\/8\/revisions"}],"predecessor-version":[{"id":30,"href":"http:\/\/lsfisher.com\/wordpress\/index.php?rest_route=\/wp\/v2\/posts\/8\/revisions\/30"}],"wp:attachment":[{"href":"http:\/\/lsfisher.com\/wordpress\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=8"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/lsfisher.com\/wordpress\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=8"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/lsfisher.com\/wordpress\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=8"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}