Product News | Journal of Gerontological Nursing

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href="/web/20131030195507/http://www.healio.com/nursing/journals"> Journals</a> <span>›</span> <a href="/web/20131030195507/http://www.healio.com/nursing/journals/jgn"> Journal of Gerontological Nursing</a> </p>   <div class="journals-content"><div class="journal-tab-group"><ul class="journal-tabs"><li><a href="/web/20131030195507/http://www.healio.com/journals/jgn">Current Issue</a></li><li><a href="/web/20131030195507/http://www.healio.com/journals/jgn/m/oar">Online Advanced Release</a></li><li><a href="/web/20131030195507/http://www.healio.com/journals/jgn/m/past-issues">Past Issues</a></li></ul><div class="journal-panes"><div class="abstract-content"><p class="kicker-top">Product News </p><h2><a href="#">Product News</a></h2><div class="journal-info"><ul class="full-text"><li class="header">Read Full Text Article</li><li class="html"><a class="active" title="View Html Version" alt="View Html Version" rel="nofollow" href="/web/20131030195507/http://www.healio.com/nursing/journals/jgn/{9c1b33ae-7f49-42ea-b348-c2ff59398de3}/product-news?fulltext=1">Html Icon</a></li><li class="pdf"><a id="pdf" href="/web/20131030195507/http://www.healio.com/~/media/Journals/JGN/2013/10_October/10_3928_00989134_20130826_89/10_3928_00989134_20130826_89.pdf" class="active" title="View Pdf Version" alt="View Pdf Version" rel="nofollow">Pdf Icon</a></li></ul><ul class="article-citation"><li>Journal of Gerontological Nursing</li><li>October 2013 - Volume 39 · Issue 10: 8-9</li><li class="doi">DOI: 10.3928/00989134-20130826-89</li></ul></div><div class="copyrights" style="float:right;"><a onclick="RightsLinkPopUpV2();" href="#"><img alt="Rights and Permissions" title="Rights and Permissions" border="0" src="https://web.archive.org/web/20131030195507im_/http://213a1ca8842e5e699a80-05ce35571e92a3f7383a191aa5840bba.r66.cf1.rackcdn.com/request-permissions.gif"></img></a><script type="text/javascript" language="javascript">function RightsLinkPopUpV2() { var location="https://web.archive.org/web/20131030195507/https://s100.copyright.com/AppDispatchServlet?publisherName=slack&publication=0098-9134&contentID=10.3928/00989134-20130826-89&publicationDate=2013&copyright=Copyright%20%26copy%3B%202013%2C%20Slack%20Inc.&title=Product%20News&volumeNum=39&issueNum=10&author=&orderBeanReset=TRUE"; window.open(location,'RightsLink','location=no,toolbar=no,directories=no,status=no,menubar=no,scrollbars=yes,resizable=yes,width=650,height=550'); } </script></div><div class="article-tab-group"><ul class="article-tabs"><li><a id="anchor-tab-article" href="#">Article</a></li><li class="cite-link"><a href="#" onclick="showCitation();">Get Citation</a><script type="text/javascript">function showCitation() {var w = window.open('', '', 'width=400,height=400,resizeable,scrollbars');w.document.write('(2013). Product News. <i>J Gerontol Nurs.</i> 39(10) 8-9. doi: 10.3928/00989134-20130826-89 <a href="https://web.archive.org/web/20131030195507/http://www.healio.com/nursing/journals/jgn/{9c1b33ae-7f49-42ea-b348-c2ff59398de3}/product-news">[link]</a>');w.document.close(); }</script></li></ul></div><div id="articleBody"><div class="ftContainer"><div class="ftArticle"><div class="ftAuthorNotes"></div><div class="ftSection"><h3>Alzheimer’s Immunization Trial Commences</h3><p>Cedars-Sinai Medical Center has launched a Phase I clinical trial to study the safety and tolerability of an experimental immunization to treat Alzheimer’s disease (AD). The treatment is based on Copaxone<sup>®</sup> (glatiramer acetate), a drug often prescribed to reduce the frequency of multiple sclerosis relapses.</p><p>In mouse models of AD, immune-modulation with Copaxone appeared to stimulate key immune cells, reduce harmful inflammation, clear toxic plaques, and support the restoration of neurons in the region of the brain that is responsible for learning and memory.</p><p>After a battery of tests, including detailed brain imaging and a spinal tap, patients will receive Copaxone shots weekly. Tests will be repeated 3 months later to determine if the drug caused any changes in the patient’s memory or brain function.</p><p>These studies result from a new way of thinking about inflammation in the central nervous system. Scientists used to believe that all inflammation in the brain and spinal cord was damaging and looked for ways to suppress immune activity. But recent studies have shown that some immune responses are beneficial, especially after injury. The new idea is to enhance recruitment of immune cells from the blood to the brain to fight the disease, regulating detrimental inflammation and supporting tissue repair and regeneration, the researchers said.</p><p>In the preclinical studies, Copax-one appeared to accomplish these tasks and protect mice against the cognitive deficits of AD by also boosting a gene (EGR1) that modulates other genes that are important for the survival and recovery of nerve cells in the brain.</p><p>Participants must have a diagnosis of probable Alzheimer’s dementia based on a series of tests. For a full list of inclusion and exclusion criteria, family members or patients may contact Cedars-Sinai at 1-800-233-2771 or e-mail neurostudyinfo@cshs.org to request information.</p><p><i>Source.</i><i>“Patient Trial of Immunization to Treat Alzheimer’s Disease Begins at Cedars-Sinai.” (2013, August 12). Retrieved August 27, 2013, from <a target="_blank" href="https://web.archive.org/web/20131030195507/http://www.cedars-sinai.edu/About-Us/News/News-Releases-2013/Patient-trial-of-immunization-to-treat-Alzheimer%E2%80%99s-disease-begins-at-Cedars-Sinai.aspx">http://www.cedars-sinai.edu/About-Us/News/News-Releases-2013/Patient-trial-of-immunization-to-treat-Alzheimer%E2%80%99s-disease-begins-at-Cedars-Sinai.aspx</a>.</i></p></div><div class="ftSection"><h3>Foldable Wheel Makes Wheelchair Travel Easier</h3><p>To help make travel easier for individuals who require mobility assistance, Maddak Inc. has introduced the MORPH<sup>™</sup> Wheels foldable wheelchair wheel. The folding wheel was originally conceptualized as a folding bicycle wheel by Duncan Fitzsimmons when he was a graduate student at the Royal College of Arts in London. After receiving public attention and calls from the wheelchair community telling him that this concept would be invaluable to wheelchair users, he redesigned it as a wheelchair wheel.</p><p>MORPH Wheels is designed to fit all wheelchairs that accommodate a wheel with a quick release axle. As a result, the folding and unfolding process is relatively simple and can be completed in seconds. In addition, it folds to almost half its size, making car and air travel easier. Once folded, the wheels are convenient to carry into vehicles and onto planes, as they fit on or under a seat and into the overhead compartment.</p><p>The wheel set weight capacity is 265 pounds, and the wheel comes with a hand rim specially designed to fold with the wheel. For more information, visit <a target="_blank" href="https://web.archive.org/web/20131030195507/http://morphwheels.com/">http://morphwheels.com</a>.</p><p><i>Source.</i><i>“World’s First Foldable Wheelchair Wheels.” (2013, July 16). Retrieved August 26, 2013, from <a target="_blank" href="https://web.archive.org/web/20131030195507/http://morphwheels.com/">http://morphwheels.com</a>.</i></p></div><div class="ftSection"><h3>Positive Results Reported on Investigational Osteoarthritis Injection</h3><p>Positive results were recently released regarding the SPRING study ( <a target="_blank" href="https://web.archive.org/web/20131030195507/http://clinicaltrials.gov/">http://clinicaltrials.gov</a>, trial NCT01839331) of Ampion for the treatment of osteoarthritis of the knee (OAK). In this study of 329 patients, those treated with a single intra-articular injection of Ampion achieved a clinically meaningful reduction in pain.</p><p>The SPRING study was a randomized, double-blind, vehicle-controlled trial designed to evaluate the safety and efficacy of Ampion in OAK patients. Patients were randomized to receive one of two doses (4 mL or 10 mL) of Ampion or corresponding saline control via intra-articular injection. The primary study objective was to evaluate the relative efficacy of Ampion 4 mL versus Ampion 10 mL. The primary endpoint was mean change in pain from baseline for Ampion compared to the same volume of saline. Secondary endpoints included evaluating safety and quality of life, as well as stiffness and function.</p><p>Ampion dose cohorts experienced statistically significant reductions in pain compared to control. There were no significant differences between the efficacy of the two Ampion doses. Selection of the optimal dose for the second Phase III trial will be decided in consultation with the U.S. Food and Drug Administration.</p><p>A brief summary of the combined Ampion topline results are as follows: <ul><li>Patients receiving Ampion achieved significantly greater reduction in pain (Western Ontario and McMaster Universities Arthritis Index [WOMAC] A) from baseline to 12 weeks compared to saline vehicle control (<i>p</i> = 0.0038).</li><li>Patients receiving Ampion experienced, on average, a greater than 40% reduction in pain from baseline.</li><li>Patients receiving Ampion also achieved significantly greater improvement in function (WOMAC C) from baseline to 12 weeks compared to saline vehicle control (<i>p</i> = 0.044).</li><li>Patients receiving Ampion also demonstrated significantly greater improvement in overall quality of life measures (Patient Global Assessment) from baseline to 12 weeks compared to saline vehicle control (<i>p</i> = 0.012).</li><li>Clinical efficacy defined as pain reduction was evident as early as 4 weeks after the injection (<i>p</i> = 0.025) and continued to show improvement through 12 weeks (<i>p</i> = 0.0038).</li><li>Ampion was well tolerated with minimal adverse events (AEs) reported in the study. AEs were well balanced between Ampion and control groups. There were no drug-related serious AEs.</li></ul></p><p><i>Source.</i><i>“Ampio Pharmaceuticals, Inc. Announces Positive Results for Ampion in Osteoarthritis of the Knee Clinical Trial.” (2013, August 14). Retrieved August 26, 2013, from <a target="_blank" href="https://web.archive.org/web/20131030195507/http://prn.to/18We4xG">http://prn.to/18We4xG</a>.</i></p></div><div class="ftSection"><h3>MCI and AD Examined in Phase III Trial</h3><p>Takeda Pharmaceutical Company Limited and its partner Zinfandel Pharmaceuticals, Inc. have announced the initiation of TOMMORROW, a global Phase III clinical trial investigating a genetic-based biomarker risk assignment algorithm to predict risk of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) within a 5-year period and to evaluate the efficacy of the investigational low-dose pioglitazone (designated AD-4833 for this use) in delaying the onset of MCI due to AD in cognitively normal individuals at high risk as determined by the risk assignment algorithm.</p><p>The TOMMORROW trial is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. The trial will use a genetic-based biomarker risk assignment algorithm comprised of apolipoprotein E (APOE) and TOMM40 genotypes and age, which is being studied to determine the risk of individuals developing MCI due to AD within a 5-year period. Cognitively normal individuals assessed as low risk will be assigned to receive placebo. Cognitively normal individuals assessed as high risk will be assigned to AD-4833 or placebo. The study duration is approximately 5 years or the time needed to achieve 410 conversions to MCI due to AD in the high-risk group. Approximately 5,800 cognitively normal individuals ages 65 to 83 at 50 centers worldwide will be randomized into the study. The study will recruit internationally from large, diverse, community-based populations.</p><p>The study has two objectives: <ul><li>For the genetic-based bio-marker risk assignment algorithm, the primary objective is to qualify the risk assignment algorithm for identification of subjects at high risk of developing MCI due to AD within the next 5 years. The primary endpoint for the risk assignment algorithm is time to diagnosis of MCI due to AD for placebo-treated, high-risk participants versus placebo-treated, low-risk participants.</li><li>For AD-4833, considered an investigational drug for this use, the primary objective is to evaluate the efficacy of AD-4833 versus placebo in delaying the onset of MCI due to AD in cognitively normal individuals assessed as high risk based on the risk assignment algorithm. The primary endpoint is time to diagnosis of MCI due to AD for AD-4833-treated participants versus placebo-treated participants in the high-risk stratum. Key secondary objectives are to evaluate the effect of AD-4833 versus placebo on the progression of cognitive decline and to compare the effects of AD-4833 versus placebo on functional decline and instrumental activities of daily living.</li></ul></p><p>For more information on the TOMMORROW trial, visit <a target="_blank" href="https://web.archive.org/web/20131030195507/http://www.clinicaltrials.gov/">http://www.clinicaltrials.gov</a>.</p><p><i>Source.</i><i>“Takeda and Zinfandel Pharmaceuticals Initiate Phase 3 TOMMORROW Trial of AD-4833 for the Delay of Onset of Mild Cognitive Impairment Due to Alzheimer’s Disease in Subjects Selected Using a Genetic-Based Bio-marker Risk Assignment Algorithm.” Retrieved September 5, 2013, from <a target="_blank" href="https://web.archive.org/web/20131030195507/http://www.takeda.com/news/2013/20130827_5942.html">http://www.takeda.com/news/2013/20130827_5942.html</a></i></p></div></div></div></div><p>10.3928/00989134-20130826-89</p></div></div></div></div> <script type="text/javascript" language="javascript"> var $artContent = $('.ftArticle').html(); $('#anchor-tab-article').click(function () { $('#articleReferences, #articleTables').hide(); $('#articleBody, #abstractPortion').show() var current = $('a.current').removeClass('current'); $(this).addClass('current'); }); </script> <div class="social-links"> <div class="fb-like" data-send="false" data-width="300" data-show-faces="true" data-action="recommend"></div> <ul class="share"> <li><a href="javascript:void(0)" id="twitter" class="twitter-link" target="_new">Tweet</a></li> <li><a href="javascript:void(0)" id="facebook" class="facebook-link" target="_new">Share</a></li> <li class="linkedin"><a href="javascript:void(0)" id="linkedin" class="linkedin-link">Link</a></li> <li><span class="db-wrapper"><span class="g-plusone" data-size="tall" data-annotation="none"></span></span></li> <li><a href="javascript:void(0)" id="email">Email</a></li> <li class="last"><a href="javascript:void(0)" id="print">Print</a></li> </ul> <input name="layout_0$maincontent_3$articleItemForTweet" type="hidden" id="layout_0_maincontent_3_articleItemForTweet" value="{5C52B3C5-955E-4CBE-97D8-CE1B01D1A657}"/> <input name="layout_0$maincontent_3$tweettext" type="hidden" id="layout_0_maincontent_3_tweettext" class="tweettext" value="A Hospital Nursing Research Enhancement Model "/> <input name="layout_0$maincontent_3$tweeturl" type="hidden" id="layout_0_maincontent_3_tweeturl" class="tweeturl"/> </div> <div id="respond"> <h4> Comments</h4> <script language="javascript" type="text/javascript"> var idcomments_acct = 'aa6ff53f9870e40f92f83e1b5df3cddf'; var idcomments_post_id = '9c1b33ae-7f49-42ea-b348-c2ff59398de3'; var idcomments_post_url; </script> <span id="IDCommentsPostTitle" style="display: none"></span> <script type="text/javascript" src="https://web.archive.org/web/20131030195507js_/http://www.intensedebate.com/js/genericCommentWrapperV2.js"></script> <p class="comment-notes"> Healio is intended for health care provider use and all comments will be posted at the discretion of the editors. 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