<div class="gmail_quote">\On Fri, Jun 8, 2012 at 2:16 AM, BillK <span dir="ltr"><<a href="mailto:pharos@gmail.com" target="_blank">pharos@gmail.com</a>></span> wrote:<br><blockquote class="gmail_quote" style="margin:0 0 0 .8ex;border-left:1px #ccc solid;padding-left:1ex">

[NEWS 6 June] A study led by Karolinska Institutet reports for the<br>
first time the positive effects of an active vaccine against<br>
Alzheimer's disease. The new vaccine, CAD106, can prove a breakthrough<br>
in the search for a cure for this seriously debilitating dementia<br>
disease. The study is published in the distinguished scientific<br>
journal Lancet Neurology.<br>
<<a href="http://ki.se/ki/jsp/polopoly.jsp?l=en&d=130&a=145109&newsdep=130" target="_blank">http://ki.se/ki/jsp/polopoly.jsp?l=en&d=130&a=145109&newsdep=130</a>><br></blockquote><div><br></div>

<div> </div><div>This was just a phase-one clinical study, meaning their objective was to determine whether anyone would die or get a terrible side effect from the treatment.  Here's the summary from the Lancet Neurology:</div>

<div><br></div><div><div id="article_link_container" style="height:42px;color:rgb(64,64,64);font-family:'Trebuchet MS',Verdana,sans-serif;font-size:13px;background-color:rgb(255,255,255)"><div id="article_cite" style="float:left;font-size:12px;margin-top:0.3em">

The Lancet Neurology, <a href="http://www.thelancet.com/journals/laneur/issue/vol11no7/PIIS1474-4422(12)X7020-0" class="article-hdr-link" style="color:rgb(179,5,56)">Volume 11, Issue 7</a>, Pages 597 - 604, July 2012</div>

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<div id="article_DOI" style="clear:both;margin-top:1px;width:40em">doi:10.1016/S1474-4422(12)70140-0<a target="newWin" href="http://www.thelancet.com/popup?fileName=cite-using-doi"><img alt="" class="help-icon-cite-doi" id="icon_info2" src="http://www.thelancet.com/images/clear.gif" style="height: 18px; width: 18px; margin: -4px 3px -4px 10px; border: 0px; background-image: url(http://www.thelancet.com/images/icon_help_TLN.jpg); background-position: initial initial; background-repeat: no-repeat no-repeat; "></a><a class="standard-link" target="newWin" href="http://www.thelancet.com/popup?fileName=cite-using-doi" style="color:rgb(64,64,64)">Cite or Link Using DOI</a></div>

</div><div class="article_collections" style="clear:both;margin-top:1px;color:rgb(64,64,64);font-family:'Trebuchet MS',Verdana,sans-serif;font-size:13px;background-color:rgb(255,255,255)">This article can be found in the following collections: <a class="standard-link" href="http://www.thelancet.com/collections/Neurology?collexcode=115" style="color:rgb(64,64,64)">Neurology</a> (<a class="standard-link" href="http://www.thelancet.com/collections/Neurology?collexcode=115&subcollexcode=115103" style="color:rgb(64,64,64)">Dementias</a>)</div>

<div class="meta" style="color:rgb(64,64,64);font-family:'Trebuchet MS',Verdana,sans-serif;font-size:13px;background-color:rgb(255,255,255)">Published Online: 06 June 2012</div><div class="ja50-article" style="line-height:1.5em;color:rgb(64,64,64);font-family:'Trebuchet MS',Verdana,sans-serif;font-size:13px;background-color:rgb(255,255,255)">

<h1 class="ja50-ce-title" style="font-size:1.8em;margin-top:0.5em;padding-top:0px;color:black;line-height:1.25em">Safety, tolerability, and antibody response of active Aâ immunotherapy with CAD106 in patients with Alzheimer's disease: randomised, double-blind, placebo-controlled, first-in-human study</h1>

<div class="ja50-ce-author-group"><span class="ja50-ce-author">Prof <a class="ja50-ce-author" href="http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Bengt+Winblad" style="color:rgb(179,5,56)">Bengt Winblad</a> MD <a title="" href="http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff1" name="back-aff1" class="ja50-ce-cross-ref" style="color:rgb(179,5,56)"><span class="ja50-ce-sup" style="font-size:0.8em;line-height:0.8em;vertical-align:0.3em">a</span></a> <a title="" href="http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#cor1" name="back-cor1" class="ja50-ce-cross-ref" style="color:rgb(179,5,56)"><img alt="Corresponding Author" border="0" src="http://www.thelancet.com/images/article_notepad.gif"></a><a class="ja50-ce-e-address" href="mailto:bengt.winblad@ki.se"><img border="0" src="http://www.thelancet.com/images/article_email.gif" alt="Email Address"></a>, </span><span class="ja50-ce-author"><a class="ja50-ce-author" href="http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Niels+Andreasen" style="color:rgb(179,5,56)">Niels Andreasen</a> MD <a title="" href="http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff1" name="back-aff1" class="ja50-ce-cross-ref" style="color:rgb(179,5,56)"><span class="ja50-ce-sup" style="font-size:0.8em;line-height:0.8em;vertical-align:0.3em">a</span></a>, </span><span class="ja50-ce-author">Prof <a class="ja50-ce-author" href="http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Lennart+Minthon" style="color:rgb(179,5,56)">Lennart Minthon</a> MD <a title="" href="http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff2" name="back-aff2" class="ja50-ce-cross-ref" style="color:rgb(179,5,56)"><span class="ja50-ce-sup" style="font-size:0.8em;line-height:0.8em;vertical-align:0.3em">b</span></a>, </span><span class="ja50-ce-author"><a class="ja50-ce-author" href="http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Annette+Floesser" style="color:rgb(179,5,56)">Annette Floesser</a> MSc <a title="" href="http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff3" name="back-aff3" class="ja50-ce-cross-ref" style="color:rgb(179,5,56)"><span class="ja50-ce-sup" style="font-size:0.8em;line-height:0.8em;vertical-align:0.3em">c</span></a>, </span><span class="ja50-ce-author"><a class="ja50-ce-author" href="http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Georges+Imbert" style="color:rgb(179,5,56)">Georges Imbert</a> PhD <a title="" href="http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff3" name="back-aff3" class="ja50-ce-cross-ref" style="color:rgb(179,5,56)"><span class="ja50-ce-sup" style="font-size:0.8em;line-height:0.8em;vertical-align:0.3em">c</span></a>,</span><span class="ja50-ce-author"><a class="ja50-ce-author" href="http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Thomas+Dumortier" style="color:rgb(179,5,56)">Thomas Dumortier</a> MSc <a title="" href="http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff4" name="back-aff4" class="ja50-ce-cross-ref" style="color:rgb(179,5,56)"><span class="ja50-ce-sup" style="font-size:0.8em;line-height:0.8em;vertical-align:0.3em">d</span></a>, </span><span class="ja50-ce-author"><a class="ja50-ce-author" href="http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=R%20Paul+Maguire" style="color:rgb(179,5,56)">R Paul Maguire</a> PhD <a title="" href="http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff3" name="back-aff3" class="ja50-ce-cross-ref" style="color:rgb(179,5,56)"><span class="ja50-ce-sup" style="font-size:0.8em;line-height:0.8em;vertical-align:0.3em">c</span></a>, </span><span class="ja50-ce-author"><a class="ja50-ce-author" href="http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Kaj+Blennow" style="color:rgb(179,5,56)">Kaj Blennow</a> MD <a title="" href="http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff5" name="back-aff5" class="ja50-ce-cross-ref" style="color:rgb(179,5,56)"><span class="ja50-ce-sup" style="font-size:0.8em;line-height:0.8em;vertical-align:0.3em">e</span></a>, </span><span class="ja50-ce-author"><a class="ja50-ce-author" href="http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Joens+Lundmark" style="color:rgb(179,5,56)">Joens Lundmark</a> MD <a title="" href="http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff6" name="back-aff6" class="ja50-ce-cross-ref" style="color:rgb(179,5,56)"><span class="ja50-ce-sup" style="font-size:0.8em;line-height:0.8em;vertical-align:0.3em">f</span></a>, </span><span class="ja50-ce-author"><a class="ja50-ce-author" href="http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Matthias+Staufenbiel" style="color:rgb(179,5,56)">Matthias Staufenbiel</a> PhD <a title="" href="http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff3" name="back-aff3" class="ja50-ce-cross-ref" style="color:rgb(179,5,56)"><span class="ja50-ce-sup" style="font-size:0.8em;line-height:0.8em;vertical-align:0.3em">c</span></a>, </span><span class="ja50-ce-author">Prof <a class="ja50-ce-author" href="http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Jean-Marc+Orgogozo" style="color:rgb(179,5,56)">Jean-Marc Orgogozo</a> MD <a title="" href="http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff7" name="back-aff7" class="ja50-ce-cross-ref" style="color:rgb(179,5,56)"><span class="ja50-ce-sup" style="font-size:0.8em;line-height:0.8em;vertical-align:0.3em">g</span></a>, </span><span class="ja50-ce-author"><a class="ja50-ce-author" href="http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Ana+Graf" style="color:rgb(179,5,56)">Ana Graf</a> MD <a title="" href="http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff4" name="back-aff4" class="ja50-ce-cross-ref" style="color:rgb(179,5,56)"><span class="ja50-ce-sup" style="font-size:0.8em;line-height:0.8em;vertical-align:0.3em">d</span></a></span></div>

<div class="ja50-ce-abstract"><h2 class="ja50-ce-section-title" style="font-size:20px;border-bottom-width:1px;border-bottom-style:solid;border-bottom-color:rgb(178,178,178);padding-bottom:5px;color:rgb(179,5,56)">Summary</h2>

<div class="ja50-ce-abstract-section" style="margin-bottom:1em"><h3 class="ja50-ce-section-title" style="display:inline;font-size:1em">Background</h3><div class="ja50-ce-simple-para" style="margin-bottom:0em">Immunotherapy targeting the amyloid â (Aâ) peptide is a potential strategy to slow the progression of Alzheimer's disease. We aimed to assess the safety and tolerability of CAD106, a novel active Aâ immunotherapy for patients with Alzheimer's disease, designed to induce N-terminal Aâ-specific antibodies without an Aâ-specific T-cell response.</div>

</div><div class="ja50-ce-abstract-section" style="margin-bottom:1em"><h3 class="ja50-ce-section-title" style="display:inline;font-size:1em">Methods</h3><div class="ja50-ce-simple-para" style="margin-bottom:0em">We did a phase 1, double-blind, placebo-controlled, 52-week study in two centres in Sweden. Participants, aged 50—80 years, with mild-to-moderate Alzheimer's disease were entered into one of two cohorts according to time of study entry and then randomly allocated (by use of a computer-generated randomisation sequence) to receive either CAD106 or placebo (4:1; cohort one received CAD106 50 ìg or placebo, cohort two received CAD106 150 ìg or placebo). Each patient received three subcutaneous injections. All patients, caregivers, and investigators were masked to treatment allocation throughout the study. Primary objectives were to assess the safety and tolerability of CAD106 and to identify the Aâ-specific antibody response. Safety assessment was done by recording of all adverse events, assessment of MRI scans, physical and neurological examinations, vital signs, electrocardiography, electroencephalography, and laboratory analysis of blood and CSF. Patients with Aâ-IgG serum titres higher than 16 units at least once during the study were classified as responders. This study is registered with <a class="ja50-ce-inter-ref" href="http://clinicaltrials.gov/" target="_blank" style="color:rgb(179,5,56)">ClinicalTrials.gov</a>, number<a class="ja50-ce-inter-ref" href="http://clinicaltrials.gov/ct2/show/NCT00411580" target="_blank" style="color:rgb(179,5,56)">NCT00411580</a>.</div>

</div><div class="ja50-ce-abstract-section" style="margin-bottom:1em"><h3 class="ja50-ce-section-title" style="display:inline;font-size:1em">Findings</h3><div class="ja50-ce-simple-para" style="margin-bottom:0em">Between August, 2005, and March, 2007, we randomly allocated 31 patients into cohort one (24 patients to CAD106 treatment and seven to placebo) and 27 patients into cohort two (22 patients to CAD106 treatment and five to placebo). 56 of 58 patients reported adverse events. In cohort one, nasopharyngitis was the most commonly reported adverse event (10 of 24 CAD106-treated patients). In cohort two, injection site erythema was the most commonly reported adverse event (14 of 22 CAD106-treated patients). Overall, nine patients reported serious adverse events—none was thought to be related to the study drug. We recorded no clinical or subclinical cases of meningoencephalitis. 16 of 24 (67%) CAD106-treated patients in cohort one and 18 of 22 (82%) in cohort two developed Aâ antibody response meeting pre-specified responder threshold. One of 12 placebo-treated patients (8%) had Aâ-IgG concentrations that qualified them as a responder.</div>

</div><div class="ja50-ce-abstract-section" style="margin-bottom:1em"><h3 class="ja50-ce-section-title" style="display:inline;font-size:1em">Interpretation</h3><div class="ja50-ce-simple-para" style="margin-bottom:0em">Our findings suggest that CAD106 has a favourable safety profile and acceptable antibody response in patients with Alzheimer's disease. Larger trials with additional dose investigations are needed to confirm the safety and establish the efficacy of CAD106.</div>

</div><div class="ja50-ce-abstract-section" style="margin-bottom:1em"><h3 class="ja50-ce-section-title" style="display:inline;font-size:1em">Funding</h3><div class="ja50-ce-simple-para" style="margin-bottom:0em">Novartis Pharma AG.</div>

<div class="ja50-ce-simple-para" style="margin-bottom:0em"><br></div><div class="ja50-ce-simple-para" style="margin-bottom:0em">Best regards,<br><br>James Clement</div></div></div></div></div></div>