{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T15:58:25Z","timestamp":1792684705438,"version":"4.5.0"},"reference-count":44,"publisher":"S. Karger AG","issue":"2","license":[{"start":{"date-parts":[[2010,1,1]],"date-time":"2010-01-01T00:00:00Z","timestamp":1262304000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"},{"start":{"date-parts":[[2010,1,1]],"date-time":"2010-01-01T00:00:00Z","timestamp":1262304000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Dement Geriatr Cogn Disord"],"published-print":{"date-parts":[[2010]]},"abstract":"<jats:p>&lt;i&gt;Background\/Aims:&lt;\/i&gt; A phase II study of the peroxisome proliferator-activated receptor-\u03b3 agonist rosiglitazone extended release (RSG XR) in mild-to-moderate Alzheimer\u2019s disease (AD) detected a treatment benefit to cognition in &lt;i&gt;apolipoprotein E&lt;\/i&gt;&lt;i&gt;(APOE)&lt;\/i&gt;-&amp;#917;&lt;i&gt;4&lt;\/i&gt;-negative subjects. The current phase III study with prospective stratification by &lt;i&gt;APOE&lt;\/i&gt; genotype was conducted to confirm the efficacy and safety of RSG XR in mild-to-moderate AD. An open-label extension study assessed the long-term safety and tolerability of 8 mg RSG XR. &lt;i&gt;Methods:&lt;\/i&gt; This double-blind, randomized, placebo-controlled study enrolled 693 subjects. Within 2 &lt;i&gt;APOE &lt;\/i&gt;allelic strata (&amp;#917;&lt;i&gt;4&lt;\/i&gt;-positive, &amp;#917;&lt;i&gt;4&lt;\/i&gt;-negative), subjects were randomized (2:2:2:1) to once-daily placebo, 2 mg RSG XR, 8 mg RSG XR or 10 mg donepezil (control). Coprimary endpoints were change from baseline to week 24 in the Alzheimer\u2019s Disease Assessment Scale-cognitive subscale (ADAS-Cog) score, and week 24 Clinician\u2019s Interview-Based Impression of Change plus caregiver input (CIBIC+). &lt;i&gt;Results:&lt;\/i&gt; At week 24, no significant differences from placebo in change from baseline in coprimary endpoints were detected with either the RSG XR dose in &lt;i&gt;APOE-&lt;\/i&gt;&amp;#917;&lt;i&gt;4&lt;\/i&gt;-negative subjects or overall. For donepezil, no significant treatment difference was detected in ADAS-Cog; however, a significant difference was detected (p = 0.009) on the CIBIC+. Peripheral edema was the most common adverse event for 8 mg RSG XR (15%) and placebo (5%), and nasopharyngitis for 2 mg RSG XR (7%). &lt;i&gt;Conclusion:&lt;\/i&gt; No evidence of efficacy of 2 mg or 8 mg RSG XR monotherapy in cognition or global function was detected in the &lt;i&gt;APOE-&lt;\/i&gt;&amp;#917;&lt;i&gt;4&lt;\/i&gt;-negative or other analysis populations. The safety and tolerability of RSG XR was consistent with its known pharmacology.<\/jats:p>","DOI":"10.1159\/000318845","type":"journal-article","created":{"date-parts":[[2010,8,25]],"date-time":"2010-08-25T06:17:29Z","timestamp":1282717049000},"page":"131-146","source":"Crossref","is-referenced-by-count":308,"title":["Rosiglitazone Monotherapy in Mild-to-Moderate Alzheimer\u2019s Disease: Results from a Randomized, Double-Blind, Placebo-Controlled Phase III 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