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Accera, Inc. Appoints Dr. Thomas Werner President & CEO and Announces FDA Acceptance of IND Application for AC-1204 for Mild-to-Moderate Alzheimer's Disease
Date:10/5/2010

y to a phase 2-3 study.  Referred to as the ALERT Protocol (AC-1204 Long-Term Efficacy Response Trial), the planned trial will be a six month, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of daily administration of AC-1204 in subjects with mild to moderate AD.  Approximately 400 study subjects are anticipated to enroll in as many as 30 clinical sites within the U.S.  The efficacy of AC-1204 versus placebo will be measured by two primary outcomes: changes from baseline test scores in the Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog) and the Clinician's Interview-Based Impression of Change Plus (CIBIC-plus).  These tests have been established as validated measurements of efficacy accepted by FDA for approval of other medications for AD.

Accera has completed four clinical trials with similar compounds in elderly normal volunteers and in patients with memory impairment or mild-to-moderate AD.  In these trials, patients with mild-to-moderate AD receiving Axona (AC-1202) for up to 90 days experienced cognitive improvement compared with placebo.  These treatment effects were notably significant among patients who were not carriers of the apolipoprotein E4 allele (APOE4), a genetic risk factor associated with a higher probability of developing AD.  Approximately 50% of individuals diagnosed with probable AD are estimated to be APOE4 positive.  Peer-reviewed results were published in Nutrition & Metabolism in August 2009 in the article entitled "Study of the ketogenic agent AC-1202 in mild to moderate Alzheimer's disease: a randomized, double-blind, placebo-controlled, multicenter trial."  Axona (AC-1202) is currently commercially available in the U.S. as a prescription medical food product.

Like Axona, AC-1204 increases production of ketone bodies, which can serve as an alternative fuel for the brain in AD patients suffering from glucose hyp
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SOURCE Accera, Inc.
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