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Ketasyn showed significant efficacy in tests of memory. On average, subjects taking Ketasyn performed significantly better on the 'First-Last Name Association' test (FLN) than subjects taking placebo (p=0.042). "On average, seniors taking Ketasyn remembered more names than those taking placebo," said Dr. Costantini.
In another memory test called Name-Face Recognition (NFA), which associates a person's name and face, Ketasyn subjects under age 59 improved significantly more than placebo subjects at Day 90 (p=0.0217). The efficacy in the NFA test observed with Ketasyn in subjects under age 59 captures a large portion of the AAMI population.
Consistent with the findings of Accera's Phase IIa and IIb AD studies, subjects who did not have the APOE4 genotype (E4(-)) responded particularly well to treatment: E4(-) subjects showed a further significant treatment effect of Ketasyn in FLN at Day 90 (p=0.012). In contrast, and also consistent with the AD trial results, APOE4(+) subjects showed no difference between Ketasyn and placebo for FLN scores at Day 90 (p=0.4639).
The safety profile of Ketasyn was excellent, as shown in the previous AD trials with Ketasyn. The incidence of adverse events was low and similar between Ketasyn and placebo groups.
Accera recently completed a Phase IIb clinical trial in AD patients
that confirmed Ketasyn's safety and efficacy as measured by improvement in
ADAS-Cog scores, the gold standard measure for efficacy in cognition and
short-term memory. Accera plans to initiate a pivotal, Phase III
multi-cent
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| SOURCE Accera, Inc. Copyright©2007 PR Newswire. All rights reserved |