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news.Memory Pharmaceuticals has reported positive top-line data from the randomized, placebo-controlled, multi-center Phase IIa proof-of-concept trial of its lead nicotinic alpha-7 receptor partial agonist, in 80 patients with mild to moderate Alzheimer's disease, over an eight-week treatment period.
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The primary endpoint of the trial was the change from baseline in the Quality of Episodic Secondary Memory (QESM) factor score of the Cognitive Drug Research (CDR) battery. QESM is a composite score derived from memory tests in the CDR battery that measure the ability to store, hold and retrieve information. Secondary endpoints in the trial included other composite scores from the CDR battery that measure working memory, attention and executive function, and the Alzheimer’s disease Assessment Scale-cognitive subscale (ADAS-Cog).
In analyses of QESM at certain other time points, and for all time points combined, the placebo group performed statistically significantly better than the treatment groups due to substantially lower QESM scores at baseline for the placebo group, at the two and four-hour time points, as compared to the treatment groups. After adding a covariate for baseline scores to the statistical model, the MEM 3454 5mg group demonstrated a statistically significant change from baseline on QESM at all time points combined compared to placebo (p=0.032).
The MEM 3454 5mg and 15mg dose groups demonstrated statistical significance (p=0.003 and p=0.023, respectively), and the 50mg dose group demonstrated a trend favoring treatment (p=0.083) for the eight hour post-dose time points on QESM. In addition, the 5mg and 15mg dose groups demonstrated a statistically significant effect on Quality of Working Memory, over all time points combined (p=0.006 and p=0.004, respectively).