New Jersey, USA-based Memory Pharmaceuticals has completed enrollment in its Phase IIa trial of MEM 3454, the company's lead nicotinic alpha-7 receptor partial agonist, in Alzheimer's disease and it expects to report top-line results for this trial in the fourth quarter of 2007.
"The rapidity with which we were able to complete enrollment of this study, along with our recent announcement that we are planning to initiate a proof-of-concept study in cognitive impairment associated with schizophrenia, underlines the enthusiasm we, our investigators and our partner Roche have for MEM 3454," said Stephen Murray, vice president of clinical development.
The Phase IIa trial is a randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability and cognitive effects of three doses of MEM 3454. It enrolled about 80 subjects with mild-to-moderate AD at multiple sites in the USA. Patients in the study were randomized to receive 5mg, 15mg or 50mg of MEM 3454 or placebo once daily for a period of eight weeks. The primary objective of the trial is to assess the effect of MEM 3454 using the Quality of Episodic Secondary Memory factor score from the Cognitive Drug Research battery. Secondary objectives include assessing the safety, tolerability, and pharmacokinetics of multiple doses of MEM 3454 and the drug candidate's effect on additional psychometric test items from the CDR battery and the Alzheimer's Disease Assessment Scale - Cognitive subscale.
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