Memory Pharmaceuticals Corp. has completed enrolment in its phase IIa trial of MEM 3454, the company's lead nicotinic alpha-7 receptor partial agonist, in Alzheimer's disease. The company expects to report top- line results for this trial in the fourth quarter of 2007.
"The rapidity with which we were able to complete enrolment 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 (CIAS), underlines the enthusiasm we, our investigators and our partner Roche have for MEM 3454," said Stephen R. Murray, Ph.D., vice president of clinical development. "We are pleased to have completed the trial's enrolment in just a few months, remaining on track to share top-line data from two phase IIa trials - MEM 3454 in Alzheimer's disease and MEM 1003 in Alzheimer's disease - in the fourth quarter of this year."
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. The trial enrolled approximately 80 subjects with mild to moderate Alzheimer's disease at multiple sites in the United States. Subjects in the study were randomized at enrolment to receive 5 mg, 15 mg or 50 mg 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 (QESM) factor score from the Cognitive Drug Research (CDR) 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.
MEM 3454 is a partial agonist of the nicotinic alpha-7 receptor, a highly specialized receptor found in the central nervous system (CNS). Compounds acting on this receptor could be beneficial in the treatment of Alzheimer's disease and schizophrenia, as well as other psychiatric and neurological disorders.