The trial is designed to assess the safety, tolerability and cognitive effects of three doses of MEM 3454 in patients with cognitive impairment associated with schizophrenia (CIAS). The trial will enroll approximately 160 patients with stable schizophrenia who are receiving atypical antipsychotic therapy. Subjects will be 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 effectiveness of MEM 3454 in CIAS using the Matrics Consensus Cognitive Battery (MCCB). Secondary objectives include measures of other symptoms of schizophrenia and functional capacity.
In June 2007, Memory Pharmaceuticals expanded its nicotinic alpha-7 receptor agonist agreement with Roche to support this Phase IIa trial of MEM 3454 in CIAS. The expanded agreement provides that Roche would have to make an additional milestone payment upon completion of the Phase IIa CIAS trial to maintain its license to MEM 3454.
Stephen Murray, chief medical officer of Memory Pharmaceuticals, said: “We currently expect to complete this trial in the fourth quarter of 2008.”