The biomarker study will enroll approximately 12 patients with stable schizophrenia who are receiving atypical antipsychotic therapy. Subjects will be randomized to receive MEM 3454 and placebo in a 5-way cross-over design. Each subject will participate in 5 treatment periods. During each period, subjects will receive single doses of 1mg, 5mg, 15mg, or 50mg of MEM 3454 or placebo, with a four-day wash-out period between each treatment period.
The primary objective of the trial is to study P50 sensory gating and mismatch negativity as potential efficacy biomarkers for nicotinic alpha-7 agonists, such as MEM 3454, in schizophrenia. P50 sensory gating and mismatch negativity are two neurophysiological measurements that have been shown to be closely associated with nicotinic alpha-7 function and schizophrenia. The biomarker study, and additional formulation and manufacturing activities for MEM 3454, will be funded by Roche, under the companies’s collaboration for the development of nicotinic alpha-7 receptor agonists.
Stephen Murray, chief medical officer of Memory Pharmaceuticals, said: “The biomarker data, together with the results of our ongoing Phase IIa study in CIAS, will help with the design of later-stage trials in schizophrenia.”