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The study will evaluate the effect of four doses of R3487/MEM 3454 on electrophysiological biomarkers (such as P50 sensory gating) that have been shown to be closely associated with schizophrenia. The study is being funded by Roche under the companies' nicotinic alpha-7 receptor agonist collaboration agreement.
The double-blind, placebo-controlled biomarker study will enroll 12 non-smoking patients with stable schizophrenia who are receiving certain types of antipsychotic drugs. Subjects will be randomized to receive R3487/MEM 3454 and placebo in a five-way cross-over design.
Each subject will participate in five treatment periods. During each period, subjects will receive single doses of either 1mg, 5mg, 15mg, or 50mg of R3487/MEM 3454 or placebo, with a four to 10-day wash-out period between each treatment period.
The primary outcome of the trial is the effect of R3487/MEM 3454 on P50 sensory gating and the potential utility of P50 as an efficacy biomarker for nicotinic alpha-7 agonists in schizophrenia. Secondary outcome measurements include additional electrophysiological biomarkers, called mismatch negativity and P300.
Stephen Murray, chief medical officer of Memory Pharmaceuticals, said: "Recent research suggests that nicotinic alpha-7 receptor agonists may improve the abnormal electrophysiological responses associated with schizophrenia. This trial will evaluate whether we can use these responses as biomarkers to predict or assess the effects of R3487/MEM 3454 in this patient population.
"This biomarker trial complements our ongoing Phase II trial of R3487/MEM 3454 in cognitive impairment associated with schizophrenia, and we look forward to reporting the results in the third quarter of 2009."
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