AstraZeneca starts mid-stage schizophrenia drug trial

The cognitive deficits in schizophrenia (CDS) trial is a double blind, placebo-controlled study being conducted at sites in the US and Canada. The trial design provides for approximately 400 patients currently taking medication from the class known as atypical anti-psychotics to be randomly assigned to one of three dose groups of AZD3480 or to placebo and to be dosed over a 12-week period.

The primary outcome measure of the trial is a cognitive test battery that includes assessments of cognitive functions across nine different domains and was developed in connection with a National Institute of Mental Health initiative known as Measurement and Treatment Research to Improve Cognition in Schizophrenia, or MATRICS. Secondary measures include measures of life functioning, such as performance in day-to-day tasks and social skills. The trial is expected to complete by the end of 2008.

“Research has shown that almost ninety percent of schizophrenics smoke,” said J Donald deBethizy, president and CEO of Targacept. “One explanation for this high rate of smoking is that schizophrenic patients may be self-medicating with nicotine in order to address the cognitive impairment associated with the disease and thus function better.

“However, unlike nicotine, which acts non-selectively throughout the central and peripheral nervous system and therefore has an undesirable side effect profile, AZD3480 was designed to target select neuronal nicotinic receptors that studies have shown to play a role in cognition to promote therapeutic effects and limit adverse side effects.”

Schizophrenia is a chronic, severe and disabling form of psychosis that, in addition to symptoms such as delusions and hallucinations, is often marked by impairments in cognitive functions such as attention, vigilance, memory and reasoning. It is estimated that approximately 75% of all schizophrenic patients are cognitively impaired.