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news.Targacept has reported positive top-line results from a Phase II proof of concept trial evaluating TC-5619 as an augmentation therapy to improve cognition in patients with schizophrenia.
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TC-5619 is a highly selective alpha7 neuronal nicotinic receptor modulator, which is subject to licence by Targacept’s strategic partner AstraZeneca.
In the trial, TC-5619 met the primary efficacy outcome measure, the Groton Maze Learning Task (GMLT) – which is a computerised test designed to assess executive function, and the drug was well-tolerated.
Positive signals were seen in the trial on several secondary efficacy outcome measures such as Scale for Assessment of Negative Symptoms, Clinical Global Impression – Global Improvement, and Subject Global Impression – Cognition scale.
Other secondary outcome measures of the study including composite measure of the CogState Schizophrenia Test Battery, did not show a drug effect.
The double blind, placebo controlled Phase II trial was conducted at 7 sites in the US and 12 sites in India.
In the study, 185 patients meeting DSM-IV criteria for schizophrenia and taking stable dose of an approved atypical antipsychotic medication, were randomised to receive TC-5619 or placebo, along with continued treatment with the atypical antipsychotic, for 12 weeks.