Phase 2 study of TC-5619 for cognitive dysfunction associated with schizophrenia
Targacept announced positive top-line results from its Phase 2 trial of TC-5619 as an augmentation therapy to improve cognition in patients with schizophrenia. The double blind, placebo controlled trial was conducted at 7 sites in the United States and 12 sites in India. In the trial, 185 patients meeting DSM-IV criteria for schizophrenia, with stable psychotic symptoms and taking a stable dose of an approved atypical antipsychotic medication (either Seroquel (quetiapine, from AstraZeneca), or Risperdal (risperidone, from Janssen)) were randomized to receive either TC-5619 or placebo, together with continued treatment with the atypical antipsychotic, for 12 weeks.
TC-5619 met the protocol criteria for a positive result on the primary efficacy outcome measure, the Groton Maze Learning Task (GMLT) of the CogState Schizophrenia Battery, and was well tolerated. In addition, positive signals were observed in the trial on several secondary efficacy outcome measures, including Scale for Assessment of Negative Symptoms, an investigator assessment of improvement on the negative symptoms of schizophrenia, Clinical Global Impression – Global Improvement, an investigator assessment of overall response, and Subject Global Impression – Cognition scale, a patient self-assessment of cognitive change. Other secondary outcome measures of the trial, including a composite measure of the CogState Schizophrenia Test Battery, did not demonstrate a drug effect.
TC-5619 is a novel small molecule that is highly selective for the alpha7 neuronal nicotinic receptor. The alpha7 NNR subtype has been shown to be a key regulator of cognitive function, including attention, memory and learning.
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