Targacept announced that it has initiated a Phase 2 clinical proof of concept trial of TC-5619 in adults with attention deficit/hyperactivity disorder (ADHD). This trial is a double-blind, placebo controlled, randomized, parallel group study being conducted in the U.S. with planned enrollment of up to 125 patients ages 18 to 65. The trial design provides for patients to be randomly assigned to one of two cohorts, TC-5619 or placebo, and dosed over a 12-week period. Patients randomized to the TC-5619 arm will be up-titrated every four weeks and tested on each of three doses of TC-5619. The primary efficacy outcome measure of the trial is change from baseline on the Conners Adult ADHD Rating Scale, a multimodal questionnaire assessment of symptoms and behaviors associated with ADHD in adults aged 18 and older.
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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