Targacept Inc. said Monday it has completed the recruitment of patients in the Phase 2b study of the drug compound TC-1734 as a treatment for mild-to-moderate Alzheimer’s disease.
The Winston-Salem biotechnology company expects to report top-line results from the study in mid-2014.
“While the pursuit of an effective new treatment for Alzheimer’s disease has been historically challenging, the unmet medical need is both enormous and growing,” said Dr. Stephen Hill, Targacept’s president and chief executive.
The study is a double blind, randomized, parallel group trial evaluating TC-1734 head-to-head against donepezil, the marketed medication most often prescribed for Alzheimer’s disease. The study, designed to randomize 300 patients, is being conducted at sites predominantly in Eastern Europe and also in the United States.
On April 18, Targacept said it had completed recruitment of patients for a Phase 2b study of TC-5619 as a treatment for negative symptoms and cognitive dysfunction in schizophrenia. The company expects to report results from the study by the end of 2013.
The clinical trial results could be the most pivotal research markers for Targacept since its TC-5214 compound failed in four Phase 3 clinical trials in 2011 and 2012.
The TC-5619 study also is being conducted in Eastern Europe and the United States involving 56 patients with stable schizophrenia who are taking a fixed dose of an atypical antipsychotic.
In March, the company said it had altered its licensing agreement with AstraZeneca PLC, with relinquishing its licensing rights for Targacept's alpha7 NNR therapeutics compounds, such as TC-5619.
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