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Lundbeck initiates clinical phase II trials with Lu AE58054 as augmentation treatment in Alzheimer's disease

01 Dec 2009 - H. Lundbeck A/S announced the initiation of a multi-centre, placebo-controlled, fixed-dose study of Lu AE58054 as add-on to donepezil in patients with moderate Alzheimer's disease. The clinical phase II study is planned to enrol approximately 270 patients. The purpose of this study is to investigate if Lu AE58054 after 24 weeks improves cognition and functional outcomes in patients with moderate Alzheimer's disease that are already in treatment with donepezil.
 
Lu AE58054 is a potent and selective 5-HT6-receptor antagonist. The 5-HT6-receptor is primarily found in areas of the brain involved in cognition. A number of early trials have demonstrated that a 5-HT6-receptor antagonist could offer potential in the treatment of disorders such as Alzheimer's disease and schizophrenia and in November 2008 Lundbeck initiated a 12 week clinical phase II trial in schizophrenia. The present study examines the possible benefit of Lu AE58054 over a much longer period in Alzheimer's disease.