Lundbeck has initiated a multi-centre, placebo-controlled, fixeddose 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.
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. Reportedly, the purpose of the 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.
Anders Gersel Pedersen, executive vice president and head of drug development at Lundbeck, said: “We are very pleased that Lundbeck can continue to deliver projects that potentially can alter the course of this debilitating neurological disease and radically change the lives of patients.”