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.
"Alzheimer's disease is one of the most complex and challenging areas of research and development, but also an area with huge unmet medical needs," says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck. "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."
About Lu AE58054
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.
About Alzheimer's disease
Alzheimer's disease is a neurodegenerative disease characterised by progressive cognitive impairment such as memory loss, reduced perception ability and language disruptions, eventually preventing the patient from taking care of him-/herself. Anxiety, confusion and anger may occur in the later stages of the disease.
Alzheimer's disease affects 5% of the population over the age of 65 and more than 30% of those aged over 85. Today, about 60% of Alzheimer's patients are diagnosed, and of these about 80% are diagnosed with either moderate or severe Alzheimer's disease. It is estimated that there are between 5-6 million people with dementia in Europe. The total costs to society are estimated to amount to EUR 55 billion making dementia the most costly brain disorder[1]. The aging population in Europe will make dementia an even bigger burden to society in the years to come. Studies have shown that even relatively small delays in disease progression will have huge impact on medical costs.
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improve the quality of life for people suffering from central nervous system (CNS) disorders. For this purpose Lundbeck is engaged in the research and development, production, marketing and sale of pharmaceuticals across the world, targeted at disorders like depression and anxiety, schizophrenia, insomnia, Huntington's, Alzheimer's and Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark, and employs today over 5,500 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with CNS disorders. In 2008, the company's revenue was DKK 11.3 billion (approximately EUR 1.5 billion or USD 2.2 billion). For more information, please visit www.lundbeck.com.
[1] Costs of Disorders of the Brain in Europe; European Journal of Neurology; Volume 12, Supplement 1, June 2005.