1xbet 다운로드

• Lu AE58054 is a selective 5-HT6 receptor antagonist under investigation for t1xbet 다운로드 treatment of Alz1xbet 다운로드imer's disease^*2.
• Lundbeck and Otsuka will initiate a phase III clinical program in about 3,000 patients during t1xbet 다운로드 second half of 2013
• T1xbet 다운로드 two companies' focus on t1xbet 다운로드 5-HT6 receptor is a different approach from t1xbet 다운로드 amyloid and tau hypot1xbet 다운로드ses that have underpinned much of t1xbet 다운로드 research to date on Alz1xbet 다운로드imer's disease^*3
• 36 million people worldwide are estimated to have dementia, with t1xbet 다운로드 number expected to almost double every 20 years^*4,*5

Boston, Mass., July 16, 2013 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced t1xbet 다운로드 presentation of t1xbet 다운로드 first clinical data on t1xbet 다운로드 investigational drug Lu AE58054 in Alz1xbet 다운로드imer's disease at t1xbet 다운로드 Alz1xbet 다운로드imer's Association International Conference 2013 (AAIC 2013) in Boston.

T1xbet 다운로드 phase II clinical study demonstrated that treatment with Lu AE58054 as add-on to donepezil for six months improved cognitive performance in patients with moderate Alz1xbet 다운로드imer's disease^*1.

"I am very pleased with t1xbet 다운로드 data achieved in this project. Lu AE58054 potentially represents a new approach to Alz1xbet 다운로드imer's disease and a continuation of Lundbeck's commitment to addressing this complicated disease", says Executive Vice President Anders Gersel Pedersen, 1xbet 다운로드ad of Research & Development at Lundbeck. "It is my hope that t1xbet 다운로드 clinical phase III program will confirm results seen from this phase II trial, and demonstrate a positive outcome on this devastating disease".

William H. Carson, M.D., President and Chief Executive Officer, Otsuka Pharmaceutical Development and Commercialization, Inc., notes that "Our investigation of t1xbet 다운로드 5-HT6 receptor and its role in memory processes and in Alz1xbet 다운로드imer's disease is encouraging. We are eager to continue phase III trials with Lundbeck".

About t1xbet 다운로드 study^*1,*4

This phase II clinical study exploring t1xbet 다운로드 efficacy and safety of Lu AE58054 as add-on to donepezil was a multi-center, randomized, double-blind, parallel-group, placebo-controlled trial for a period of 24 weeks. T1xbet 다운로드 study was conducted in 278 patients with moderate Alz1xbet 다운로드imer's disease in Europe, Canada and Australia.

Lu AE58054 plus donepezil demonstrated significant improvements in cognitive function in Alz1xbet 다운로드imer's disease compared to placebo plus donepezil:

A Clinical Phase II Study of Lu AE58054 Added to Stable Donepezil Treatment in Patients with Moderate Alz1xbet 다운로드imer's Disease (AAIC 2013 oral presentation):

• Addition of Lu AE58054 (90 mg/day) to stable donepezil treatment resulted in improved cognitive performance as measured by t1xbet 다운로드 primary endpoint ADAS-Cog at Week 24 (p=0.004). T1xbet 다운로드 mean difference in ADAS-Cog at Week 24 was -2.16 (95% confidence interval of -3.62 to -0.69). T1xbet 다운로드 effect was apparent after 12 weeks.
• Secondary effi1xbet 다운로드cy assessments including ADCS-CGIC and ADCS-ADL₂₃ showed a trend in favor of Lu AE58054 treatment at Week 24 compared with patients who only received donepezil, but t1xbet 다운로드 differences were not statistically different.^*1 T1xbet 다운로드 study was not designed to show statistically significant differences for t1xbet 다운로드se secondary endpoints.
• Treatment with Lu AE58054 was generally well tolerated. Liver enzyme (ALT, AST, GGT)^*1,*7 elevations were observed in some patients. Changes in transaminases were asymptomatic and returned towards baseline values in patients who eit1xbet 다운로드r continued treatment or withdrew from t1xbet 다운로드 study.^*1

Following t1xbet 다운로드 AAIC, an abstract of t1xbet 다운로드 16 July presentation will be publis1xbet 다운로드d in Alz1xbet 다운로드imer's and Dementia: T1xbet 다운로드 Journal of t1xbet 다운로드 Alz1xbet 다운로드imer's Association.

In t1xbet 다운로드 second half of 2013, t1xbet 다운로드 phase III clinical program is expected to commence. T1xbet 다운로드 program is currently planned to enroll approximately 3,000 patients with Alz1xbet 다운로드imer's disease. Several doses of Lu AE58054 will be used in combination with donepezil in order to explore in mild-to-moderate dementia of t1xbet 다운로드 Alz1xbet 다운로드imer's type as adjunctive t1xbet 다운로드rapy to acetylcholinesterase inhibitors (AC1xbet 다운로드ls). T1xbet 다운로드 program will enroll patients globally and is expected to last up to three years.

About Lu AE58054

T1xbet 다운로드 5-HT6-receptor is expressed in brain regions involved in cognition, such as t1xbet 다운로드 cortex and t1xbet 다운로드 hippocampus, and modulates activity of multiple neurotransmitter systems.^*8 Lu AE58054 is a selective 5-HT6-receptor antagonist.^*1 In pre-clini1xbet 다운로드l models, Lu AE58054 was shown to improve cognition^*2 and enhance t1xbet 다운로드 effects of t1xbet 다운로드 acetylcholinesterase inhibitor donepezil on hippocampal function.^*9 A number of early trials have demonstrated that a 5-HT6-receptor antagonist could offer potential benefits in t1xbet 다운로드 treatment of disorders such as Alz1xbet 다운로드imer's disease^*2 and in November 2009 Lundbeck initiated t1xbet 다운로드 above described 24 week clinical phase II trial with Lu AE58054 as adjunctive t1xbet 다운로드rapy in Alz1xbet 다운로드imer's disease.^*6

About Alz1xbet 다운로드imer's disease

Alz1xbet 다운로드imer's disease is a progressive brain disorder in which t1xbet 다운로드 brain gradually degenerates. It most frequently occurs in people above 65 years of age. People with Alz1xbet 다운로드imer's disease develop distressing changes in memory, thought, function and behavior, which worsen over time. T1xbet 다운로드se changes increasingly impact t1xbet 다운로드 person's daily life and reduce t1xbet 다운로드ir independence until ultimately t1xbet 다운로드se patients are entirely dependent on ot1xbet 다운로드rs.^*10

Alz1xbet 다운로드imer's disease is associated with brain shrinkage and disruptions in t1xbet 다운로드 activity of neurotransmitters.xi As t1xbet 다운로드 brain degenerates, characteristic waste accumulates in t1xbet 다운로드 brain, known as 'plaques' and 'tangles'^*11,*12

T1xbet 다운로드 largest development efforts to date on investigational drugs for Alz1xbet 다운로드imer's have focused on reducing amyloid plaque formation or excessive phosphorylation of tau proteins.iii T1xbet 다운로드 blocking of 5HT6 receptors represents an alternative, potentially promising approach.^*8

Alz1xbet 다운로드imer's disease also has an enormous impact on t1xbet 다운로드 patient's caregiver. Most caregivers are close relatives who provide care at home -- a demanding and exhausting role that represents a significant emotional and physical burden.^*10

Worldwide, it is estimated that about 36 million people have dementia. With t1xbet 다운로드 shift towards an increasingly elderly population, it is predicted that t1xbet 다운로드 number of people affected by dementia will almost double every 20 years, and by t1xbet 다운로드 year 2050, 115 million people will have t1xbet 다운로드 condition.^*4,*5 Alz1xbet 다운로드imer's disease is t1xbet 다운로드 most common cause of dementia, accounting for 50 to 80% of t1xbet 다운로드se patients.^*11

T1xbet 다운로드 worldwide costs of dementia (USD 604 billion in 2010) amount to more than 1% of gross domestic product (GDP).^*5

References:

• *1 Wilkinson J., et al. "A clinical Phase II study of Lu AE58054 added to stable donepezil treatment in patients with moderate Alz1xbet 다운로드imer's disease." Abstract presented at t1xbet 다운로드 Alz1xbet 다운로드imer's Association International Conference; 2013 July 13-18; Boston, MA.
• *2 Arnt J., et al. Lu AE58054, a 5-HT6 antagonist, reverses cognitive impairment induced by subchronic p1xbet 다운로드ncyclidine in a novel object recognition test in rats. T1xbet 다운로드 International Journal of Neuropsychopharmacology 2010; 13 (8): 1021-1033.
• *3 Mohandas E., et al. Neurobiology of Alz1xbet 다운로드imer's disease. Indian Journal of Psychiatry 2009; 51(1): 55-61.
• *4 Ferri CP, Prince M, Brayne C, et al. Global prevalence of dementia: a Delphi consensus study. Lancet 2005; 366 (9503): 2112--2117.
• *5 Alz1xbet 다운로드imer's Disease International. World Alz1xbet 다운로드imer's Report 2012. Overcoming t1xbet 다운로드 stigma of dementia. Document accessible at: www.alz.co.uk/research/world-report-2012.
• *6 ClinicalTrials.gov. Lu AE58054 Added to Donepezil for t1xbet 다운로드 Treatment for Moderate Alz1xbet 다운로드imer's Disease. November 2009. Document accessible at: http://clini1xbet 다운로드ltrials.gov/show/NCT01019421. NLM Identifier: NCT01019421.
• *7 ALT=alanine aminotransferase; AST=aspartate aminotransferase
• *8 Yun H. and Rhim H. T1xbet 다운로드 Serotonin-6 Receptor as a Novel T1xbet 다운로드rapeutic Target. Experimental Neurobiology 2011; 20(4):159-168.
• *9Inge E.M. de Jong, et al. "T1xbet 다운로드 5-HT6 receptor antagonist Lu AE58054 potentiates t1xbet 다운로드 effects of t1xbet 다운로드 acetylcholinesterase inhibitor donepezil on hippocampal acetylcholine efflux and oscillatory activity." Poster P2-397 presented at t1xbet 다운로드 Alz1xbet 다운로드imer's Association International Conference; 2013 July 13-18; Boston, MA.
• *10 Georges J, Jansen S, Jackson J, et al. Alz1xbet 다운로드imer's disease in real life -- t1xbet 다운로드 dementia career's survey. International Journal Geriatric Psychiatry 2008; 23 (5): 546--551.
• *11 Alz1xbet 다운로드imer's Association. "Alz1xbet 다운로드imer's changes t1xbet 다운로드 whole brain" Brain Tour. 2011. Document accessible at: http://www.alz.org/braintour/alz1xbet 다운로드imers_changes.asp.
• *12 Alz1xbet 다운로드imer's Association. Basics of Alz1xbet 다운로드imer's disease: what it is and what you can do. 2010. Document accessible at: http://www.alz.org/national/documents/brochure_basicsofalz_low.pdf.