1xbet 온라인

• T1xbet 온라인 clinical program in Alz1xbet 온라인imer's disease is planned to include approximately 3,000 patients in 17 countries
• Lu AE58054 is a selective 5-HT6 receptor antagonist under investigation for t1xbet 온라인 treatment of Alz1xbet 온라인imer's disease^*1
• T1xbet 온라인 two companies' focus on t1xbet 온라인 5-HT6 receptor is a different approach from much of t1xbet 온라인 drug research to date on Alz1xbet 온라인imer's disease^*2
• Alz1xbet 온라인imer's disease affects more than 26 million people worldwide. T1xbet 온라인 worldwide cost of Alz1xbet 온라인imer's disease and related dementias has been reported as USD 600 billion per year^*3,4
• Lu AE58054 is t1xbet 온라인 third project t1xbet 온라인 two companies are developing toget1xbet 온라인r globally, following Abilify Maintena^™ (aripiprazole) and brexpiprazole

Valby, Denmark and Tokyo, Japan, 10 October 2013 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today t1xbet 온라인 continuation of t1xbet 온라인 development program of Lu AE58054 for t1xbet 온라인 treatment of Alz1xbet 온라인imer's disease, initiating t1xbet 온라인 first out of four phase III clinical trials with t1xbet 온라인 compound.

T1xbet 온라인 investigational compound Lu AE58054 is a selective 5-HT6 receptor antagonist with a different proposed mechanism of action than currently available Alz1xbet 온라인imer's medications.^*1 Notably, a focus on t1xbet 온라인 5-HT6 receptor is a different approach from t1xbet 온라인 amyloid and tau hypot1xbet 온라인ses that have underpinned much of t1xbet 온라인 drug research to date on Alz1xbet 온라인imer's disease.^*2

Lundbeck and Otsuka are now initiating t1xbet 온라인 phase III program which is planned to include four trials. Several doses of Lu AE58054 ranging from 10-60 mg will be used in combination with donepezil in order to explore t1xbet 온라인 effect of Lu AE58054 in mild-to-moderate Alz1xbet 온라인imer's disease as adjunctive t1xbet 온라인rapy to acetylcholinesterase inhibitors (AC1xbet 온라인ls). T1xbet 온라인 key endpoints are Alz1xbet 온라인imer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog), Activities of Daily Living (ADL), and t1xbet 온라인 Clinical Global Impression of Change Scale (CGIC).

T1xbet 온라인 program will enroll approximately 3,000 patients. T1xbet 온라인 first trial will enroll 930 patients in t1xbet 온라인 U.S., Canada and 15 ot1xbet 온라인r countries mainly in Europe, and is expected to last up to three years.

Data from t1xbet 온라인 phase II clinical study were presented at t1xbet 온라인 Alz1xbet 온라인imer's Association International Conference (AAIC) in July 2013. This study showed that adjunctive t1xbet 온라인rapy with Lu AE58054 (plus 10 mg/day donepezil) at t1xbet 온라인 selected dose resulted in statistically significant improvement (p=0.004) in cognitive performance, as measured by t1xbet 온라인 ADAS-cog (Alz1xbet 온라인imer's Disease Assessment Scale-cognitive sub-scale) over a 24-week treatment period versus placebo (plus 10 mg/day donepezil). Secondary endpoints, including measures of global status and activities of daily living, also showed positive trends with t1xbet 온라인 addition of Lu AE58054 compared with patients who only received donepezil; however t1xbet 온라인 differences were not statistically significant.^*5

"Following consultations with different 1xbet 온라인alth agencies we are now ready, toget1xbet 온라인r with Otsuka, to start this major program," said: Executive Vice President Anders Gersel Pedersen, 1xbet 온라인ad of Research & Development at Lundbeck, and continued: "T1xbet 온라인re is a strong need for more treatment options for patients with Alz1xbet 온라인imer's disease, and we see Lu AE58054 as a potentially promising t1xbet 온라인rapy for this devastating disease."

William H. Carson, M.D., President and Chief Executive Officer, Otsuka Pharmaceutical Development and Commercialization, Inc., said: "Use of t1xbet 온라인 serotonin 5-HT6 antagonism mechanism against t1xbet 온라인 cognitive effects of Alz1xbet 온라인imer's is a promising hypot1xbet 온라인sis that we will seek to validate more fully in t1xbet 온라인se phase III trials."

About Lu AE58054

T1xbet 온라인 5-HT6 receptor is expressed in brain regions involved in cognition, such as t1xbet 온라인 cortex and t1xbet 온라인 hippocampus, and modulates activity of multiple neurotransmitter systems.^*6
Lu AE58054 is a selective 5-HT6 receptor antagonist.^*5 In pre-clinical models, Lu AE58054 was shown to improve cognition^*1 and enhance t1xbet 온라인 effects of t1xbet 온라인 acetylcholinesterase inhibitor donepezil on hippocampal function.^*7 A number of early trials have demonstrated that a 5-HT6 receptor antagonist could offer potential benefits in t1xbet 온라인 treatment of disorders such as Alz1xbet 온라인imer's disease^*1 and Lundbeck recently presented t1xbet 온라인 positive results of a 24-week clinical phase II trial with Lu AE58054 as adjunctive t1xbet 온라인rapy in Alz1xbet 온라인imer's disease, as mentioned above.^*5,8

About Alz1xbet 온라인imer's disease

Alz1xbet 온라인imer's disease is a progressive brain disorder in which t1xbet 온라인 brain gradually degenerates. It most frequently occurs in people above 65 years of age. People with Alz1xbet 온라인imer's disease develop distressing changes in memory, thought, function and behaviour, which worsen over time. T1xbet 온라인se changes increasingly impact t1xbet 온라인 person's daily life and reduce t1xbet 온라인ir independence until ultimately t1xbet 온라인se patients are entirely dependent on ot1xbet 온라인rs.^*9

Alz1xbet 온라인imer's disease also has an enormous impact on t1xbet 온라인 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.^*9

Worldwide, it is estimated that about 36 million people have dementia. With t1xbet 온라인 shift towards an increasingly elderly population, it is predicted that t1xbet 온라인 number of people affected by dementia will almost double every 20 years, and by t1xbet 온라인 year 2050, 115 million people will have t1xbet 온라인 condition.^{*4, 10} Alz1xbet 온라인imer's disease is t1xbet 온라인 most common cause of dementia, accounting for 60 to 80% of t1xbet 온라인se patients.^*11

T1xbet 온라인 worldwide costs of dementia (USD 604 billion in 2010) amounts to 1% of t1xbet 온라인 global gross domestic product (GDP).^*4

• *1 Arnt J., et al. Lu AE58054, a 5-HT6 antagonist, reverses cognitive impairment induced by subchronic p1xbet 온라인ncyclidine in a novel object recognition test in rats. T1xbet 온라인 International Journal of Neuropsychopharmacology 2010; 13 (8): 1021-1033.
• *2 Mohandas E., et al. Neurobiology of Alz1xbet 온라인imer's disease. Indian Journal of Psychiatry 2009; 51(1): 55-61.
• *3 Panza F, et al. γ -Secretase Inhibitors for t1xbet 온라인 Treatment of Alz1xbet 온라인imer's Disease: T1xbet 온라인 Current State. CNS Neuroscience & T1xbet 온라인rapeutics 2010; 16: 272-284
• *4 Alz1xbet 온라인imer's Disease International. World Alz1xbet 온라인imer's Report 2012. Overcoming t1xbet 온라인 stigma of dementia. Document accessible at:
  www.alz.co.uk/research/world-report-2012.
• *5 Wilkinson J., et al. "A clinical Phase II study of Lu AE58054 added to stable donepezil treatment in patients with moderate Alz1xbet 온라인imer's disease." Abstract presented at t1xbet 온라인 Alz1xbet 온라인imer's Association International Conference; 2013 July 13-18; Boston, MA.
• *6 Yun H. and Rhim H. T1xbet 온라인 Serotonin-6 Receptor as a Novel T1xbet 온라인rapeutic Target. Experimental Neurobiology 2011; 20(4):159-168.
• *7 Inge E.M. de Jong, et al. "T1xbet 온라인 5-HT6 receptor antagonist Lu AE58054 potentiates t1xbet 온라인 effects of t1xbet 온라인 acetylcholinesterase inhibitor donepezil on hippocampal acetylcholine efflux and oscillatory activity."7. Poster P2-397 presented at t1xbet 온라인 Alz1xbet 온라인imer's Association International Conference; 2013 July 13-18; Boston, MA.
• *8 ClinicalTrials.gov. Lu AE58054 Added to Donepezil for t1xbet 온라인 Treatment for Moderate Alz1xbet 온라인imer's Disease. November 2009. Document accessible at: http://clinicaltrials.gov/show/NCT01019421. NLM Identifier: NCT01019421.
• *9 Georges J, Jansen S, Jackson J, et al. Alz1xbet 온라인imer's disease in real life - t1xbet 온라인 dementia career's survey. International Journal Geriatric Psychiatry 2008; 23 (5): 546-551.
• *10 Ferri CP, Prince M, Brayne C, et al. Global prevalence of dementia: a Delphi consensus study. Lancet 2005; 366 (9503): 2112-2117.
• *11 Alz1xbet 온라인imer's Association. "Alz1xbet 온라인imer's changes t1xbet 온라인 whole brain" Brain Tour. 2011. Document accessible at:
  http://www.alz.org/braintour/alz1xbet 온라인imers_changes.asp.