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The Chair reminded members of the history of the appraisal. Dr Alec Miners then gave a presentation on the additional information which had been submitted by the manufacturer and its impact on the cost effectiveness of memantine for the treatment of moderately-severe to severe Alzheimer's disease, in each of the scenarios for which the additional data had been requested.
ApEn 1, 20% ; provides a scale- and model-independent regularity statistic to quantitate the orderliness of serial measurements 25 ; . Higher ApEn denotes greater relative randomness or disorderliness of subpatterns. Mathematical models and clinical experiments establish that increased irregularity predicts altered feedforward and or feedback cou.
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Figure 2. Treatment with memantine compared with no treatment was associated with a reduction in costs to.
As used below in the present specification and claims memantine will be deemed to encompass both the free base and pharmaceutically acceptable salts thereof.
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In fact, current guidelines for use of memantine in the treatment of alzheimer's disease recommend that memantine be administered as a starting dose of 5 mg day and escalated to the 20 mg day dose by weekly increases in the dose by 5 mg.
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| Memantine benefits1-40 ; . Brain Res 2002; 958 1 ; : 210-21. 52. Livingston G, Katona C. The place of memantine in the treatment of Alzheimer's disease: a number needed to treat analysis. Int J Geriatr Psychiatry 2004; 19 10 ; : 919-25. 53. Hynd MR, Scott HL, Dodd PR. Glutamate-mediated excitotoxicity and neurodegeneration in Alzheimer's disease. Neurochem Int 2004; 45 5 ; : 583-95. 54. Reisberg B, Doody R, Stffler A, Schmitt F, Ferris S, Mbius HJ; Memantine Study Group. Memantine in moderate-to-severe Alzheimer's disease. N Engl J Med 2003; 348 14 ; : 1333-41. 55. Sano M, Ernesto C, Thomas RG, et al. A controlled trial of selegiline, alpha-tocopherol, or both as treatment for Alzheimer's disease. The Alzheimer's Disease Cooperative Study. N Engl J Med 1997; 336 17 ; : 1216-22. 56. Cummings JL, Frank JC, Cherry D, et al. Guidelines for managing Alzheimer's Disease, part II: treatment. Fam Physician 2002; 65 12 ; : 2525-34. 57. Sultzer D, Cummings JL. Alzheimer's disease. In: Rakel RE, Conn HF, eds. Current therapy, 1993: Latest approved methods of treatment for the practicing physician. Philadelphia: Saunders; 1993: 838-40. 58. Finkel SI. Managing the behavioral and psychological signs and symptoms of dementia. Int Clin Psychopharmacol 1997; 12 supplement 4 ; : S25-S28. 59. Mintzer JE. Underlying mechanisms of psychosis and aggression in patients with Alzheimer's disease. J Clin Psychiatry 2001; 62 supplement 21 ; : 23-5. 60. Wirshing DA, Spellberg BJ, Erhart SM, Marder SR, Wirshing WC. Novel antipsychotics and new onset diabetes. Biol Psychiatry 1998; 44 8 ; : 778-83. 61. Wirshing WC. Movement disorders associated with neuroleptic treatment. J Clin Psychiatry 2001; 62 supplement 21 ; : 15-8. 62. Chan WC, Lam LC, Choy CN, Leung VP, Li SW, Chiu HF. A double-blind randomized comparison of risperidone and haloperidol in the treatment of behavioural and psychological symptoms in Chinese dementia patients. Int J Geriatr Psychiatry 2001; 16 12 ; : 1156-62. 63. Johannessen CU. Mechanisms of action of valproate: a commentary. Neurochem Int 2000; 37 2-3 ; : 103-10. 64. Muller-Oerlinghausen B, Retzow A, Henn FA, Giedke H, Walden J. Valproate as an adjunct to neuroleptic medication for the treatment of acute episodes of mania: a prospective, randomized, double-blind placebo-controlled, multicenter study. European Valproate Mania Study. J Clin Psychopharmacol 2000; 20 2 ; : 195-203. 65. Bowden CL, Calabrese JR, McElroy SL, et al. A randomized, placebo-controlled 12-month trial of divalproex and lithium in treatment of outpatients with bipolar I disorder. Divalproex Maintenance Study Group. Arch Gen Psychiatry 2000; 57 5 ; : 481-9. 66. Post RM, Weiss SRB, Chuang DM, Ketter TA. Mechanisms of action of carbamazepine in seizure and affective disorders. In: Joffe RT, Calabrese JR, eds. Anticonvulsants in mood disorders. New York: M. Dekker; 1994: 43-92. 67. Schneider LS, Tariot PN, Lyketsos CG, et al. National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness CATIE ; : Alzheimer disease trial methodology. J Geriatr Psychiatry 2001; 9 4 ; : 346-60. 68. Lebowitz BD, Pearson JL, Schneider LS, et al. Diagnosis and treatment of depression in late life: consensus statement update. JAMA 1997; 278 14 ; : 1186-90. 69. Physicians' desk reference. 59th ed. Oradell, N.J.: Medical Economics; 2005. 70. McEvoy GK. AHFS drug information 2005. Bethesda, Md.: American Society of Health-System Pharmacists; 2005. 71. Friedlander AH, Marder SR. The psychopathology, medical management and dental implications of schizophrenia. JADA 2002; 133 5 ; : 603-10. 72. Arai K, Sumi Y, Uematsu H, Miura H. Association between dental health behaviors, mental physical function and self-feeding ability among the elderly: a cross-sectional survey. Gerodontology 2003; 20 2 ; : 78-83. 73. Ship JA, DeCarli C, Friedland RP, Baum BJ. Diminished submandibular salivary flow in dementia of the Alzheimer type. J Gerontol 1990; 45 2 ; : M61-6. 74. Ship JA, Puckett SA. Longitudinal study on oral health in subjects with Alzheimer's disease. J Geriatr Soc 1994; 42 1 ; : 57-63. 75. Chiappelli F, Bauer J, Spackman S, et al. Dental needs of the elderly in the 21st century. Gen Dent 2002; 50 4 ; : 358-63. 76. Ship JA. Oral health of patients with Alzheimer's disease. JADA 1992; 123 1 ; : 53-8. 77. Jones JA, Lavallee N, Alman J, Sinclair C, Garcia RI. Caries inci and meprobamate.
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Given that memantine has been introduced for patients with moderately severe to severe AD, it presents as an additional prescribing cost to the NHS, at a price of 900 per year from March 2005 ; for the 20-mg daily dosage as used in the two included RCTs ; . Following from earlier NICE guidance and predicting that around 15, 000 patients per year may be treated with memantine, there could be an additional prescribing cost in the region of 14 million per year, where memantine was prescribed for moderately severe to severe AD, although it might take a number of years before prescription of this product reached such a large patient group. Where the potential patient group was predicted to be smaller, with a limited uptake from physicians, at around 5000 patients per year, additional prescribing costs would be in the region of 5 million per year. The industry submission Lundbeck ; to NICE for memantine predicts a potential treatment group of 23, 448 moderately severe to severe AD patients, with a mean treatment period of around 6 months, calculating a prescribing cost for memantine at approximately 10.9 million per year with this level of prescribing not being reached until year 2, following a positive recommendation guidance from NICE ; . In addition to the prescription cost for products discussed, there will also be an additional cost burden on the NHS related to additional monitoring of patients while on treatment. It is suggested that this resource use may be limited to two additional outpatient appointments per year while on treatment, approximately 216 per year per patient treated. Any potential cost savings, due to possible delays in institutionalisation, are likely to be felt by the PSS sector rather than the NHS!
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A fifth drug, memantine namenda ; , was recently approved for use in the united states.
Modality Precontrast T1-weighted and T2-weighted MR imaging Combined pre- and postcontrast MR imaging Postcontrast MR imaging Helical CT Precontrast T1-weighted MR imaging Postcontrast T1-weighted MR imaging Note.--Numbers in parentheses are percentages and meropenem.
Finding preventive strategies will require better ways to detect the earliest Alzheimer's brain changes and to gauge treatment effectiveness. The effort to address these issues took a huge leap forward in October when the National The year 2004 opened on a hopeful note in the quest for more treatment options with the January availability of the newly approved Alzheimer's drug memantine Namenda ; . Although memantine is not known to stop the underlying death of nerve cells in the Alzheimer's brain, it is.
Memantine plasma concentrations can be determined using hplc coupled to mass spectrometric detection as described in periclou et al, annals of pharmacotherapy 89-94 2004 and mesna.
Mental capacity, causes difficulty in concentrating, decline in performance, and decreased or lack of motivation. Studies show marijuana adversely affects the brain, reproduction process, immune system, respiratory system, cardiovascular system, and remains in the body for extended periods of time because it is fat-soluble. In addition, marijuana use often impairs normal thought process, distorts reality, reduces selfcontrol, and releases inhibitions. Some of the release in inhibitions results in criminal activity. There is proof that marijuana increases harmful and criminal behavior on the part of the user. Many times, the user is unaware he or she is being affected unless otherwise told by others. Scientific research reveals marijuana use does result in health consequences that not only affect the users themselves, but also research reveals that there is profound health consequences on those yet born. Furthermore, marijuana use leads to chronic and interim effects from regular use, specifically with regards to decreased testosterone, reduced sperm count and motility, altered sperm structure with chromosomal and DNA alterations ; , interference with ovulation and the hormone cycle in women, suspected mutagenic alterations in DNA of germ cell chromosomes, and embryocidal toxicity and development impairment in the fetus and newborn exposed in utero or in milk supply of newborns C. Sprague, "Marijuana Update for Concerned Parents, Physicians, Youth and Citizens of Hawaii, " 44 Haw. Med. J. 24 1985 and memantine.
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We believe that the pooled analysis should use the results of both the two memantine monotherapy RCTs and the memantine plus donepezil RCT. Although donepezil is not licensed for the severe stages of Alzheimer's, it is licensed for the moderate stage and we know of a number of people with dementia who have benefited from taking the two drug treatments. The evidence suggests this may be the best treatment option. In addition, it is harder to demonstrate benefit from memantine in patients who are already stabilised on donepezil, so the positive results from this trial should be given more weighting. A carer told us: `My husband has early onset Alzheimer's which was diagnosed over three years ago and was prescribed Aricept with amazing results and then for the last year has, in addition, been prescribed Ebixa which, until very recently, enabled him to continue at work.' As demonstrated by the quote above, for some people memantine brings a considerably improvement. However, even the small changes it can bring for others are very important in the later stages of Alzheimer's. We highlighted these in our original submission, but feel it is important to reiterate them to ensure their importance is not lost: Memantine may help the person retain the ability to speak a few words. This could mean that they are able to ask to go to the toilet or say when they are hungry or thirsty, helping to avoid dehydration or malnutrition. Retaining some mobility may mean that hoists and the distress they cause are avoided. It can also mean that the person is less likely to get pressure sores. If the person with dementia is able to feed themselves, they are less likely to suffer from dehydration or malnutrition. This is particularly likely when they are in hospital or in a care home, where care staff may not be aware that they are not eating or drinking adequate amounts. An important benefit of memantine is enabling people to maintain key skills that may delay moves to more specialised care or may enable them to remain at home. The Alzheimer's Society believes that a key consideration of clinicians considering prescribing memantine should be whether it may enable a person to maintain key skills therefore delaying a move from the home or to more specialist care. Treatment with memantine should continue if there are no severe adverse effects or significant deterioration and a positive benefit is shown. 3.2 Memantine is particularly effective for behavioural symptoms and metamucil.
Payment of , 052, 448 from Merz Pharmaceuticals GmbH Merz ; for sales of Memantine for the treatment of moderate-to-severe Alzheimer's disease in the quarter ended Q1 05; pursuant to its strategic research and marketing cooperation agreement with Merz, on sales of Memantine by Merz and its marketing partners, Forest Laboratories, Inc. and H. Lundbeck A S. We project that NTII could receive approximately m in royalty revenue for the 2006 fiscal year. The costs of the ViprinexTM phase III trials are projected to be million. NTII has a to million dollar shortage of cash to fund this gap. A strategic alliance of XERECEPT could fund this gap. Management sounded quite confident that they could raise the money necessary to fund the clinical trials for ViprinexTM and meperidine.
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JPET#122036 Hz p 0.001 paired t-test, n 21; Fig. 2A, D ; and in 12 cells it transformed their typical tonic firing into rhythmic bursts of action potentials Fig. 2B ; . In order to examine whether this effect of memantine could be due to reduction of tonic NMDA receptors stimulation within the neuronal circuitry, we repeated the same experiments in the presence of MK-801 10 M ; or AP5 50 M ; , however, both these NMDA receptor antagonists did not mimic nor prevent the effects of memantine 100 M ; on dopamine neurons firing Fig. 2C, D ; . Memantine has also been reported to act as an antagonist of 5-HT3 and 7-containing nicotinic receptors Reiser at al., 1988; Rammes et al., 2001; Maskell et al., 2003; Aracava et al., 2005 ; , however, in the presence of the 5-HT3 receptor antagonist.
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