Alzheimer's & Dementia: The Journal of the Alzheimer's Association
Volume 6, Issue 1 , Pages 39-53 , January 2010

Disease progression meta-analysis model in Alzheimer's disease

References 

  1. Alzheimer's Association. 2009 Alzheimer's disease facts and figures. Alzheimers Dement. 2009;5:234–270
  2. Stern RG, Mohs RC, Davidson M, Schmeidler J, Silverman J, Kramer-Ginsberg E, et al. A longitudinal study of Alzheimer's disease: measurement, rate, and predictors of cognitive deterioration. Am J Psychiatry. 1994;151:390–396
  3. Doraiswamy PM, Kaiser L, Bieber F, Garman RL. The Alzheimer's disease assessment scale: evaluation of psychometric properties and patterns of cognitive decline in multicenter clinical trials of mild to moderate Alzheimer's disease. Alzheimer Dis Assoc Disord. 2001;15:174–183
  4. Holford NH, Peace KE. Methodologic aspects of a population pharmacodynamic model for cognitive effects in Alzheimer patients treated with tacrine. Proc Natl Acad Sci USA. 1992;89:11466–11470
  5. Holford NH, Peace KE. Results and validation of a population pharmacodynamic model for cognitive effects in Alzheimer patients treated with tacrine. Proc Natl Acad Sci USA. 1992;89:11471–11475
  6. Holford NH, Peace K. The effect of tacrine and lecithin in Alzheimer's disease. A population pharmacodynamic analysis of five clinical trials. Eur J Clin Pharmacol. 1994;47:17–23
  7. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF QUOROM Group. Improving the quality of reports of meta-analyses of randomized controlled trials: the QUOROM statement. Lancet. 1999;354:1896–1900
  8. Aupperle PM, Koumaras B, Chen M, Rabinowicz A, Mirski D. Long-term effects of rivastigmine treatment on neuropsychiatric and behavioral disturbances in nursing home residents with moderate to severe Alzheimer's disease: results of a 52-week open-label study. Curr Med Res Opin. 2004;20:1605–1612
  9. Lockwood P, Ewy W, Hermann D, Holford N. Application of clinical trial simulation to compare proof-of-concept study designs for drugs with a slow onset of effect: an example in Alzheimer's disease. Pharm Res. 2006;23:2050–2059
  10. Doraiswamy PM, Bieber F, Kaiser L, Krishnan KR, Reuning-Scherer J, Gulanski B. The Alzheimer's disease assessment scale: patterns and predictors of baseline cognitive performance in multicenter Alzheimer's disease trials. Neurology. 1997;48:1511–1517
  11. Beal SL, Sheiner LB, Boeckmann AJ, eds. NONMEM Users Guides. Ellicott City, MD: ICON Development Solutions; 1989–2006.
  12. Mandema JW, Verotta D, Sheiner LB. Building population pharmacokinetic-pharmacodynamic models. I. Models for covariate effects. J Pharmacokinet Biopharm. 1992;20:511–528
  13. Maitre PO, Bührer M, Thomson D, Stanski DR. A three-step approach combining Bayesian regression and NONMEM population analysis: application to midazolam. J Pharmacokinet Biopharm. 1991;19:377–384
  14. Ette EI, Ludden TM. Population pharmacokinetic modeling: the importance of informative graphics. Pharma Res. 1995;12:1845–1855
  15. Farlow M, Gracon SI, Hershey LA, Lewis KW, Sadowsky CH, Dolan UJ. A controlled trial of tacrine in Alzheimer's disease. JAMA. 1992;268:2523–2529
  16. Knapp MJ, Knopman DS, Solomon PR, Pendlebury WW, Davis CS, Gracon SI. A 30-week randomized controlled trial of high-dose tacrine in patients with Alzheimer's disease. JAMA. 1994;271:985–991
  17. Antuono PG. Effectiveness and safety of velnacrine for the treatment of Alzheimer's disease: a double-blind, placebo-controlled study. Arch Intern Med. 1995;155:1766–1772
  18. Rogers SL, Friedhoff LT. The efficacy and safety of donepezil in patients with Alzheimer's disease: results of a US multicentre, randomized, double-blind, placebo-controlled trial. Dementia. 1996;7:293–303
  19. Schneider LS, Farlow MR, Henderson VW, Pogoda JM. Effects of estrogen replacement therapy on response to tacrine in patients with Alzheimer's disease. Neurology. 1996;46:1580–1584
  20. Sano M, Ernesto C, Thomas RG, Klauber MR, Schafer K, Grundman M, 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;336:1216–1222
  21. Corey-Bloom J, Anand R, Veach J ENA 713 B352 Study Group. A randomized trial evaluating the efficacy and safety of ENA713 (rivastigmine tartrate), a new acetylcholinesterase inhibitor, in patients with mild to moderately severe Alzheimer's disease. Int J Geriatr Psychopharmacol. 1998;1:55–65
  22. Rogers SL, Doody RS, Mohs RC, Friedhoff LT. Donepezil improves cognition and global function in Alzheimer disease: a 15-week, double-blind, placebo-controlled study. Arch Intern Med. 1998;158:1021–1031
  23. Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT. A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Neurology. 1998;50:136–145
  24. Burns A, Rossor M, Hecker J, Gauthier S, Petit H, Moller HJ, et al. The effects of donepezil in Alzheimer's disease—results from a multinational trial. Dement Geriatr Cogn Disord. 1999;10:237–244
  25. Forette F, Anand R, Gharabawi G. A phase II study in patients with Alzheimer's disease to assess the preliminary efficacy and maximum tolerated dose of rivastigmine (Exelon). Eur J Neurol. 1999;6:423–429
  26. Rosler M, Anand R, Cicin-Sain A, Gauthier S, Agid Y, Dal-Bianco P, et al. Efficacy and safety of rivastigmine in patients with Alzheimer's disease: international randomized controlled trial. Br Med J [Clin Res]. 1999;318:633–638
  27. Aisen PS, Davis KL, Berg JD, Schafer K, Campbell K, Thomas RG, et al. A randomized controlled trial of prednisone in Alzheimer's disease. Neurology. 2000;54:588–593
  28. Greenberg SM, Tennis MK, Brown LB, Gomez-Isla T, Hayden DL, Schoenfeld DA, et al. Donepezil therapy in clinical practice: a randomized crossover study. Arch Neurol. 2000;57:94–99
  29. Homma A, Takeda M, Imai Y, Udaka F, Hasegawa K, Kameyama M, et al. Clinical efficacy and safety of donepezil on cognitive and global function in patients with Alzheimer's disease. A 24-week, multicenter, double-blind, placebo-controlled study in Japan. Dement Geriatr Cogn Disord. 2000;11:299–313
  30. Kumar V, Anand R, Messina J, Hartman R, Veach J. An efficacy and safety analysis of exelon in Alzheimer's disease patients with concurrent vascular risk factors. Eur J Neurol. 2000;7:159–169
  31. Raskind MA, Peskind ER, Wessel T, Yuan W. Galantamine in AD: a 6-month randomized, placebo-controlled trial with a 6-month extension. Neurology. 2000;54:2261–2268
  32. Tariot PN, Solomon PR, Morris JC, Kershaw P, Lilienfeld S, Ding CA. 5-month, randomized, placebo-controlled trial of galantamine in AD. Neurology. 2000;54:2269–2276
  33. Thal LJ, Calvani M, Amato A, Carta AA. 1-year controlled trial of acetyl-L-carnitine in early-onset AD. Neurology. 2000;55:805–810
  34. Wilcock GK, Lilienfeld S, Gaens E. Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomized controlled trial. Br Med J [Clin Res]. 2000;321:1445–1449
  35. Doody RS, Geldmacher DS, Gordon B, Perdomo CA, Pratt RD. Open-label, multicenter, phase 3 extension study of the safety and efficacy of donepezil in patients with Alzheimer disease. Arch Neurol. 2001;58:427–433
  36. Farlow MR, Hake A, Messina J, Hartman R, Veach J, Anand R. Response of patients with Alzheimer disease to rivastigmine treatment is predicted by the rate of disease progression. Arch Neurol. 2001;58:417–422
  37. Rockwood K, Mintzer J, Truyen L, Wessel T, Wilkinson D. Effects of a flexible galantamine dose in Alzheimer's disease: a randomized, controlled trial. J Neurol Neurosurg Psychiatry. 2001;71:589–595
  38. Van GWA, Weinstein HC, Scheltens P, Walstra GJ. Effect of hydroxychloroquine on progression of dementia in early Alzheimer's disease: an 18-month randomized, double-blind, placebo-controlled study. Lancet. 2001;358:455–460
  39. Wilkinson D, Murray J. Galantamine: a randomized, double-blind, dose comparison in patients with Alzheimer's disease. Int J Geriatr Psychiatry. 2001;16:852–857
  40. Erkinjuntti T, Kurz A, Gauthier S, Bullock R, Lilienfeld S, Damaraju CV. Efficacy of galantamine in probable vascular dementia and Alzheimer's disease combined with cerebrovascular disease: a randomized trial. Lancet. 2002;359:1283–1290
  41. Wilkinson DG, Passmore AP, Bullock R, Hopker SW, Smith R, Potocnik FC, et al. A multinational, randomized, 12-week, comparative study of donepezil and rivastigmine in patients with mild to moderate Alzheimer's disease. Int J Clin Pract. 2002;56:441–446
  42. Aisen PS, Schafer KA, Grundman M, Pfeiffer E, Sano M, Davis KL, et al. Effects of rofecoxib or naproxen vs. placebo on Alzheimer disease progression: a randomized controlled trial. JAMA. 2003;289:2819–2826
  43. Blesa R, Davidson M, Kurz A, Reichman W, van Baelen B, Schwalen S. Galantamine provides sustained benefits in patients with “advanced moderate” Alzheimer's disease for at least 12 months. Dement Geriatr Cogn Disord. 2003;15:79–87
  44. Krishnan KR, Charles HC, Doraiswamy PM, Mintzer J, Weisler R, Yu X, et al. Randomized, placebo-controlled trial of the effects of donepezil on neuronal markers and hippocampal volumes in Alzheimer's disease. Am J Psychiatry. 2003;160:2003–2011
  45. Tune L, Tiseo PJ, Ieni J, Perdomo C, Pratt RD, Votaw JR, et al. Donepezil HCL (E2020) maintains functional brain activity in patients with Alzheimer disease: results of a 24-week, double-blind, placebo-controlled study. Am J Geriatr Psychiatry. 2003;11:169–177
  46. Wilcock G, Howe I, Coles H, Lilienfeld S, Truyen L, Zhu Y, et al. A long-term comparison of galantamine and donepezil in the treatment of Alzheimer's disease. Drugs Aging. 2003;20:777–789
  47. Aguglia E, Onor ML, Saina M, Maso E. An open-label, comparative study of rivastigmine, donepezil and galantamine in a real-world setting. Curr Med Res Opin. 2004;20:1747–1752
  48. Jones RW, Soininen H, Hager K, Aarsland D, Passmore P, Murthy A, et al. A multinational, randomized, 12-week study comparing the effects of donepezil and galantamine in patients with mild to moderate Alzheimer's disease. Int J Geriatr Psychiatry. 2004;19:58–67
  49. Lyketsos CG, Reichman WE, Kershaw P, Zhu Y. Long-term outcomes of galantamine treatment in patients with Alzheimer disease. Am J Geriatr Psychiatry. 2004;12:473–482
  50. Raskind MA, Peskind ER, Truyen L, Kershaw P, Damaraju CV. The cognitive benefits of galantamine are sustained for at least 36 months: a long-term extension trial. Arch Neurol. 2004;61:252–256
  51. Reines SA, Block GA, Morris JC, Liu G, Nessly ML, Lines CR, et al. Rofecoxib: no effect on Alzheimer's disease in a 1-year, randomized, blinded, controlled study. Neurology. 2004;62:66–71
  52. Brodaty H, Corey-Bloom J, Potocnik FC, Truyen L, Gold M, Damaraju CR. Galantamine prolonged-release formulation in the treatment of mild to moderate Alzheimer's disease. Dement Geriatr Cogn Disord. 2005;20:120–132
  53. Feldman HH, Van BB, Kavanagh SM, Torfs KEL. Cognition, function, and caregiving time patterns in patients with mild-to-moderate Alzheimer disease: a 12-month analysis. Alzheimer Dis Assoc Disord. 2005;19:29–36
  54. Karaman YEF, Koseoglu E, Turan T, Ersoy AO. A 12-month study of the efficacy of rivastigmine in patients with advanced moderate Alzheimer's disease. Dement Geriatr Cogn Disord. 2005;19:51–56
  55. Liu HCCC, Ko SY, Wang HC, Hong CJ, Lin KN, Wang PN, et al. Cholinesterase inhibitor affects the amyloid precursor protein isoforms in patients with Alzheimer's disease. Dement Geriatr Cogn Disord. 2005;19:345–348
  56. Farlow MR, Small GW, Quarg P, Krause A. Efficacy of rivastigmine in Alzheimer's disease patients with rapid disease progression: results of a meta-analysis. Dement Geriatr Cogn Disord. 2005;20:192–197
  57. Petersen RC, Thomas RG, Grundman M, Bennett D, Doody R, Ferris S, et al. Vitamin E and donepezil for the treatment of mild cognitive impairment. N Engl J Med. 2005;352:2379–2388
  58. Visser PJ, Scheltens P, Pelgrim E, Verhey FR. Medial temporal lobe atrophy and ApoE genotype do not predict cognitive improvement upon treatment with rivastigmine in Alzheimer's disease patients. Dement Geriatr Cogn Disord. 2005;19:126–133
  59. Peskind ER, Potkin SG, Pomara N, Ott BR, Graham SM, Olin JT, et al. Memantine treatment in mild to moderate Alzheimer disease: a 24-week randomized, controlled trial. Am J Geriatr Psychiatry. 2006;14:704–715
  60. Rockwood K, Fay S, Song X, MacKnight C, Gorman M. Attainment of treatment goals by people with Alzheimer's disease receiving galantamine: a randomized controlled trial. Can Med Assoc J. 2006;174:1099–1105
  61. Suh GH, Jung HY, Lee CU, Oh BH, Lee SK, Lee N, et al. Effect of the apolipoprotein E epsilon4 allele on the efficacy and tolerability of galantamine in the treatment of Alzheimer's disease. Dement Geriatr Cogn Disord. 2006;21:33–39
  62. Thavichachart N, Phanthumchinda K, Chankrachang S, Praditsuwan R, Nidhinandana S, Senanarong V, et al. Efficacy study of galantamine in possible Alzheimer's disease with or without cerebrovascular disease and vascular dementia in Thai patients: a slow-titration regimen. Int J Clin Pract. 2006;60:533–540
  63. Chu LW, Yik PY, Mok W, Chung CP. A 2-year open-label study of galantamine therapy in Chinese Alzheimer's disease patients in Hong Kong. Int J Clin Pract. 2007;61:403–410
  64. Feldman HH, Lane R, Study G. Rivastigmine: a placebo controlled trial of twice daily and three times daily regimens in patients with Alzheimer's disease. J Neurol Neurosurg Psychiatry. 2007;78:1056–1063
  65. Wallin AK, Andreasen N, Eriksson S, Batsman S, Näsman B, Ekdahl A, et al. Donepezil in Alzheimer's disease: what to expect after 3 years of treatment in a routine clinical setting. Dement Geriatr Cogn Disord. 2007;23:150–160
  66. Winblad B, Cummings J, Andreasen N, Grossberg G, Onofrj M, Sadowsky C, et al. A six-month double-blind, randomized, placebo-controlled study of a transdermal patch in Alzheimer's disease—rivastigmine patch versus capsule. Int J Geriatr Psychiatry. 2007;22:456–467
  67. Aisen PS, Schneider LS, Sano M, Diaz-Arrastia R, Dyck CH, Weiner MF, et al. High-dose B vitamin supplementation and cognitive decline in Alzheimer disease. JAMA. 2008;300:1774–1783
  68. Rockwood K, Dai D, Mitnitski A. Patterns of decline and evidence of subgroups in patients with Alzheimer's disease taking galantamine for up to 48 months. Int J Geriatr Psychiatry. 2008;23:207–214
  69. Salloway S, Ferris S, Kluger A, Goldman R, Griesing T, Kumar D, et al. Efficacy of donepezil in mild cognitive impairment. Neurology. 2004;63:651–657
  70. Seltzer B, Zolnouni P, Nunes M, Goldman R, Kumar D, Ieni J, et al. Efficacy of donepezil in early-stage Alzheimer disease. Arch Neurol. 2004;61:1852–1856
  71. Winblad B, Gauthier S, Scinto L, Feldman H, Wilcock GK, Truyen L, et al. Safety and efficacy of galantamine in subjects with mild cognitive impairment. Neurology. 2008;70:2024–2035
  72. Feldman HH, Ferris S, Winblad B, Sfikas N, Mancione L, He Y, et al. Effect of rivastigmine on delay to diagnosis of Alzheimer's disease from mild cognitive impairment: the InDDEx Study. Lancet Neurol. 2007;6:501–512
  73. Corrigan B. ASCPT Workshop. Computer modeling and biosimulation in clinical pharmacology: specific application in Alzheimer's disease and aging population. Disease progression in Alzheimer's: an update. Workshop in Washington DC. Available at http://www.ascpt.org/annualmeeting2009/presentations/031909/ComputerModelingandSimulation.pdf
  74. Schneider LS, Dagerman K, Shaikh Z, Insel P. No secular trend and high variability for ADAS-cog change among placebo groups from clinical trials. Alzheimers Dement. 2008;4:T167
  75. Jones R, Schwam E, Wilkinson D, Waldemar G, Feldman H, Zhang R, et al. Variation in placebo decline across a decade of Alzheimer's disease trials. Alzheimers Dement. 2008;4:T334
  76. Lalonde RL, Kowalski KG, Hutmacher MM, Ewy W, Nichols DJ, Milligan PA, et al. Model-based drug development. Clin Pharmacol Ther. 2007;82:21–32
  77. Henning S, Nyberg J, Hooker AC, Karlsson MO. Trial treatment length optimization with an emphasis on disease progression studies. J Clin Pharmacol. 2009;49:323–335
  78. Gillespie WR, Rogers JA, Ito K, Gastonguay MR. Population dose-response model for ADAS-cog scores in patients with Alzheimer's disease by meta-analysis of a mixture of summary and individual data. Clin Pharmacol Ther. 2009;85(Suppl.):S62

PII: S1552-5260(09)02013-5

doi: 10.1016/j.jalz.2009.05.665

Alzheimer's & Dementia: The Journal of the Alzheimer's Association
Volume 6, Issue 1 , Pages 39-53 , January 2010