Long-term donepezil treatment in 565 patients with Alzheimer's disease (AD2000): Randomised double-blind trial

Lancet

Volumn 363, Issue 9427, 2004, Pages 2105-2115

  Courtney, C ^a   Farrell, D ^a   Gray, R ^a   Hills, R ^a   Lynch, L ^a   Sellwood, E ^a   Edwards, S ^b   Hardyman, W ^a   Raftery, J ^a   Crome, P ^c,o   Lendon, C ^a   Shaw, H ^d   Bentham, P ^e   Patel, A ^e   Reed, M ^e   Wright, J ^e   Khaw, K T ^f   Peto, R ^g   Warlow, C ^h   Coates, J ^a   Craddock, N ^a   Harris, J ^a   Pritchard, A ^a   Sahakian, B ^f   Fitzpatrick, R ⁱ   Melzer, D ^j   Woods, K ^k   Richards, R ^l   Ballard, C ^m   Lilford, R ^d   Stein, K ⁿ   Williams, A ^p   Lockwood, N ^q   Chambers, C ^r   White, J ^r   Curnyn, E ^s   Hingley, T ^s   Lyons, J ^s   Rudman, S ^t   Scott, D ^t   Walker, M ^t   Goh, S ^b   Krishnan, R ^b   Ram, M ^b   Dadds, K ^u   Baker, S ^v   Ballantyne, S ^v   Clegg, S ^v   Ehtisham, M ^v   Kendall, H ^v   Ritch, S ^v   Simons, M ^v   Sturman, S ^v   Billingham, L ^w   Madeley, P ^b   Mallick, H ^b   Swe, T ^b   Yahia, A ^b   Haworth, J ^x   ElGohary, T ^b   Davies, R ^b   Ellis, M ^y   Headen, A ^y   Hill, P ^y   Colgate, R ^z   Cope, N ^z   Kinsella, A ^z   Thomas, T ^z   Bryan, S ^a   Yao, G ^a   Bufton, C ^aa   Dalziel, J ^aa   Godbert, K ^aa   Jones, D ^aa   Jones, S ^aa   May, K ^aa   Spillane, J ^aa   Staples, V ^aa   Wagner, N ^aa   Overstall, P ^ab   Brown, B ^ac   Rayner, I ^ac   Sandifer, Q ^ad   Bingham, A ^ae   Lewis, J ^ae   Pathirana, C ^ae   Walton, J ^ae   Dhariwal, A ^af   Fletcher, M ^af   Mohan, R ^af   Samarasinghe, L ^af   Whan Kan, C ^af   Nalpass, A ^ag   Boden, J ^ah   Bassi, S ^ai   Bland, J ^ai   Hofmans, E ^ai   Lidder, J ^ai   Santharam, G ^ai   Solanki, R ^ai   Stones, S ^ai   Battin, D ^aj   Leung, K ^o   Austin, A ^ak   Shaw, S ^ak,ao   Simpson, H ^ak   Dyer, M ^al   Wychrij, O ^al   Gray, M ^am   Madhu, A ^am   Terry, J ^am   Brown, L ^an   Butler, J ^ao   Green, K ^ao   Roberts, N ^ao   Singh, I ^ao   Thatcher, G ^ao   Waghray, S ^ao   Campbell, A ^ap   Deeks, J ^ap   Kingscote Davies, T ^aq   Sneddon, F ^aq   Sharpe, K ^ar   Stoakley, A ^ar   Wears, R ^ar   Crofts, F ^as   Grewal, G ^as   Acey, G ^at   Callaghan, A ^at   Chambers, S ^at   Deane, A ^at   Anand, S ^au   Elsmore, J ^au   Khan, M ^au   Stokes, G ^au   Dysch, L ^av   Forrester, L ^av   Job, D ^av   Somerville, J ^av   Surawy, I ^av   Challenger, J ^aw   Collier, P ^aw   Everett, S ^aw   Mansell, D ^aw   Rule, J ^aw   Evans, J ^ax   Morgan, V ^ax   Reese, J ^ax   Thomas, D ^ax   Williams, D ^ax   Leggett, S ^ay   Martin, P ^ay   Shaw, M ^ay   Tarry, J ^al   more..

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^b Research and Innovation   (United Kingdom)

^c KEELE UNIVERSITY SCHOOL OF MEDICINE   (United Kingdom)

^d NHS Executive West Midlands   (United Kingdom)

^e QUEEN ELIZABETH PSYCHIATRIC HOSPITAL   (United Kingdom)

^f ADDENBROOKE S HOSPITAL   (United Kingdom)

^g RADCLIFFE INFIRMARY   (United Kingdom)

^h WESTERN GENERAL HOSPITAL   (United Kingdom)

ⁱ UNIVERSITY OF OXFORD   (United Kingdom)

^j UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^k LEICESTER ROYAL INFIRMARY   (United Kingdom)

^l Newark and Sherwood NHS Trust   (United Kingdom)

^m NEWCASTLE GENERAL HOSPITAL   (United Kingdom)

ⁿ PENINSULA MEDICAL SCHOOL   (United Kingdom)

^o UNIVERSITY HOSPITAL OF NORTH STAFFORDSHIRE   (United Kingdom)

^p QUEEN ELIZABETH HOSPITAL   (United Kingdom)

^q Sandwell Health Authority   (United Kingdom)

^r Bassetlaw District General Hospital   (United Kingdom)

^s BIRMINGHAM HEARTLANDS HOSPITAL   (United Kingdom)

^t Bloxwich Hospital   (United Kingdom)

^u Cefn Coed Hospital   (United Kingdom)

^v CITY HOSPITAL   (United Kingdom)

^w UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^x Department of Public Health   (United Kingdom)

^y Garngoch Hospital   (United Kingdom)

^z Glanrhyd Hospital   (United Kingdom)

^aa HEREFORD COUNTY HOSPITAL   (United Kingdom)

^ab WYE VALLEY NHS TRUST   (United Kingdom)

^ac Highcroft Hospital   (United Kingdom)

^ad Department of Public Health Medicine   (United Kingdom)

^ae Kidderminster General Hospital   (United Kingdom)

^af Little Bromwich Centre   (United Kingdom)

^ag Lucy Baldwin Unit   (United Kingdom)

^ah UK yvonne digestiblenutritioncouk   (United Kingdom)

^ai Millbrook Mental Health Unit   (United Kingdom)

^aj Newtown Hospital   (United Kingdom)

^ak Oaklands Assessment Day Centre   (United Kingdom)

^al WORCESTERSHIRE HEALTH AND CARE NHS TRUST   (United Kingdom)

^am PRINCESS OF WALES HOSPITAL   (United Kingdom)

^an QUEEN S HOSPITAL   (United Kingdom)

^ao Queen's Park Hospital   (United Kingdom)

^ap RUSSELLS HALL HOSPITAL   (United Kingdom)

^aq SANDWELL GENERAL HOSPITAL   (United Kingdom)

^ar SOLIHULL HOSPITAL   (United Kingdom)

^as Solihull Mental Health Service   (United Kingdom)

^at St Chad s House   (United Kingdom)

^au St Michael s Hospital   (United Kingdom)

^av CITY GENERAL HOSPITAL   (United Kingdom)

^aw Tonna Hospital   (United Kingdom)

^ax Westfa Day Hospital   (United Kingdom)

^ay WORCESTERSHIRE ROYAL HOSPITAL   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DONEPEZIL;

ADULT; AGED; ALZHEIMER DISEASE; ARTICLE; CLINICAL FEATURE; CLINICAL TRIAL; COGNITION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; DAILY LIFE ACTIVITY; DEATH; DOUBLE BLIND PROCEDURE; DRUG DETERMINATION; HUMAN; INSTITUTIONAL CARE; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MEDICAL ASSESSMENT; MENTAL HEALTH; OUTCOMES RESEARCH; PRIORITY JOURNAL; PSYCHOLOGICAL ASPECT; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RISK ASSESSMENT; SIDE EFFECT; STATISTICAL SIGNIFICANCE; TREATMENT OUTCOME;

EID: 3042567016     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(04)16499-4     Document Type: Article

References (46)

1. Melzer D, Pearce K, Cooper B, Brayne C. Alzheimer's disease and other dementias. In: Stevens A, Raftery J, Mant J, eds. Health care needs assessment: the epidemiologically based needs assessment reviews - 1st series update. Abingdon: Radcliffe Medical Press (in press). Available at http://hcna. radcliffe-oxford.com/dementiaframe.htm (accessed June 16, 2004).
2. The Audit Commission. Forget-me-not: mental health services for the older people. London: Audit Commission, 2000: 18.
3. Bartus RT, Dean RL, Beer B, Lippa AS. The cholinergic hypothesis of geriatric memory dysfunction. Science. 217:1982;408-417
4. Birks JS, Harvey R. Donepezil for dementia due to Alzheimer's disease (Cochrane Review). In: The Cochrane Library, issue 3. Oxford: Update Software, 2003.
5. Birks J, Grimley Evans J, Iakovidou V, Tsolaki M. Rivastigmine for Alzheimer's disease (Cochrane Review). In: The Cochrane Library, issue 3. Oxford: Update Software, 2003.
6. Olin J, Schneider L. Galantamine for Alzheimer's disease (Cochrane Review). The Cochrane Library. 2003;Update Software, issue 3. Oxford
7. 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 randomised trial. Lancet. 359:2002;1283-1290
8. McKeith I, Del Ser T, Spano P, et al. Efficacy of rivastigmine in dementia with Lewy bodies: a randomised double-blind, placebo controlled international study. Lancet. 356:2000;2031-2036
9. Rogers S, 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. 7:1996;293-303
10. Imbimbo BP. Pharmacodynamic-tolerability relationships of cholinesterase inhibitors for Alzheimer's disease. CNS Drugs. 15:2001;375-390
11. Hills R, Gray R, Stowe R, Bentham P. Drop-out bias undermines findings of improved functionality with cholinesterase inhibitors. Neurobiol Aging 2002; 23 (suppl 1): S89 (abstr 338).
12. Collins R, Peto R, Gray R, Parish S. Large-scale randomized evidence: trials and overviews, chapter 2.4. Weatherall D, Ledingham JGG, Warrell DA. Oxford textbook of medicine. 1996;21-32 Oxford University Press, vol 1. Oxford
13. Lavori PW. Clinical trials in psychiatry: should protocol deviation censor patient data? Neuropsychopharmacology. 6:1992;39-48
14. Mortimer JA, Ebbitt B, Jun SP, Finch MD. Predictors of cognitive and functional progression in patients with probable Alzheimer's disease. Neurology. 42:1992;1689-1696
15. Stein K. Donepezil in the treatment of mild to moderate Alzheimer's disease: South and West regional development and evaluation service, report no 69. Wessex Institute for Health Research and Development, 1997.
16. Anon. Donepezil for Alzheimer's disease? Drug Ther Bull 1997; 35: 75-76.
17. Clegg A, Bryant J, Nicholson T, et al. Clinical and cost-effectiveness of donepezil, rivastigmine and galantamine for Alzheimer's disease: a rapid and systematic review. Health Technol Assess. 5:2001;1-137
18. Fuller V. Alzheimer's lottery. Geriatr Med. 27:1997;9
19. National Institute for Clinical Excellence. Donepezil, rivastigmine and galantamine for the treatment of Alzheimer's disease. http://www.nice.org.uk/ article.asp?a=14487 (accessed April 26, 2004).
20. American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 4th edn. Washington: APA, 1994.
21. Neumann PJ, Hermann RC, Kuntz KM, et al. Cost-effectiveness of donepezil in the treatment of mild or moderate Alzheimer's disease. Neurology. 52:1999;1138-1145
22. Bucks RS, Ashworth DL, Wilcock GK, Siegfried K. Assessment of activities of daily living in dementia: development of the Bristol activities of daily living scale. Age Ageing. 25:1996;113-120
23. Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gombein J. The neuropsychiatric inventory: comprehensive assessment of psychopathology in dementia. Neurology. 44:1994;2308-2314
24. Folstein MF, Folstein SE, McHugh PR. "Mini-mental state": a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 12:1975;189-198
25. Goldberg DP, Williams P. A user's guide to general health questionnaire. 1988;NFER-Nelson, Windsor
26. Clipp EJ, Moore MC. Caregiver time use; an outcome measure in clinical trial research on Alzheimer's disease. Clin Pharmacol Ther. 58:1995;228-236
27. Davis KL, Marin DB, Kane R, et al. The caregiver activity survey (CAS): development and validation of a new measure for caregivers of persons with Alzheimer's disease. Int J Geriatr Psychiatry. 12:1997;978-988
28. Hu TW, Huang LF, Cartwright WS. Evaluation of the costs of caring for the senile demented elderly: a pilot study. Gerontologist. 26:1986;158-163
29. Netten A, Curtis L. Unit costs of health and social care: personal social services research unit. 2000;University of Kent, Canterbury
30. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomised clinical trials requiring prolonged observation of each patient: II - analysis and examples. Br J Cancer. 35:1977;1-39
31. Fleiss JL. The statistical basis of meta-analysis. Stat Methods Med Res. 2:1993;121-145
32. Jones B, Kenward MG. Design and analysis of cross-over trials. 1989;Chapman and Hall, London
33. Coucill W, Bentham P, Raftery J, Gray R. AD2000: is this a more clinically representative population? Age Ageing. 30:(suppl 1):2001;55
34. Rockwood K, MacKnight C. Assessing the clinical importance of statistically significant improvement in anti-dementia trials. Neuroepidemiology. 20:2001;51-56
35. Food and Drug Administration. Peripheral and central nervous system drugs advisory committee meeting, July 7, 1989. Rockville: Department of Health and Human Services, Public Health Service, Food and Drug Administration, 1989: 227.
36. Burback D, Molnar FJ, St John P, Man-Son-Hing M. Key methodological features of randomized controlled trials of Alzheimer disease therapy: minimal clinically important difference, sample size and trial design. Dement Geriatr Cogn Disord. 10:1999;534-540
37. Byrne LMT, Wilson PMA, Bucks RS, Hughes AO, Wilcock GK. The sensitivity of change over time of the Bristol activities of daily living scale in Alzheimer's disease. Int J Geriatr Psychiatry. 15:2000;656-661
38. Mega M, Masterman DM, O'Connor SM, Barclay TR, Cummings JL. The spectrum of behavioural responses to cholinesterase inhibitor therapy in Alzheimer disease. Arch Neurol. 56:1999;1388-1393
39. Kaufer D, Cummings JL, Christine D. Effect of tacrine on behavioural symptoms in Alzheimer disease: an open-label study. J Geriatr Psychiatry Neurol. 9:1996;1-6
40. Trinh N-H, Hoblyn J, Mohanty S, Yaffe K. Efficacy of cholinesterase inhibitors in the treatment of neuropsychiatric symptoms and functional impairment in Alzheimer disease: a meta-analysis. JAMA. 289:2003;210-216
41. Stewart A, Phillips R, Dempsey G. Pharmacotherapy for people with Alzheimer's disease: a Markov-cycle evaluation of five years' therapy using donepezil. Int J Geriatr Psych. 13:1997;445-453
42. Geldmacher DS, Provenzano G, McRae T, Mastey V, Ieni JR. Donepezil is associated with delayed nursing home placement in patients with Alzheimer's disease. J Am Geriatr Soc. 51:2003;937-944
43. Wimo A, Winblad B, Engedal K, et al. An economic evaluation of donepezil in mild to moderate Alzheimer's disease: results of a 1-year double-blind, randomized trial. Dement Geriatr Cogn Disord. 15:2003;44-54
44. International Conference on Harmonisation. Structure and content of clinical study reports, E3, 1995. Available at http://www.ich.org.
45. Rosenberg RN, Aminoff M, Boller F, et al. Reporting clinical trials: full access to all the data. Mov Disord. 17:2002;3-4
46. Bentham P, Gray R, Hills R, Sellwood E, Courtney C. Twelve-week response to cholinesterase inhibitors does not predict future benefit:the AD2000 trial experience. Neurobiol Aging 2002; 23 (suppl 1): S89 (abstr 337).