Donepezil (Aricept®) for treatment of Alzheimer´s disease and other dementing conditions

References

• Bachman DL, Wolf PA, Linn RT et al Incidence of dementia and probable Alzheimer's disease in a general population — the Framingham Study. Neurology43, 515–519 (1993).
   PubMed Web of Science ®Google Scholar
• White LR, Cartwright WS, Cornoni-Huntley J, Brock DB. Geriatric epidemiology. Ann. Rev. Cerontal CetiatE 6,215–311 (1986).
   PubMedGoogle Scholar
• Doody RS, Stevens JC, Beck C et al Practice parameter: management of dementia (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology56,1154–1166 (2001).
   PubMed Web of Science ®Google Scholar
• •Evidence-based review which concludes that despite modest benefits, acetylcholinesterase inhibitors (AChEls) should be considered standard of care in the treatment of mild-to-moderate Alzheimer's disease (AD).
   Google Scholar
• Folstein ME, Folstein SE, Mchugh PR. Mini-Mental State: a practical method of grading cognitive state of patients for the clinician. J. PsychiatE Res. 12,189-198 (1975).
   Google Scholar
• National Institute For Clinical Excellence (NICE). Guidance on the use of donepezil, rivastigmine and galantamine for the treatment of Alzheimer's disease. Technology Appraisal Guidance No. 19. National Institute for Clinical Excellence, London, UK (2001).
   Google Scholar
• Sugimoto H, Iimura Y, Yamanishi Y, Yamatsu K. Synthesis and structure-activity-relationships of acetylcholinesterase inhibitors - 1-benzy1-4-([5,6—dimethoxy-1—oxoindan-2—yll methyl)piperidine hydrochloride and related-compounds. J. Medicinal Chem. 38, 4821–4829 (1995).
   Google Scholar
• Kawakami Y, Inoue A, Kawai T, Wakita M, Sugimoto H, Hopfinger AJ. The rationale for E2020 as a potent acetylcholinesterase inhibitor. Bioorganic Med. Chem. 4, 1429–1446 (1996).
   Google Scholar
• •Excellent description of the rationale and process for developing donepezil, including the techniques used to enhance AChE specificity
   Google Scholar
• Matsui K, Oda Y, Ohe H, Tanaka S, Asakawa N. Direct determination of E2020 enantiomers in plasma by liquid chromatography-mass spectroscopy and column-switching techniques. Chromatography A. 695,209-218 (1995).
   Google Scholar
• Hulse JG, Rogers SL, Friedhoff LT, Sukovaty R, Pedersen JE, Lee JW. A radioenzyme assay of acetylcholinesterase activity in red blood cells and its correlation with 1-benzy1-4-(5,6-dimethoxy-1-indanon) -2-y1 methyl piperidine HC1. Pharm. Res. 9,S228 (1992).
   Google Scholar
• Tiseo PJ, Rogers SL, Friedhoff LT Pharmacokinetic and pharmacodynamic profile of donepezil CH1 following evening administration. BE J. Clin. Pharmacol 46\(Suppl. 1), 13–18 (1998).
   Google Scholar
• Rogers SL, Friedhoff LT, The donepezil Study Group. The efficacy and safety of donepezil in patients with Alzheimer's disease: results of a US multicenter randomized, double-blind, placebo-controlled study. Dementia 7,293–303 (1996).
   PubMedGoogle Scholar
• Rogers SL, Doody RS, Mohs RC et al Donepezil Improves Cognition and Global Function in Alzheimer's disease: a 15-week, double-blind, placebo-controlled study Aith. Int. Med. 158,102 —1031 (1998).
   Google Scholar
• •Pivotal study demonstrating safety and efficacy for US Food and Drug Administration (FDA).
   Google Scholar
• Rogers SL, Farlow MR, Doody RS et al A 24-week double-blind placebo-controlled trial of donepezil in patients with Alzheimer's disease. Neurology50, 136–145 (1998).
   PubMed Web of Science ®Google Scholar
• •Pivotal study demonstrating safety and efficacy for the US FDA.
   Google Scholar
• Shinotoh H, Aotsuka A, Fukushi K. Effect of donepezil on brain acetylcholinesterase activity in patients with AD measured by PET Neurology56,408–410 (2001).
   Google Scholar
• Kuhl DE, Minoshima S, Frey IKA, Foster NL, Kilbourn MR, Koeppe RA. Limited donepezil inhibition of acetylcholinestrase measured with positron emission tomography in living Alzheimer cerebral cortex. Ann. Neural. 49,416–417 (2000).
   Google Scholar
• Brown DR, Hunter R, Wyper DJ eta]. Longitudinal changes in cognitive function and regional cerebral function in Alzheimer's disease: a SPECT blood flow study. I Psych. Res. 30,109-126 (1996).
   Google Scholar
• Staff RT, Gemmell HG, Shanks ME, Murray AD, Venneri A. Changes in the rCBF images of patients with Alzheimer's disease receiving donepezil therapy. Nun Med. Communication 21,37–41 (2000).
   Google Scholar
• Nobili F, Vitali P, Canfora M etal. Effects of long-term donepezil therapy on rCBF of Alzheimer's patients. Clin. Neurophysiol 113,1241–1248 (2002).
   PubMed Web of Science ®Google Scholar
• Tune L, Tiseo PJ, Ieni J et al Donepezil HC1 (E2020) maintains functional brain activity in patients with Alzheimer's disease: results of a 24-week, double-blind, placebo-controlled study. Am J. Geriatric Psych. 11, 169–177 (2003).
   Google Scholar
• Jann MW, Shirley KL, Small GW. Clinical pharmacokinetics and pharmacodynamics of cholinesterase inhibitors. Clin. Pharmacokinetics 41, 719–739 (2002).
   PubMed Web of Science ®Google Scholar
• ••Useful comparison of the AChEls incommon use, especially in regard to pharmacokinetics.
   Google Scholar
• Rogers SL, Friedhoff LT Pharmacokinetic and pharmacodynamic profile of donepezil HC1 following single oral doses. BE J. Clin. Pharmacol 46\(Suppl. 1), 1–6 (1998).
   Google Scholar
• Rogers SL, Cooper NM, Sukovarty R, Pedersen JE, Lee JN, Friedhoff LT Pharmacokinetic and pharmacodynamic profile of donepezil HC1 following multiple oral doses. Brj Clin. Pharmacol 46\(Suppl. 1), 7–12 (1998).
   Google Scholar
• Dooley M, Lamb MET. Donepezil. Drugs Aging16, 199–226 (2000).
   PubMed Web of Science ®Google Scholar
• Barner EL, Gray SL. Donepezil in Alzheimer's disease. Ann. Pharmacother. 32, 70–77 (1998).
   PubMed Web of Science ®Google Scholar
• Shintani EY, Uchida KM. Donepezil: an anticholinesterase inhibitor for Alzheimer's disease. Am. J. Health Syst. Pharm. 54, 2805–2810 (1997).
   PubMed Web of Science ®Google Scholar
• Tiseo PJ, Perdomo CA, Friedhoff LT Metabolism and elimination of 14C donepezil in healthy volunteers: a single dose study. BE .1. Clin. Pharmacol 46\(Suppl. 1), 19–24 (1998).
   Google Scholar
• Ohnishi A, Mihara M, Kamakura H et al Comparison of the pharmacokinetics of E2020, a new compound for Alzheimer's disease, in healthy young and elderly subjects. .1. Clin. Pharmacol 33, 1086–1091 (1993).
   Google Scholar
• Tiseo PJ, Vargas R, Perdomo C et al An evaluation of the pharmacokinetics of donepezil hydrochloride in patients with impaired hepatic function. BE j Clin. Pharmacol 46\(Suppl. 1), 51–55 (1998).
   Google Scholar
• Tiseo PJ, Foley K, Friedhoff LT et al An evaluation of the pharmacokinetics of donepezil hydrochloride in patients with moderate to severe renal impairment. BE J. Clin. Pharmacol 46\(Suppl. 1), 56–60 (1998).
   Google Scholar
• Tiseo PJ, Perdomo CA, Friedhoff LT Concurrent administration of donepezil HC1 and cimetidine: assessment of pharmacokinetic changes following single and multiple doses. BE j Clin. Pharmacol 46\(Suppl. 1), 25–29 (1998).
   Google Scholar
• Tiseo PJ, Perdomo CA, Friedhoff LT Concurrent administration of donepezil HC1 and ketoconazole: assessment of pharmacokinetic changes following single and multiple doses. BE J. Gun. Pharmacol 46\(Suppl. 1), 30–34 (1998).
   Google Scholar
• Mckhann G, Drachman D, Folstein M et al Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA work group under the auspices of the Department of Health and Human Services Task Force on Alzheimer's disease. Neurology34, 939–44 (1984).
   PubMed Web of Science ®Google Scholar
• Jobst KA, Barnetson LP, Shepstone BJ. Accurate prediction of histologically confirmed Alzheimer's disease and the differential diagnosis of dementia: the use of NINCDS-ADRDA and DSM-III-R criteria, SPECT, x-ray CT and Apo E4 in medial temporal lobe dementias. Oxford Project to Investigate Memory and Aging. Int. PTchogeriatr 10,271–302 (1998).
   Google Scholar
• Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology 43, 2412–2414 (1993).
   PubMed Web of Science ®Google Scholar
• Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am. J. fiychiatry141,1356–1364 (1984).
   Google Scholar
• Schneider LS, Olin JT, Doody RS et al Validity and reliability of the Alzheimer's disease Co-operative Study-Clinical Global Impression of Change. Alz. Dis. Assoc. Disordll(Suppl. 2), S22—S32 (1997).
   Google Scholar
• Homma A, Imai Y, Hagiguchi S, Kameyama M, Nishimura T Late Phase II clinical study of acetylcholinesterase inhibitor E2020 in patients with Alzheimer-type dementia. Gun. Eva'. 26, 251–284 (1998).
   Google Scholar
• Burns A, Rossor M, Hecker J et al The effects of donepezil in Alzheimer's disease — results from a multinational trial. Dementia Geriatr Cogn. Dis. 10,237–244 (1999).
   PubMed Web of Science ®Google Scholar
• Homma A, Takeda M, Imai Yet 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. E2020 Study Group. Dementia Ger. Cogn. Dis. 11, 299–313 (2000).
   Google Scholar
• Winblad B, Engedal K, Soininen H et al A 1-year, randomized, placebo-controlled study of donepezil in patients with mild to moderate AD. Neurology57, 489–495 (2001).
   PubMed Web of Science ®Google Scholar
• •Longest double-blind placebo-controlled trial to date.
   Google Scholar
• Bea'ne G, Gottfries CG, Winblad B. The Gottfries-Brane-Steen scale: validity, reliability and application in antidementia drug trials. Dement. Geriatr Cogn. Disold 12,1-14 (2001).
   Google Scholar
• Dejong R, Osterlund OW Roy GW. Measurement of quality-of-life changes in patients with Alzheimer's disease. Gun. Ther. 11,545–554 (1989).
   Google Scholar
• Reisberg B, Ferris SH et al The Global Deterioration Scale for assessment of primary degenerative dementia. Am. J. Psych. 139,1136–1139 (1982).
   PubMed Web of Science ®Google Scholar
• Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology 44,2308–2314 (1994).
   PubMed Web of Science ®Google Scholar
• Mohs R, Doody R, Morris J et al A 1-year, placebo-controlled preservation of function survival study of donepezil in AD patients. Neurology57, 481–488 (2001).
   PubMed Web of Science ®Google Scholar
• •Novel study using survival analysis with functional ability, rather than cognition, as the primary outcome.
   Google Scholar
• Feldman H, Gauthier S, Hecker J eta]. A 24- week, randomized, double-blind study of donepezil in moderate to severe Alzheimer's disease. Neurology57, 613–620 (2001).
   Google Scholar
• •Interesting demonstration of potent AChEI response even in more severely affected cases.
   Google Scholar
• Panisset M, Roudier M, Saxton J et al Severe impairment battery: a neurological test for severely demented patients. Atrh. Neural 51,41–45 (1994).
   Google Scholar
• Gélinas I, Gauthier L, Mcintyre M et al Development of a functional measure for persons with Alzheimer's disease: the disability assessment for dementia. Am J. Occup. Ther. 53,471–481 (1999).
   PubMed Web of Science ®Google Scholar
• Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist9, 179–186 (1969).
   PubMed Web of Science ®Google Scholar
• Feldman H, Schulzer M, Wang S et al The Functional Rating Scale in Alzheimer's disease assessment: a longitudinal study. In: Research Advances in Alzheimer disease and Related Dismrlers. Iqbal K, Mortimer JA, Winblad B, Wisniewski HM, (Eds). Wiley, Chichester, UK, 235-241(1995).
   Google Scholar
• Tariot PN, Cummings JL, Katz IR et al A randomized, double-blind, placebo-controlled study of the efficacy and safety of donepezil in patients with Alzheimer's disease in the nursing home setting. J. Am. Geriatr Soc. 49,1590–1599 (2001).
   PubMed Web of Science ®Google Scholar
• Greenberg SM, Tennis MK, Brown LB et al Donepezil therapy in clinical practice: a randomized crossover study. Arch. Neural 57,94–99 (2000).
   PubMed Web of Science ®Google Scholar
• •Crossover trial that used a sample designed to more closely reflect general practice.
   Google Scholar
• Doody R, Geldmacher D, Gordon B, Perdomo C, Pratt R. Open-label, multicenter, Phase III extension study of the safety and efficacy of donepezil in patients with Alzheimer's disease. Atrh. Neural 58,427–433 (2001).
   Google Scholar
• ••Long term follow-up of cognitive testscores among pivotal trial subjects. Illustrates the effects of discontinuation and resumption of therapy with donepezil.
   Google Scholar
• Geldmacher DS, Provenzano G, Mcrae T, Mastey V, Ieni J. Donepezil is associated with delayed nursing home placement in patients with Alzheimer's disease. J. Am. Geriatr Soc. (2003)
   Google Scholar
• ••Long-term follow-up of dispositionamong pivotal trial subjects. Illustrating a very meaningful clinical outcome even though patients have worsened on treatment.
   Google Scholar
• Lopez OL, Becker JT, Wisniewski S, Saxton J, Kaufer DI, Dekosky ST Cholinesterase inhibitor treatment alters the natural history of Alzheimer's disease. J. Neural Neurosurg. PTchiatry72, 310–314 (2002).
   PubMed Web of Science ®Google Scholar
• ••Study conducted independently of thedrug manufacturer and showed robust effect of AChEIs on reducing risk for nursing home placement.
   Google Scholar
• Hill JW, Futterman R, Mastey V, Fillit H. The effect of donepezil therapy on health costs in a Medicare managed care plan. Managed Cam Interface 15,63–70 (2002).
   PubMedGoogle Scholar
• Pratt RD, Perdomo CA. Donepezil-treated patients with probable vascular dementia demonstrate cognitive benefits. Ann. NY Acad. Li. 977,513–522 (2002).
   PubMed Web of Science ®Google Scholar
• Roman GC, Tatemichi TK, Erkinjunti T et al Vascular dementia: diagnostic criteria for research studies. Report of the NINDS-AIREN international workshop. Neurology 43,250–260 (1993).
   Google Scholar
• Wilkinson D, Doody R, Helme R et al Donepezil in vascular dementia: a randomized, placebo-controlled study. Neurology61, 479–486 (2003).
   PubMed Web of Science ®Google Scholar
• Black S, Roman GC, Geldmacher DS et al Efficacy and tolerability of donepezil in vascular dementia: positive results of a 24-week, multicenter, international, randomized, placebo-controlled clinical trial. Stmke 34,2323–2330 (2003).
   Google Scholar
• Aarsland D, Laake K, Larsen JP, Janvin C. Donepezil for cognitive impairment in Parkinson's disease: a randomised controlled study. I Neural Neurosurg. PTchiatry72,708–712 (2002).
   PubMed Web of Science ®Google Scholar
• Litvan I, Phipps M, Pharr VL, Hallett M, Grafman J, Salazar A. Randomized placebo-controlled trial of donepezil in patients with progressive supranuclear palsy. Neurology57,467–473 (2001).
   PubMed Web of Science ®Google Scholar
• Yesavage JA, Mumenthaler MS, Taylor JL eta]. Donepezil and flight simulator performance: effects on retention of complex skills. Neumlogy59,123–125 (2002).
   PubMed Web of Science ®Google Scholar
• Prasher VP, Huxley A, Hague MS, Down's Syndrome Ageing Study Group. A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Down's syndrome and Alzheimer's disease-pilot study. Int. .1. Geriatric Psych. 17,270-278 (2002).
   Google Scholar
• Sahin HA, Gurvit IH, Bilgic B, Hanagasi HA, Emre M. Therapeutic effects of an acetylcholinesterase inhibitor (donepezil) on memory in Wernicke-Korsakoff's disease. Clin. Neuropharmacol 25,16–20 (2002).
   Google Scholar
• Friedman JI, Adler DN, Howanitz E eta]. A double-blind placebo-controlled trial of donepezil adjunctive treatment to risperidone for the cognitive impairment of schizophrenia. Biological Bych. 51, 349–357 (2002).
   Google Scholar
• Birks JS, Melzer D, Beppu H. Donepezil for mild and moderate Alzheimer's disease. Cochrane Dementia and Cognitive Improvement Group. Cochrane Database Sys. Rev (2003). Important evidence-based comprehensive review, but the current edition does not include several recent studies.
   Google Scholar
• Petersen RC, Doody R, Kurz A et al Current concepts in mild cognitive impairment. Awl?. Neural 58,1985–1992 (2001).
   Google Scholar
• Boise L, Camicioli R, Morgan DL, Rose JH, Congleton L. Diagnosing dementia: perspectives of primary care physicians. Gerontologist 39,457–464 (1999).
   PubMed Web of Science ®Google Scholar
• •Useful exploration of prescribing physicians' views of dementia and its treatment.
   Google Scholar
• Callaway E, Halliday R, Naylor H. Cholinergic activity and constraints on information processing. Bid Psychiatry 33, 1–22 (1992).
   Google Scholar
• Sillito AM. The cholinergic neuromodulatory system: an evaluation of its functional roles. In: Progress in Blain Research. Cuello AC (Ed.). Elsevier, Amsterdam, Holland 98,371–378 (1993).
   Google Scholar
• Winblad B, Brodaty H, Gauthier S et al Pharmacotherapy of Alzheimer's disease: is there a need to redefine treatment success? Int.j Geriatric fiychiatr 16,653–656 (2001).
   PubMed Web of Science ®Google Scholar
• Cummings SR, Black DM, Thompson DE et al Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. PIMA 280, 2077–2082 (1998).
   Google Scholar
• Larosa JC, He J, Vupputuri S. Effect of statins on risk of coronary disease: a meta-analysis of randomized controlled trials. PIN/A 282,2340–2346 (1999) .
   Google Scholar
• Anonymous. Effect of ramipril on mortality and morbidity of survivors of acute myocardial infarction with clinical evidence of heart failure. The Acute Infarction Ramipril Efficacy (AIRE) Study Investigators. Lancet 342,821–8288 (1993).
   Google Scholar