Donepezil treatment of severe Alzheimer's disease in nursing home settings. A responder analysis

Dementia and Geriatric Cognitive Disorders

Volumn 26, Issue 5, 2008, Pages 458-466

  Jelic, Vesna ^a,b   Haglund, Anders ^c   Kowalski, Jan ^c   Langworth, Sven ^c   Winblad, Bengt ^b  

^a KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^b KAROLINSKA INSTITUTE   (Sweden)

^c PFIZER INC   (United States)

Author keywords

Activities of daily living; Alzheimer's disease; Behavioural symptoms; Clinical trials; Cognitive function; Donepezil; Responders

Indexed keywords

DONEPEZIL; PLACEBO;

ADULT; AGED; ALZHEIMER DISEASE; ALZHEIMERS DISEASE COOPERATIVE STUDY ACTIVITIES OF DAILY LIVING SCALE; ARTICLE; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL TRIAL; COGNITION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MINI MENTAL STATE EXAMINATION; NEUROPSYCHIATRIC INVENTORY; NURSING HOME; PRIORITY JOURNAL; RATING SCALE; SEVERE IMPAIRMENT BATTERY;

ACTIVITIES OF DAILY LIVING; AGED; AGED, 80 AND OVER; ALZHEIMER DISEASE; BEHAVIOR; BODY MASS INDEX; COGNITION; FEMALE; HUMANS; INDANS; MALE; MIDDLE AGED; NEUROPSYCHOLOGICAL TESTS; NOOTROPIC AGENTS; NURSING HOMES; PIPERIDINES; TREATMENT OUTCOME;

EID: 55149114382     PISSN: 14208008     EISSN: None     Source Type: Journal    
DOI: 10.1159/000167267     Document Type: Article

References (24)

1. Holtzer R, Wegesin DJ, Albert SM, Marder K, Bell K, Albert M, Brandt J, Stern Y: The rate of cognitive decline and risk of reaching clinical milestones in Alzheimer disease. Arch Neurol 2003;60:1137-1142.
2. Livingston G, Katona C, Francois C, Guilhaume C, Cochran J, Sapin C: Characteristics and health status change over 6 months in people with moderately severe to severe Alzheimer's disease in the UK. Int Psychogeriatr 2006;18:527-538.
3. Geldmacher DS, Frolich L, Doody RS, Erkinjuntti T, Vellas B, Jones RW, Banerjee S, Lin P, Sano M: Realistic expectations for treatment success in Alzheimer's disease. J Nutr Health Aging 2006;10:417-429.
4. Edvardsson D, Winblad B, Sandman PO: Person-centred care of people with severe Alzheimer's disease: current status and ways forward. Lancet Neurol 2008;7:362-367.
5. Feldman H, Gauthier S, Hecker J, Vellas B, Subbiah P, Whalen E;Donepezil MSAD Study Investigators Group: A 24-week, randomized, double-blind study of donepezil in moderate to severe Alzheimer's disease. Neurology 2001;57:613-620.
6. Tariot PN, Cummings JL, Katz IR, Mintzer J, Perdomo CA, Schwam EM, Whalen E: 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 2001;49:1590-1599.
7. Winblad B, Kilander L, Eriksson S, Minthon L, Båtsman S, Wetterholm AL, Jansson-Blixt C, Haglund A;Severe Alzheimer's Disease Study Group: Donepezil in patients with severe Alzheimer's disease: double-blind, parallel-group, placebo-controlled study. Lancet 2006;367:1057-1065.
8. Black SE, Doody R, Li H, McRae T, Jambor KM, Xu J, Sun Y, Perdomo CA, Richardson S: Donepezil preserves cognition and global function in patients with severe Alzheimer's disease. Neurology 2007;69:459-469.
9. Homma A, Imai Y, Tago H, Asada T, Shigeta M, Iwamoto T, Takita M, Arimoto I, Koma H, Ohbayashi T: Donepezil treatment of patients with severe Alzheimer's disease in a Japanese population: results from a 24-week, double-blind, placebo-controlled, randomized trial. Dement Geriatr Cogn Disord 2008;25:399-407.
10. Folstein MF, Folstein SE, McHugh PR: Mini-Mental State: a practical method for grading the cognitive state of patients for the clinician. J Psychiatry Res 1975;12:189-198.
11. Reisberg B: Functional Assessment Staging (FAST). Psychopharmacol Bull 1988;24:653-659.
12. Reisberg B, Ferris SH, de Leon MJ, Crook T: The global deterioration scale for assessment of primary degenerative dementia. Am J Psychiatry 1982;139:1136-1139.
13. Panisset M, Roudier M, Saxton J, Boller F: Severe impairment battery, a neuropsychological test for severely demented patients. Arch Neurol 1994;51:41-45.
14. Galasko DR, Schmitt FA, Thomas R, Jin S, Bennet D;Alzheimer's Disease Cooperative Study: Detailed assessment of activities of daily living in moderate to severe Alzheimer's disease. J Int Neuropsychol Soc 2005;11:446-453.
15. Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J: The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology 1994;44:2308-2314.
16. Guy W: ECDEU Assessment Manual for Psychopharmacology. DHEW publication. US Department of Health, Education and Welfare, 1976.
17. Schneider LS, Olin JT, Doody RS, Clarck CM, Morris JC, Reisberg B, Schmitt FA, Grundman M, Thomas RG, Ferris SH: Validity and reliability of the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change: The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord 1997;11(suppl 2):S22-S32.
18. Schmitt FA, Ashford W, Ernesto C, Saxton J, Schneider LS, Clark CM, Ferris SH, Mackell JA, Schafer K, Thal LJ: The severe impairment battery: concurrent validity and assessment of longitudinal change in Alzheimer's disease. Alzheimer Dis Assoc Disord 1997;11(suppl 2):S51-S56.
19. Gauthier S, Feldman H, Hecker J, Vellas B, Ames D, Subbiah P, Whalen E, Emir B; Donepezil MSAD Study Investigators Group: Efficacy of donepezil on behavioral symptoms in patients with moderate to severe Alzheimer's disease. Int Psychogeriatr 2002;14:389-404.
20. European Medicine Evaluation Agency (EMEA): Note for Guidance on Medicinal Products in the Treatment of Alzheimer's Disease. London, EMEA, 1997.
21. U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, and U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health: Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 2006;4:79.
22. Committee for Medicinal Products for Human Use (CHMP): Guideline on medicinal products for the treatment of Alzheimer's disease and other dementias. Doc ref CPMP/EWP/553/95 rev 1. London, EMEA, 2007. http://www.emea.europa.eu/ pdfs/human/ewp/055395endraft.pdf.
23. Mega MS, Masterman DM, O'Connor SM, Barclay TR, Cummings JL: The spectrum of behavioural responses to cholinesterase inhibitor therapy in Alzheimer disease. Arch Neurol 1999;56:1388-1393.
24. Van Dyck CH, Schmitt FA, Olin JT; Memantine MEM-MD-02 Study Group: A responder analysis of memantine treatment in patients with Alzheimer disease maintained on donepezil. Am J Geriatr Psychiatry 2006;14:428-437.