A randomized, double-blind, placebo-controlled study of aripiprazole for the treatment of psychosis in nursing home patients with alzheimer disease

American Journal of Geriatric Psychiatry

Volumn 16, Issue 7, 2008, Pages 537-550

  Streitn, Joel E ^a,b   Porsteinsson, Anton P ^c   Breder, Christopher D ^d   Swanink, Rene ^d   Marcus, Ronald ^d   McQuade, Robert ^e   Carson, William H ^e  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b VETERANS AFFAIRS MEDICAL CENTER   (United States)

^c Program in Neurobehavioral Therapeutics to Alzheimer's Disease Care   (United States)

^d BRISTOL MYERS SQUIBB   (United States)

^e OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC   (United States)

Author keywords

Alzheimer disease; Aripiprazole; Behavioral symptoms; Dementia; Psychotic symptoms

Indexed keywords

ANALGESIC AGENT; ANTIPYRETIC AGENT; ANXIOLYTIC AGENT; ARIPIPRAZOLE; NOOTROPIC AGENT; PLACEBO; SEROTONIN UPTAKE INHIBITOR; TEMAZEPAM; TRAZODONE; ZOLPIDEM; NEUROLEPTIC AGENT; PIPERAZINE DERIVATIVE; QUINOLONE DERIVATIVE;

ACCIDENTAL INJURY; ADULT; AGED; AGITATION; ALZHEIMER DISEASE; ANXIETY; ARTICLE; ASTHENIA; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DELUSION; DEPRESSION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; DRUG WITHDRAWAL; ECCHYMOSIS; EXTRAPYRAMIDAL SYMPTOM; FEMALE; HALLUCINATION; HUMAN; HYPOTENSION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NURSING HOME PATIENT; PSYCHOLOGICAL RATING SCALE; PSYCHOSIS; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SIDE EFFECT; SKIN ULCER; SOMNOLENCE; SYNCOPE; TREATMENT DURATION; URINARY TRACT INFECTION; VOMITING; WEIGHT GAIN; WEIGHT REDUCTION; BEHAVIOR; DRUG TOXICITY; MIDDLE AGED; NURSING HOME; UNITED STATES;

AGED; AGED, 80 AND OVER; ALZHEIMER DISEASE; ANTIPSYCHOTIC AGENTS; BEHAVIORAL SYMPTOMS; DOUBLE-BLIND METHOD; DRUG TOXICITY; FEMALE; HUMANS; MALE; MIDDLE AGED; NURSING HOMES; PIPERAZINES; PSYCHOTIC DISORDERS; QUINOLONES; UNITED STATES;

EID: 50349098704     PISSN: 10647481     EISSN: 15457214     Source Type: Journal    
DOI: 10.1097/JGP.0b013e318165db77     Document Type: Article

References (56)

1. Evans DA, Funkenstein HH, Albert MS, et al: Prevalence of Alzheimer's disease in a community population of older persons. Higher than previously reported. JAMA 1989; 262:2551-2556
2. Paulsen JS, Salmon DP, Thal LJ, et al: Incidence of and risk factors for hallucinations and delusions in patients with probable AD. Neurology 2000; 54:1965-1971
3. Eustace A, Coen R, Walsh C, et al: A longitudinal evaluation of behavioural and psychological symptoms of probable Alzheimer's disease. Int J Geriatr Psychiatry 2002; 17:968-973
4. Devanand DP, Brockington CD, Moody BJ, et al: Behavioral syndromes in Alzheimer's disease. Int Psychogeriatr 1992; 4:161-184
5. Schneider LS, Katz IR, Park S, et al: Psychosis of Alzheimer disease: validity of the construct and response to risperidone. Am J Geriatr Psychiatry 2003; 11:414-425
6. Wancata J, Windhaber J, Krautgartner M, et al: The consequences of non-cognitive symptoms of dementia in medical hospital departments. Int J Psychiatry Med 2003; 33:257-271
7. Tractenberg RE, Weiner MF, Patterson MB, et al: Comorbidity of psychopathological domains in community - dwelling persons with Alzheimer's disease. J Geriatr Psychiatry Neurol 2003; 16:94-99
8. Lloyd C, Hafner RJ, Holme G: Behavioral disturbance in dementia. J Geriatr Psychiatry Neurol 1995; 8:213-216
9. Rosen J, Zubenko GS: Emergence of psychosis and depression in the longitudinal evaluation of Alzheimer's disease. Biol Psychiatry 1991; 29:224-232
10. Lopez OL, Wisniewski SR, Becker JT, et al: Psychiatric medication and abnormal behavior as predictors of progression in probable Alzheimer disease. Arch Neurol 1999; 56:1266-1272
11. Chui HC, Lyness SA, Sobel E, et al: Extrapyramidal signs and psychiatric symptoms predict faster cognitive decline in Alzheimer's disease. Arch Neurol 1994; 51:676-681
12. Stern Y, Albert M, Brandt J, et al: Utility of extrapyramidal signs and psychosis as predictors of cognitive and functional decline, nursing home admission, and death in Alzheimer's disease: prospective analyses from the Predictors Study. Neurology 1994; 44:2300-2307
13. Steele C, Rovner B, Chase GA, et al: Psychiatric symptoms and nursing home placement of patients with Alzheimer's disease. Am J Psychiatry 1990; 147:1049-1051
14. Drevets WC, Rubin EH: Psychotic symptoms and the longitudinal course of senile dementia of the Alzheimer type. Biol Psychiatry 1989; 25:39-48
15. Everitt DE, Fields DR, Soumerai SS, et al: Resident behavior and staff distress in the nursing home. J Am Geriatr Soc 1991; 39: 792-798
16. Coen RF, Swanwick GR, O'Boyle CA, et al: Behaviour disturbance and other predictors of carer burden in Alzheimer's disease. Int J Geriatr Psychiatry 1997; 12:331-336
17. Clyburn LD, Stones MJ, Hadjistavropoulos T, et al: Predicting caregiver burden and depression in Alzheimer's disease. J Geron-tol B Psychol Sci Soc Sci 2000; 55:S2-S13
18. Nagaratnam N, Lewis-Jones M, Scott D, et al: Behavioral and psychiatric manifestations in dementia patients in a community: caregiver burden and outcome. Alzheimer Dis Assoc Disord 1998; 12:330-334
19. Donaldson C, Tarrier N, Burns A: Determinants of carer stress in Alzheimer's disease. Int J Geriatr Psychiatry 1998; 13:248-256
20. De Deyn PP, Rabheru K, Rasmussen A, et al: A randomized trial of risperidone, placebo, and haloperidol for behavioral symptoms of dementia. Neurology 1999; 53:946-955
21. Katz IR, Jeste DV, Mintzer JE, et al: Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia: a randomized, double-blind trial. Risperidone Study Group. J Clin Psychiatry 1999; 60:107-115
22. Street JS, Clark WS, Gannon KS, et al: Olanzapine treatment of psychotic and behavioral symptoms in patients with Alzheimer disease in nursing care facilities: a double-blind, randomized, placebo-controlled trial. The HGEU Study Group. Arch Gen Psychiatry 2000; 57:968-976
23. Brodaty H, Ames D, Snowdon J, et al: A randomized placebo-controlled trial of risperidone for the treatment of aggression, agitation, and psychosis of dementia. J Clin Psychiatry 2003; 64:134-143
24. De Deyn PP, Carrasco MM, Deberdt W, et al: Olanzapine versus placebo in the treatment of psychosis with or without associated behavioral disturbances in patients with Alzheimer's disease. Int J Geriatr Psychiatry 2004; 19:115-126
25. Alexopoulos GS, Streim J, Carpenter D, et al: The Expert Consensus Guideline Series: using antipsychotics in older patients. J Clin Psychiatry 2004; 65(suppl 2): 1-105
26. Wooltorton E: Risperidone (Risperdal): increased rate of cerebro-vascular events in dementia trials. CMAJ 2002; 167:1269-1270
27. Wooltorton E: Olanzapine (Zyprexa): increased incidence of ce-rebrovascular events in dementia trials. CMAJ 2004; 170:1395
28. FDA: Safety Alert: Risperidone (Risperdal) [Dear Healthcare Professional Letter]. Rockville, MD, US Food and Drug Administration, 2003
29. MHRA: Summary of clinical trial data on cerebrovascular adverse events (CVAEs) in randomised clinical trials of risperidone conducted in patients with dementia. Available at: http://www. mhra.gov.uk/home/groups/pl-p/documents/ drugsafetymessage/con019490.pdf. 2004
30. Health Canada advises consumers about important safety information on atypical antipsychotic drugs and dementia. Available at http://www.hc-sc.gc.ca/ ahc-asc/media/advisories-avis/2005/2005-63-e.html. Health Canada, 2005
31. FDA: FDA Public Health Advisory. Deaths With Antipsychotics in Elderly Patients With Behavioral Disturbances. Rockville, MD, US Food and Drug Administration, 2005.
32. Herrmann N, Mamdani M, Lanctot KL: Atypical antipsychotics and risk of cerebrovascular accidents. Am J Psychiatry 2004; 161:1113-1115
33. Finkel S, Kozrna C, Long S, et al: Risperidone treatment in elderly patients with dementia: relative risk of cerebrovascular events versus other antipsychotics. Int Psychogeriatr 2005; 17:617-629
34. Wang PS, Schneeweiss S, Avorn J, et al: Risk of death in elderly users of conventional vs. atypical antipsychotic medications. N Engl J Med 2005; 353:2335-2341
35. Iverson GL, Hopp GA, DeWolfe K, et al: Measuring change in psychiatric symptoms using the Neuropsychiatric Inventory: Nursing Home version. Int J Geriatr Psychiatry 2002; 17:438-443
36. Bell M, Milstein R, Beam-Goulet J, et al: The positive and negative syndrome scale and the brief psychiatric rating scale. Reliability, comparability, and predictive validity. J Nerv Ment Dis 1992; 180:723-728
37. Miller RJ, Snowdon J, Vaughan R: The use of the Cohen-Mansfield Agitation Inventory in the assessment of behavioral disorders in nursing homes. J Am Geriatr Soc 1995; 43:546-549
38. Cohen-Mansfield J: Assessment of disruptive behavior/agitation in the elderly: function, methods, and difficulties. J Geriatr Psychiatry Neurol 1995; 8:52-60
39. Cohen-Mansfield J, Billig N: Agitated behaviors in the elderly. I. A conceptual review. J Am Geriatr Soc 1986; 34:711-721
40. Weiner MF, Tractenberg RE, Jin S, et al: Assessing Alzheimer's disease patients with the Cohen-Mansfield Agitation Inventory: scoring and clinical implications. J Psychiatr Res 2002; 36: 19-25
41. Alexopoulos GS, Abrams RC, Young RC, et al: Cornell Scale for Depression in Dementia. Biol Psychiatry 1988; 23:271-284
42. Koch G, Gansky S: Statistical considerations for multiplicity in confirmatory protocols. Drug Inf J 1996; 30:523-534
43. De Deyn P, Jeste DV, Swanink R, et al: Aripiprazole for the treatment of psychosis in patients with Alzheimer's Disease: A randomized, placebo-controlled study. J Clin Psychopharmacol 2005; 25:463-467
44. Mintzer JE, Yune LE, Breder CD, et al. Aripiprazole for the treatment of psychoses in institutionalized patients with Alzheimer dementia: a multicenter, randomized, double-blind, placebo-controlled assessment of three fixed doses. Am J Geriatr Psychiatry 2007; 15:918-931
45. Jeste DV, Finkel SI: Psychosis of Alzheimer's disease and related dementias. Diagnostic criteria for a distinct syndrome. Am J Geriatr Psychiatry 2000; 8:29-34
46. Zhong KX, Tariot PN, Mintzer J, et al: Quetiapine to treat agita-tion in dementia: a randomized, double-blind, placebo-controlled study. Curr Alzheimer Res 2007; 4:81-93
47. Schneider LS, Tariot PN, Dagerman KS, et al. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer's disease. N Engl J Med 2006; 355:1525-1538
48. Caligiuri MP, Rockwell E, Jeste DV: Extrapyramidal side effects in patients with Alzheimer's disease treated with low-dose neuro-leptic medication. Am J Geriatr Psychiatry 1998; 6:75-82
49. Frels C, Williams P, Narayanan S, et al: Iatrogenic causes of falls in hospitalised elderly patients: a case-control study. Postgrad Med J 2002; 78:487-489
50. Deberdt WG, Dysken MW, Rappaport SA, et al: Comparison of olanzapine and risperidone in the treatment of psychosis and associated behavioral disturbances in patients with dementia. Am J Geriatr Psychiatry 2005; 13:722-730
51. Katz IR, Rupnow M, Kozma C, et al: Risperidone and falls in ambulatory nursing home residents with dementia and psychosisor agitation: secondary analysis of a double-blind, placebo-controlled trial. Am J Geriatr Psychiatry 2004; 12:499-508
52. Gillette-Guyonnet S, Nourhashemi F, Andrieu S, et al: Weight loss in Alzheimer disease. Am J Clin Nutr 2000; 71:637S-642S
53. White H, Pieper C, Schmader K: The association of weight change in Alzheimer's disease with severity of disease and mortality: a longitudinal analysis. J Am Geriatr Soc 1998; 46:1223-1227
54. Breder C, Kostic D, Forbes A, et al: Overall Safety of Aripiprazole in Trials of Patients with Psychosis of Alzheimer's Dementia. Atlanta, GA, American Psychiatric Association, 2005
55. Schneider LS, Dagerman KS, Insel P: Risk of death with atypical antipsychotic drug treatment for dementia. Meta-analysis of randomized placebo-controlled trials. JAMA 2005; 294:1934-1943
56. Schneider LS, Dagerman K, Insel PS: Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials. Am J Geriatr Psychiatry 2006; 14:191-210