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Meta-Analysis
. 2006 Jan 25;2006(1):CD003476.
doi: 10.1002/14651858.CD003476.pub2.

The effectiveness of atypical antipsychotics for the treatment of aggression and psychosis in Alzheimer's disease

C Ballard  1 , J Waite
Affiliations
Meta-Analysis

The effectiveness of atypical antipsychotics for the treatment of aggression and psychosis in Alzheimer's disease

C Ballard et al. Cochrane Database Syst Rev. .

Abstract

Background: Aggression, agitation or psychosis occur in the majority of people with dementia at some point in the illness. There have been a number of trials of atypical antipsychotics to treat these symptoms over the last five years, and a systematic review is needed to evaluate the evidence in a balanced way.

Objectives: To determine whether evidence supports the use of atypical antipsychotics for the treatment of aggression, agitation and psychosis in people with Alzheimer's disease.

Search strategy: The trials were identified from a last updated search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group on 7 December 2004 using the terms olanzapine, quetiapine, risperidone, clozapine, amisulpride, sertindole, zotepine, aripiprazole, ziprasidone. This Register contains articles from all major healthcare databases and many ongoing trials databases and is updated regularly.

Selection criteria: Randomised, placebo-controlled trials, with concealed allocation, where dementia and psychosis and/or aggression were assessed.

Data collection and analysis: 1. Two reviewers extracted data from included trials2. Data were pooled where possible, and analysed using appropriate statistical methods3. Analysis included patients treated with an atypical antipsychotic, compared with placebo

Main results: Sixteen placebo controlled trials have been completed with atypical antipsychotics although only nine had sufficient data to contribute to a meta-analysis and only five have been published in full in peer reviewed journals. No trials of amisulpiride, sertindole or zotepine were identified which met the criteria for inclusion. The included trials led to the following results:1. There was a significant improvement in aggression with risperidone and olanzapine treatment compared to placebo.2. There was a significant improvement in psychosis amongst risperidone treated patients.3. Risperidone and olanzpaine treated patients had a significantly higher incidence of serious adverse cerebrovascular events (including stroke), extra-pyramidal side effects and other important adverse outcomes.4. There was a significant increase in drop-outs in risperidone (2 mg) and olanzapine (5-10 mg) treated patients.5. The data were insufficient to examine impact upon cognitive function.

Authors' conclusions: Evidence suggests that risperidone and olanzapine are useful in reducing aggression and risperidone reduces psychosis, but both are associated with serious adverse cerebrovascular events and extra-pyramidal symptoms. Despite the modest efficacy, the significant increase in adverse events confirms that neither risperidone nor olanzapine should be used routinely to treat dementia patients with aggression or psychosis unless there is marked risk or severe distress. Although insufficient data were available from the considered trials, a meta-analysis of seventeen placebo controlled trials of atypical neuroleptics for the treatment of behavioural symptoms in people with dementia conducted by the Food and Drug Administration (using data not in the public domain) suggested a significant increase in mortality (OR 1.7).

PubMed Disclaimer

Conflict of interest statement

Professor Ballard and Dr Waite have given sponsored talks for Janssen, Astra‐Zeneca and Eli Lilly; and Clive Ballard has acted as a paid advisor to Janssen and Astra‐Zeneca.

Figures

1.1
1.1. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 1 BEHAVE‐AD or NPI TOTAL (change from baseline at 10‐13 weeks) ITT.
1.2
1.2. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 2 BEHAVE‐AD or NPI PSYCHOSIS (change from baseline at 8‐13 weeks) ITT.
1.3
1.3. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 3 BEHAVE‐AD AGGRESSIVENESS (change from baseline at 12‐13 weeks) ITT.
1.4
1.4. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 4 CMAI TOTAL AGGRESSIVENESS (change from baseline at 10‐13 weeks) ITT.
1.5
1.5. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 5 Number of dropouts before end of treatment at 8‐13 weeks.
1.6
1.6. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 6 Number of dropouts due to adverse events before end of treatment at 8‐13 weeks.
1.7
1.7. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 7 Number of adverse events before end of treatment at 8‐13 weeks.
1.8
1.8. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 8 Number of adverse events of somnolence before end of treatment at 8‐13 weeks.
1.9
1.9. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 9 Number of adverse events of injury before end of treatment at 8‐13 weeks.
1.10
1.10. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 10 Number of adverse events of purpura before end of treatment at 12‐13 weeks.
1.11
1.11. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 11 Number of adverse events of pain before end of treatment at 12‐13 weeks.
1.12
1.12. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 12 Number of adverse events of coughing before end of treatment at 12‐13 weeks.
1.13
1.13. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 13 Number of adverse events of rhinitis before end of treatment at 12‐13 weeks.
1.14
1.14. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 14 Number of adverse events of upper respiratory tract infection before end of treatment at 8‐13 weeks.
1.15
1.15. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 15 Number of adverse events of a fall before end of treatment at 8‐13 weeks.
1.16
1.16. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 16 Number of adverse events of extrapyramidal disorder before end of treatment at 8‐13 weeks.
1.17
1.17. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 17 Number of adverse events of urinary tract infection before end of treatment at 12‐13 weeks.
1.18
1.18. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 18 Number of adverse events of peripheral oedema before end of treatment at 12‐13 weeks.
1.19
1.19. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 19 Number of adverse events of fever before end of treatment at 12‐13 weeks.
1.20
1.20. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 20 Number of adverse events of agitation before end of treatment at 8‐13 weeks.
1.21
1.21. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 21 Number of adverse events of tremor before end of treatment at 8‐13 weeks.
1.22
1.22. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 22 Number of adverse events of abnormal gait before end of treatment at 8‐13 weeks.
1.23
1.23. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 23 Number of adverse events of confusion before end of treatment at 8‐13 weeks.
1.24
1.24. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 24 Number of adverse events of hallucination before end of treatment at 8‐13 weeks.
1.25
1.25. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 25 Number of adverse events of urinary incontinence before end of treatment at 8‐13 weeks.
1.26
1.26. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 26 Number of adverse events of asthenia before end of treatment at 8‐13 weeks.
1.27
1.27. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 27 Number of adverse events of hostility before end of treatment at 8‐13 weeks.
1.28
1.28. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 28 Number of adverse events of flu syndrome before end of treatment at 8‐13 weeks.
1.29
1.29. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 29 Number of adverse events of dyspnea before end of treatment at 8‐13 weeks.
1.30
1.30. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 30 Number of adverse events of angina pectoris before end of treatment at 8‐13 weeks.
1.31
1.31. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 31 Number of cerebrovascular adverse events before end of treatment at 8‐13 weeks.
1.32
1.32. Analysis
Comparison 1 RISPERIDONE VS PLACEBO, Outcome 32 Number of deaths before end of treatment at 8‐13 weeks.
2.1
2.1. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 1 BEHAVE‐AD (change from baseline at 12 weeks) ITT.
2.2
2.2. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 2 BEHAVE‐AD PSYCHOSIS (change from baseline at 12 weeks) ITT.
2.3
2.3. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 3 BEHAVE‐AD AGGRESSION(change from baseline at 12 weeks) ITT.
2.4
2.4. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 4 Number of dropouts before end of treatment at 12 weeks.
2.5
2.5. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 5 Number of dropouts due to adverse events before end of treatment at 12 weeks.
2.6
2.6. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 6 Number of adverse events of somnolence before end of treatment at 12 weeks.
2.7
2.7. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 7 Number of adverse events of injury before end of treatment at 12 weeks.
2.8
2.8. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 8 Number of adverse events of fall before end of treatment at 12 weeks.
2.9
2.9. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 9 Number of adverse events of extrapyramidal disorder before end of treatment at 12 weeks.
2.10
2.10. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 10 Number of adverse events of urinary tract infection before end of treatment at 12 weeks.
2.11
2.11. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 11 Number of adverse events of peripheral oedema before end of treatment at 12 weeks.
2.12
2.12. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 12 Number of adverse events of purpura before end of treatment at 12 weeks.
2.13
2.13. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 13 Number of adverse events of fever before end of treatment at 12 weeks.
2.14
2.14. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 14 Number of adverse events of pain before end of treatment at 12 weeks.
2.15
2.15. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 15 Number of adverse events of coughing before end of treatment at 12 weeks.
2.16
2.16. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 16 Number of adverse events of agittion before end of treatment at 12 weeks.
2.17
2.17. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 17 Number of adverse events of rhinitis before end of treatment at 12 weeks.
2.18
2.18. Analysis
Comparison 2 RISPERIDONE 2 mg/day vs 1 mg/day, Outcome 18 Number of adverse events of upper respiratory tract infection before end of treatment at 12 weeks.
3.1
3.1. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 1 NPI‐NH TOTAL (change from baseline at 6‐10 weeks) ITT.
3.2
3.2. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 2 NPI‐NH PSYCHOSIS (change from baseline at 6‐10 weeks) ITT.
3.3
3.3. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 3 NPI‐NH AGITATION/AGGRESSION (change from baseline at 6‐10 weeks) ITT.
3.4
3.4. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 4 NPI‐NH ANXIETY (change from baseline at 6‐10 weeks) ITT.
3.5
3.5. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 5 NPI‐NH APATHY/INDIFFERENCE (change from baseline at 6‐10 weeks) ITT.
3.6
3.6. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 6 NPI‐NH EUPHORIA/ELATION (change from baseline at 6‐10 weeks) ITT.
3.7
3.7. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 7 NPI‐NH IRRITABILITY/LABILITY (change from baseline at 6‐10 weeks) ITT.
3.8
3.8. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 8 NPI‐NH ABERRANT MOTOR (change from baseline at 6‐10 weeks) ITT.
3.9
3.9. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 9 NPI‐NH DEPRESSION (change from baseline at 6‐10 weeks) ITT.
3.10
3.10. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 10 NPI‐NH CARER DISTRESS (change from baseline at 6‐10 weeks) ITT.
3.11
3.11. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 11 BPRS TOTAL (change from baseline at 6‐10 weeks) ITT.
3.12
3.12. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 12 Number of dropouts before end of treatment at 6‐10 weeks.
3.13
3.13. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 13 Number of dropouts due to adverse events before end of treatment at 6‐10 weeks.
3.14
3.14. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 14 Number of deaths before end of treatment at 6‐10 weeks.
3.15
3.15. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 15 Number of adverse events due to accidental injury before end of treatment at 6‐10 weeks.
3.16
3.16. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 16 Number of adverse events due to somnolence before end of treatment at 6‐10 weeks.
3.17
3.17. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 17 Number of adverse events due to pain before end of treatment at 6‐10 weeks.
3.18
3.18. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 18 Number of adverse events due to abnormal gait before end of treatment at 6‐10 weeks.
3.19
3.19. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 19 Number of adverse events due to anorexia before end of treatment at 6‐10 weeks.
3.20
3.20. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 20 Number of adverse events due to ecchymosis before end of treatment at 6‐10 weeks.
3.21
3.21. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 21 Number of adverse events due to fever before end of treatment at 6‐10 weeks.
3.22
3.22. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 22 Number of adverse events due to agitation before end of treatment at 6‐10 weeks.
3.23
3.23. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 23 Number of adverse events due to weight loss before end of treatment at 6‐10 weeks.
3.24
3.24. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 24 Number of adverse events due to increased cough before end of treatment at 6‐10 weeks.
3.25
3.25. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 25 Number of adverse events due to peripheral oedema before end of treatment at 6‐10 weeks.
3.26
3.26. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 26 Number of adverse events due to nervousness before end of treatment at 6‐10 weeks.
3.27
3.27. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 27 Number of adverse events due to hostility before end of treatment at 6‐10 weeks.
3.28
3.28. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 28 Number of adverse events due to confusion before end of treatment at 6‐10 weeks.
3.29
3.29. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 29 Number of adverse events due to anxiety before end of treatment at 6‐10 weeks.
3.30
3.30. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 30 Number of adverse events due to dry mouth before end of treatment at 6‐10 weeks.
3.31
3.31. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 31 Number of adverse events due to akathisia before end of treatment at 6‐10 weeks.
3.32
3.32. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 32 Number of adverse events due to falls before end of treatment at 6‐10 weeks.
3.33
3.33. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 33 Number of adverse events due to weight increase before end of treatment at 6‐10 weeks.
3.34
3.34. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 34 Number of adverse events due to hallucination before end of treatment at 6‐10 weeks.
3.35
3.35. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 35 Number of adverse events due to urinary incontinence before end of treatment at 6‐10 weeks.
3.36
3.36. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 36 Number of adverse events due to asthenia before end of treatment at 6‐10 weeks.
3.37
3.37. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 37 Number of adverse events due to flu syndrome before end of treatment at 6‐10 weeks.
3.38
3.38. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 38 Number of adverse events due to dyspnea before end of treatment at 6‐10 weeks.
3.39
3.39. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 39 Number of adverse events due to angina pectoris before end of treatment at 6‐10 weeks.
3.40
3.40. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 40 Number of cerebrovascular adverse events before end of treatment at 6‐10 weeks.
3.41
3.41. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 41 CGI (change from baseline at 6‐10 weeks) ITT.
3.42
3.42. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 42 MMSE (change from baseline at 6‐10 weeks) ITT.
3.43
3.43. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 43 BEHAVE‐AD TOTAL (change from baseline at 6‐10 weeks).
3.44
3.44. Analysis
Comparison 3 OLANZAPINE VS PLACEBO, Outcome 44 CGI‐Severity (change from baseline at 6‐10 weeks) ITT.
4.1
4.1. Analysis
Comparison 4 ARIPIPRAZOLE VS PLACEBO, Outcome 1 BEHAVE‐AD PSYCHOSIS (change from baseline at 10 weeks) ITT.
4.2
4.2. Analysis
Comparison 4 ARIPIPRAZOLE VS PLACEBO, Outcome 2 BPRS TOTAL (change from baseline at 10 weeks) ITT.
4.3
4.3. Analysis
Comparison 4 ARIPIPRAZOLE VS PLACEBO, Outcome 3 BPRS ‐ PSYCHOSIS SUBSCALE (change from baseline at 10 weeks) ITT.
4.4
4.4. Analysis
Comparison 4 ARIPIPRAZOLE VS PLACEBO, Outcome 4 Number of dropouts before end of treatment at 10 weeks.
4.5
4.5. Analysis
Comparison 4 ARIPIPRAZOLE VS PLACEBO, Outcome 5 Number of dropouts due to adverse events before end of treatment at 10 weeks.
4.6
4.6. Analysis
Comparison 4 ARIPIPRAZOLE VS PLACEBO, Outcome 6 Number of deaths before end of treatment at 10 weeks.
4.7
4.7. Analysis
Comparison 4 ARIPIPRAZOLE VS PLACEBO, Outcome 7 Number of adverse events due to urinary tract infection before end of treatment at 10 weeks.
4.8
4.8. Analysis
Comparison 4 ARIPIPRAZOLE VS PLACEBO, Outcome 8 Number of adverse events due to accidental injury before end of treatment at 10 weeks.
4.9
4.9. Analysis
Comparison 4 ARIPIPRAZOLE VS PLACEBO, Outcome 9 Number of adverse events due to somnolence before end of treatment at 10 weeks.
4.10
4.10. Analysis
Comparison 4 ARIPIPRAZOLE VS PLACEBO, Outcome 10 Number of adverse events due to bronchitis before end of treatment at 10 weeks.
4.11
4.11. Analysis
Comparison 4 ARIPIPRAZOLE VS PLACEBO, Outcome 11 Number of adverse events due to extrapyramidal symptoms before end of treatment at 10 weeks.
5.1
5.1. Analysis
Comparison 5 QUETIAPINE VS PLACEBO, Outcome 1 CMAI TOTAL (change from baseline at 6 weeks) ITT.
5.2
5.2. Analysis
Comparison 5 QUETIAPINE VS PLACEBO, Outcome 2 CMAI TOTAL (change from baseline at 26 weeks) ITT.
5.3
5.3. Analysis
Comparison 5 QUETIAPINE VS PLACEBO, Outcome 3 SIB (change from baseline at 6 weeks) ITT.
5.4
5.4. Analysis
Comparison 5 QUETIAPINE VS PLACEBO, Outcome 4 SIB (change from baseline at 26 weeks) ITT.
5.5
5.5. Analysis
Comparison 5 QUETIAPINE VS PLACEBO, Outcome 5 Number of dropouts by end of treatment at 26 weeks.
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Update of

References

References to studies included in this review

Ballard 2005 {published data only}
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Breder 2004 {published data only}
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Brodaty 2001 {published data only}
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    1. Brodaty H, Clarnette R, Ames D, Snowdon, Woodward M, Kirwan J, Lee E, Lyons B, Grossman F. Risperidone in the treatment of agitation, aggression and psychosis of dementia. Proceedings of the 8th International Conference on Alzheimer's Disease and Related Disorders; 2002 July 20‐25, Stockholm, Sweden. 2002:Abstract No 289.
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CATIE {published data only}
    1. Davis SM, Koch GG, Davis CE, LaVange LM. Statistical approaches to effectiveness measurement and outcome‐driven re‐randomizations in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) studies. Schizophrenia Bulletin 2003;29(1):73‐80. - PubMed
    1. Ismail MS, Schneider LS, Tariot P, Dagerman KS, Davis S. NIMH Comparative Effectiveness of Antipsychotic Medications in Patients with Alzheimer's disease (CATIE‐AD): Clinical course. NeuroBiology of Aging 2004;25(S2):P1‐320, p 188.
    1. Schneider LS, Ismail MS, Dagerman K, Davis S, Olin J, McManus D, Pfeiffer E, Ryan JM, Sultzer DL, Tariot PN. Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer's disease trial. Schizophrenia bulletin 2003;29(1):57‐72. - PubMed
    1. Schneider LS, Tariot P, Lebowitz B. Health outcomes and effectiveness of atypical antipsychotics in outpatients with psychosis or agitation associated with AD. Proceedings of the World Alzheimer Congress; 2000 Jul 9‐13, Washington, DC. 2000b.
    1. Schneider LS, Tariot PN, Alexopoulos G, Davis K, Davis S, Jeste D, Katz I, Keefe R, LaVange L, Lebowitz B, Lyketsos C, Pollock B, Rabins P, Rosenheck R, Small G, Stroup S, Davis CE, Ferris S, Hsiao J, Krishnan R, Lieberman J, Mittelman M, Mohs R, Perkins D, Swartz M. Comparative Effectiveness of Antipsychotic Medications in patients with Alzheimer's Disease. Clinicaltrialsgov 2000a.
DeDeyn 2003 {published data only}
    1. Anon. Aripiprazole improves psychotic symptoms in Alzheimer's disease outpatients. http://mblcommunications.com/newsdetail.php3?id=90 2003h.
    1. Anon. Safety experience in elderly patients with psychosis associated with Alzheimer's disease. http://www.healthscout.com/rxdetail/68/101/3/main.html 2003g.
    1. Anon. Study of aripiprazole in the treatment of patients with psychosis associated with dementia of the Alzheimer's type. Clinicaltrials.gov 2003b.
    1. Breder C, Deyn PP, Jeste DV, Auby P, Carson W, Marcus R, Kujawa M, McQuade RD, Schneider LS, Mintzer J. Aripiprazole for psychosis of Alzheimer's disease. NCDEU Poster abstacts 2003, issue Poster session II‐65.
    1. Darves B. Aripiprazole Effective in Reducing Psychotic Symptoms Associated with AD‐related Dementia. Annual Meeting of the American Association for Geriatric Psychiatry, Honolulu, Hawai, March 2003. 2003.
F1D‐MC‐HGAO/Satterle {published data only}
    1. Satterlee WG, Reams SG, Burns PR, Hamilton S, Tran PV, Tollefson GD. A clinical update on olanzapine treatment in schizophrenia and in elderly Alzheimer's disease patients. Psychopharmacology Bulletin 1995;31:534.
F1D‐MC‐HGEU/Clark/St {published data only}
    1. Clark W, Street J, Sanger T, Breier A. Reduction of psychotic symptoms in patients with lewy body like symptoms treated with olanzapine. Proceedings of the Annual Scientific Meeting of the American Geriatric Society and the American Federation for Aging Research; 2000 May 17‐21, Nashville. 2000e:176.
    1. Clark WS, Street J, Gannon KS, Sanger T, Breier A. Reduction of psychotic symptoms in patients with lewy‐body‐like‐symptoms treated with olanzapine. European Journal of Neurology 1999a;6(Suppl 3):27.
    1. Clark WS, Street J, Gannon KS, Sanger T, Tollefson GD, Breier A. Olanzapine in the prevention of psychosis among nursing home patients with behavioral disturbances associated with Alzheimer's disease. Journal of the European College of Neuropsychopharmacology 1999c;9(suppl 5):S332.
    1. Clark WS, Street J, Gannon KS, Sanger T, Tollefson GD, Breier A. Olanzapine in the prevention of psychosis among nursing home patients with behavioral disturbances associated with alzheimer's disease. European Journal of Neurology 1999b;6(Suppl 3):115.
    1. Clark WS, Street J, Sanger T, Breier A. Olanzapine in the prevention of psychosis among nursing home patients with behavioral disturbances associated with alzheimer's disease. Proceedings of the Annual Scientific Meeting of the American Geriatric Society and the American Federation for Aging Research; 2000 May 17‐21, Nashville. 2000a:144.
F1D‐MC‐HGGU/Deberdt {published data only}
    1. Deberdt WG, Dysken MW, Rappaport SA, Feldman PD, Young CA, Hay DP, Lehman DL, Dossenbach M, Degenhardt EK, Breier A. Comparison of olanzapine and risperidone in the treatment of psychosis and associated behavioral disturbances in patients with dementia. American Journal of Geriatric Psychiatry 2005;13(8):722‐730. - PubMed
    1. Eli Lilly Inc. Olanzapine versus Risperidone and Placebo in the Treatment of Psychosis and Associated Behavioral Disturbances in Patients with Dementia. http//www.ifpma.org/clinicaltrials.html 2005:1‐38.
F1D‐MC‐HGIV/DeDeyn {published data only}
    1. Deyn PP, Carrasco MM, Deberdt W, Jeandel C, Hay DP, Feldman PD, Young CA, Lehman DL, Breier A. Olanzapine versus placebo in the treatment of psychosis with or without associated behavioral disturbances in patients with Alzheimer's disease. International Journal of Geriatric Psychiatry 2004;19(2):115‐26. - PubMed
RIS‐INT‐24/DeDeyn {published data only}
    1. DeDeyn P. Risperidone in the treatment of behavioral disturbances in dementia. Proceedings of the 8th Congress of the International Psychogeriatric Association: Jerusalem, Israel, August 17‐22, 1997. 1997a:10.
    1. DeDeyn P, Lemmens P, Smedt D. Risperidone in the treatment of behavioral disturbances in dementia. Proceedings of the 9th Biennial Winter Workshop on Schizophrenia; 1998 Feb 7‐13, Davos, Switzerland 1998c;29(1,2):145.
    1. DeDeyn P, Lemmens P, Smedt G. Risperidone in the treatment of behavioral disturbances in dementia. Proceedings of the 21st Collegium Internationale Neuropsychopharmacologium (CINP) Congress; 1998 Jul 12‐16 Glasgow, Scotland. 1998a:ABSTRACT REF: PW11025.
    1. DeDeyn P, Lemmens P, Smedt G. Risperidone in the treatment of behavioral disturbances in dementia. Proceedings of the 36th Annual Meeting of the American College of Neuropsychopharmacology; 1997 December 8‐12, Waikoloa, Hawai, USA. 1997b.
    1. DeDeyn P, Middelheim AZ, Smedt G. Risperidone in the treatment of behavioral disturbances in dementia. Proceedings of the 10th European College of Neuropsychopharmacology Congress (ECNP); 1997 Sep 13‐17, Vienna, Austria. 1997.
RIS‐USA‐232/Colon {published data only}
    1. Colon S, Figueroa C, Thein S, Siegal A, Arias B, Ganadara J, Haefner G, Segal S, Steen S, Blanchette P, Mee‐Lee D, Lindahl L, Rappaport SA, Kelsh D, Rayner A, Litman R, Shua‐Haim J, Brenner R, Calder C, Sloan B, Gupta S, Lantz M, Levy M, Lebadeva Z, Patel M, Beckett L, Cranmer K, Richter R, Ainslie G, Rosenzweig A, Mintzer J, Fuller W, Gwirtsman H, Petrie W, Barnhart B, Demmler RW, Fedro D, Frank HD, Gazda S, Lewis R, Peters P, Schiffer R, Weiner M, Williams B, Winston J, Swerdlow R, RIS‐USA‐232. Efficacy and safety of a flexible dose of risperidone versus placebo in the treatment of psychosis of Alzheimer's disease. Clinical Trials Journal 2002:1‐6.
RIS‐USA‐63/Katz {published data only}
    1. Brecher M. Follow‐up study of risperidone in the treatment of patients with dementia: Interim results on tardive dyskinesia and dyskinesia severity. Proceedings of the 11th European College of Neuropsychopharmacology Congress (ECNP); 1998 Oct 31‐Nov 4, Paris. 1998a:Abstract: P4005.
    1. Brecher M. Nursing home research from industry's perspective. International Psychogeriatrics 1996;8(Suppl 3):367‐70. - PubMed
    1. Brecher M, Clyde C, Risperidone Study Group. Risperidone in the treatment of psychosis and aggressive behavior in patients with dementia. Proceedings of the 8th Congress of the International Psychogeriatric Association: Jerusalem, Israel, August 17‐22, 1997. 1997:10.
    1. Brecher M, Katz I, Clyde C, The Risperidone Study Group. Risperidone in the treatment of psychosis and aggressive behavior. Proceedings of the 21st Collegium Internationale Neuropsychopharmacologium (CINP) Congress; 1998 Jul 12‐16 Glasgow, Scotland. 1998b.
    1. Brecher M, Okamoto A, Napolitano J, Kane JM, Risperidone Study Group. Low frequency of tardive dyskinesia in elderly patients with dementia exposed to risperidone for up to one year. American Journal of Geriatric Psychiatry 1999a;7(4):53‐4.
STAR/046 {published data only}
    1. Astrazeneca 1. Additional results presented. http://www.astrazeneca.com/pressrelease/2577.aspx 2004.
    1. Astrazeneca 2. Study suggests potential benefits in agitation associated with dementia. http://www.astrazeneca.com/ 2004.
    1. Tariot P. Medication helps quell the agitation of dementia. http://www.urmc.rochester.edu/pr/news/story.cfm?id=593 2004f.
Streim 2004 {published data only}
    1. Kujawa MJ, Marcus R, Breder C, Kostic D, Archibald DG, Iwamoto T, Carson WH, Yamamoto Y, Bristol‐Myers Squibb Company, Plainsboro, NJ, USA. Safety and Tolerability Profile of Aripiprazole in Elderly Patients With Psychosis of Alzheimer's Disease: A Pooled Analysis. NeuroBiology of Aging 2004;25(S2):183.
    1. Streim J, Breder C, Swanink R, McQuade R, Iwamoto T, Carson W, Stock E, The University of Pennsylvania School of Medicine, Philadelphia, PA, USA. Flexible‐Dose Aripiprazole in Psychosis of Alzheimer's Disease. NeuroBiology of Aging 2004;25(S2):191.
Tariot 2002/039 {published data only}
    1. Tariot PN, Profenno LA, Ismail MS. Efficacy of atypical antipsychotics in elderly patients with dementia. Journal of clinical psychiatry, The 2004i;65 Suppl 11:11‐5. - PubMed

References to studies excluded from this review

Allain 2003 {published data only}
    1. Allain H, Tessier T, Bentue‐Ferrer D, et al. Effects of Risperidone on psychometric and cognitive functions in healthy elderly volunteers. Psychopharmacology (Berl) 2003;165(4):419‐429. - PubMed
Beuzen 1999 {published data only}
    1. Beuzen JN, Taylor N, Wesnes K, Wood A. comparison of the effects of olanzapine, haloperidol and placebo on cognitive and psychomotor functions in healthy elderly volunteers. Journal of Psychopharmacology (Oxf) 1999;13(2):152‐158. - PubMed
Cassidy 2001 {published data only}
    1. Cassidy EL, Sheikh JI. Specific interventions for agitation in Alzheimer's disease. ClinicalTrials.gov 2001.
Chan 2001 {published data only}
    1. Chan WC, Lam LCW, Choy CNP, Leung VPY, Li SW, Chiu HFK. A double‐blind randomised comparison of risperidone and haloperidol in the treatment of behavioural and psychological symptoms in Chinese dementia patients.. Int J Geriatr Psychiatry 2001;16(12):1156‐62. - PubMed
    1. Onalaja D, Jainer AK. Re: Chan et al A double‐blind randomised comparison of risperidone and haloperidol in the treatment of behavioural and psychological symptoms in Chinese dementia patients. author reply. International Journal of Geriatric Psychiatry 2002;17(11):1076‐77. - PubMed
Davidson 2001 {published data only}
    1. Davidson M. Long‐term safety of risperidone. Journal of Clinical Psychiatry 2001;62(Suppl 21):26‐28. - PubMed
Defilippi 2000 {published data only}
    1. Defilippi JL, Crismon ML. Antipsychotic agents in patients with dementia. Pharmacotherapy 2000; Vol. 20, issue 1:23‐33. - PubMed
Devanand 1996 {published data only}
    1. Devanand DP. Antipsychotic treatment in outpatients with dementia. International Psychogeriatrics 1996;8(Suppl 3):355‐61. - PubMed
Devanand 1998 {published data only}
    1. Devanand, DP, Michaels K, Sackeim HA, Marder K, Mayeux RP. Antipsychotics in the treatment of dementia complicated by Psychosis. Conference proceedings 151st Annual Meeting of the American Psychiatric Association.; 30th May‐4th June, 1998; Toronto, Ontario, Canada. 1998:No. 27D.
Ebell 2000 {published data only}
    1. Ebell M. Which is most effective for managing the behavioral symptoms of dementia: risperidone or haloperidol?. Evidence‐Based‐Practice 2000;3(1):2‐3.
F1D‐MC‐HGHX {published data only}
    1. Clinical Study Summary: Study F1D‐MC‐HGHX.
Fontaine 2003 {published data only}
    1. Fontaine CS, Hynan LS, Koch K, Martin Cook K, Svetlik D, Weiner MF. A double‐blind comparison of olanzapine versus risperidone in the acute treatment of dementia‐related behavioral disturbances in extended care facilities. Journal of Clinical Psychiatry 2003;64(6):726‐30. - PubMed
Grossberg 1997 {published data only}
    1. Buckley P, Cutler N, Silber C, O'Neil J, Mack R. The safety and tolerability of Sertindole in elederly patients with dementia. Schizophrenia Research 1997;24(1‐2):201.
    1. Cutler N, Sramek J, Kurtz N, Jhee S, O'Neil I, Mack R. The safety and tolerability of Sertindole in Elderly Patients with Dementia. Proceedings of the 10th Annual Meeting and Symposium of the American Academy of Geriatric Psychiatry; 1997 Mar 2‐5, Orlando. 1997:3.
    1. Grossberg GT, Cutler NR, Silber C, O'Neil J, Mack R. Sertindole Treatment in Elderly Patients with Dementia. Proceedings of the 150th Annual Meeting of the American Psychiatric Association; 1997 May 17‐22, San Diego. 1997.
Hoeltmann 2002 {published data only}
    1. Hoeltmann BJ, Delius‐Stute H, Rettig K, Schwalen S. Less daytime sedation, dizziness and abnormal gait under risperidone in comparison with melperone. Proceedings of the 8th International Conference on Alzheimer's Disease and Related Disorders; 2002 July 20‐25, Stockholm, Sweden. 2002:Abstract No 347.
Howard 2003 {published data only (unpublished sought but not used)}
    1. Howard R, Bullock R, Burns A, Lindesay J, O'Brien JT. The CALM‐AD trial ‐ a randomised clinical trial of a cholinesterase inhibitor and atypical antipsychotic in the management of agitation in dementia. National Research Register.
Jones 2000 {published data only}
    1. Jones B, Wang H, David SR, Nisivoccia JR, Beasley CM, Meehan KM. A double‐blind, placebo‐controlled study of short‐acting intramuscular olanzapine and lorazepam in acutely agitated patients with dementia. Proceedings of the 39th Annual Meeting of the American College of Neuropsychopharmacology (ACNP); 2000 Dec 10‐14, San Juan, Puerto Rico. 2000:190.
Lavretsky 1998 {published data only}
    1. Lavretsky H, Sultzer D. A structured trial of risperidone for the treatment of agitation in dementia. American Journal of Geriatric Psychiatry 1998; Vol. 6, issue 2:127‐35. - PubMed
Legangneux 1998 {published data only}
    1. Legangneux E, McEwen J, Wesnes K, et al. Effects of low doses of amisulpride on psychomotor and memory performances in healthy elderly subjects. Proceedings of the 11th European College of Neuropsychopharmacology Congress (ECNP); 1998 Oct 31‐Nov 4, Paris. 1998:Abstr P.2.004.
McKeith 2000 {published data only}
    1. McKeith IG, Daniel S, Ballard CG, Swann A, Fairbairn AF, Perry EK. Recent advances in therapy in dementia with lewy bodies. Proceedings of the International Psychogeriatric Association Conference (Non‐Alzheimer Cognitive Impairment); 2000 Apr 4‐7, Newcastle upon Tyne. 2000.
Meehan 2001 {published data only}
    1. Jones B, Wang H, David SR, Nisivoccia JR, Beasley CM, Meehan KM. A double‐blind, placebo‐controlled study of short‐acting intramuscular olanzapine and lorazepam in acutely agitated patients with dementia. Proceedings of the 39th Annual Meeting of the American College of Neuropsychopharmacology (ACNP); 2000 Dec 10‐14, San Juan, Puerto Rico. 2000:190.
    1. Meehan KM, Wang H, David JR, Nisivoccia, Jones B, Beasley CM, Fieldman A, Breier A. A double‐blind, placebo‐controlled study of rapid‐acting intramuscular olanzapine and lorazepam in acutley agitated patients with dementia. Journal of the American Geriatrics Society 2001b;49(4):S92. - PubMed
    1. Meehan KM, Wang H, David SR, Nisivoccia JR, Jones B, Beasley CM Jr, Feldman PD, Breier A. A double‐blind, placebo‐controlled study of intramuscular (IM) olanzapine and IM lorazepam in acutely agitated patients with dementia. Biological Psychiatry 2001a;49(8 Suppl 1):55S. - PubMed
    1. Meehan KM, Wang H, David SR, Nisivoccia JR, Jones B, Beasley CM Jr, Feldman PD, Mintzer JE, Beckett LM, Breier A. Comparison of rapidly acting intramuscular olanzapine, lorazepam, and placebo: a double‐blind, randomized study in acutely agitated patients with dementia. Neuropsychopharmacology 2002;26(4):494‐504. - PubMed
    1. Meehan KM, Wang H, David SR, Nisivoccia JR, Jones B, Beasley CM, Feldman PD, Breier A. A double‐blind, placebo‐controlled study of short‐acting intramuscular olanzapine and lorazepam in acutely agitated patients with dementia. Proceedings of the 14th Annual Meeting of the American Association for Geriatric Psychiatry; 2001 Feb 23‐26, San Francisco. 2001c.
Meguro 2004 {published data only}
    1. Meguro K, Meguro M, Tanaka Y, Akanuma K, Yamaguchi K, Itoh M. Risperidone is effective for wandering and disturbed sleep/wake patterns in Alzheimer's disease. Journal of geriatric psychiatry and neurology 2004;17(2):61‐7. - PubMed
Mintzer 2002b {published data only}
    1. Mintzer J, Meehan K, Wang H, et al. A double‐blind, placebo‐controlled study of rapid‐acting intramuscular olanzapine and lorazepam in acutely agitated patients with dementia. Proceedings of the 8th International Conference on Alzheimer's Disease and Related Disorders; 2002 July 20‐25, Stockholm, Sweden. 2002, issue Abstr 133.
Parsa 2000 {published data only}
    1. Parsa MA, Poggi E, Barte L. Treatment of dementia patients with psychotic and behavioural symptoms with quetiapine and donepezil. Journal of the European College of Neuropsychopharmacology. Proceedings of the 13th ECNP Congress; 2000 Jul 9‐13, Munich 2000; Vol. 10, issue Suppl 3:S302.
Pesco 2000 {published data only}
    1. Pesco‐Koplowitz L, Parier JL, Zhao Q, Heron J. Pharmacokinetics of risperidone/donepezil combination. Biological Psychiatry 2000;47:167S.
Ruggiero 1997 {published data only}
    1. Ruggiero U, Ovallesco V, Pizza V, Agresta A, Colucci D'amato C. Clozapine and validation therapy in the treatment of dementia. Functional Neurology 1997;12(3‐4):240‐1.
Slawson 2001 {published data only}
    1. Slawson DC. Is olanzapine effective in the treatment of agitation/aggression and psychosis in patients with Alzheimer disease (AD)?. Evidence Based Practice 2001;4(1):5‐6.
Tariot 2000 {published data only}
    1. Tariot PN, Salzman C, Yeung PP, Pultz J, Rak IW. Long‐term use of quetiapine in elderly patients with psychotic disorder. Clinical‐Therapeutics 2000; Vol. 22, issue 9:1068‐84. - PubMed
Weiser 2002 {published data only}
    1. Weiser M, Davidson M, Rotmensch H, et al. A pilot randomized open‐label trial assessing safety and pharmacokinetic parameters of co‐adminstration of rivastigmine with risperidone in dementia patients with behavioral disturbances. Proceedings of the 8th International Conference on Alzheimer's Disease and Related Disorders; 2002 July 20‐25, Stockholm, Sweden. 2002:abstract 633. - PubMed
    1. Weiser M, Rotmensch HH, Korczyn AD, et al. A pilot, randomized, open‐label trial assessing safety and pharmakokinetic parameters of co‐administration of rivastigmine with risperidone in dementia patients with behavioral disturbances. International Journal of Geriatric Psychiatry 2002;17(4):343‐6. - PubMed
Williams 2000 {published data only}
    1. Williams H, Clarke R, Bouras N, Martin J, Holt G. Use of the atypical antipsychotics Olanzapine and Risperidone in adults with intellectual disability. Journal of Intellectual Disability Research 2000; Vol. 44, issue 2:164‐9. - PubMed
Wolfgang 1999 {published data only}
    1. Wolfgang SA. Olanzapine in whole, not half, tablets for psychosis from Alzheimer's dementia [letter]. American Journal of Health System Pharmacy 1999;56(21):2245‐6. - PubMed

References to studies awaiting assessment

DeDeyn 1999b {published data only}
    1. Deyn PP, Brecher M, DeSmedt G. Risperidone in 969 patients with dementia. XI World Congress of Psychiatry , Hamburg, August 6‐11, 1999. 1999b:Abstracts Volume II:70.

References to ongoing studies

Ballard 2002 {published data only}
    1. No information. Ongoing study Starting date of trial not provided. Contact author for more information.
Blanchard 2000 {published data only}
    1. Blanchard MR. Risperidone in the treatment of behavioural disturbances in dementia. National Research Register 2000.
No Author 2000 b {published data only}
    1. No author. Risperidone vs Olanzapine vs Placebo (ORP): Alzheimer's Disease with Psychosis. John Hospkins University Clinical Trials Database 2000j. [MEDLINE: ]
No author 2000 g {published data only}
    1. Anon. A study to evaluate Olanzapine for Alzheimer's disease. Centerwatch 2000n.
No Author 2004 f {published data only}
    1. Anon. A Safety & Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed with Dementia. Clinicaltrials.gov 2004i.
Pellegrino 2000 {published data only}
    1. Pellegrino M. A 10‐week, double‐blind, comparative study evaluation of the effectiveness of Risperidone versus Olanzapine to placebo in patients with Alzheimer's Dementia. Centerwatch 2000. [MEDLINE: ]

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References to other published versions of this review

Ballard 2006
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