PMID- 18591574
OWN - NLM
STAT- MEDLINE
DCOM- 20080828
LR  - 20220409
IS  - 1545-7214 (Electronic)
IS  - 1064-7481 (Linking)
VI  - 16
IP  - 7
DP  - 2008 Jul
TI  - A randomized, double-blind, placebo-controlled study of aripiprazole for the 
      treatment of psychosis in nursing home patients with Alzheimer disease.
PG  - 537-50
LID - 10.1097/JGP.0b013e318165db77 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of aripiprazole treatment for 
      psychotic symptoms associated with Alzheimer disease (AD). METHODS: In this 
      parallel group, randomized, double-blind, placebo-controlled, flexible-dose 
      trial, institutionalized subjects with AD and psychotic symptoms were randomized 
      to aripiprazole (n = 131) or placebo (n = 125) for 10 weeks. The aripiprazole 
      starting dose was 2 mg/day, and could be titrated to higher doses (5, 10, and 15 
      mg/day) based on efficacy and tolerability. RESULTS: No significant differences 
      in mean change [2 x SD] from baseline between aripiprazole (mean dose 
      approximately 9 mg/day at endpoint; range = 0.7-15.0 mg) and placebo were 
      detected in the coprimary efficacy endpoints of Neuropsychiatric 
      Inventory-Nursing Home Version (NPI-NH) Psychosis score (aripiprazole, -4.53 
      [9.23]; placebo, -4.62 [9.56]; F = 0.02, df = 1, 222, p = 0.883 [ANCOVA]) and 
      Clinical Global Impression (CGI)-Severity score (aripiprazole, -0.57 [1.63]; 
      placebo, -0.43 [1.65]; F = 1.67, df = 1, 220, p = 0.198 [ANCOVA]) at endpoint. 
      However, improvements in several secondary efficacy measures (NPI-NH Total, Brief 
      Psychiatric Rating Scale Total, CGI - improvement, Cohen-Mansfield Agitation 
      Inventory and Cornell Depression Scale scores) indicated that aripiprazole may 
      confer clinical benefits beyond the primary outcome measures. Treatment-emergent 
      adverse events (AEs) were similar in both groups, except for somnolence 
      (aripiprazole, 14%; placebo, 4%). Somnolence with aripiprazole was of mild or 
      moderate intensity, and not associated with accidental injury. Incidence of AEs 
      related to extrapyramidal symptoms was low with aripiprazole (5%) and placebo 
      (4%). CONCLUSIONS: In nursing home residents with AD and psychosis, aripiprazole 
      did not confer specific benefits for the treatment of psychotic symptoms; but 
      psychological and behavioral symptoms, including agitation, anxiety, and 
      depression, were improved with aripiprazole, with a low risk of AEs.
FAU - Streim, Joel E
AU  - Streim JE
AD  - Section on Geriatric Psychiatry, University of Pennsylvania, Philadelphia, PA 
      19104-3309, USA. jstreim@mail.med.upenn.edu
FAU - Porsteinsson, Anton P
AU  - Porsteinsson AP
FAU - Breder, Christopher D
AU  - Breder CD
FAU - Swanink, Rene
AU  - Swanink R
FAU - Marcus, Ronald
AU  - Marcus R
FAU - McQuade, Robert
AU  - McQuade R
FAU - Carson, William H
AU  - Carson WH
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Am J Geriatr Psychiatry
JT  - The American journal of geriatric psychiatry : official journal of the American 
      Association for Geriatric Psychiatry
JID - 9309609
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Piperazines)
RN  - 0 (Quinolones)
RN  - 82VFR53I78 (Aripiprazole)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Alzheimer Disease/*drug therapy
MH  - Antipsychotic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Aripiprazole
MH  - Behavioral Symptoms/*drug therapy
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nursing Homes
MH  - Piperazines/administration & dosage/adverse effects/*therapeutic use
MH  - Psychotic Disorders/*drug therapy
MH  - Quinolones/administration & dosage/adverse effects/*therapeutic use
MH  - United States
EDAT- 2008/07/02 09:00
MHDA- 2008/08/30 09:00
CRDT- 2008/07/02 09:00
PHST- 2008/07/02 09:00 [pubmed]
PHST- 2008/08/30 09:00 [medline]
PHST- 2008/07/02 09:00 [entrez]
AID - 16/7/537 [pii]
AID - 10.1097/JGP.0b013e318165db77 [doi]
PST - ppublish
SO  - Am J Geriatr Psychiatry. 2008 Jul;16(7):537-50. doi: 
      10.1097/JGP.0b013e318165db77.