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Table 1 Characteristics of included studies

From: Efficacy and safety of pharmacotherapy for Alzheimer’s disease and for behavioural and psychological symptoms of dementia in older patients with moderate and severe functional impairments: a systematic review of controlled trials

  Study
(Author, year)
Duration Sample size (n) Age of study population
(IG/CG)
Baseline MMSE
(IG/CG)
Intervention Endpoints Results
AChEI Burns et al., 2009 [57] 6 months 407 83.7/83.5 8.8/9.1 Galantamine:
24 mg/day target dose (12 mg twice a day). Dose reduction to 8 mg twice a day to improve tolerability was possible.
Placebo.
MDS-ADL, SIB Significantly improved cognitive function. No significant improvement in the co-primary outcome of ADLs.
Tariot et al., 2001 [58] 24 weeks 208 85.4/85.9 14.4 Donepezil:
10 mg/day target dose. Dose reduction to improve tolerability was possible.
Placebo.
CDR-SoB, MMSE, NPI-NH, PSMS Donepezil-treated patients improved or maintained in cognition. Impact of donepezil on BPSD remains unclear.
Antidepressants Petracca et al., 1996 [59]
(cross-over trial)
2 × 6 week treatment period, separated by a 2-week wash-out period 24 71.5/72.4 21.0/22.1 Clomipramine: 100 mg/day target dose.
Placebo.
FIM, HAM-D, MMSE Clomipramine was significantly more effective in lowering depression scores compared to placebo. No changes in ADL measures.
Petracca et al., 2001 [56] 6 weeks 41 70.2/71.3 23.2 Fluoxetine:
40 mg/day target dose.
Placebo.
CGI-I, FIM, HAM-A, HAM-D, MMSE No significant differences in treatment effects on depression comparing fluoxetine and placebo.
Anticonvulsants Olin et al., 2001 [60] 6 weeks 21 74.7 5.9/6.1 Carbamazepine: 400 mg/day target dose.
Placebo.
BPRS, CGI-I, HAM-D, IADL, MMSE, PSMS Modest clinical benefit in global impression and a particular benefit for hostile behaviour in carbamazepine-treated patients was shown.
Porsteinsson et al., 2001 [61] 6 weeks 56 85.3/84.7 7.0/6.7 Carbamazepine: 375 mg/day starting dose, followed by flexible dose regimen.
Placebo.
BPRS, CERAD BRSD, CGI-I, MMSE, OAS, PSMS Possible short-term efficacy of valproate in reduction of agitation in patients with dementia in the nursing home.
Tariot et al., 1994 [62]
(cross-over trial)
2 × 5 week treatment period, separated by a 2 week wash-out period 25 84.5 7.6 Carbamazepine: 100–800 mg/day based on physician’s review. BPRS, CGI-I, DMAS, MMSE, OAS, PSMS Short-term therapy with Carbamazepine may have beneficial effects on BPSD in patients with dementia and agitation (significant reduction in BPRS total score).
Tariot et al., 1998 [63] 6 weeks 51 87.1/84.8 3.9/8.3 Carbamazepine: 100 mg/day starting dose, increased by 50 mg/day every 2–4 days; in the absence of toxicity a serum level of 5–8 μg/ml was maintained.
Placebo.
BPRS, CERAD BRSD, CGI-I, MMSE, PSMS Carbamazepine showed significant short-term efficacy for agitation. Significant reduction of the BPRS agitation and hostility factor compared with placebo.
Antipsychotics Tariot et al., 2006 [64] 10 weeks 284 Q: 81.9
H: 83.6
P: 83.9
Q: 12.4
H: 12.7
P: 13.2
Quetiapine:
100 mg/day target dose, maximum dose of 600 mg/day according to clinical response and tolerability
Haloperidol:
2 mg/day target dose, maximum dose of 12 mg/day according to clinical response and tolerability.
Placebo.
AIMS, BPRS, CGI-S, MMSE, MOSES, NPI-NH, PSMS, SAS No significant improvement in BPRS total scores. Inconsistent significant improvement in some parts of BPSD for haloperidol treated patients. Tolerability was better for quetiapine compared with haloperidol.
Antipsychotics/antidepressants Teranishi et al., 2013 [65] 8 weeks 82 R: 80.7
F: 83.2
Y: 83.5
R: 5.2
F: 4.5
Y: 4.4
Flexible oral dosing regimen.
Risperidone:
0.5–2 mg/day target dose.
Fluvoxamine:
25–200 mg/day target dose.
Yokukansan: 2.5–7.5 g/day target dose.
DIEPSS, FIM, MMSE, NPI-NH NPI-NH scores decreased in all three groups with no significant differences.
Tolerability for yokukansan and quetiapine seemed to be more favourable than for risperidone.
  1. CG control group, F fluvoxamine, H haloperidol, IG intervention group, P placebo, Q quetiapine, R risperidone, Y yokukansan; Endpoints: AIMS Abnormal Involuntary Movement Scale, BPRS Brief Psychiatric Rating Scale, CDR-SoB Clinical Dementia Rating – Sum of Boxes, CERAD BRSD Behavior Rating Scale for Dementia of the Consortium to Establish a Registry for Alzheimer’s Disease, CGI-I, Clinical Global Impression of Improvement, CGI-S Clinical Global Impression of Illness Severity, DIEPSS Drug-Induced Extra-Pyramidal Symptom Scale, DMAS Dementia Mood Assessment Scale, FIM Functional Independence Measure, HAM-A/-D Hamilton Rating Scale for Anxiety/Depression, IADL instrumental activities of daily living by Lawton and Brody, MDS-ADL, Minimum Data Set – Activities of Daily Living, MMSE Mini-Mental State Examination, MOSES Multidimensional Observation Scale for Elderly Subjects, NPI-NH Neuropsychiatric Inventory – Nursing Home Version, OAS Overt Aggression Scale, PSMS Physical Self-Maintenance Scale, SAS Simpson-Angus Scale, SIB Severe Impairment Battery