Table 1 Characteristics of included studies
|
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. |