NCT00287742 2006.

Study characteristics
Methods	Study design: randomised controlled trial Study grouping: parallel group Study duration: 8 weeks Rescue medication: no information provided
Participants	Number randomised: 33 (13 risperidone, 17 placebo, 3 unclear) Mean age: unclear, around 77 years Sex (female): 77% Type of dementia: Alzheimer's dementia Severity of dementia: moderate Indication: psychosis Setting: In‐ or outpatients Country: Japan
Interventions	Intervention characteristics Risperidone dosage: flexible dose regimen of 0.5 mg to 2.0 mg daily in 2 doses Placebo
Outcomes	Psychosis: Behavioural Pathology in Alzheimer's Disease (BEHAVE‐AD) psychotic symptom cluster score Extrapyramidal symptoms Any adverse event Any serious adverse event Discontinuation (any reason)
Identification
Notes	Sponsorship source: Janssen Pharmaceutical K.K.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information provided
Allocation concealment (selection bias)	Unclear risk	No information provided
Comparability of groups (selection bias)	Unclear risk	Clear difference in psychosis between groups at baseline. Other characteristics not reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	"Double‐blind" trial, but unclear who was blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"Double‐blind" trial, but unclear who was blinded.
Incomplete outcome data (attrition bias) All outcomes	High risk	Dropout was 7 of 33 (21%) in total and differed for 18% between groups. Outcomes were provided for all participants at endpoint.
Selective reporting (reporting bias)	High risk	Only BEHAVE‐AD Psychotic Symptom Cluster Score reported. Results for ADL and MMSE not reported. Early terminated trial. No full article.
Other bias	High risk	Single‐blind (with placebo) run‐in of 1 week.