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. 2012 Sep 12;2012(9):CD009132. doi: 10.1002/14651858.CD009132.pub2

Narasimhalu 2010

Methods 24‐week investigator‐initiated, single‐centre, double‐blind, randomised placebo‐controlled trial
Participants Country: Singapore
154 individuals screened 3 months after an ischaemic stroke, aged 55 to 85 years
50 individuals randomised
Selection criteria: impaired in at least 1 cognitive domain but were not considered to fulfil DSM‐IV criteria for dementia at a multidisciplinary consensus conference, neuroradiologist confirmed cerebrovascular disease was present on MRI
Exclusion criteria: advanced, severe or unstable disease of any kind, major depression according to DSM‐IV, a disability that may prevent participation in the study, known sensitivity to cholinergic compounds, ingestion of drugs that could interfere with the trial in the previous 4 weeks, and ingesting metrifonate in the preceding 3 months
Interventions 1. Rivastigmine 1.5 mg bd increasing after a minimum of 4 weeks to 3 mg bd and subsequently to 4.5 mg bd. Flexible dosing regimen apart from 4‐week minimum before increases
2. Placebo
Outcomes Change from baseline in Clock test and Colour Trails Test
Change from baseline in ADAS‐Cog and neuropsychological test battery (MMSE, cognitive battery, FAB)
ADCS‐ADL scale for MCI
GDS
NPI
Notes All patients had MCI following a stroke therefore are not comparable with participants in other studies
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was by the pharmaceutical company's "validated system" approved by a Biostatistics Quality Assurance Group
Allocation concealment (selection bias) Low risk Quote: "A trial coordinator blind to the treatment allocation randomized each patient"
Blinding (performance bias and detection bias) All outcomes Low risk All investigators were blind to treatment allocation
Incomplete outcome data (attrition bias) All outcomes Low risk While only 36/50 people completed the trial, almost all were included in analyses
Selective reporting (reporting bias) Low risk All outcomes reported on
Other bias Low risk No additional biases