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 |
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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 |
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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 |
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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 |