Salloway 2004

Methods	24‐week, multi‐centre, randomised, double‐blind, placebo‐controlled, parallel group study
Participants	Country: USA 22 centres 270 individual randomised, aged 55 to 89 years Selection criteria: generally healthy, living independently and capable of complying with testing procedures. Documented memory complaint, MMSE ≥ 24, CDR = 0.5, ADLs normal or only slightly impaired, delayed paragraph recall test (WMS‐R) below education‐matched norms and modified Hachinski ≤ 4 Exclusion criteria: HAM‐D > 12, possible or probably AD, drug or alcohol abuse/dependence in the last 5 years, poorly controlled diabetes or other medical conditions, or previous treatment with a cholinesterase inhibitor
Interventions	1. Donepezil 5 mg/day increased to 10 mg after 42 days 2. Placebo
Outcomes	Change from baseline in NYU paragraph test delayed recall CGIC‐MCI Modified ADAS‐Cog WMS‐R digit span backwards test Symbol digit modalities test NYU Paragraph test immediate recall Neuropsychological test battery (Modified Boston naming, verbal fluency, maze and number cancellation tests) Patient Global Assessment
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomised"
Allocation concealment (selection bias)	Unclear risk	Quote: "randomised in a 1:1 ratio" Quote: "double‐blind"
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Quote: "double‐blind"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Efficacy analyses used last observation carried forward in 3 populations, including "observed cases" and the "fully evaluable" population
Selective reporting (reporting bias)	Low risk	All outcomes reported
Other bias	Low risk	No additional biases