Winblad 2008 (Study 2)

Methods	24‐month randomised, double‐blind, parallel‐group, placebo‐controlled, flexible‐dose study
Participants	16 countries 177 sites 1058 individuals enrolled, aged 50 years or over Selection criteria: declining cognitive ability of gradual onset and slow progression, CDR = 0.5, CDR memory ≥ 0.5, and insufficient impairment of cognition and ADLs Delayed recall score ≤ 10 on NYU paragraph recall test
Interventions	1. Galantamine 4 mg bd increasing to 8 mg bd after 1 month, if tolerated. At 2 months, either 8 mg bd or 12 mg bd depending on tolerance 2. Placebo
Outcomes	CDR ADAD‐Cog/MCI DSST ADCS‐ADL/MCI
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	See above for comments on paper reporting studies 1 and 2
Allocation concealment (selection bias)	Unclear risk	See above for comments on paper reporting studies 1 and 2
Blinding (performance bias and detection bias) All outcomes	Unclear risk	See above for comments on paper reporting studies 1 and 2
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	See above for comments on paper reporting studies 1 and 2
Selective reporting (reporting bias)	Unclear risk	See above for comments on paper reporting studies 1 and 2
Other bias	Unclear risk	See above for comments on paper reporting studies 1 and 2

AD: Alzheimer's disease; ADAS‐Cog: Alzheimer's Disease Assessment Scale‐Cognitive subscale; ADCS‐ADL: Alzheimer's Disease Co‐operative Study ‐ Activities of Daily Living Inventory; ADL: activities of daily living; bd: twice daily; BDI: Beck Depression Inventory; CDR: Clinical Dementia Rating; CERAD: Consortium to Establish a Registry for Alzheimer's Disease; DSST: Digit symbol substitution test ; GDS: Geriatric Depression Scale; CGIC‐MCI: Clinical Global Impression of Change Scale for Mild Cognitive Impairment; CT: computerised tomography; DSM‐IV‐TR: Diagnostic and Statistical Manual of Mental Disorders, 4th edition ‐ text revision; FAB: Frontal Assessment Battery; FAQ: Functional Assessment Questionnaire; GDS: Global Deterioration Scale; HAM‐D: Hamilton Depression Rating Scale; ITT: intention to treat; IU: International Units; MCI: mild cognitive impairment; MMSE: Mini Mental State Examination; MRI: magnetic resonance imaging; NINCDS‐ADRDA: National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association; NPI: Neuropsychiatric Inventory; NYU: New York University; SD: standard deviation; TIA: transient ischaemic attack; WMS‐R: Wechsler Memory Scale‐Revised.