Winblad 2008 (Study 1)
| Methods | 24‐month randomised, double‐blind, parallel‐group, placebo‐controlled, flexible‐dose study | |
| Participants | 16 countries 177 sites 990 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 |
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| 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 |
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| Outcomes | CDR ADAS‐Cog/MCI DSST ADCS‐ADL/MCI |
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| 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 |