Peters 2012
| Methods | 2 year, multicentre, double‐blinded, placebo‐controlled study terminated early following publication of increased mortality in galantamine trials in MCI (Johnson & Johnson 2005b; Winblad 2008 (combined)) | |
| Participants | Country: Germany 12 sites 232 individuals recruited Mean (sd) age: placebo 67.2 (7.6), galantamine 67.9 (8.3), galantamine + memantine 67.3 (7.7) Selection criteria: (A) complaint about decline in cognitive ability, (B) deficits in at least one of the domains learning/memory, language, attention and visuoconstructional ability of the CERAD battery, (C) general intellectual functioning unimpaired, (D) ADLs normal (BAYER‐ADL < 4), (E) CDR = 0.5. Also: availability of a consistent informant, and sufficient visual, hearing and communication capabilities Exclusion criteria: other clinically significant medical, psychiatric, neurodegenerative or intracerebral diseases |
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| Interventions | 1. Placebo 2. Galantamine 8 mg bd 3. Galantamine 8 mg bd + memantine 10 mg bd |
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| Outcomes | Primary outcomes: Development of dementia ADAS‐Cog Other measures: CERAD Wechsler Memory Scale revised Clock Drawing test Trail Making Test A and B |
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| Notes | Trial terminated early Change in ADAS‐Cog reported as median and quartiles therefore not included in meta‐analysis |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation procedure not defined |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment not outlined: "Provided all entry criteria were met, randomization occurred immediately before administration of study medication" |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Investigators blind. Double‐dummy technique used |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis conducted |
| Selective reporting (reporting bias) | Low risk | Does not report conversion rates to dementia but trial significantly shorter than planned |
| Other bias | Low risk | No additional biases |