| Methods | Allocation: randomisation Blindness: double blind Duration: 36 weeks |
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| Participants | Diagnosis: Alzheimer’s dementia. N=36 Age: Mean 72.5, SD 8.4, range 56-87 years Sex: F 15, M 17 Setting:Australia Inclusion: diagnosis of probable AD using NINCDS-ADRDA, an ADAS-Cog score of 20-45, an MMSE score of between 10-24 and having been on donepezil 5-10 mg for over six months |
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| Interventions | Clioquinol started at 125 mg twice daily from weeks 1 to 12, 250 mg daily from weeks 13 to 24, and 375 mg twice daily from weeks 25 to 36 | |
| Outcomes | Primary outcome: change from the baseline ADAS-Cog at weeks 4, 12, 24 and 36 Secondary outcomes: ADAS-NC, MMSE, CIBIC Plasma Aß, zinc and copper levels | |
| Notes | Plasma Aß, zinc, and copper levels were measured every 4 weeks | |
| Risk of bias | ||
| Bias | Authors’ judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Details not given in the paper |
| Allocation concealment (selection bias) | Unclear risk | Details not given in the paper |
| Blinding of participants and personnel (performance bias) All outcomes |
Low risk | Study is described as double blind |
| Blinding of outcome assessment (detection bias) All outcomes |
Low risk | Study is described as double blind |
| Incomplete outcome data (attrition bias) All outcomes |
Unclear risk | No information given on subjects who did not complete the trial |
| Selective reporting (reporting bias) | High risk | Subjects were stratified by “severity” for secondary analyses |