Doody 2008.
| Methods | Multi‐centre, double‐blind, randomized, placebo controlled trial | |
| Participants | ‐ aged 50 years or older ‐ diagnosis of Alzheimer's disease according to DSM‐IV and NINCDS‐ADRDA criteria ‐ MMSE between 10 and 24 ‐ have not taken anti‐dementia medications (including cholinesterase inhibitors or memantine) within last 60 days |
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| Interventions | Participants were randomized to either: ‐ latrepirdine (10 mg PO TID for 1 week followed by 20 mg PO TID until endpoint) ‐ matched placebo Duration: 26 weeks with choice of extention to 52 weeks Enrolment: ‐ 183 patients randomized (89 to latrepirdine, 94 to placebo) ‐ 120 patients completed 52‐week extention (61 on latrepirdine, 59 on placebo) |
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| Outcomes | Primary ‐ 11‐item ADAS‐Cog (cognition) Secondary ‐ MMSE (cognition) ‐ NPI (behaviour) ‐ ADCS‐ADL (function) ‐ CIBIC‐Plus ‐ ADCS‐CGIC Safety ‐ adverse events |
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| Notes | Funding: Medivation Inc. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The randomisation code (one‐to‐one ratio, stratified by site, with a block size of six) was generated by Pacific Data Designs....Patients were randomly assigned to dimebon or placebo sequentially, starting from the lowest allocation number according to the computer‐generated randomisation scheme." p.208 |
| Allocation concealment (selection bias) | Low risk | "No personnel participating in the conduct of the study had access to the randomisation code" p.209 |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "no patient or study investigator was made aware of their treatment during the study" p.209 |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "no patient or study investigator was made aware of their treatment during the study" p.209 |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The reasons for withdrawal from the study were provided in the patient flowchart (p.208) and were balanced between groups |
| Selective reporting (reporting bias) | Low risk | "The protocol‐specified objectives were met, compliance with the study protocol was high" p.215. Although, it should be noted that the study protocol has not been made available by the authors |
| Other bias | Low risk | There were no other major sources of bias in the methodology |