Tariot 2009.
| Methods | Double‐blind, randomized, placebo controlled trial | |
| Participants | ‐ aged 50 years or older ‐ diagnosis of Alzheimer's disease according to DSM‐IV‐TR and NINCDS‐ADRDA criteria ‐ stable on 10 mg donepezil (and no other ChEIs or memantine) for at least 60 days prior to enrolment ‐ not currently taking H1 receptor antihistamines, dextromethorphan or narcotic analgesics within 15 days prior to enrolment |
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| Interventions | Participants were randomized to either: ‐ latrepirdine (20 mg PO TID) for 28 days ‐ matched placebo Enrolment: 24 patients randomized (15 to latrepirdine, 9 to placebo) |
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| Outcomes | Safety and tolerability ‐ discontinuation ‐ frequency and severity of adverse events ‐ changes in vital signs ‐ changes in laboratory values ‐ changes in ECG results |
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| Notes | Funding: Medivation Inc. and Pfizer Inc. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomized to treatment with dimebon or placebo in an approximately 2:1 ratio" |
| Allocation concealment (selection bias) | Unclear risk | This information has not been made available |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "double‐blind" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "double‐blind" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Only one subject dropped out of the study, though the reasons were not provided |
| Selective reporting (reporting bias) | High risk | The authors did not report on all safety outcome measures in their poster presentation of this study |
| Other bias | Unclear risk | There were no other major sources of bias |