CONCERT.
| Methods | Multi‐centre, double‐blind, randomized, placebo controlled trial | |
| Participants | ‐ aged 50 years or older ‐ diagnosis of probable Alzheimer's disease according to DSM‐IV‐TR and NINCDS‐ADRDA criteria ‐ MMSE between 12 and 24 ‐ stable on donepezil for at least 6 months |
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| Interventions | Participants were randomized to either: ‐ latrepirdine (5 mg PO TID) ‐ latrepirdine (10 mg PO TID for 1 week followed by 20 mg PO TID until endpoint) ‐ matched placebo Duration: 52 weeks Enrolment: 662 patients randomized (322 to latrepirdine, 340 to placebo) |
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| Outcomes | Primary ‐ ADAS‐Cog (cognition) ‐ ADCS‐ADL (daily function) Secondary ‐ CIBIC‐Plus (global function) ‐ RUD‐lite ‐ NPI (behaviour) ‐ EQ‐5 (quality of life) ‐ MMSE (cognition) |
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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" |
| 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 (subject, care‐giver, investigator)" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "double‐blind (subject, care‐giver, investigator)" |
| Incomplete outcome data (attrition bias) All outcomes | High risk | This information has not been made available |
| Selective reporting (reporting bias) | High risk | The data reported in Cano‐Cuenca 2014 included the pre‐determined primary outcome measures (ADCS‐ADL and ADAS‐Cog). However, some secondary outcomes (CIBIC‐Plus, RUD lite, EQ‐5D) as well as safety and tolerability data were not reported |
| Other bias | Unclear risk | As the study has not been published by the study investigators and the information available in ClinicalTrials.gov is limited, we are not able to evaluate other sources of bias |