NCT00912288.
| 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 5 and 14, inclusive ‐ have taken memantine for at least 6 months prior to enrolment |
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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 Enrolment: ‐ 86 patients randomized (44 to latrepirdine, 42 to placebo) ‐ 5 patients completed (3 in latrepirdine, 2 in placebo) |
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| Outcomes | Primary ‐ SIB (cognition) ‐ ADCS‐ADL (daily function) Secondary ‐ MMSE (cognition) ‐ NPI (behaviour) ‐ CIBIC‐Plus (global function) ‐ RUD‐lite ‐ EQ‐5D ‐ pharmacokinetics ‐ adverse events |
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| Notes | Funding: Medivation Inc. and Pfizer Inc. ‐ this study was terminated on 7 May 2010 by the investigators due to lack of efficacy in the completed CONNECTION study. The authors maintain that termination was not due to safety concerns |
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| 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 | Low risk | The reasons for withdrawal from the study were provided in the patient flow table and were balanced between groups. This information is available in ClinicalTrials.gov |
| Selective reporting (reporting bias) | High risk | Data on primary and secondary outcome measures have not been made available (ClinicalTrials.gov) |
| 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 were not able to evaluate other sources of bias |