NCT00838110.

Methods	Multi‐centre, 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 ‐ MMSE between 12 and 26 inclusive ‐ If on existing anti‐dementia medications (including cholinesterase inhibitors or memantine), must be on a stable dose 60 days prior to enrolment ‐ If not taking anti‐dementia therapy (including cholinesterase inhibitors or memantine), must not have received medication 60 days prior to enrolment
Interventions	Participants were randomized to either: ‐ latrepirdine (10 mg PO TID for 1 week followed by 20 mg PO TID until endpoint) for 26 weeks ‐ placebo (10 mg PO TID for 1 week followed by 20 mg PO TID until endpoint) for 26 weeks ‐ latrepirdine (10 mg PO TID for 1 week followed by 20 mg PO TID until endpoint) for 12 weeks ‐ placebo (10 mg PO TID for 1 week followed by 20 mg PO TID until endpoint) for 12 weeks enrollment: 741 patients randomized (370 to latrepirdine, 371 to placebo) in combined 12 and 26‐week cohorts
Outcomes	Safety and tolerability ‐ % participants with abnormal clinically significant vital signs (blood pressure, heart rate, etc.) ‐ % participants with abnormal clinically significant ECG findings (PR and QRS intervals, etc.) ‐ % participants with abnormal clinically significant laboratory values (liver/renal function, electrolytes, etc.) ‐ % participants with adverse events
Notes	Funding: Pfizer Inc. and Medivation 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	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)	Low risk	Data are available for all pre‐determined study outcome measures (ClinicalTrials.gov)
Other bias	Low risk	There were no other major sources of bias