Table A2.

Data sources for modeling

Trial description	Placebo subjects, n	Study details
12W, DB, PC study	75	Patients stratified on baseline MMSE of 26 through 21 or 20 through 12; Visits @ BL, 6W, 12W; No use of Mem or ChI within 3M of the baseline visit
6M, DB, PC, study outpatients with AD treated with ChI	85	MMSE score of 12 to 26; ChI use required and must have been administered for 3M before the BL visit; Visits at BL, 6W, 12W, 24W
18M, PC study	58	Visits @ BL, 3M, 5M, 7M, 13M, follow-up at 19M and 24M; MMSE score between 16 and 26 inclusive; On stable dose of background ChI and/or Mem at least 60 days prior to dosing (not required if the subject had previously demonstrated a lack of toleration)
6M, DB, PC study	94	MMSE score of between 10 and 24, inclusive No use of Mem or ChI within 60 days prior to enrollment
26W, DB, PC study	198	MMSE score between 10 and 24 inclusive No use of Mem or ChI within 90 days prior to enrollment
52W, DB, PC study	340	Visits @ BL, 1W, 2W, 6W, 13W, 26W, 39W, and 52W; MMSE score between 12 and 24 inclusive; Taking Dz for at least 6M, with stable dosing at 10 mg/day for at least the last 4M prior to Day 1
24W, DB PC study	104	Visits @ BL, 6W, 12W, 18W, 24W; MMSE scores of 12 to 24 inclusive; No use of Mem or ChI within 90 days prior to enrollment

BL, baseline; DB, double blind; Dz, donepezil; ChI, cholinesterase inhibitor; M, month; Mem, memantine; MMSE, Mini-Mental State Examination; PC, placebo controlled; W, week.