GAL‐USA‐10 Tariot.

Methods	Randomized Double‐blind Parallel‐group Placebo‐controlled, with 4‐week placebo run in Duration: 5 months
Participants	Country: United States No. of Centers: Unstated Diagnosis: At least 6 month history of progressive cognitive decline, Senile Dementia Alzheimer's Type defined by: NINCDS‐ADRDA. Inclusion: MMSE score of 10 to 22, ADAS‐cog score > 17; CT or MRI < 12 months previously with no evidence of multi‐infarct dementia or active cerebrovascular disease; responsible caregiver; free for 30 days of medications indicated for dementia; free for 60 days for cholinomimetic agents. Exclusion: Uncontrolled hypertension, heart failure, type II diabetes mellitus, hypothyroidism; other neurodegenerative disorders; cardiovascular disease that would affect completion of the trial; clinically significant psychiatric, hepatic, renal, pulmonary, metabolic, endocrine conditions; urinary outflow obstruction; active peptic ulcer; history of epilepsy, significant substance abuse. Total No. of patients: 978 Sex: 353 males Age: 76.0 +/‐ 0.6 to 77.7 +/‐ 0.4
Interventions	Route: oral Treatment: galantamine 4mg b.i.d. galantamine 8mg b.i.d. galantamine 12mg b.i.d. Treatment commenced at 8mg/d and was increased 8mg/d every 4 weeks until the target dose had been reached. Control: Placebo b.i.d.
Outcomes	ADAS‐cog ADCS‐CGIC ADCS‐ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living), NPI (Neuropsychiatric Inventory)
Notes	No. excluded after randomization: 199 No. not included in observed cases analysis: 199