GAL‐USA‐1 Raskind.

Methods	Randomized Double‐blind Parallel‐group Placebo‐controlled, with 4‐week placebo run‐in Duration: 26 weeks/ 6 months
Participants	Country: USA No. of Centers: 33 Diagnosis: Senile Dementia Alzheimer's Type defined by: NINCDS‐ADRDA. Inclusion: MMSE score of 11 to 24 inclusive, ADAS‐cog score > 11; responsible caregiver; free for 30 days of medications indicated for dementia (3 months for cholinesterase inhibitors); written informed consent by patient or appropriate representative. 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: 636 Sex: 242 males. Age: 70.3 +/‐ 1.6 to 71.1 +/‐ 1.5 (broken down by treatment group)
Interventions	Route: oral Treatment: galantamine 12mg b.i.d. galantamine 16mg b.i.d. Treatment commenced at 4mg b.i.d. and was increased weekly by 8mg/d to assigned maximum dose. Control: Placebo b.i.d.
Outcomes	ADAS‐cog ADCS‐CGIC DAD (Disability Assessment for Dementia)
Notes	No. excluded after randomization: 198 No. not included in observed case analysis: 198
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate