RIV‐B304.

Methods	26 week double‐blind randomized placebo‐controlled parallel‐group
Participants	Country: Australia, Canada, Italy, South Africa, UK 38 centres 678 participants Inclusion: DSM‐IV, NINCDS‐ADRDA criteria for probable AD. MMSE range 10‐26 inclusive Exclusion: significant illness, severe chronic pulmonary disease, psychiatric or neurological disorder, severe cardiovascular problems, clinically significant lab tests, including those indicative of impaired renal or liver function
Interventions	1.rivastigmine 2‐12 mg/day divided into 2 doses 2.rivastigmine 2‐12 mg/day divided into 3 doses 3.placebo titration to highest tolerated dose during weeks 1 and 2. During weeks 3‐26 dose variation allowed
Outcomes	ADAS‐Cog CIBIC‐plus PDS GDS CAS MMSE
Notes	Main hypothesis: to evaluate the efficacy and safety of individual highest well tolerated doses (range 2‐12 mg/d) of rivastigmine bid or tid for 26 weeks compared to placebo, in the therapy of patients with probable AD