| Methods |
26 week
double‐blind
randomized:method described
placebo‐controlled
parallel‐group |
| Participants |
Country: USA
22 centres
699 participants (426 female, 273 male)
age range 45‐89 years, mean =74.5 years
inclusion: DSM‐IV, NINCDS‐ADRDA criteria for probable AD. MMSE range 10‐26 inclusive
head computed tomography or magnetic resonance imaging scan consistent with AD within 12 months, most concomitant disease, most medications
exclusion: severe and unstable medical illnesses, anticholinergic drugs, acetylcholine precursor health food supplements, memory enhancers, insulin, psychotropic drugs (apart from occasional use of chloral hydrate for agitation or insomnia) |
| Interventions |
1.rivastigmine 1‐4mg/day divided into 2 doses
2.rivastigmine 6‐12mg/day divided into 2 doses
3.placebo
titration phase week 0‐7, flexible phase weeks 8‐26, dose bid with food |
| Outcomes |
ADAS‐Cog
CIBIC‐plus
PDS
GDS
CAS
MMSE |
| Notes |
primary hypothesis:to evaluate efficacy and safety of rivastigmine
assessments: baseline, 12,18,26 weeks
open label extension |
