| Methods |
26 week
double‐blind
randomized
placebo‐controlled
parallel‐group |
| Participants |
Country: USA
14 centres
702 participants (393 female, 309 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:3 mg/day divided into 2 doses
2.rivastigmine:6 mg/day divided into 2 doses
3.rivastigmine:9 mg/day divided into 2 doses
4.placebo
titration during weeks 1‐12 to the fixed dose, no dose reductions allowed |
| Outcomes |
ADAS‐Cog
CIBIC‐plus
PDS
GDS
CAS
MMSE
CAS |
| Notes |
Main hypothesis: to evaluate the efficacy and safety of 3 fixed doses of rivastigmine (3,6,9 mg/d) and placebo for 26 weeks of treatment, and dose/efficacy and dose/safety relationships in patients with probable mild to moderate AD
Assessments: baseline, 12,18,26 weeks |
