Page 194 - Drug Class Review

Page 127 of 205
Drug Effectiveness Review Project

placebo NR NR NR 23.29 54.1

rivastigmine 6-12 mg/d NR NR NR 23.57 55.22 Timing of assessments: Primary outcome measures at baseline and weeks 12, 18 and 26; secondary Scores on PDS improved in patients taking high dose RIV when compared with placebo, P < 0.05 (LOCF analysis); no significant difference observed between low dose RIV and placebo, P > PDS scores significantly more improved for high dose RIV compared to placebo (P < 0.05) but Scores on ADAS-Cog improved in patients taking high dose RIV (6-12 mg/d) when compared with placebo, P < 0.05 (LOCF analysis); no significant difference obser

Alzheimer classification: Mild to moderately severe

Groups similar at baseline: Yes

rivastigmine 1-4 mg/d NR NR NR 23.87 53.8 Primary Outcome Measures: ADAS-Cog; PDS; CIBIC Secondary Outcome Measures: MMSE; GDS outcome measures at baseline and week 26 Health Outcome Measures: 0.05* not for low dose RIV Intermediate Outcome Measures: RIV (1-4 mg/d) and placebo, P > 0.05* not for low dose RIV

• • • • •

Final Report Update 1 Authors: Rösler et al. Year: 1999 POPULATION CHARACTERISTICS: Mean age (years): Sex (% female): Ethnicity: Other germane population qualities: Baseline ADAS-Cog • Baseline PDS • OUTCOME ASSESSMENT: RESULTS: Alzheimer's Drugs