Page 312 - Drug Class Review
P. 312
Page 186 of 205
Drug Effectiveness Review Project
placebo 75.2 46 0% 99.8% 0.2% 24.1 20.2 Primary Outcome Measures: ADAS-Cog 11; CIBIC-plus (only primary outcome measures reported in Timing of assessments: ADAS-Cog 11 performed at screening, baseline, 6 weeks, and months 3 and 6; CIBIC-plus, NPI, and DAD performed at baseline, and months 3 and 6 Subgroup analysis for AD-patients with CVD (ADAS-Cog & CIBIC-plus only): At 6 months patients taking GAL had a significantly greater improvement in ADAS-Cog scores compared with patients on placebo (treatment difference 2.7 points; P < 0.0005)* At 6 months a greater
Groups similar at baseline: Yes
Alzheimer classification: NR
galantamine 75.0 48 0.5% 99.5% 0% 22.3 20.7 the subgroup analysis of patients with AD & CVD) Secondary Outcome Measures: ADAS-Cog 13; NPI; DAD Health Outcome Measures: N/A Intermediate Outcome Measures: to placebo (32% vs. 19%; P = 0.019)
• • •
Final Report Update 1 Authors: Erkinjuntti et al. Year: 2002 POPULATION CHARACTERISTICS: Mean age (years): Sex (% female): Ethnicity: Black • White • Asian • Other germane population qualities: ADAS-Cog score • MMSE • OUTCOME ASSESSMENT: RESULTS: Alzheimer's Drugs