Page 232 - Drug Class Review

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Drug Effectiveness Review Project

placebo 72.7 61.4 19.3

galantamine 32 mg 72.1 63.3 19.0 Secondary Outcome Measures: Proportion of patients with improvements from baseline on the ADAS- Timing of assessments: Baseline and weeks 3 (ADAS-Cog only), 12 and 24 ITT analysis of DAD at 6 months revealed significant benefit of GAL only at 32 mg/d; mean difference = 3.4; 95% CI: 0.1 – 6.7; P < 0.05; 24 mg/d mean difference = 2.8; P value not ITT analysis of ADAS-Cog scores at 6 months revealed significant benefit of GAL over placebo (24 mg/d mean difference = 2.9; 95% CI: 1.6 – 4.1; P < 0.001); (32 mg/d mean difference = 3.1; ITT anal

Alzheimer classification: Mild-Moderate

Groups similar at baseline: Yes

galantamine 24 mg 71.9 63.2 19.5 Primary Outcome Measures: ADAS-Cog; CIBIC-plus Cog of ≥ 0 and ≥ 4; DAD Health Outcome Measures: significant Intermediate Outcome Measures: 95%: CI 1.9 – 4.4; P < 0.001)* the placebo group (49.5%)*

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Final Report Update 1 Authors: Wilcock et al. Year: 2000 POPULATION CHARACTERISTICS: Mean age (years): Sex (% female): Other germane population qualities: MMSE score • OUTCOME ASSESSMENT: RESULTS: Alzheimer's Drugs