Page 158 - Drug Class Review
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Drug Effectiveness Review Project
placebo 75.3 61.5 92 95.3% 19.2
galantamine 32 mg/d 75.0 58.8 90 91.9% 19.1 Secondary Outcome Measures: ADAS-Cog 13; ADAS-Cog 11 responders (≥ 4 point improvement); Timing of assessments: Baseline and 3 weeks, 3 months, 6 months No significant differences between treatment groups in the mean change in total DAD score from GAL-treated patients showed significantly improved cognitive function relative to placebo (3.9 pts (lower dose) and 3.8 (higher dose) on the ADAS-Cog 11 (P < 0.001) for observed cases analysis); ITT analysis also was significant but showed smaller differences 0.1 pts (lower dose)
Alzheimer classification: Mild-moderate
Groups similar at baseline: Yes
galantamine 24 mg/d 75.9 65.6 92 94.3% 19.5 Primary Outcome Measures: ADAS-Cog 11; CIBIC-plus Health Outcome Measures: baseline Intermediate Outcome Measures: ADAS-Cog 13: NR (higher dose) difference relative to placebo 0.001)
DAD • • • • •
Final Report Update 1 Authors: Raskind et al. Year: 2000 POPULATION CHARACTERISTICS: Mean age (years): Sex (% female): Ethnicity (% white): Other germane population qualities: Other medical conditions • MMSE score • OUTCOME ASSESSMENT: RESULTS: Alzheimer's Drugs
