Page 210 - Drug Class Review

Page 135 of 205
Drug Effectiveness Review Project

placebo 77.1 62.2 93 17.7 29.4 Secondary Outcome Measures: ADAS-Cog 11 responders (improvement ≥ 4 points) and ADAS-Cog11 Significantly less mean reduction in ADCS/ADL for 16 mg/d GAL (-0.7 vs. -3.8; P < 0.001) and Significantly less reduction in mean NPI change from baseline for GAL 16 mg/d (-0.1 vs. 2.0; P < Changes in ADCS/ADL scores correlated significantly with change scores on the cognitive Mean change in ADCS/ADL scores from baseline was significantly different from placebo treatment for both GAL treatment groups in the subgroup of patients with the greatest i

Authors and Year: Tairot et al. 2000; Cummings et al. 2004, Galasko et al. 2004
Alzheimer classification: Mild-moderate
galantamine 8; 16; 24 mg/d 76; 76.3; 77.7 64.2; 62.3; 67 94; 93; 91 18; 17.8; 17.7 27.8; 29.4; 29 Primary Outcome Measures: ADAS-Cog 11; CIBIC-plus improvers (≥ 7 points); ADCS/ADL; NPI Timing of assessments: Baseline, weeks 4 and 13, and at 5 months Health Outcome Measures: • 24 mg/d GAL (-1.5 vs. -3.8; P < 0.01) compared to placebo • 0.05) and 24 mg/d GAL (0.0 vs. 2.0; P < 0.05) compared to placebo • subscale of the AD Assessment Scale (r = -0.24). • on baseline ADAS-cog scores (ADAS-cog >30, P < 0.0001 for both doses). Intermediate Outcome Measures:

Groups similar at baseline: Yes

Final Report Update 1 POPULATION CHARACTERISTICS: Mean age (years): Sex (% female): Ethnicity (% white): Other germane population qualities: MMSE • ADAS-Cog • OUTCOME ASSESSMENT: RESULTS: Alzheimer's Drugs