Page 148 - Drug Class Review

Page 104 of 205
Drug Effectiveness Review Project

Any oral dose of GAL versus placebo for a duration greater than 4 weeks; outcome measures included

ADAS-Cog, CIBIC-plus, ADCS-CGIC, ADCS-ADL, DAD, and NPI)

• Global Rating Scales (CIBIC-plus k = 2; ADCS-CGIC k = 4; unspecified physician global rating k = 1) Data were dichotomized into those that had no change or improvement versus those that worsened; for ITT analyses trials of 3 months duration, doses of 18 mg/d (OR 2.44; 95% CI: 1.2 – 5.0), 24 mg/d (OR 2.11; 95% CI: 1.0 – 4.6) and 36 mg/d (OR 2.7; 95% CI: 1.2 – 6.2) revealed statistically significant benefit of GAL versus placebo; for trials of 6 months duration, 8 mg/d failed to have an effect whereas other doses demonstrated significant benefit of GAL over placebo (16mg: O

Final Report Update 1 Authors: Olin & Schneider, Loy & Schneider Year: 2004, 2005 CHARACTERISTICS OF INTERVENTIONS: MAIN RESULTS: Alzheimer's Drugs