Page 76 - Drug Class Review

The CDR-SB showed a benefit with 5 and 10 mg/d of DON compared with placebo at 12 weeks and
Page 68 of 205
Drug Effectiveness Review Project
DON given at any dose for more than one day with parallel concomitant placebo group; outcome measures
function was shown by improvement in the ADAS-Cog and MMSE test scores at 12 and 24 weeks
included: Global assessment (CIBIC-plus, GBS, MENFIS, CDR-SB, ADAS-Cog, MMSE); ADL’s (PDS,
Evidence of benefits associated with 5 and 10 mg/d of DON compared with placebo on cognitive
showing improvement; overall there are benefits associated with 5 and 10 mg/d DON compared
Pooled data from 2 studies provided evidence of benefit of DON at 12 and 24 weeks (P < 0.01)
The CIBIC-plus scale was dichotomized into those showing no change or decline against those

DAD, IADL, PSMS, CMCS); behavioral disturbances; QOL; caregiver stress; side effects

Quality of life No significant difference between DON and placebo for QOL and behavioral disturbance • Activities of daily living • Global assessment • with placebo at 12 and 24 weeks (P < 0.005) as shown by the ITT-LOC analyses: 24 weeks, 10 mg/d: OR 2.18; 95% CI: 1.53 – 3.11; P < 0.001 24 weeks 5 mg/d: OR 2.38; 95% CI: 1.78 – 3.19; P < 0.001 • 10 mg/d of DON compared with placebo at 24 weeks 24 weeks, 10 mg/d: WMD -0.53; 95% CI: -0.73 – -0.33; P < 0.001 24 weeks 5 mg/d: WMD -0.51; 95% CI: -0.70 – -0.32; P < 0.001 Cognitive fun

Final Report Update 1 Authors: Birks et al. Year: 2004 CHARACTERISTICS OF INTERVENTIONS: MAIN RESULTS: Alzheimer's Drugs