Page 228 - Drug Class Review

placebo (P < 0.001); odds of improvement in CIBIC-plus scores were twice as great with DON 5 or 10 mg/d
Blindly accepted trials if they were randomized, double-blind, placebo-controlled, parallel group studies and
Drug Effectiveness Review Project
compared with 62% of placebo treated patients; discontinuations due to adverse events were higher in DON
Page 144 of 205
outcome measures included ADAS-Cog treatment difference; ADAS-Cog response (improvement of 4 or 7
10 trials comparing either 5 or 10 mg/d over 12 to 24 weeks in patients with mild to moderate AD; primary
10 mg/d (13.9%) than in DON 5 mg/d (6.3%) or placebo (5.8%) group; significantly greater incidence of
ADAS-Cog score statistically significantly better for 5 or 10 mg/d DON at all time points compared with
nausea, diarrhea, vomiting, headache and insomnia in DON 10 mg/d than DON 5 mg/d or placebo group
No systematic search was reported; the trials were provided by the DON clinical Development Program
Adverse events occurred in 65% and 83% of patients treated with 5 or 10 mg/d DON respectively,

as with placebo and statistically significant (P < 0.001)

points); CIBIC-plus; MMSE; CDR-SB

included in the meta-analysis if patients satisfied inclusion criteria; no other methods were discussed as to how trials were evaluated to be

Fair

Final Report Update 1 Authors: Whitehead et al. Year: 2004 CHARACTERISTICS OF INTERVENTIONS: MAIN RESULTS: ADVERSE EVENTS: COMPREHENSIVE LITERATURE SEARCH STRATEGY: STANDARD METHOD OF APPRAISAL OF STUDIES: QUALITY RATING: Alzheimer's Drugs