Page 253 - Drug Class Review

Drug Effectiveness Review Project

Drugs Author: Winblad et al. 48 Country: Multinational (Northern European countries) Pfizer Pharmaceuticals Group, Pfizer, Inc. To evaluate the long-term clinical efficacy and safety of DON versus placebo over 1 year in patients with mild to moderate AD Setting: Multi-center (52 sites in 5 countries: Denmark, Finland, Norway, Sweden, The Netherlands) placebo donepezil N/A (2.8% did not escalate dose) 10 mg/d (8.5% on 5mg/d) 52 week 52 week 144 142 Diagnosis of AD consistent with NINCDS/ADRDA and DSM-IV; age 40 to 90 years; mild to moderate AD confirmed by MMSE score of 1

Alzheimer Year: 2001 Study design: RCT Sample size: 286 were not permitted

Final Report Update 1 Efficacy/Effectiveness STUDY: FUNDING: RESEARCH OBJECTIVE: DESIGN: INTERVENTION: Dose: Duration: Sample size: INCLUSION: EXCLUSION: OTHER MEDICATIONS/ INTERVENTIONS ALLOWED: Alzheimer's Drugs