Page 254 - Drug Class Review

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Drug Effectiveness Review Project
Setting: Multi-center (52 sites in 5 countries: Denmark, Finland, Norway, Sweden, The Netherlands)
To evaluate the long-term clinical efficacy and safety of DON versus placebo over 1 year in patients

placebo N/A (2.8% did not escalate dose) 52 week 144 Diagnosis of AD consistent with NINCDS/ADRDA and DSM-IV; age 40 to 90 years; mild to moderate AD confirmed by MMSE score of 10 – 26; CT or MRI scans were obtained at screenings if not performed in last 12 months; healthy and ambulatory or ambulatory aided, with vision and hearing sufficient for compliance with testing procedures; laboratory test values had to be within normal limits or considered to be clinically insignificant by the investigator; reliable care giver Clinically significant and uns

Drugs Author: Winblad et al. 48 Country: Multinational (Northern European countries) Pfizer Pharmaceuticals Group, Pfizer, Inc. with mild to moderate AD donepezil 10 mg/d (8.5% on 5mg/d) 52 week 142

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