Page 173 - Drug Class Review

examine the relationships between plasma DON concentration, red blood cell AChE activity and clinical
Drug Effectiveness Review Project
To evaluate the efficacy and safety of DON in patients with mild to moderately severe AD and to
Eisai America, Inc., Teaneck, NJ, USA and Eisai Co Ltd., Tokyo, Japan
donepezil placebo donepezil N/A 5 mg 3 mg 12 weeks 12 weeks 12 weeks 40 39 40 Male and female subjects ages 55-85 with established diagnosis of mild to moderately severe AD for at least 1 year prior to study; MMSE between 18 and 26 and CDR of 1 or 2; fully ambulatory or able to walk with assistive device and had vision and hearing sufficient for compliance with test procedures; females at least 2 years post-menopausal or surgically sterile; presence of AD supported by CT or MRI Patients with other psychiatric or neurological dis

Drugs Authors: Rogers et al. 45 Setting: Multi-center donepezil 1 mg 12 weeks 42

Alzheimer Year: 1996 Country: US response Study design: RCT Sample size: 161 NR

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