Page 180 - Drug Class Review
P. 180
Page 120 of 205
Drug Effectiveness Review Project
placebo N/A 12 weeks 153
To examine the efficacy and safety of DON in treatment of mild to moderately severe AD
donepezil 10 mg 10 mg/d 12 weeks 158 >50 yrs old; diagnosis of probable AD consistent with NINCDS and DSM-IV criteria; mild to moderately severe disease based on MMSE scores of 10-26; CDR scores of 1 or 2 Major medical illness – diabetes, COPD, asthma, hematologic or oncologic disorders; vitamin B 12 or folate deficiency; gastrointestinal, renal, hepatic, endocrine, or cardiovascular disease; evidence of other psychiatric or neurological disorders; HIS score > 5; known hypersensitivity to ChE inhibitors Occasional use of hypnotics and cold prepara
Drugs Authors: Rogers et al. 43 Eisai Inc, Teaneck NJ and Eisai Co Ltd, Tokyo Japan Setting: Multi-center (23 clinical centers) donepezil 5 mg 5 mg/d 12 weeks 157 certain antihypertensives were prohibited
Alzheimer Year: 1998 Country: US Study design: RCT Sample size: 468
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