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Drug Effectiveness Review Project
To investigate the efficacy and safety of DON in a multinational setting in patients with mild to
placebo N/A 24 weeks 274
donepezil 10 mg 10 mg/d 24 weeks 273 Fifty years of age or older; met DSM-III-R criteria for AD; met NINCDS/ADRDA for probable AD; MMSE scores between 10 and 26 (inclusive); CDR scores of 1 or 2 Patients with structural lesions or significant vascular changes in a recent CT or MRI scan; patients with other neurological or psychiatric disorders; patients with asthma or significant uncontrolled
Drugs Authors: Burns et al. 39 Country: Multinational (9 countries) Eisai Inc., Teaneck, NJ and Eisai Co. Ltd., Tokyo, Japan moderately severe AD Setting: Multi-center (82 clinical centers) donepezil 5 mg 5 mg/d 24 weeks 271 gastrointestinal, renal, hepatic, endocrine or oncological disorders NR; patients taking “prohibited” study medications were excluded
Alzheimer Year: 1999 Study design: RCT Sample size: 818
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
