Page 112 - Drug Class Review
P. 112
Page 86 of 205
Drug Effectiveness Review Project
Authors and year: Feldman et al. 2001; 40, 93 Gauthier et al. 2002; 71 Gauthier et al. 2002; 72 Feldman
To examine the efficacy and safety of DON in patients with moderate to severe AD; subgroup analyses
placebo N/A 24 weeks 146 All of the following criteria: probable or possible AD according to DSM-IV and the NINCDS; a screening standardized MMSE score of 5-17; Functional Assessment Staging Test of ≤ 6 at baseline; ambulatory; CT or MRI scan within past 24 months consistent with AD Patients requiring total nursing care; evidence of other cause of dementia; complicating delirium, depression, or other concurrent diagnosis that might interfere with study participation; history of drug or alcohol misuse; hypersensitivity to AChE inhibitors; significan
Drugs Country: Multinational (Canada, Australia, France) Eisai, Inc. and Pfizer, Inc. focus on behavioral symptoms and patients with moderate severity Setting: Multi-center (32) donepezil 5-10 mg/d 24 weeks 144
Alzheimer et al. 2003 73 Study design: RCT Sample size: 290 system disease investigational drugs
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