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To examine the effects of DON compared to placebo on the preservation of function in patients with AD
Page 100 of 205
Drug Effectiveness Review Project
placebo N/A 54 weeks 217 Probable AD according to DSM-IV and the NINCDS; a MMSE score of 12-20; CDR score of 1 (mild) or 2 (moderate); MHIS ≤ 4 at both screening and baseline; protocol amendment allowed patients to enroll with MMSE scores of 21 at baseline if their scores at screening were 20; subjects were also required to be able to perform 8 of 10 instrumental ADL (each score ≤ 2) on the ADFACS at both screening and Evidence of stroke; Parkinson’s Disease; schizophrenia; dementia complicated by other organic disease; delirium; depression; AD wit
Drugs Authors: Mohs et al. 42 Eisai, Inc. and Pfizer, Inc. Setting: Multi-center (31) donepezil 10 mg/d (28 day escalation) 54 weeks 214 and neuroleptics were not permitted; no reliable caregiver Vitamin E; Gingko biloba; NSAIDs; and estrogens
Alzheimer Year: 2001 Country: US over a 1-year period Study design: RCT Sample size: 431 baseline
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