Page 140 - Drug Class Review
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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
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