Page 208 - Drug Class Review
P. 208

To investigate the efficacy and tolerability of GAL using slow dose escalating schedule of up to 8 weeks
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             Drug Effectiveness Review Project




                                 Authors and Years: Tairot et al., 2000; 52  Cummings et al., 2004; 64  Galasko et al., 2004 65
























                                                               placebo   N/A   5 months   286  History of cognitive decline gradual in onset and progressive over a period of at least 6 months; diagnosis  of probable AD according to NINCDS/ADRDA; MMSE score 10 – 22; ADAS-Cog 11 score of >18  Any other neurodegenerative disorders; cardiovascular disease; clinically significant psychiatric, hepatic,  renal pulmonary, metabolic, or endocrine conditions, or urinary outflow obstruction; active peptide ulcer;  history of epilepsy or significant drug or alcohol abuse; treated for AD with a cholinomemetic agent in  Concomitant medica
























                          Drugs        Janssen Research Foundation   in 978 patients with mild to moderate AD   Setting: Multi-center   galantamine   8; 16; 24 mg/d   5 months   140; 279; 273




                          Alzheimer     Country: US      Study design: RCT   Sample size: 978      preceding 60 days





















             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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