Page 207 - Drug Class Review

Drug Effectiveness Review Project

Drugs Authors and Years: Tairot et al., 2000; 52 Cummings et al., 2004; 64 Galasko et al., 2004 65 Janssen Research Foundation To investigate the efficacy and tolerability of GAL using slow dose escalating schedule of up to 8 weeks in 978 patients with mild to moderate AD Setting: Multi-center placebo galantamine N/A 8; 16; 24 mg/d 5 months 5 months 286 140; 279; 273 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 ne

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