Page 156 - Drug Class Review
P. 156
To evaluate the efficacy and safety of two doses of galantamine compared with placebo over 6 months in
Page 108 of 205
Drug Effectiveness Review Project
placebo N/A 6 months 213 History of cognitive decline that had been gradual in onset and progressive over a period of at least 6 months; diagnosis of probable AD according to the criteria of the NINCDS-ARDA; presence of mild to moderate dementia; MMSE score of 11 to 24 and a score of ≥ 12 on the standard cognitive subscale of Patients with evidence of any neurodegenerative disorders other than AD; cardiovascular disease thought likely to prevent completion of the study; clinically significant CVD; active major psychiatric disorders; hepatic, renal,
Drugs Authors: Raskind et al. 50 Janssen Research Foundation patients with mild to moderate AD Setting: Multi-center (33 sites) galantamine 24 or 32 mg/d 6 months 212/211 (423 total) the ADAS-Cog; responsible caregiver
Alzheimer Year: 2000 Country: US Study design: RCT Sample size: 636 preceding 3 months
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
