Page 88 - Drug Class Review

Page 74 of 205
Drug Effectiveness Review Project
To evaluate the efficacy and tolerability of a flexible dosing regimen of galantamine prolonged-release

placebo N/A 6 months 324

capsule compared with galantamine IR and placebo in patients with mild to moderate AD

Country: Multinational (US, Australia, Canada, South Africa, New Zealand)

galantamine 16 or 24 mg/d 6 months 327 Clinical diagnosis of mild to moderate AD based on NINCDS-ADRDA criteria; score of 10-24 on the MMSE; score of 18 or greater on the ADAS-cog/11; responsible caregiver; cognitive decline that was Neurodegenerative disorders or cognitive impairment due to acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency states, infection, mental retardation, cerebral neoplasia, endocrine or metabolic disease; vascular dementia or clinically active cerebrovascular disease; epilepsy; psychiatric disease; peptic u

Alzheimer Drugs Authors: Brodaty et al. 49 Year: 2005 NR (one author from Johnson & Johnson Pharmaceuticals) Study design: RCT Setting: Multi-center (93 sites) Sample size: 971 galantamine PRC 16 or 24 mg/d 6 months 320 gradual in onset over a period of 6 months or greater the trial None for the treatment of dementia

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