Page 235 - Drug Class Review

Drug Effectiveness Review Project

Drugs Authors: Wilcock et al. 27 Janssen-Cilag UK, Janssen Pharmaceutica Products L.P., Shire Pharmaceuticals Ltd. To compare the long-term efficacy and safety of GAL 24 mg/d and DON 10 mg/d in patients with AD Study design: Randomized, rater-blinded trial Setting: Multi-center (18) donepezil galantamine 10 mg/d 24 mg/d 52 weeks 52 weeks 88 94 Diagnosis of probable AD (NINCDS/ADRDA); MMSE score 9 – 18 at screening; history of cognitive decline gradual onset over last 12 months; caregiver who lived with subject or visited at least 5 days/week and could assist with medic

Alzheimer Year: 2003 Country: UK Sample size: 182 Yes

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