Page 236 - Drug Class Review
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Drug Effectiveness Review Project
To compare the long-term efficacy and safety of GAL 24 mg/d and DON 10 mg/d in patients with AD
Janssen-Cilag UK, Janssen Pharmaceutica Products L.P., Shire Pharmaceuticals Ltd.
donepezil 10 mg/d 52 weeks 88 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 medication, attend assessments and provide information about the subject; MRI/high resolution CAT scan after diagnosis and consistent with AD Use of AChE inhibitor within 30 days prior to study entry (other dementia Rx can be discontinued at enrollment); previous GAL or DON use; neurodegenerative di
Drugs Authors: Wilcock et al. 27 Study design: Randomized, rater-blinded trial Setting: Multi-center (18) galantamine 24 mg/d 52 weeks 94 would compromise patient’s ability to complete the trial
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
