Possible pregnancy or lactation Treatment Form - dosing route matching tablets - oral Dose 4 mg 8 mg 12 mg Galantamine Dosage 2 tablets daily (bid) with meals, at 8 AM and 6 PM Duration of treatment 6 months Duration of trial 6 months Disallowed medication drugs for treating dementia (nootropic or cholinomimetic agents, estrogens, chronic NSAIDs, ≥30 IU vitamin E daily, deprenyl) sedatives given more than twice weekly Item 8: Clinical/Statistical Data Page 12 (galantamine) Tablets New Drug Application 21-169 Janssen Research Foundation JRF Clinical Research Report - GAL-USA-3 Assessments Initial (Final visit of GAL-USA-1) 13 Weeks 1,2,3 M1 M2 M3 M 4,5 Final M6 Efficacy = Alzheimer’s Disease Assessment Scale CIBIC=Clinician’s Interview-based Impression of Change DAD=Disability Assessment in Dementia M=Month Statistical Methods Variable Change at Month 6 in ADAS-cog/11, cog/13, -cog/10, -cog/mem DAD, PGWB CIBIC-plus Adverse events Change in vital signs, body weight, ECG Laboratory results Item 8: Clinical/Statistical Data Method ANOVA, paired t-test, Fisher’s LSD ANCOVA (subgroup only) Cochran-Mantel-Haenszel, Van Elteren test Number/ with AE ANOVA, paired t-test, Fisher’s LSD Tabulations of values outside normal and pathological limits Page 13 REMINYL (galantamine) Tablets New Drug Application Research Foundation JRF Clinical Research Report - GAL-USA-3 14 Main features of the patient sample and summary of the results Baseline characteristics: patient disposition Number of patients treated (M/F) Age: yrs (mean±SE) Premature discontinuations - reason • adverse event • noncompliant • other Total of discontinuations PL
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