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- W2149848215 abstract "Galantamine showed improvement in cognition, activities of daily living, and behavioral symptoms in Alzheimer's disease (AD) patients after 5 to 6 months of treatment. Aim: To examine long-term outcomes, this study was conducted to assess if continuing of galantamine treatment beyond 12 months delayed cognitive deterioration. 12 months multicenter open label (OL) followed by a 24 months double blind (DB), randomized withdrawal study. Subjects with probable AD and a MMSE between 11-24 were included and eligible to enter DB if cognitive decline of < 4 points on ADAS-cog/11 at OL endpoint was recorded. Galantamine was titrated to 16mg/day. Assessments included ADAS-cog/11, DAD, CIBIC-Plus, safety parameters. Patients were withdrawn if the ADAS-cog/11 deteriorated by 4 or more points. The differences between Galantamine and placebo in time to dropout for any reason and dropout for lack of efficacy were estimated using the Cox proportional hazard model. 47.4% of galantamine and 31.7% of placebo subjects completed the DB phase. Placebo subjects were more likely to discontinue prematurely than galantamine subjects for any reason (hazard ratio [HR] 1.76, 95% confidence interval [CI] 1.10-2.81, P = 0.02), or lack of efficacy (HR 1.80, 95% CI 1.02-3.18, P = 0.04); no statistically significant difference was seen for a change in ADAS-cog 4 between treatment groups (HR 1.66, 95% CI 0.78-3.54, P 0.19). Subjects who responded to 12 months of galantamine treatment benefited from continued drug therapy for up to 36 months. No unexpected AE occurred during OL or DB. Reported serious AEs were unrelated to treatment. Galantamine was effective in delaying time to deterioration in subjects with mild to moderate AD. Treatment was generally safe and well tolerated." @default.
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- W2149848215 date "2011-07-01" @default.
- W2149848215 modified "2023-10-16" @default.
- W2149848215 title "P4‐251: Cessation versus continuation of 12 months galantamine therapy in patients with Alzheimer's disease: A randomised, double blind, placebo controlled withdrawal trial" @default.
- W2149848215 doi "https://doi.org/10.1016/j.jalz.2011.05.2276" @default.
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