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eISSN: 1643-3750

An open-label study to evaluate the safety, tolerability and efficacy of rivastigmine in patients with mild to moderate probable Alzheimer's disease in the community setting.

Maria Barcikowska, Anna Pfeffer, Stanisław Ochudło, Krzysztof Sołtys, Joanna Łapin, Stanisław Puzyński, Ryszard Podemski, Grzegorz Opala, Adam Bilikiewicz, Małgorzata Bilińska, Bogusław Paradowski, Tadeusz Parnowski, Tomasz Gabryelewicz

Med Sci Monit 2002; 8(2): PI9-15

ID: 420923

Available online: 2002-02-22

Published: 2002-02-22

BACKGROUND: Long-term safety and efficacy of Exelon (rivastigmine) wasevaluated in a multi-center open-label study of 62 patients with probable mild to moderate Alzheimer'sdisease living in community setting. MATERIAL/METHODS: The patients started treatment with 1.5 mg bid(3 mg/day) Exelon and were scheduled to receive doses of 1.5 mg bid Exelon escalating on a biweekly basis.The patients were maintained on the highest tolerated dose within the assigned dose range 1.5-6.0 mgbid (3-12 mg/day) for the rest of the study. Evaluations were scheduled at biweekly intervals for thefirst 8 weeks and subsequently at study weeks 12, 18 and 26. Effects of Exelon on cognition were evaluatedusing the mini-mental state examination (MMSE) and selected items of Alzheimer's disease assessment scale(ADAS-cog) and the staging of the disease was measured using the global deterioration scale (GDS). Safetywas monitored by physical examinations, vital signs, laboratory tests, ECG recording and by the assessmentof adverse events. RESULTS: 55 patients completed the study (89%). Patients treated for 26 weeks showedthe mean MMSE, ADAS-cog and GDS scores close to baseline values (p=NS) with no improvement and no deterioration.Exelon was generally well tolerated with 11% of patients withdrawing due to adverse events. The mostfrequently reported adverse events related to the gastrointestinal tract. CONCLUSIONS: In conclusion,the study data indicate that treatment with Exelon is safe, generally well tolerated and inhibits theprogression of cognitive decline in patients with mild to moderate Alzheimer's disease over 26 weeksof treatment.

Keywords: Aged, 80 and over, Alzheimer Disease, Carbamates, Disease Progression, Neuroprotective Agents, Phenylcarbamates, Research Support, Non-U.S. Gov