22 February 2002
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
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
01 June 2023 : EditorialEditorial: Infectious Disease Surveillance Using Artificial Intelligence (AI) and its Role in Epidemic and Pandemic Preparedness
Med Sci Monit 2023; 29:e941209
01 Jun 2023 : Clinical ResearchRoot Canal Numbers and Configurations in 1080 Permanent Canine Teeth in 270 Saudi Subjects Using Cone-Beam ...
Med Sci Monit In Press; DOI: 10.12659/MSM.940472
01 Jun 2023 : Clinical ResearchInternal Orifice Alloy Closure: A New Procedure for Treatment of Perianal Fistulizing Crohn’s Disease
Med Sci Monit In Press; DOI: 10.12659/MSM.940873
01 Jun 2023 : Clinical ResearchEffectiveness of Needle Aspiration versus Surgical Excision for Symptomatic Synovial Cysts of the Hip: A Si...
Med Sci Monit In Press; DOI: 10.12659/MSM.940187
01 Jun 2023 : Clinical ResearchInfluence of Insulin Resistance on Diabetes Nephropathy
Med Sci Monit In Press; DOI: 10.12659/MSM.939482
Most Viewed Current Articles
13 Nov 2021 : Clinical ResearchAcceptance of COVID-19 Vaccination and Its Associated Factors Among Cancer Patients Attending the Oncology ...
Med Sci Monit 2021; 27:e932788
30 Dec 2021 : Clinical ResearchRetrospective Study of Outcomes and Hospitalization Rates of Patients in Italy with a Confirmed Diagnosis o...
Med Sci Monit 2021; 27:e935379
08 Mar 2022 : Review articleA Review of the Potential Roles of Antioxidant and Anti-Inflammatory Pharmacological Approaches for the Man...
Med Sci Monit 2022; 28:e936292
01 Jan 2022 : EditorialEditorial: Current Status of Oral Antiviral Drug Treatments for SARS-CoV-2 Infection in Non-Hospitalized Pa...
Med Sci Monit 2022; 28:e935952