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

Long-term safety and efficacy of Exelon (rivastigmine) was evaluated in a multi-center open-label study of 62 patients with probable mild to moderate Alzheimer's disease living in community setting. 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 mg bid (3-12 mg/day) for the rest of the study. Evaluations were scheduled at biweekly intervals for the first 8 weeks and subsequently at study weeks 12, 18 and 26. Effects of Exelon on cognition were evaluated using 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). Safety was monitored by physical examinations, vital signs, laboratory tests, ECG recording and by the assessment of adverse events. 55 patients completed the study (89%). Patients treated for 26 weeks showed the 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 most frequently reported adverse events related to the gastrointestinal tract. In conclusion, the study data indicate that treatment with Exelon is safe, generally well tolerated and inhibits the progression of cognitive decline in patients with mild to moderate Alzheimer's disease over 26 weeks of treatment.