Objective: to investigate the safety, tolerability, and efficacy of high dose rivastigmine treatment for treatment of Alzheimer's disease
Design: prospective evaluation
Methods: A prospective evaluation of all patients in our clinical practice who were receiving treatment with rivastigmine 12 mg/day was conducted. Enrollment in this study required meeting all of the following inclusion criteria: all met the DSM-IV and NINCDS-ADRDA criteria for possible Alzheimer's disease; all were being treated with rivastigmine 12 mg/day for at least one month; all denied experiencing adverse events during the previous dose titration; All were free from renal or hepatic disease; all had a subjective decline in cognitive ability as reported by caregivers which was confirmed with cognitive testing.
At baseline, each patient was being treated with rivastigmine 6 mg one hour after breakfast and dinner. The initial dose modification was an additional 1.5 mg added to the P.M. dose. If no adverse events were reported, the A.M. dose was also increased to 7.5 mg. This regimen was continued for one month, and then each patient was evaluated by a physician at our office. If the 15 mg/day was tolerated, the patient was then instructed to increase the P.M. dose by another 1.5 mg for a total daily dose of 17.5 mg/day.
Folstein Mini Mental Status Examination (MMSE) was obtained at baseline and at the conclusion of the study.
The average length of the titration period was two months. Patients who experienced adverse events were instructed to return to their previously tolerated regimen. A re-challenge was then performed after four weeks, and ultimately, most patients reached the target dose of 15-17.5 mg/day.
Results: A total of six patients completed the study. The average age was 78.2 and average baseline MMSE was 17.4 (range 15-21). Four of the patients were treated with rivastigmine 15 mg/day and two of the patients received 17.5 mg/day. No adverse events were reported. The average MMSE one month after full titration was 19.6 (range 16-26). Except one, all caregivers reported noticeable cognitive improvement.
Conclusion: Titration of rivastigmine to 15-17.5 mg/day was well tolerated by Alzheimer's patients who were previously tolerating 12 mg/day. Cognitive benefit was noticed in our study population, and further research is indicated.
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