Thursday, 21 August 2003
This presentation is part of : Thursday Poster Sessions

PD-069 Safety and Tolerability of High Dose Donepezil in Patients with Alzheimer’s disease: A Preliminary Report of A Pilot Study

Joshua R. Shua-Haim, Mark Pass, and Sameer Patel. Meridian Institute for Aging, Manchester Township, NJ, USA

Objective: To investigate the safety and tolerability of donepezil medication in the treatment of patients with Alzheimer’s disease.

Materials and Methods: Inclusion criteria for the study were patients who have been treated already with donepezil for at least two years, and caregivers or family members were noticing lack of efficacy or cognitive / functional deterioration. All patients included in the study met the- DSM-IV and NINCDS-ADRDA criteria for possible Alzheimer’s disease. All patients were treated with donepezil at the maximal dose of 10mg once a day for at least 4 months. An increased dose of donepezil was offered only to patients whose family / caregivers voiced their frustration regarding lack of efficacy with the current treatment. They were offered to switch donepezil to other approved drugs, or to increase donepezil to 15mg/d and after one month to 20mg a day. Caregivers and family members were educated regarding the FDA approval dosing of donepezil. There was no prior information regarding efficacy or safety with donepezil treatment in the dosing of 15-20mg a day. The possible lack of efficacy was also addressed with caregivers at high dose of treatment. Family consent was obtained before treatment began. Since no prescription plan would approve/cover high dose treatment, a prescription of 10 mg was given to the family, and samples of 5mg tablets were supplied from our office. Patients were instructed to take the donepezil at dose 10mg in am and 5mg in pm with meals for one month. Thereafter, there were treated with donepezil 10mg bid with meals. Patients were followed in the office after one week, and after one month after each dose change.

Results: There were a total of 9 patients in the study. Average age was 76 (72-83). After one week of treatment with donepezil 15mg, one patient experienced increased agitation and confusion and this patient was withdrawn from the high dose treatment program. Interestingly, cognitive improvement was noted after stopping treatment altogether. There was only one patient who did not tolerate 10mg bid due to nightmares. He was treated with 10mg in am and 5mg in pm with meals.

Conclusion: High dose donepezil (15-20 mg/day) appears to be safe in this small pilot study. A larger study should be considered to determine the long-term safety and efficacy of this medication.

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