Shaw, E.G., Rosdhal, R., D’Agostino, R.B., Lovato, J. Naughton, M.J., Robbins, M.E., & Rapp, S.R. (2006). Phase II study of donepezil in irradiated brain tumor patients: Effect on cognitive function, mood, and quality of life. Journal of Clinical Oncology, 24(9), 1415–1420.
The study was conducted to determine whether donepezil improved cognitive functioning, mood, and quality of life in patients who had irradiated brain tumors.
All participants received 5 mg/day of donepezil for 6 weeks, then 10 mg/day of donepezil for 18 weeks, followed by a washout period of 6 weeks where no treatment was administered.
This was a prospective, open-label, phase II study.
Significant improvement was noted between the pre-treatment baseline and week 24 on measures of attention/concentration, verbal memory, figural memory, and a trend for verbal fluency (all p < 0.05). Confused mood was also improved from baseline to 24 weeks (p = 0.03). Health-related quality of life improved from baseline to 24 weeks in brain-specific concerns (p = 0.003), emotional functioning (p = 0.04), and social functioning (p = 0.02), with a trend for improvement in total health-related quality of life (p = 0.07).
Ten of 21 participants, or 48% of those who completed the study through the 30-week assessment, chose to go back on donepezil. A total of 63 toxicities ranging from grade 1 to grade 3 were reported.
Mood, health-related quality of life, and cognitive functioning (attention/concentration, verbal memory, and figural memory) were significantly improved following a 24-week course of donepezil.