(HealthDay News) – For patients with dementia with Lewy bodies (DLB), treatment with 5mg/day or 10mg/day donepezil is associated with significant cognitive, behavioral, and global function improvements, according to research published in the July issue of the Annals of Neurology.
Etsuro Mori, MD, PhD, of the Tohoku University Graduate School of Medicine in Sendai, Japan, and colleagues conducted a randomized, double-blind, placebo-controlled trial involving 140 patients with DLB who received either placebo or 3mg, 5mg, or 10mg of donepezil hydrochloride per day for 12 weeks (35, 35, 33, and 37 patients, respectively). Cognitive function was measured using the Mini-Mental State Examination (MMSE); behavioral changes were measured using the Neuropsychiatric Inventory; global function was evaluated using the Clinician’s Interview-Based Impression of Change-plus Caregiver Input (CIBIC-plus); and caregiver burden was also assessed.
The researchers found that, compared with placebo treatment, the MMSE scores were significantly better with donepezil 5mg (mean difference, 3.8) and 10mg (mean difference, 2.4), but the 3mg/day dose was not significantly better than placebo (P=0.017). Donepezil at doses of 3mg/day, 5mg/day, and 10mg/day correlated with significant improvements versus placebo on CIBIC-plus. Both the 5mg and 10mg doses of donepezil resulted in significant improvements in behavioral measures. Caregiver burden also improved, but only with the 10mg/day dose. The safety results were similar among the groups and were consistent with the known profile.
“Donepezil at 5mg/day and 10mg/day produces significant cognitive, behavioral, and global improvements that last at least 12 weeks in DLB patients, reducing caregiver burden at the highest dose,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Eisai Co., which funded the study and manufactures donepezil.