(HealthDay News) – For patients with dementia with Lewy bodies (DLB), 5 and 10mg/day doses of donepezil are associated with significant improvements in behavioral, cognitive, and global symptoms, according to a phase II study published online Feb. 8 in the Annals of Neurology.
Etsuro Mori, MD, PhD, from the Tohoku University Graduate School of Medicine in Sendai, Japan, and colleagues randomly assigned 140 patients with DLB to receive placebo or 3, 5, or 10mg of donepezil hydrochloride daily for 12 weeks. The Mini-Mental State Examination (MMSE) and several domain-specific neuropsychological tests were used to assess changes in cognitive function. Changes in behavior were evaluated using the Neuropsychiatric Inventory, and changes in caregiver burden were measured by the Zarit Caregiver Burden Interview. Global function was measured using the Clinician’s Interview-Based Impression of Change-plus Caregiver Input (CIBIC-plus).
The researchers found that 5 and 10mg/day doses of donepezil were significantly superior to placebo on both MMSE and CIBIC-plus. Treatment with 3mg/day donepezil was significantly superior to placebo on CIBIC-plus (P<0.001), but not on MMSE (P=0.017). Behavioral measures improved significantly with 5 and 10mg/day donepezil, and significant improvement was seen in caregiver burden with 10mg/day. The safety results for donepezil were consistent with the established profile and were similar among groups.
“Donepezil at 5 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, which manufactures donepezil.