Annals of Neurology , 03/15/2012 Clinical Article
Etsuro Mori MD, PhD1,†,*, Manabu Ikeda MD, PhD2, Kenji Kosaka MD, PhD3, on behalf of the Donepezil-DLB Study Investigators
Copyright © 2012 American Neurological Association
*Department of Behavioral Neurology and Cognitive Neuroscience, Tohoku University Graduate School of Medicine, 2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
Donepezil for dementia with Lewy bodies: A randomized, placebo-controlled trial
- One-hundred and forty patients with DLB, recruited from 48 specialty centers in Japan, were randomly assigned to receive placebo, 3, 5, or 10 mg of donepezil hydrochloride daily for 12 weeks (n=35, 35, 33, and 37, respectively).
- Effects on cognitive function were assessed using the Mini-Mental State Examination (MMSE) and several domain-specific neuropsychological tests.
- Changes in behavior were evaluated using the Neuropsychiatric Inventory (NPI), caregiver burden using the Zarit Caregiver Burden Interview (ZBI), and global function using the Clinician’s Interview-Based Impression of Change-plus Caregiver Input (CIBIC-plus).
- Safety measures included the Unified Parkinson’s Disease Rating Scale (UPDRS) part III.
- Donepezil at 5 and 10 mg/day were significantly superior to placebo on both MMSE (mean difference, 95%CI, p value; 5 mg, 3.8, 2.3 to 5.3, p<0.001; 10 mg, 2.4, 0.9 to 3.9, p=0.001) and CIBIC-plus (p<0.001 for each): 3 mg/day was significantly superior to placebo on CIBIC-plus (p<0.001), but not on MMSE (p=0.017).
- Significant improvements were found also in behavioral measures (p<0.001) at 5 and 10 mg/day and caregiver burden (p=0.004) at 10 mg/day.
- The safety results were consistent with the known profile of donepezil and similar among groups.
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