Donepezil for Dementia with Lewy bodies: A Randomized, Placebo-controlled Trial

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

DOI: 10.1002/ana.23557

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 

Mori E et al. – Donepezil at 5 and 10 mg/day produces significant cognitive, behavioral, and global improvements that last at least 12 weeks in dementia with Lewy bodies (DLB) patients, reducing caregiver burden at the highest dose. Donepezil is safe and well–tolerated.


  • 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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