Donepezil for dementia with Lewy bodies: a randomized, placebo-controlled, confirmatory phase III trial.

ABSTRACT:

Introduction

The efficacy of a cholinesterase inhibitor, donepezil, in patients with dementia with Lewy bodies (DLB) was investigated to confirm the superiority over placebo in the 12-week, double-blind phase of this phase III study.

Methods

Patients with probable DLB (n = 142) were randomly assigned to placebo or to 5 mg or 10 mg of donepezil administered once daily for 12 weeks. The co-primary endpoints were changes in cognitive function assessed using the Mini-Mental State Examination (MMSE) and behavioral and neuropsychiatric symptoms using the Neuropsychiatric Inventory (NPI-2: hallucinations and fluctuations). The superiority of each active group over placebo was determined with simultaneous statistical significance in both endpoints. Safety evaluations included advers

SUBMITTER: Ikeda M 

PROVIDER: S-EPMC4338565 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature