OBJECTIVE: To determine whether donepezil treatment (10 mg/day over 24
weeks) is associated with delayed emergence of apathy in patients with
mild to moderate Alzheimer's disease (AD) and to explore relationships
between donepezil's effects on apathy and other Neuropsychiatric
Inventory (NPI)-measured behavioural symptoms. METHODS: Two randomised,
double-blind, parallel-group, placebo-controlled studies that met
prespecified criteria and were sufficiently similar to allow data
pooling were derived from all donepezil AD clinical trials. Patients
scoring from 10 to 26 on baseline Mini-Mental Status Examination were
included. A clinical milestone for apathy and other NPI items was
defined as the first emergence of a composite score (frequency x
severity)>/=3. Differences in time to event (i.e. milestone) between
donepezil- and placebo-treated groups were assessed using the
Kaplan-Meier method and log-rank test. Shift tables were constructed to
evaluate clinical milestone status for apathy and other NPI items at
baseline and endpoint, and were analysed using the
Cochran-Mantel-Haenszel (CMH) test, stratified by baseline status.
RESULTS: Of all NPI items, apathy had the highest proportion of subjects
scoring>/=3 at baseline. Donepezil was superior to placebo on both
apathy milestone analyses (time-to-event log-rank test and shift table
CMH test, p = 0.01). Aberrant motor behaviour demonstrated similar
benefit. CONCLUSIONS: Donepezil treatment appears to have resulted in a
significant reduction over 6 months of the emergence of apathy in
patients with AD. These data suggest that a prospective clinical trial
in patients with early AD that includes apathy as a primary outcome
measure may be warranted. Copyright (c) 2010 John Wiley&Sons, Ltd.
source : dementianotes.blogspot.com
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