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Divalproex (valproate) is frequently used to treat agitation in demented patients despite the absence of sufficient supportive data. In an NIH- and manufacturer-funded, 2-year, prospective study, researchers aimed to determine whether valproate would prevent or slow the onset of agitation or psychosis in 313 patients with mild-to-moderate Alzheimer disease who had not yet experienced these common and disabling complications.
Patients were randomized to valproate (12-month mean modal dose, 250 mg/day; mean serum level, 42.7 µg/mL) or placebo. Ninety-four patients underwent magnetic resonance imaging (MRI) at baseline and after 12 months; 88 of these had valid data on brain volumes.
The valproate and placebo groups did not differ in dropouts, a…