BACKGROUND: We report the findings from the first large, double-blind, placebo-controlled study conducted to evaluate the efficacy and safety of @entity1090 in the treatment of @entity716 and behavioral symptoms in institutionalized elderly @entity1 with @entity303 . METHOD: 625 @entity1 (67.8% @entity1 ; mean age = 82.7 years) with DSM-IV diagnoses of @entity195 (73%), @entity1294 (15%), or mixed @entity303 (12%) and significant @entity716 and behavioral symptoms were included. Each @entity1 was randomly assigned to receive placebo or 0.5 mg/day, 1 mg/day, or 2 mg/day of @entity1090 for 12 weeks. The primary outcome measure was the Behavioral Pathology in @entity195 rating scale (BEHAVE-AD). RESULTS: The study was completed by 70% of the @entity1 . Baseline Functional Assessment Staging scores were 6 or 7 in more than 95% of the @entity1 , indicating severe @entity303 . At endpoint, significantly greater reductions in BEHAVE-AD total scores and @entity716 and @entity146 subscale scores were seen in @entity1 receiving 1 and 2 mg/day of @entity1090 than in placebo @entity1 (p = .005 and p < .001, respectively). At week 12, 0.5 mg/day of @entity1090 was superior to placebo in reducing BEHAVE-AD aggression scores (p = .02). More adverse events were reported by @entity1 receiving 2 mg/day of @entity1090 than 1 mg/day. The most common dose-related adverse events were @entity21 , @entity2147 , and mild @entity4 . The frequency of @entity21 in @entity1 receiving 1 mg/day of @entity1090 was not significantly greater than in placebo @entity1 . CONCLUSION: @entity1090 significantly improved symptoms of @entity716 and @entity146 in @entity1 with severe @entity303 . Results show that 1 mg/day of @entity1090 is an appropriate dose for most elderly @entity1 with @entity303 .

Comparison of XXXX and placebo for @entity716 and @entity146 associated with @entity303 : a randomized, double-blind trial. @entity1090 Study Group.

@entity1 :: ('9606', 'Species') :: ['women', 'patients', 'patient'] @entity146 :: ('MESH:D001523', 'Disease') :: ['aggressive behavior', 'aggressiveness'] @entity303 :: ('MESH:D003704', 'Disease') :: ['dementia'] @entity1294 :: ('MESH:D015140', 'Disease') :: ['vascular dementia'] @entity4 :: ('MESH:D004487', 'Disease') :: ['peripheral edema'] @entity2147 :: ('MESH:D006970', 'Disease') :: ['somnolence'] @entity716 :: ('MESH:D011605', 'Disease') :: ['psychotic', 'psychosis'] @entity195 :: ('MESH:D000544', 'Disease') :: ["Alzheimer's disease", "Alzheimer's Disease"] @entity21 :: ('MESH:D001480', 'Disease') :: ['extrapyramidal symptoms'] @entity1090 :: ('MESH:D018967', 'Chemical') :: ['risperidone', 'Risperidone']
@entity1090 :: (MESH:D018967,Chemical) :: ['risperidone']
