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Music therapy (MT) has been proposed as valid approach for behavioral and psychologic symptoms (BPSD) of dementia. However, studies demonstrating the effectiveness of this approach are lacking.To assess MT effectiveness in reducing BPSD in subjects with dementia.Fifty-nine persons with dementia were enrolled in this study. All of them underwent a multidimensional assessment including Mini Mental State Examination, Barthel Index and Neuropsychiatry Inventory at enrolment and after 8, 16, and 20 weeks. Subjects were randomly assigned to experimental (n=30) or control (n=29) group. The MT sessions were evaluated with standardized criteria. The experimental group received 30 MT sessions (16 wk of treatment), whereas the control group received educational support or entertainment activities.NPI total score significantly decreased in the experimental group at 8th, 16th, and 20th weeks (interaction time× group: F3, 165=5.06, P=0.002). Specific BPSD (ie, delusions, agitation, anxiety, apathy, irritability, aberrant motor activity, and night-time disturbances) significantly improved. The empathetic relationship and the patients' active participation in the MT approach, also improved in the experimental group.The study shows that MT is effective to reduce BPSD in patients with moderate-severe dementia.