Up to 75% of patients with dementia experience significant agitation at some point during the course of the illness. The consequences of such behaviors are serious, impairing the quality of life of the patient and the patient's caregivers. Only preliminary studies characterizing such behaviors have been performed, and there are even fewer studies guiding a rational approach to somatic therapy for them. Neuroleptic medications have been studied at some length and have only modest effects at best. Of the non-neuroleptic psychotropic medications, carbamazepine offers itself as a logical possibility. Case reports and open studies, including one performed by the Principal Investigator, suggest that it may have a therapeutic effect. The primary aim of the proposed Intervention Development Study is to determine what effects carbamazepine has on the behavior of nursing home patients suffering from dementia who are agitated. Secondary aims include the following: 1.) the preliminary assessment of the global clinical efficacy of carbamazepine for treatment of agitation in the nursing home; 2.) the preliminary assessment of toxicity of carbamazepine treatment; 3.) the preliminary assessment of effects of carbamazepine upon level of function and cognitive performance; 4.) the post hoc assessment of factors predictive of good or poor drug response; 5.) the enhanced characterization of the spectrum of agitated behaviors associated with dementia of nursing home patients; 6.) field testing of a new instrument, developed by the CERAD Behavioral Pathology Committee in order to better assess disturbed behaviors that occur in dementia, to ascertain the utility of this instrument as a measure of outcome in intervention studies. If efficacy is established in the nursing home setting, the study will be expended to focus on outpatients who are at risk for institutionalization because of agitation associated with dementia. If feasibility can be established in the outpatient study, the data obtained will be used to seek further funding for a comprehensive investigation in outpatients, with more emphasis on health care implications of the intervention.
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