Treatment of Behavioral Symptoms in Alzheimer's Disease

Inclusion Criteria: Meets DSM-IV criteria for dementia either sex, age 50-95 years Meets NINCDS-ADRDA criteria for probable Alzheimer's disease Meets Folstein Mini-Mental State Exam score of 5-26, inclusive Intellectual impairment reported for at least six months Availability of family member who has had direct contact with the patient for an average of at least once every week during the three months prior to study entry Has current symptoms of psychosis or agitation. Criteria for "psychosis" requires the presence of delusions and/or hallucinations identified by the Columbia University Scale for Psychopathology in Alzheimer's Disease (CUSPAD) and a minimum Brief Psychiatric Rating Scale (BPRS) psychosis factor score of at least 4 (moderate severity) on one of the following two items: These two items comprise the psychosis factor, excluding the item for conceptual disorganization. Agitation is defined as a score of greater than 3 (present at least 10 days per month) on one or more of the CERAD Behavioral Rating Scale for Dementia items for agitation, purposeless wandering, verbal aggression or physical aggression. Free of psychotropic medication for at least two weeks prior to study entry, or able to tolerate medication washout for this period. Informed consent by patient and family member, as per IRB procedures at New York State Psychiatric Institute. Exclusion Criteria: Acute unstable medical condition, delirium, alcohol or substance abuse or dependence within the past 1 year Clinical evidence of stroke, other dementias including vascular or Lewy body or frontotemporal dementia, multiple sclerosis, Parkinson's disease, Huntington's disease, tardive dyskinesia Diagnosis of a psychotic disorder antedating the onset of dementia Antipsychotic medication usage during 4 weeks prior to study entry Contraindication to the use of haloperidol