Alzheimer's patients with behavioral problems (e.g., sleep disturbance, agitation) and/or psychosis are commonly treated with antipsychotic medications like haloperidol. This study focuses on the treatment of behavioral symptoms in Alzheimer's disease with haloperidol and whether long term treatment is necessary. The study is conducted in two phases: First, for five months active haloperidol is given, titrating the dose (1-4 mg. daily) for maximum effectiveness while closely monitoring side effects.

Second, for those patients who respond and remain stable on the medication, we examine whether continuation medication treatment is necessary. To this end, they are treated for another 24 weeks in a randomized double-blind placebo-controlled manner. After completing the study, patients are transferred back to their primary physician once the behavioral disturbance and/or psychosis is optimally treated.

Drs. D.P. Devanand and G. Pelton are conducting this project.

Inclusion Criteria:

• Meets DSM-IV criteria for dementia
• Meets NINCDS-ADRDA criteria for probable Alzheimer's disease
• 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
• Fulfills criteria for "psychosis" or "behavioral disturbance" defined as follows: A) Criteria for "psychosis" i. based on Columbia University Scale for Psychopathology in Alzheimer's Disease, the presence of a delusion that meets the "narrow" definition, or a hallucination that is rated as "clear" and ii. a Brief Psychiatric Rating Scale (BPRS) score of at least 4 (moderate severity) on one of the following two items: hallucinatory behavior or unusual thought content, or a total score of greater than 6 on these two items added together B) Criteria for "behavioral disturbance" i. a score of greater than 4 on any one of the following BPRS items: hostility, suspiciousness, uncooperativeness (hostile-suspiciousness factor), or a score of greater than 8 on the sum of these three items, or: ii. a score of greater than 4 on one of the following items from the Behavioral Syndromes Scale for Dementia: physical aggression or motor agitation (item score) or catastrophic reaction (global rating for category)
• 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:

• History of alcohol or drug dependence (DSM-IV criteria), or history of substance abuse within the past one year
• Major primary affective disorder prior to onset of intellectual deficits
• History of clinical evidence of stroke (patients will be excluded if they demonstrate definite evidence of infarction > 2 cm on any slice on MRI scan, conducted as part of the initial clinical evaluation
• History of clinical evidence of Parkinson's disease, Huntington's disease, tardive dyskinesia, or multiple sclerosis
• Diffuse Lewy body disease by McKeith et al. criteria
• Severe concomitant medical conditions and non-ambulatory patients
• Inability to tolerate psychotropic medication washout for two weeks prior to study entry
• Neuroleptic usage during the 4 weeks prior to study entry.