1. Issues to be addressed Is BPSD one entity? Is BPSD part of the diagnosis of dementia? Are BPSD symptoms which cut across diagnoses? Which syndromes have been reliably identified in BPSD? Should drugs be developed to address BPSD? What are some of the issues that need to be addressed in the design of pharmacological drug studies for BPSD?

2. Is BPSD one entity?

3. Studies regarding the relationship between type of agitation and level of cognitive functioning.

5. Is BPSD part of the diagnosis of dementia?

6. Are BPSD symptoms which cut across diagnoses?

7. Agitated Behaviors- diagnoses with similar manifestations Normal Children with attention-deficit/hyperactivity disorder - motor hyperactivity Children or adolescents with conduct disorders - aggression Adults with intermittent explosive disorder - aggression Stereotypic movement disorder – repetitive movements

8. Delusions and Hallucinations- diagnoses with similar manifestations Schizophrenia – delusions and hallucinations

9. Sleep problems- diagnoses with similar manifestations substance abuse circadian rhythm sleep disorders

10. Delusions and Hallucinations Delusions – Confabulations Hallucinations – Visual sensory deprivations

11. Which syndromes have been reliably identified in BPSD?

12. Examples of studies of factor analyses in agitation

13. Syndromes  Agitation – 3 syndromes  Psychotic symptoms – delusions and hallucinations  Depression – depressed affect vs. vegetative symptoms

14. Should drugs be developed to address BPSD?

15. Nonpharmacologic etiologies & therapies

16. Figure 2. Impact of nonpharmacologic intervention: Initial Results. N=12 Identified Needs 75%n=9 Residents Intervened 100%n=12 Failure25%n=3 SuccessfulIntervention42%n=5 Partial success 33%n=4 1 Unresolved medical problems 1 Possible candidate for pharmacological treatment 1 Severe infectious disease

17. Which BPSDs need to be treated? Many BPSDs do not have to be treated. Some BPSDs should not be treated with psychotropic drugs. Etiology of the symptom needs to be determined and addressed. For a small proportion of patients whose behavior is dangerous or grossly disturbing, and no nonpharmacologic approach is effective, a pharmacologic approach is appropriate

18. Issues in pharmacologic drug studies for BPSD which need to be addressed Sample representativeness Impact on nontarget symptom

19. Conclusion BPSD is not a diagnosis, nor can BPSD be considered symptoms which occur across diagnoses. A way to address BPSD is as a secondary diagnosis, such as dementia with aggressive features Several syndromes have been described consistently and reliably, and there is no shortage of assessment instruments to identify and quantify them. A reliable characterization is a necessary but not a sufficient condition for drug trials.

20. Conclusion There is a need to: –Investigate the possible etiologies of behaviors or psychological symptoms. Therefore: differentiate between psychiatric symptoms and natural sequelae of memory problems address probable etiologies via nonpharmacologic interventions prior to pharmacological ones. –Document need for pharmacological treatment beyond the presence of symptoms Pharmacologic studies design needs to assure that: –Studies are conducted with the same population for which the drug is to be prescribed –Studies examine impact on nontarget behaviors