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?

Is BPSD one entity?

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

Population Setting N Reference

French PsychogeriatricHospital

17 Micas et al., 1995

U.S. Communitydwelling –ADCS data

305 Cohen-Mansfield et al.,in press

U.S. Nursing home 408 Cohen-Mansfield et al.,1995

U.S. Adult day care 200 Cohen-Mansfield et al.,1995

Physically non-aggressive behavior

brief cognitive rating scale

876543210

3

2

1

0

Physical aggressive behavior

brief cognitive rating scale

876543210

3.0

2.5

2.0

1.5

1.0

.5

Verbal/vocal agitated behavior

brief cognitive rating scale

876543210

3

2

1

0

Is BPSD part of the diagnosis of dementia?

Are BPSD symptoms which cut across diagnoses?

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

Delusions and Hallucinations- diagnoses with similar manifestations

Schizophrenia – delusions and hallucinations

Sleep problems- diagnoses with similar

manifestations

• substance abuse

• circadian rhythm sleep disorders

Delusions and Hallucinations

• Delusions – Confabulations

• Hallucinations – Visual sensory deprivations

Which syndromes have been reliably identified in BPSD?

Examples of studies of factor analyses in agitation

Population Setting N Reference

Dutch Psychiatric Hospital -observation clinic forolder persons

334 De Jonghe & Kat, 1996

Chinese Inpatient and outpatientpsychogeriatric units

164 Lam et al., 2000

Japanese Nursing home 396 Schreiner, Yamamoto, &Shiotani, 1999

U.S. Nursing home 408 Cohen-Mansfield et al.,1989

U.S. Adult day care centers 200 Cohen-Mansfield et al.,1995

Syndromes

Agitation – 3 syndromes

Psychotic symptoms – delusions and hallucinations

Depression – depressed affect vs. vegetative symptoms

Should drugs be developed to address BPSD?

Nonpharmacologic etiologies & therapies

Treatment N Success Rate Source

Social Interaction 36 69% Success rate Cohen-Mansfield &Werner, 1998

StaffEducationProgram

275 50% decrease inaggressive behaviors

Hagen & Sayers, 1995

Walking Program 11 30% decrease inaggressive events

Holmberg, 1997.

SimulatedPresence

27 91% decrease inproblem behaviors

Woods & Ashley,1995

Figure 2. Impact of nonpharmacologic intervention: Initial Results. N=12

Identified NeedsIdentified Needs75%75%n=9n=9

Residents IntervenedResidents Intervened100%100%n=12n=12

FailureFailure25%25%n=3n=3

Successful Successful InterventionIntervention

42%42%n=5n=5

Partial successPartial success33%33%n=4n=4

1 Unresolved medical problems1 Possible candidate for pharmacological treatment1 Severe infectious disease

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

Issues in pharmacologic drug studies for

BPSD which need to be addressed

• Sample representativeness

• Impact on nontarget symptom

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.

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