It is my pleasure to write an introduction to this supplement. It is the first to appear under my editorship. We are very grateful to Drs. Radebaugh, Buckholtz, and Khachaturian for acting as guest editors.

The U.S. Senate Committee for Appropriations (for the Departments of Labor, Health and Human Services, and Education and Related Agencies), in its report of the fiscal year 1994 appropriations bill, directed the National Institute on Aging (NIA) to develop a long-range plan for taking advantage of scientific opportunities in Alzheimer's disease (AD) research.

The premise underlying the implementation of any intervention aimed at changing behavioral or other symptoms of Alzheimer's disease (AD) is that the change will be beneficial in some manner for the patient and the benefits will outweigh any negative consequences that may simultaneously result from the intervention. Consequently, the ultimate task of investigators studying the impact of proposed interventions is to identify and measure the benefit that stems from the intervention, as well as any negative effects. When interventions are intended to create organic changes, as is traditionally true with pharmacologic interventions, the identification of relevant outcomes is made relatively simple through indicators of organic functioning. However, when intended changes are behavioral, the identification of appropriate outcomes is far more complex. An individual's behavior ultimately has an impact on all the actors within his or her social setting, directly or indirectly. Furthermore, changes in an individual's behavior may have an impact on other persons in such a way that these secondary changes feed back to further influence the initial target individual. Hence, it is likely that the most appropriate study designs for assessing the impact of interventions aimed at behavioral problems will include multiple outcome measures for multiple actors.

To address the development of studies for behavioral problems in patients with Alzheimer's disease (AD), a framework is used that includes the patient, the caregiver (formal or informal), the patient-caregiver interaction, the environment, the organization of care within institutions, and systems for the delivery of care to patients and caregivers. Within each of these components, there will be indicated the areas that are ready for testing using a clinical trial design and the areas that need further study using less controlled designs. Finally, recommendations will be made that address all components of the framework.

Barriers to behavioral research are multifactorial. They include attitudinal, conceptual, financial, and administrative factors. In general, behavioral research and clinical research have received less support than basic science research (Marshall, 1994). The traditional emphasis has been on funding of basic research with the expectation that clinical research can be pursued without specific financial support. Although this might have been possible in the past, the increasingly tight control of clinicians' time and the need for cost-effective healthcare delivery have rendered this approach obsolete. Advances in clinically applicable information will require the type of research funding usually reserved for basic science endeavors.

Dementia is a major public health problem in the United States and the world, requiring the expenditure of enormous economic and human resources. Dementia is common in the elderly, and, as the size of the aged population increases, the number of dementia victims will rise. Many dementias are fatal, producing the gradual erosion of intellectual abilities and eventual death of the patient. Demands made on family members and caregivers of dementia patients are extraordinary and often result in their emotional and financial exhaustion. Although basic science efforts are devoted to finding a cure for Alzheimer's disease (AD) and other dementing illnesses, there is an urgent need for research that has immediate applicability to the 4 million current dementia patients.

In 1785, an anonymous author published what may be the first case report of a patient with dementia. This dramatic case report highlighted the distressing and disruptive behavioral manifestations that the patient suffered.

Alzheimer's disease (AD) is a progressive condition associated with a broad variety of clinical symptoms. These symptoms can, for the most part, be conceptualized as falling within three primary categories: (I) cognitive symptoms, (II) functional symptoms, and (III) behavioral (disturbance) symptoms. All of these symptom categories may potentially respond to specific behavioral intervention approaches to treatment and management. However, at this time, few behavioral approaches have convincingly been substantiated to be effective in treating any of the symptoms in any of these categories.

A majority of patients with dementia of the Alzheimer type (DAT) display behavioral disturbances of varying degrees of severity. These disturbances include both behavioral excesses and deficits. The behavioral excesses reported in this population include physical aggression, wandering, and disruptive vocalization, to name but a few (Burgio et al., 1988b). Disruptive behaviors have been reported in at least 50% of individuals diagnosed with DAT (Cummings et al., 1987). Research has shown that individuals with dementia frequently display severe deficits in performing activities of daily living such as feeding, bathing, and dressing (Burgio et al., 1988b). Although these deficits are, in part, a natural result of the dementing illness, it has long been recognized by gerontologists that many demented individuals display “excess deficits” (Brody et al., 1971), i.e., symptoms of functional incapacity greater than those warranted by the actual organic impairment.

Disruptive behaviors have been reported in at least 50% of patients with Alzheimer's disease (AD) at some point during the course of their illness (Cummings et al., 1987). If patients with AD were carefully followed from the onset of illness through its terminal stages, the cumulative incidence of clinically significant disruptive behaviors would be even higher. Despite the paucity of data from well-designed studies evaluating the efficacy of management approaches to these disruptive behaviors, the prescription of antipsychotic medications (such as thioridazine and haloperidol) or antianxiety medications (such as benzodiazepines) to AD patients with disruptive behaviors is wide-spread, particularly in the long-term care setting (Harrington et al., 1992). The few interpretable placebo-controlled studies evaluating pharmacologic approaches to the management of disruptive behaviors have focused on anti-psychotic medications. Although these medications appear somewhat effective (approximately 20% greater than placebo response) (Barnes et al., 1982; Petrie et al., 1982; Schneider et al., 1990), their efficacy is much less than that observed in younger, nondemented patients with such major psychiatric diseases as schizophrenia. In addition, these medications often produce substantial motor and cognitive adverse effects that further minimize the variable and modest benefits of pharmacotherapy.

Behavioral disturbances are a frequent feature of Alzheimer's disease (AD) and other dementing disorders. Although this observation has been noted since the beginning of this century, subsequent investigations into dementia have focused primarily on memory and cognitive impairments, with little attention to disturbances in behavior.

This article addresses three areas of consideration in designing behavioral studies that will assist in slowing the progression of the symptoms of Alzheimer's disease (AD). The areas are (a) the type and design of intervention studies needed, (b) the development and use of outcome measures, and (c) the issue of efficacy versus effectiveness.

Current approaches to the behaviorally based treatment and management of Alzheimer's disease (AD) often fail to take advantage of technological developments in related fields. Thus, there are instances in which the need is not to discover new behavioral approaches, but to make use of “discoveries” made in other fields, charting a course for their application in dealing with AD. This assertion is suggested as a basis for strategic planning involving information transfer, to be conducted in addition to tactical planning regarding research design, implementation, and dissemination.

Behavioral symptoms in people with Alzheimer's and other diseases and conditions that cause dementia are important because they imply distress and because they are likely to have negative consequences for the person, his or her family, and other informal and formal (paid) caregivers who work with the person in any setting. In nursing homes and other residential care facilities, the behavioral symptoms of people with dementia are also likely to have negative consequences for other residents who live in close proximity to demented individuals.

The purpose of this article is to discuss one of the key behavioral scientific problems facing the Alzheimer's disease (AD) research community: sleep-activity rhythm disruption. Research opportunities in this area have the potential for a significant positive impact on the management of AD in the home and in various institutional environments. Barriers that impede timely implementation of programs of research in this area, suggestions for overcoming these barriers, and resources needed to facilitate the rapid advance of research are also discussed.

In examining the current status and future potential of behavioral treatments for Alzheimer's disease (AD), it is important to begin by defining the scope and goals of such treatments. The category of behavioral treatments includes not only nonpharmacologic techniques to modify or enhance patient behavior, but also psychosocial interventions applied to family members and paid care providers. Caregiver interventions are important because they can reduce the negative impact of AD on those directly and indirectly affected by the disease. Based on current knowledge about the pathophysiology of AD, it is not considered likely that behavioral treatments can have a direct impact on the disease itself by affecting its clinical onset, rate of progression, or prognosis. Although it is conceivable that certain long-term behavioral interventions might delay onset of symptoms (e.g., mental “exercise” to enhance dendritic growth and increase “cognitive reserve,” or long-term stress reduction methods to minimize possible degenerative central nervous system effects of chronic stress), such approaches remain speculative, and their effectiveness would be difficult and expensive to demonstrate. Thus, the current goal of behavioral treatments is to reduce the negative effects of AD on the patient, on the patient's primary caregiver and immediate family, on the healthcare system, and on society as a whole. Such a goal is far from trivial because (a) successful treatment of primary pathophysiology is not on the immediate horizon, and (b) the impact of AD on the family and society represents a major cost of this tragic disease.

Alzheimer's disease (AD) results in severe cognitive decline, deterioration in the ability to perform routine activities such as bathing or walking, and changes in affect and behavior. It severely diminishes the quality of life of the affected person and presents a colossal burden to caregivers and a tremendous financial liability to society. The impetus for research relates specifically to these burdens by testing new ways to approach the manifestations of the disease and effectively communicating these ways to caregivers.

This article will discuss briefly the definitions of behavior problems and behavioral interventions. Next, the following series of intervention points related to the quality of life of patients with Alzheimer's disease (AD) will be considered: cognition, activities of daily living (ADLs), agitation, social behavior, nonsocial positive behaviors, and affect states. The article concludes with a discussion of three areas dealing with environmental aspects of AD care: the design of environments, effects of AD on social context, and AD in planned housing.

This discussion must begin with a consideration of the assumptions in the mandate given to the National Institute on Aging (NIA) from the U.S. Senate Appropriations Committee. The Senate report states that the broad objectives of the plan to be developed by the NIA are “to slow the rate of deterioration from Alzheimer's by 5 years during the next 5 years, and by 10 years within 10 years.”

Recent biological and genetic studies focused on the causes and treatment of Alzheimer's disease (AD) have provided findings that are encouraging. These findings have raised the hopes of family members, as well as those of the research community, that the cause and/or treatment of AD will emerge in the near future. Despite these hopes, however, families and the research community acknowledge the reality that, for thousands, these discoveries will come too late. Even as they continue to hope, families must contend with the difficult tasks of caring for persons with AD. This care can be intensive, extensive, and exhausting. Because families deal with the day-to-day reality of caring for persons who are progressively deteriorating, there is a need to focus on the social and behavioral aspects of AD.