The conceptualization of an international consensus conference for the purpose of beginning to establish an operational definition for “behavioral disturbances of dementia” was born at the 7th International Psychogeriatric Association (IPA) Congress in Sydney, Australia, in November 1995. At that time, a special symposium on “research methodological issues in evaluating behavioral disorders of dementia” took place. From the high level of interest and attendance, it was clear that this matter was a source of great attention and concern by clinicians and researchers working with demented elderly. Although we have been aware that patients with dementias, including Alzheimer's disease (AD), manifest psychotic, depressive, and behavioral symptoms over the course of the illness, such symptoms until recently have elicited little interest or research support. Further, research was hampered by the absence of viable measurements and scales developed for this specific population. In addition, rigorous clinical trials were rare and virtually nonexistent in those with moderate and advanced dementias. Prior to 1992, only seven randomly assigned, double-blind trials in this population had been published, only one in a nursing home setting.

After 9 months, the editorial office of International Psychogeriatrics is now comfortably housed in St. Louis. Nancy Raley, the Assistant to the Editor-in-Chief, has the flow of manuscripts well in hand. The time between submission and acceptance is now down to 2 to 4 months, with a total of 9 months from submission to publication. This has been achieved by making the journal a quarterly, by reducing the review time, and by Nancy's diligence. For those of you who have kindly reviewed manuscripts, a special thanks. You are the unsung heroes of International Psychogeriatrics.

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 conceptualization and research focus on the behavioral and psychological manifestations of dementia have increased significantly over the past decade. To reflect this evolution, a recent consensus conference, convened by the International Psychogeriatric Association and subsequent to the compilation of this issue, concluded that the term “behavioral disturbances of dementia” (BDD) be replaced by “the behavioral and psychological signs and symptoms of dementia” (BPSSD).

The articles and round table discussions in this issue are all from a special meeting of the International Psychogeriatric Association (IPA) sponsored by the IPA's Pharmacy and Therapeutics Committee, The meeting was entitled “Outcome Methodologies for Pharmacologic Trials in Mild, Moderate, and Severe Alzheimer's Disease” and was held on July 26, 1994, at the New York University Medical Center, New York. NY. The following is a list of the participants in this meeting (with their affiliations as noted at the time of the meeting).

With this issue we welcome Dr. Robin Eastwood as the new editor-in-chief of International Psychogeriatrics. His appointment follows a comprehensive search for an editor with long-standing experience in psychogeriatrics, an extensive clinical and research background, and prior knowledge of journal editing. We wanted an editor who has also published articles in refereed journals and who has an international orientation. Dr. Eastwood exemplifies all these qualities and thus, after an extensive search, he received unanimous support from the publications committee as well as the International Psychogeriatric Association Board of Directors.

Interpretation of cognitive test performance among individuals from a given population requires an understanding of cognitive norms in that population. Little is known about normative test performance among elderly illiterate non-English-speaking individuals. An age-stratified random sample of men and women, aged 55 years and older, was drawn from a community-based population in the rural area of Ballabgarh in northern India. These Hindi-speaking individuals had little or no education and were largely illiterate. A battery of neuropsychological tests, specially adapted from the CERAD neuropsychological battery, which was adminstered to this sample, is described. Subjects also underwent a protocol diagnostic examination for dementia. Norms for test performance of 374 nondemented subjects on these tests are reported across the sample and also by age, gender, and literacy.

As the population ages in the United States and other countries, we will be confronted with an increasing number of patients with neurodegenerative disorders, such as Alzheimer's disease and Parkinson's disease. The progressive cognitive impairment that characterizes Alzheimer's disease leaves patients increasingly unable to care for themselves. Patients with Alzheimer's disease also are prone to dementia-related behavioral disturbances, which can range from annoying (such as repetitive questioning) to disturbing (such as vocal outbursts) to dangerous (such as hitting and pushing).

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.

Behavioral disturbances of dementia have been noted by early researchers in the field, including Esquirol (1838) and Alzheimer in his seminal case description (1907). Increasingly, family members, healthcare providers, and policy makers are realizing that neuropsychiatric symptoms and behavioral problems are an intrinsic component of Alzheimer's disease and result in caregiver psychopathology, early institutionalization, substantial societal costs, and detriment in the quality of life for the patient and caregivers.

This issue is a product of a special meeting ofthe International Psychogeriatric Association (IPA). The meeting, entitled “Outcome Methodologies for Pharmacologic Trials in Mild, Moderate, and Severe Alzheimer's Disease,” was held under the auspices of the IPA's Pharmacy and Therapeutics Comniittee on July 26, 1994, at the New York University Medical Center in New York City. The purpose of the meeting was to bring together leading scientists, clinicians, and regulatory personnel to address issues surrounding assessment of treatment efficacy in Alzheimer's disease (AD).

The purpose of this study was to assess quantitative and qualitative changes that occurred in the drawing of the human figure during depression and dementia in the elderly. A modified scale version of the Draw a Person Test (DAP) is presented. The first study (80 subjects) enabled the reduction of the number of items from 73 to 20 according to interrater reliability and diagnostic sensitivity to differentiate patients with dementia from control subjects. The second study (160 subjects: 51 with dementia, 70 with major depression, 39 elderly controls) used this 20-item DAP for cognitive assessment. The second study also featured an additional qualitative assessment (DAP 50) considering five components based upon a projective examination of the drawings. Combination of the 20-item DAP and the DAP 50 provides a complete approach to patients in accordance with the affective dimension. Results showed the ability of the 20-item DAP to discriminate dementia from depression with a better cutoff score of 7 and the usefulness of the DAP 50 in the investigation of impaired components during depression and dementia in the elderly, with the goal of specifying key aspects of psychopathology in dementia.

International Psychogeriatrics has moved. In January 1996, I took over as editor-in-chief and the editorial office moved to St. Louis University Medical School, where I am located. Fern Finkel will remain as managing editor in Chicago. Springer Publishing Company will continue to publish the journal from New York.

The Nurses' Observation Scale for Geriatric Patients (NOSGER) is a rating scale for use in geriatric patients that can be applied by nurses or other caregivers. It deals with the daily behavior of elderly patients and measures impairment in six areas (dimensions): memory; instrumental activities of daily living (IADL); (basic) activities of daily living (ADL); mood; social behavior; and disturbing behavior. Objectivity, stability, construct validity, and acceptance of the scale have been established in previous studies using an earlier version of the NOSGER. The present validation study considered 50 healthy old subjects, 25 patients with mild dementia, 25 patients with advanced (mostly moderate according to DSM-III-R criteria) dementia, and 25 elderly patients with depression. The NOSGER was completed by relatives in the case of subjects living in their own homes and by nurses or other caregivers for institutionalized subjects. In addition to the NOSGER, selected tests of concentration, memory, and performance were applied as outside criteria.

Interrater reliability (objectivity) was estimated by variance component analysis. Values between rtt = .68 and rtt = .89 (all p < .001) were found for the six NOSGER dimensions, the values being higher for the cognitive dimensions (memory, IADL, ADL) than for the noncognitive ones (mood, social behavior, disturbing behavior). Retest realibility (stability), which was calculated via rank order correlations, was somewhat higher for the cognitive NOSGER dimensions (memory rs = .91,IADLrs = .92, ADLrs = .88; p < .001) than for the noncognitive ones (mood rs = .85, social behavior rs = .87, disturbing behavior rs = .84; p < .001). All these values satisfy the level of rtt ≥ .80 required in accordance with psychometric standards. The concurrent validity of the NOSGER dimensions was assessed using correlations with external criteria with which similarity of content was expected. The NOSGER dimensions memory, IADL, ADL, and social behavior were found to correlate closely with external criteria of similar content, whereas no satisfactory concurrent validities were found for the dimensions mood or disturbing behavior. The NOSGER dimensions were also correlated with a number of unrelated external criteria so as to reveal any discordances. For the dimensions memory, IADL, ADL, and social behavior, no clear-cut discriminant validities were found. This suggests that these four dimensions may function as parameters not just of different areas of behavior, but also of a general factor that might be described as “cognitive intactness.” As a further aspect of construct validity, significant differences (all p < .001) between the four groups of subjects were found in five of the six NOSGER dimensions (memory, IADL, ADL, mood, social behavior): The healthy subjects differed significantly from all three patient groups in five of the six dimensions; the moderately demented group differed from the depressed group in four of the six dimensions and from the mildly demented group in two of the six dimensions; and the mildly demented group differed significantly from the depressed group in terms of mood (significance levels are after application of the Bonferroni correction). Significant group differences (p generally < .001) were also found for most of the objective performance tests used (data not presented).

As life expectancy continues to rise, research is focusing increasingly on improving the quality of life of individuals, particularly the geriatric population. As blockbuster pharmacological breakthroughs become more expensive and even more elusive, the research environment is also changing. This has been evident in recent years in the pharmaceutical industry as well as in academic institutions where the rationalization and internationalization of research and development activities have manifested as major restructuring and development of collaborative associations.

With a world population increasing in size and age, the number of elderly people with behavioral distrubances in dementia (BDD) is becoming an increasing problem. The burden of caring for someone with BDD may be so great that it leads to premature institutionalization of the patient. Few clinical trials have focused on noncognitive behavioral symptoms in this group of elderly patients, and little is known about the efficacy of drugs against these symptoms. The pharmaceutical companies have recently begun to assess different medications, but clinical trials in the elderly present a variety of problems not encountered in other patient populations. This article describes how the administration, initiation, logistics, finances, and methodology of such trials must be carefully assessed. Consideration of these factors together with improved definitions of behavioral symptoms and the advances in medication in this area should lead to an improvement in the treatment and management of behavioral disorders in the elderly.

To address the issue of mild, moderate, and severe Alzheimer's disease (AD), it is necessary to initially establish some agreement on terminology. In recent decades, these terms have frequently been defined using screening instrument scores with measures such as the Mini-Menal State Examination (MMSE). There are many problems with this approach, perhaps the most salient of which is that it has contributed to the total and tragic neglect of patients with severe AD. An alternative approach to the classification of AD severity is staging. This approach has advanced to the point where moderately severe and severe AD can be described in detail. Procedures for describing this previously neglected latter portion of AD have recently been extensively validated. Staging is also uniquely useful at the other end of the severity spectrum, in differentiating early aging brain/behavior changes, incipient AD, and mild AD. Temporally, with staging procedures, it is possible to track the course of AD approximately three times more accurately than with the MMSE. The net result of the advances in AD delineation is that issues such as prophylaxis, modification of course, treatment of behavioral distrubances, loss of ambulation, progressive rigidity, and the development of contractures in AD patients can now be addressed in a scientifically meaningful way that will hopefully bestow much benefit in AD patients and those who care for them.

Brain tissue from 12 subjects with pure Alzheimer's disease (AD) and 21 subjects with senile dementia of the Alzheimer type (SDAT) was investigated for membrane lipids and compared with that in age-matched controls. In brain tissue from the patients with AD, phospholipids were significantly decreased compared with that from SDAT patients and controls, cholesterol was reduced compared with that in controls, and gangliosides were significantly reduced in all gray-matter areas investigated compared with those in both SDAT subjects and controls. A reduction in gangliosides also occurred in the SDAT group, but it was smaller. In the white matter, the pattern of changes was the opposite. Phospholipids, cholesterol, cerebroside, and sulfatide were significantly reduced in the frontal-lobe white matter in the SDAT group compared with that in age-matched controls and AD patients. Gangliosides in the cerebrospinal fluid also separated AD from SDAT and controls. The findings indicate synapse degeneration as an important pathogenetic factor in AD. This disorder should be separated from SDAT, in which white-matter degeneration appears to be more prominent.

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.

Disturbances of mood, thought content, perception, and behavior are common concomitants of dementia that often produce suffering and excess disability. These disturbances also interfere with caregiving, precipitate institutionalization, and hasten death. The current lack of an effective means of preventing or controlling the pathophysiologic events that lead to dementia in late life has stimulated efforts to understand and treat these phenomena. In particular, clinically significant depression and psychosis often emerge in patients with dementia, regardless of its origins, and are an important focus of treatment.