The Alzheimer's disease activities of daily living international scale (ADL-IS).

BACKGROUND: Activities of daily living (ADL) deficits are integral components of dementia disorders, and ADL measures are among the most robust markers of the course of Alzheimer's disease (AD). Despite this acknowledged importance, no clearly useful ADL instrument for cross-cultural application in pharmacologic trials in the early stages of AD had been available. METHOD: An international effort was launched to develop an ADL scale for pharmacologic trials in early AD. Steps taken from 1990 to the present included: (1) international scientific working group meetings and reviews, (2) reviews of existing measures, (3) collating of existent, nonredundant items, (4) querying experts for new items, (5) interviews with informants and subjects in the USA, France, and Germany, toward the identification of potential new items, (6) identification of an item pool based upon these procedures, (7) creation of a trial instrument, (8) piloting of this instrument, and (9) refinement of the scale based upon statistical analysis of the pilot data. Final item selection was based upon: (1) relevance for > or = 80% of subjects in severity-stratified USA and German samples; (2) absence of gender and national biases; (3) significant (p <.05) discrimination between (a) normal versus mildly impaired and (b) mildly impaired versus moderately to moderately severely impaired subjects; and (4) Global Deterioration Scale (GDS) scores accounting for > or = 12% of variance in the item after controlling for age and gender. RESULTS: An ADL scale consisting of 40 items that correlate with the global and cognitive progress of AD is developed for international usage in pharmacologic trials in incipient, mild, moderate, and moderately severe AD. The scale contains 40 items falling within 13 ADL categories. The 40-item scale is shown to have .81 correlation with GDS staging, .81 with mental status assessment (Mini-Mental State Examination), and .81 with a psychometric test (the SKT) (p values < .001). CONCLUSION: This scale can be used to measure therapeutic response in AD.

The Bayer-Activities of Daily Living Scale (B-ADL): results from a validation study in three European countries.

The Bayer-Activities of Daily Living Scale (B-ADL) is a 25-item, informant-rated questionnaire which was developed as a brief and internationally applicable instrument for assessing functional disabilities. The scale's target group are elderly patients suffering from mild to moderate dementia or cognitive impairment. To investigate the reliability and validity of different language versions, the B-ADL was administered in the UK, Germany, and Spain to a total of 1,433 subjects with a wide range of cognitive decline. The results from the three country samples were very similar, with internal consistency being above 0.98 (Cronbach alpha). A factor analysis revealed that a one-factor solution accounted for most of the variance. The B-ADL total score significantly increased between adjacent Global Deterioration Scale (GDS) stages 1 to 5. A second factor analysis entering additional variables (GDS stage, Mini-Mental State Examination or MMSE subscores, age, years of education, gender, and country) revealed that all B-ADL items loaded on the same factor, "dementia severity", and that they were not related to age, education, gender, or country. In the identification of subjects with clinically manifest dementia symptoms (GDS stages 4 and 5), the B-ADL proved to be as efficient as the MMSE in the UK and German samples and superior to the MMSE in the Spanish sample.

[Loss of activities of daily living function (ADL) and cognitive impairment in various stages of dementia. A comparison of ADL informant ratings, ADL self ratings and psychometric test results]. / Beeinträchtigungen der Alltagsaktivitäten (ADL) und der kognitiven Leistungsfähigkeit in unterschiedlichen Demenzstadien. Ein Vergleich von ADL-Fremdbeurteilungen, ADL-Selbsteinschätzungen und einem psychometrischen Leistungstest.

In addition to cognitive performance tests, the assessment of activities of daily living (ADL) is becoming increasingly important in diagnosing and following up dementia. Therefore, we compared results obtained from ADL informant and self reports and from the SKT short test for assessing deficits of memory and attention. Data were available from a total of 193 elderly subjects in different stages of cognitive decline (GDS stages 1-5). First, we determined for each GDS group separately the numbers of subjects assessed as being impaired by each of the three methods alone as well as in combination. Furthermore, the contribution of the two ADL measures, the SKT total score, age, depression and education in the prediction of the global severity assessment according to GDS was evaluated. Finally, the influence of the latter three variables on the ADL and SKT results was estimated by existing correlations. In GDS stage 2, ADL self rating was the only approach revealing impairment with a majority of patients. The number of patients assessed as being impaired by ADL informant ratings and the SKT only increased after GDS stage 2. Analyses of patterns of impairment showed that 66% of subjects in GDS stage 1 were rated as unimpaired by each of the three methods. Of patients classified as GDS 4 and 5, 85% and 92% respectively were unanimously rated as impaired. In GDS stages 2 and 3 a great heterogeneity of patterns was found. In a logistic regression model predicting clinically manifest dementia symptomatology (GDS 4 + 5 vs GDS 1 + 2 + 3) the SKT and ADL informant ratings were included. In a second model predicting membership in a group without cognitive impairment (GDS 1 + 2) or in a group suffering from mild cognitive impairment (GDS 3) self-rated ADL and age were additionally entered. Especially for an early diagnosis of dementia, on the basis of the study results the usage of different assessment methods (ADL informant rating, ADL self rating, psychometric test) is suggested.

Outcome measures for the study of activities of daily living in vascular dementia.

Decline in functional abilities is a major component of the dementia syndrome. The definition of dementia in the International Classification of Diseases (10th rev.) requires a cognitive impairment sufficient to impair personal activities of daily living (ADL). The Diagnostic and Statistical Manual of Mental Disorders (4th ed.) also requires cognitive deficits sufficiently severe to cause impairment in occupational or social functioning and must represent a decline from a higher level of functioning. However, the term disability is more appropriate than impairment to describe a loss in activities, as opposed to a loss of elementary functions, and is consistent with World Health Organization definitions of impairment, disability, and handicap. There is no doubt that ADL outcomes are required in therapeutic drug studies on vascular dementia, and there is a good rationale and some evidence for the use of ADL scales developed for therapeutic research in Alzheimer disease, favoring scales devoid of items sensitive to physical disabilities. Similarly, ADL-related clinical milestones could be used for longer-term studies aiming predominantly at slowing progression of disease in both early and later stages of dementia. Slower decline in ADL and delay in reaching ADL-related clinical milestones should be considered as valid outcomes by regulatory bodies in the process of dementia drug approval.

The Bayer Activities of Daily Living Scale (B-ADL).

The Bayer Activities of Daily Living Scale (B-ADL) has been developed on an international basis to assess deficits in the performance of everyday activities. The scale's main target group is community dwelling patients who suffer mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items and takes the form of a questionnaire to be completed by a caregiver or other informant sufficiently familiar with the patient. Statistical, clinical and domain-related criteria were used to select items from among a large number of activities of daily living (ADL) questions field tested in pilot studies in the USA, Germany, UK, Russia and Greece. The items included in the B-ADL have been chosen for their sensitivity to cognitive impairment, simplicity of concept, international applicability and their relevance to patients coping with the demands of everyday life. The scale uses items which reflect a wide range of domains. On account of its brevity, it is thought especially suitable for application within a GP and primary care context for both screening a patient's ADL capacities as well as for documentation of treatment effects and the progress of dementia. This paper focuses on a description of the scale and its application.

Alzheimer's Disease Assessment Scale: reliability and validity in a multicenter clinical trial.

Psychometric characteristics of the Alzheimer's Disease Assessment Scale (ADAS) were examined on the basis of data from 440 patients with dementia of the Alzheimer type that were collected before treatment in a multicenter clinical drug trial. Coefficients of internal consistency of above .80 for the cognitive (ADAS-Cog) and the noncognitive section (ADAS-Noncog) indicated a high degree of homogeneity of item contents within the two assessment domains. Test-retest reliability was estimated to be .93, .98, and .96 for ADAS-Cog, ADAS-Noncog, and the total score (ADAS-Total), respectively. Reliably detectable individual changes, which were derived from the reliability estimates, were 7, 3, and 8 points for ADAS-Cog, ADAS-Noncog, and ADAS-Total, in that order. Factor analysis and correlations with MMSE, SKT, and NOSGER scores support the validity of the ADAS-Cog and ADAS-Noncog scores with regard to the cognitive and the noncognitive assessment domains. The ADAS summary scores, almost all of the cognitive items, and some of the noncognitive items discriminated significantly between stages of severity of dementia, as classified independently by MMSE and SKT scores.

Evidence of the cross-cultural stability of the factor structure of the SKT short test for assessing deficits of memory and attention.

Many of the psychometric instruments employed in dementia research are adapted versions of tests developed in countries different from those in which they are applied. The validity of these instruments has been established in their countries of origin; however, there is little information available regarding their validity when transferred to other cultures. The SKT, a short cognitive performance test for the assessment of memory and attention deficits developed and validated in Germany, was administered in research centers in Chile, Greece, Russia, and England. SKT raw scores were factor analyzed with regard to a prespecified target structure, i.e., the factor solution found for a large German reference sample. The cross-cultural stability of the test was assessed using a statistical method that combined the perfect congruent weights approach and the bootstrapping technique. This procedure allowed for testing the similarity between factorial solutions obtained for the different centers. Results clearly indicate the factorial stability of the SKT in the countries participating in the study.

Deficiência da funçäo cerebral na idade avançada: nimodipina utilizada em clínica geral / Impairment of cerebral function in old age: nimodipine in general practice

A eficácia e tolerabilidade da nimodipina (Nimotrop) no tratamento da demência senil foi avaliada neste estudo de observação de pós-comercialização. No total, 4.104 pacientes receberam tratamento com nimodipina 30 mg/dia, três vezes ao dia, durante até três meses para distúrbios da função cerebral na idade avançada. A eficácia da nimodipina nas doenças do tipo demenência foi avaliada em três meses para distúrbios da função cerebral na idade avançada. A eficácia da nimodipina nas doenças do tipo demência foi avalidada em três níveis: utilizando-se clinicamente a escala de impressão clínica global (CGI); psicometricamente com o teste curto da síndrome (SST), e pelo registro dos sintomas gerais. Observou-se melhora média nos escores de SST de três pontos (612) pacientes incluídos). Todos os sintomas, particularmente os mais comuns, de distúrbios da memória e ausência de concentração melhoram durante o tratamento. Os médicos classificaram a eficácia do tratamento como "boa" ou "muito boa" em 70 por cento dos pacientes. Os médicos classificaram a tolerabiblidade com "muito boa" em 89 por cento dos pacientes, e "fraca" em 2 por cento dos casos. O tratamento foi descontinuado em 236 casos durante o período de três meses de avaliação. Os efeitos colaterais determinaram descontinuação em 91 pacientes. Os efeitos colaterais ocorreram em cerca de 6 por cento do número total de casos, sendo cefaléia e vasodilatação os efeitos mais comuns.

Informant-rated activities-of-daily-living (ADL) assessments: results of a study of 141 items in the U.S.A., Germany, Russia, and Greece from the International ADL Scale Development Project.

The analyses of an international pilot study presented in this article focused on the development of a cross-nationally valid activities-of-daily-living (ADL) scale sensitive to therapeutic effects in patients with mild memory impairment and mild to moderately severe dementia. The present report, which is part of an ongoing international research project, describes field testing results for 141 informant-rated items. The comparability of samples investigated in research centers in the U.S.A., Germany, Russia, and Greece concerning cognitive decline was evaluated globally as well as psychometrically using the Global Deterioration Scale, the Short Cognitive Performance Test, and the Mini-Mental State Examination. In the participating countries, a composite ADL score discriminated well between different stages of cognitive impairment because of dementia. However, international differences between the applied measures were observed. A practical ADL scale showing therapeutic sensitivity and international utility, will be constructed from the 141 informant-rated items under investigation in this pilot work.

The SKT--a short cognitive performance test for assessing deficits of memory and attention.

The SKT is a simple and short test for assessing cognitive impairment of memory and attention. The test consists of nine subtests, each limited to a maximum performance time of 60 seconds. Thus, total testing time normally does not exceed 10 to 15 minutes. Test scoring and auditing are also accomplished within a short time and are easily learned. The test is useful for staging the severity of cognitive deficits and for assessing the benefits of therapy, especially with patients suffering from dementia. The SKT is highly accepted both by patients, who are motivated by the appealing character of the tasks and their play-like nature, and hospital clinicians and general practitioners (GPs) because of its brevity and simplicity. The SKT was introduced in Germany two decades ago and has been successfully validated. Test versions of the SKT in English and other languages have confirmed its international applicability and validity, a point of particular importance in light of the current attempts to harmonize methods for assessing the efficacy of pharmaceutical products.

Deficiencia da funcao cerebral na idade avancada: nimodipina utilizada em clinica geral

A eficacia e tolerabilidade da nimodipina (Nimotop) no tratamento da demencia senil foi avaliada neste estudo de observacao de pos-comercializacao. No total, 4.104 pacientes receberam tratamento com nimodipina 30 mg/dia, tres vezes ao dia, durante ate tres meses para disturbios da funcao cerebral na idade avancada. A eficacia da nimodipina nas doencas do tipo demencia foi avaliada em tres niveis: utilizando-se clinicamente a escala de impressao clinica global (CGI); psicometricamente com o teste curto da sindrome (SST), e pelo registro dos sintomas gerais. Observou-se melhora media nos escores de SST de tres pontos (612 pacientes incluidos). Todos os sintomas, particularmente os mais comuns, de disturbios da memoria e ausencia de concentracao melhoraram durante o tratamento. Os medicos classificaram a tolerabilidade como 'boa' ou 'muito boa' em 70 por cento dos pacientes. Os medicos classificaram a tolerabilidade como 'muito boa' ou 'boa' em 89 por cento dos pacientes, e 'fraca' em 2 por cento dos casos. O tratamento foi descontinuado em 236 casos durante o periodo de tres meses de avaliacao. Os efeitos colaterais determinaram descontinuacao em 91 pacientes. Os efeitos colaterais ocorreram em cerca de 6 por cento do numero total de casos, sendo cefaleia e vasodilatacao os efeitos mais comuns.

[Hypertension and disorders of cognitive function]. / Hypertonie und kognitive Funktionsstörungen.

In the treatment of hypertension, the aspect of cognitive function is now becoming ever more important. In recent years, the influence of hypertension itself--as well as that of anti-hypertensive treatment--on cognitive functioning has repeatedly been investigated. The results obtained differ too widely to permit any final statement to be made on the relationships involved. The reasons for these differences seem to be due in particular to differences in the methods of investigation and random sampling involved in the studies. More recent studies, however, seem to support a relationship between hypertension and decreased cognitive performance. Improved investigations are expected to produce more detailed results in the future.

Efficacy and tolerance of vinpocetine in ambulant patients suffering from mild to moderate organic psychosyndromes.

The efficacy and tolerance of orally administered vinpocetine was investigated in patients suffering from mild to moderate organic psychosyndromes including primary dementia. Two hundred and three patients were included in a placebo-controlled, randomized double-blind, multicentre trial and received every day for 16 weeks either: 3 x 10 mg doses of vinpocetine, 3 x 20 mg doses of vinpocetine, or 3 x placebo. Patients were assessed on ratings of clinical global impression, cognitive performance and on measures of the quality of life including depressive illness. There were no clinically relevant side-effects reported and the frequencies of adverse events between patients treated with vinpocetine (30 mg or 60 mg) and placebo were comparable. Statistically significant improvements were found in favour of both active treatment groups compared to placebo in both confirmatory evaluations of efficacy of treatment: the "Global Improvement" (on the CGI scale) and cognitive performance (SKT). Vinpocetine was also superior to placebo in ratings of the "severity of illness". This study demonstrates the usefulness and efficacy of vinpocetine in the management of patients with moderate organic psychosyndromes. An apparently greater therapeutic efficacy of 3 x 10 mg vinpocetine compared with the higher vinpocetine dosage is statistically not significant.

[The course of functional psychoses (author's transl)]. / Verlaufsdarstellung von Funktionspsychosen.

Functional psychoses correspond to a universal reduction of mental and intellectual function which, fundamentally reversible and unspecific, appear as sequelae of disturbances of cerebral function. They are the most common psychoses in medical practice and in hospitals. With the Syndrome Short Test and Functional Psychosis Scale B we now have a mutually equilibrated test system for the measurement of the whole range of severity of functional psychoses. With these two psychopathometric methods a relatively differentiated investigation of cross section and course can be performed, for example in arriving at a diagnosis, checking medical measures, monitoring the effect of drugs and in the prognosis of a disease.