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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 .SO 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 thenoncognitiveassessment domains. The ADASsummary scores, almost all of the cognitive items, and someof the noncognitive items discriminated significantly between stages of severity of dementia, as classified independently by MMSE and SKT scores.The Alzheimer's Disease Assessment Scale (ADAS; Rosen et al., 1984) was designed specifically to evaluate the severity of cognitive and noncognitive symptoms in patients with dementia of the Alzheimer type (DAT). The scale con-

The efficacy of the ginkgo biloba special extract EGb 761 in outpatients with presenile and senile primary degenerative dementia of the Alzheimer type (DAT) and multi-infarct dementia (MID) according to DSM-III-R was investigated in a prospective, randomized, double-blind, placebo-controlled, multi-center study. After a 4-week run-in period, 216 patients were included in the randomized 24-week treatment period. These received either a daily oral dose of 240 mg EGb 761 or placebo. In accordance with the recommended multi-dimensional evaluation approach, three primary variables were chosen: the Clinical Global Impressions (CGI Item 2) for psychopathological assessment, the Syndrom-Kurztest (SKT) for the assessment of the patient's attention and memory, and the Nürnberger Alters-Beobachtungsskala (NAB) for behavioral assessment of activities of daily life. Clinical efficacy was assessed by means of a responder analysis, with therapy response being defined as response in at least two of the three primary variables. The data from the 156 patients who completed the study in accordance with the study protocol were taken into account in the confirmatory analysis of valid cases. The frequency of therapy responders in the two treatment groups differed significantly in favor of EGb 761, with p < 0.005 in Fisher's Exact Test. The intent-to-treat analysis of 205 patients led to similar efficacy results. Thus, the clinical efficacy of the ginkgo biloba special extract EGb 761 in dementia of the Alzheimer type and multi-infarct dementia was confirmed. The investigational drug was found to be well tolerated.

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 ≥ 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 ≥ 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.

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