Background: Activities of daily living (ADL) deficits are integral componen
ts of dementia disorders, and ADL measures are among the most robust marker
s of the course of Alzheimer's disease (AD). Despite this acknowledged impo
rtance, 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 pharmacolo
gic 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) quer
ying experts for new items, (5) interviews with informants and subjects in
the USA, France, and Germany, toward the identification of potential new it
ems, (6) identification of an item pool based upon these procedures, (7) cr
eation of a trial instrument, (8) piloting of this instrument, and (9) refi
nement of the scale based upon statistical analysis of the pilot data. Fina
l item selection was based upon: (1) relevance for greater than or equal to
80% of subjects in severity-stratified USA and German samples; (2) absence
of gender and national biases; (3) significant (p < .05) discrimination be
tween (a) normal versus mildly impaired and (b) mildly impaired versus mode
rately to moderately severely impaired subjects; and (4) Global Deteriorati
on Scale (GDS) scores accounting for greater than or equal to 12% of varian
ce in the item after controlling for age and gender. Results: An ADL scale
consisting of 40 items that correlate with the global and cognitive progres
s of AD is developed for international usage in pharmacologic trials in inc
ipient, mild, moderate, and moderately severe AD. The scale contains 40 ite
ms falling within 13 ADL categories. The 40-item scale is shown to have .81
correlation with GDS staging,.81 with mental status assessment (Mini-Menta
l 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.