AN INVENTORY TO ASSESS ACTIVITIES OF DAILY LIVING FOR CLINICAL-TRIALSIN ALZHEIMERS-DISEASE

We developed a set of informant-based items describing performance of activities of daily living (ADL) by patients with Alzheimer's disease (AD) to identify which ADL are useful for assessment of patients in cl inical trials. Evaluation of ADL is an important outcome measure in AD clinical trials. For clinical trial measurement, ADL should have broa d applicability, good test-retest reliability, scaling to cover a rang e of performance, and sensitivy to detect change in disease progressio n. A total of 45 ADL items developed from literature review and clinic al experience were administered to informants of 242 AD patients and 6 4 elderly controls as part of the multicenter Alzheimer's Disease Coop erative Study Instrument protocol. Half of the subjects were re-evalua ted at 1 and 2 months and all at 6 and 12 months. Controls performed v irtually all ADL items optimally at baseline and at 12 months. Among s ubjects with AD, 27 of the 45 ADL were widely applicable, i.e., perfor med at baseline or premorbidly by >90% of subjects; showed good test-r etest reliability between baseline and 1 and 2 months; correlated with MMSE scores of AD patients cross-sectionally; and showed a decline in performance from baseline to 12 months in at least 20% of AD patients . ADL could be identified that capture change in functional ability in patients across the entire range of the MMSE, The remaining 18 ADL in cluded several that may be useful for trials that target specific popu lations, e.g., women with AD. Because change on specific items depends on baseline MMSE, ADL evaluation should include items relevant to the severity of dementia of patients enrolled in a clinical trial.