THE SPANISH INSTRUMENT PROTOCOL - DESIGN AND IMPLEMENTATION OF A STUDY TO EVALUATE TREATMENT EFFICACY INSTRUMENTS FOR SPANISH-SPEAKING PATIENTS WITH ALZHEIMERS-DISEASE

Development of improved outcome measures for Alzheimer's disease (AD) clinical trials is a major objective of the Alzheimer's Disease Cooper ative Study (ADCS), an NIA-sponsored, multisite clinical trials consor tium. The ADCS is committed to recruiting and following minority patie nts in clinical trials. At present, a serious impediment to recruiting non-English-speaking minorities is the lack of instruments with adequ ate translation. Because Spanish is the second most commonly spoken la nguage in the United States and because persons of Hispanic origin rep resent approximately 10% of the population, we conducted an instrument development protocol for Spanish-speaking patients. Evaluating treatm ent efficacy in Spanish-speaking AD patients requires the development of assessments that are comparable to those used for English-speaking participants in clinical trials. The ADCS Instrument Development Proje ct evaluated the sensitivity, reliability, and validity of new or impr oved measures in each of five assessment domains: (a) cognition (immed iate and delayed memory, praxis, attention, and executive function); ( b) clinical global change; (c) activities of daily living; (d) behavio ral symptoms (agitation and other noncognitive symptoms); and (e) cogn ition in severely impaired patients. These new treatment efficacy inst ruments were translated for Spanish speakers and a Spanish Instrument Study was conducted in parallel with the English version of the study. This report describes instrument translation, entry criteria, and rec ruitment procedures. In addition, the demographic and clinical charact eristics of the cohort at baseline are presented and compared to the E nglish-speaking cohort. Implications for the development of comparably sensitive Spanish language instruments are discussed.