MULTI-CENTER TRIAL TO EVALUATE HOME-BASED ASSESSMENT METHODS FOR ALZHEIMER DISEA

Wake Forest University Health Sciences, Winston-Salem NC

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Abstract

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a randomized study of 600 subjects, comparing three methods of test administration and data collection (N=200/method). Each enrolled subject will have an In-person (Standard) assessment (in the clinic or at home) prior to baseline. All eligible subjects will be randomly assigned to an assessment method and to a frequency of assessment. Based on an algorithm using data from the in-person evaluation, participants will be classified as either non-demented or AL-MCI and randomization will be done with stratification for this classification. All domains (i.e., cognitive performance, self-rated cognitive complaint, functioning in daily life, affective symptoms, global change, quality of life and resource use) will be assessed in each method at each visit. The total time for the at-home assessments (cognitive performance battery plus the brief questionnaires for the other domains) will be approximately 45 minutes. In addition, all subjects will be provided a multi-vitamin to be taken twice a day, and a measure of medication adherence will be collected for each assessment method.