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Multi-Center Trial to Evaluate Home-Based Assessment Methods for Alzheimer Disease Prevention Research in People Over 75 Years Old (HBA)

Multi-Center Trial to Evaluate Home-Based Assessment Methods for Alzheimer Disease Prevention Research in People Over 75 Years Old

There is an unmet need for effective, efficient and economical methods for conducting AD prevention trials. Traditional in-person visits to clinical assessment sites are time consuming and costly and may exclude certain constituencies from participation, such as those who are older, or are less mobile or with significant medical illnesses. These may be the very people who are at greatest risk for cognitive decline, as well as those without financial resources for services such as transportation to a study site. Furthermore, prevention trials require long observation periods and these same issues of health, resources, and transportation may cause significant drop out. These obstacles increase expense of clinical trials, as they require large sample sizes, costly clinical staff and long observation periods. Thus, home-based assessments may lead to more representative recruitment of those most at risk for decline, better retention and reduced study costs. In previous work, the use of mail-in and phone assessments was examined as possible methods for assessment. 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. Based on existing data, a predefined score on a specific cognitive measure will be used to identify significant impairment that will ”trigger” an in-person assessment. The in-person assessment will provide the Standard for assessing change and diagnostic categorization of normal, amnestic MCI (single or multiple domains), non-amnestic MCI (single or multi-domain) impaired not MCI, or dementia (i.e., specifically Alzheimer’s Disease, or another dementia). We estimate that 12-13% of the study population may trigger over the 4 years of the study and may progress to a more impaired diagnostic category. In addition, a random sample of non-triggered controls (25%) may be selected for an in-person re-assessment during the 4 years of the protocol as a comparison for the trigger case group. The trigger case/non-trigger control selection criteria may be adjusted throughout the study to ensure comparability at the end of the study. At the end of the 4-year study period all subjects will undergo an in-person evaluation.  


Last Updated: 08-19-2016
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