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The National Institutes of Health (NIH) Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER) is a validated laptop-based battery of executive functioning tests. A modified tablet version of the EXAMINER was developed on the UCSF Tablet-based Cognitive Assessment Tool (TabCAT-EXAMINER). Here we describe the battery and investigate the reliability and validity of a composite score.
Methods:
A diagnostically heterogeneous sample of 2135 individuals (mean age = 65.58, SD = 16.07), including controls and participants with a variety of neurodegenerative syndromes, completed the TabCAT-EXAMINER. A composite score was developed using confirmatory factor analysis and item response theory. Validity was evaluated via linear regressions that tested associations with neuropsychological tests, demographics, clinical diagnosis, and disease severity. Replicability of cross-sectional results was tested in a separate sample of participants (n = 342) recruited from a frontotemporal dementia study. As this separate sample also collected longitudinal TabCAT-EXAMINER measures, we additionally assessed test-retest reliability and associations between baseline disease severity and changes in TabCAT-EXAMINER scores.
Results:
The TabCAT-EXAMINER score was normally distributed, demonstrated high test-retest reliability, and was associated in the expected directions with independent tests of executive functioning, demographics, disease severity, and diagnosis. Greater baseline disease severity was associated with more rapid longitudinal TabCAT-EXAMINER decline.
Conclusions:
The TabCAT-EXAMINER is a tablet-based executive functioning battery developed for observational research and clinical trials. Performance can be summarized as a single composite score, and results of this study support its reliability and validity in cognitive aging and neurodegenerative disease cohorts.
Frontotemporal lobar degeneration (FTLD), a major cause of dementia worldwide, is an unrelenting and ultimately fatal set of pathological processes without any approved disease-modifying therapies. Clinical trial development in FTLD has previously been challenging, due to its pathological heterogeneity aand the clinical heterogeneity of frontotemporal dementia (FTD) and other clinical syndromes that arise from FTLD. Advances in FTLD basic science research have recently translated into a growing field of FTLD clinical trial development, with a particular focus on therapies tailored to distinct clinical syndromes with the highest specificity for particular FTLD pathophysiologies. The expansion of FTLD clinical programs has been fostered by a variety of advocacy groups and a number of large multi-site clinical research consortia, the latter of which have advanced the investigation of fluid biomarkers and clinical and neuroimaging measures for use in future clinical trials. This chapter covers the unique considerations of clinical trials in patients with FTLD pathology and review previous and current clinical trial programs investigating disease-modifying therapies targeting FTLD.
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