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. 2021 Jul:106:106425.
doi: 10.1016/j.cct.2021.106425. Epub 2021 Apr 30.

Development of novel measures for Alzheimer's disease prevention trials (NoMAD)

Sophie A Bell  1 , Hannah R Cohen  1 , Seonjoo Lee  2 , Hyun Kim  3 , Adam Ciarleglio  4 , Howard Andrews  5 , Andres M Rivera  6 , Kay Igwe  6 , Adam M Brickman  6 , D P Devanand  3 , Philip D Harvey  7 , Lon S Schneider  8 , Terry E Goldberg  9
Affiliations

Development of novel measures for Alzheimer's disease prevention trials (NoMAD)

Sophie A Bell et al. Contemp Clin Trials. 2021 Jul.

Abstract

Introduction: Assessment of cognition and everyday function is essential in clinical trials for Alzheimer's disease (AD). Two novel measures of cognition (No Practice Effects (NPE) cognitive battery and Miami Computerized Functional Assessment Scale (CFAS)) were designed to have robust psychometric properties and reduced practice and ceiling effects. This study aims to evaluate if the NPE and CFAS demonstrate stronger psychometric properties and reduced practice effects compared with established measures, including the Preclinical Alzheimer Cognitive Composite (PACC), Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), and Functional Activities Questionnaire (FAQ).

Methods: This parallel group, four-site study will randomize 320 cognitively intact adults aged 60 to 85 years to novel or well-established measures of cognition and function. All participants will receive assessments at baseline (week 0), 3-months, and 12-months, as well as a brain MRI scan and Apolipoprotein E genetic test at study entry. Analyses will determine psychometric properties of the NPE and CFAS, compare the sensitivity of measures to AD risk markers, and identify cognitive domains within the NPE.

Discussion: Practice effects have been a major limitation of Alzheimer's disease clinical trials that typically assess cognitive changes over serial assessments. Detection of functional impairment in cognitively normal individuals with biomarkers for Alzheimer's disease requires instruments sensitive to very subtle functional changes. This study is intended to support the validation of two new composite measures, the NPE battery and the CFAS, which may advance clinical testing of interventions for individuals across the spectrum of early stage Alzheimer's disease.

Trial registration: NCT03900273.

Keywords: Alzheimer's disease; Cognition; Computerized assessment; Practice effects; Preclinical Alzheimer's disease.

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Figures

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Fig. 1.
Aims and hypotheses.
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N-Back task.
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Fig. 3.
Miami computerized functional assessment scale.
See this image and copyright information in PMC

References

    1. Weuve J, Proust-Lima C, Power MC, et al., Guidelines for reporting methodological challenges and evaluating potential bias in dementia research, Alzheimers Dement. 11 (9) (2015) 1098–1109, 10.1016/j.jalz.2015.06.1885 [published Online First: 2015/09/24]. - DOI - PMC - PubMed
    1. Czaja SJ, Loewenstein DA, Lee CC, et al., Assessing functional performance using computer-based simulations of everyday activities, Schizophr. Res 183 (2017) 130–136, 10.1016/j.schres.2016.11.014 [published Online First: 2016/12/04]. - DOI - PMC - PubMed
    1. Donohue MC, Sperling RA, Salmon DP, et al., The preclinical Alzheimer cognitive composite: measuring amyloid-related decline, JAMA Neurol. 71 (8) (2014) 961–970, 10.1001/jamaneurol.2014.803 [published Online First: 2014/06/03]. - DOI - PMC - PubMed
    1. Rosen WG, Mohs RC, Davis KL, A new rating scale for Alzheimer’s disease, Am. J. Psychiatry 141 (11) (1984) 1356–1364, 10.1176/ajp.141.11.1356 [published Online First: 1984/11/01]. - DOI - PubMed
    1. Pfeffer RI, Kurosaki TT, Harrah CH Jr., et al., Measurement of functional activities in older adults in the community, J. Gerontol 37 (3) (1982) 323–329, 10.1093/geronj/37.3.323 [published Online First: 1982/05/01]. - DOI - PubMed

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