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Neuropsychological, Psychiatric, and Functional Correlates of Clinical Trial Enrollment

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Abstract

Screen failure rates in Alzheimer’s disease (AD) clinical trial research are unsustainable, with participant recruitment being a top barrier to AD research progress. The purpose of this project was to understand the neuropsychological, psychiatric, and functional features of individuals who failed screening measures for AD trials. Previously collected clinical data from 38 patients (aged 50–83) screened for a specific industry-sponsored clinical trial of MCI/early AD (Biogen 221AD302, [EMERGE]) were analyzed to identify predictors of AD trial screen pass/fail status. Worse performance on non-memory cognitive domains like crystalized knowledge, executive functioning, and attention, and higher self-reported anxiety, was associated with failing the screening visit for the EMERGE AD clinical trial, whereas we were not able to detect a relationship between screening status and memory performance, self-reported depression, or self-reported daily functioning. By identifying predictors of AD trial screen passing/failure, this research may influence decision-making about which patients are most likely to successfully enroll in a trial, thereby potentially lowering participant burden, maximizing study resources, and reducing costs.

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Acknowledgement

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Funding

Funding: Funding for this project was provided by University of Utah Center for Alzheimer’s Care, Imaging and Research.

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Authors and Affiliations

  1. Center for Alzheimer’s Care, Imaging, and Research, Department of Neurology, University of Utah, 650 Komas Drive #106-A, Salt Lake City, UT, 84108, USA

    Dustin B. Hammers, N. L. Foster & K. Duff

  2. Center for Quantitative Cancer Imaging, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA

    J. M. Hoffman

  3. Study Design and Biostatistics Center, University of Utah, Salt Lake City, UT, USA

    T. H. Greene

Authors
  1. Dustin B. Hammers
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  2. N. L. Foster
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  3. J. M. Hoffman
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  4. T. H. Greene
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  5. K. Duff
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Corresponding author

Correspondence to Dustin B. Hammers.

Ethics declarations

Ethical standards: This study was conducted according to the University of Utah’s standards for Ethical Research. All procedures for the current study received approval by the University’s Institutional Review Board.

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Hammers, D.B., Foster, N.L., Hoffman, J.M. et al. Neuropsychological, Psychiatric, and Functional Correlates of Clinical Trial Enrollment. J Prev Alzheimers Dis 6, 242–247 (2019). https://doi.org/10.14283/jpad.2019.38

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  • DOI: https://doi.org/10.14283/jpad.2019.38

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