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Neuropsychological, Psychiatric, and Functional Correlates of Clinical Trial Enrollment

  • Dustin B. HammersEmail author
  • N. L. Foster
  • J. M. Hoffman
  • T. H. Greene
  • K. Duff
Short Communication

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.

Key words

Cognition Alzheimer’s disease mild cognitive impairment clinical trial 

Notes

Acknowledgement

None.

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

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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Copyright information

© Serdi and Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Dustin B. Hammers
    • 1
    Email author
  • N. L. Foster
    • 1
  • J. M. Hoffman
    • 2
  • T. H. Greene
    • 3
  • K. Duff
    • 1
  1. 1.Center for Alzheimer’s Care, Imaging, and Research, Department of NeurologyUniversity of UtahSalt Lake CityUSA
  2. 2.Center for Quantitative Cancer Imaging, Huntsman Cancer InstituteUniversity of UtahSalt Lake CityUSA
  3. 3.Study Design and Biostatistics CenterUniversity of UtahSalt Lake CityUSA

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