Neuropsychological, Psychiatric, and Functional Correlates of Clinical Trial Enrollment
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 wordsCognition Alzheimer’s disease mild cognitive impairment clinical trial
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.
- 9.US National Library of Medicine: 221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer’s Disease (EMERGE) [online]. Available at: https://clinicaltrials.gov/ct2/show/NCT02484547.
- 13.Lezak M, Howieson D, Loring D. Neuropsychological Assessment, 4th ed. New York, NY: Oxford University Press, 2004.Google Scholar
- 14.George, D, Mallery, P. SPSS for Windows Step by Step: A Simple Guide and Reference 17.0 Update. Boston, MA: Pearson, 2010.Google Scholar
- 15.Tabachnick B, Fidell L. Using Multivariate Statistics, 6th ed. Boston: Pearson Education, 2013.Google Scholar
- 17.Burke SL, Cadet T, Alcide A, O’Driscoll J, Maramaldi P. Psychosocial risk factors and Alzheimer’s disease: the associative effect of depression, sleep disturbance, and anxiety. Aging Ment Health 2017:1–8.Google Scholar
- 18.Gomar JJ, Bobes-Bascaran MT, Conejero-Goldberg C, Davies P, Goldberg TE, Alzheimer’s Disease Neuroimaging I. Utility of combinations of biomarkers, cognitive markers, and risk factors to predict conversion from mild cognitive impairment to Alzheimer disease in patients in the Alzheimer’s disease neuroimaging initiative. Arch Gen Psychiatry 2011;68:961–969.CrossRefGoogle Scholar