| Autor: |
Christiano, Caitlyn, Moreno, Stephanie, Anzai, Juliana A. U., Viera, Andrea M Román, Palou, Mariana Margarita, Kirn, Dylan, Muniz, Martha C., Ramirez, Jennifer, Papp, Kathryn V., Amariglio, Rebecca E., Chhatwal, Jasmeer P., Johnson, Keith A., Rentz, Dorene M., Selkoe, Dennis J, McGinnis, Scott M., Marshall, Gad A, Gale, Seth A, Sperling, Reisa A., Yang, Hyun‐Sik |
| Zdroj: |
Alzheimer's & Dementia: The Journal of the Alzheimer's Association; Dec2023 Supplement 24, Vol. 19, p1-2, 2p |
| Abstrakt: |
Background: Many Alzheimer's disease (AD) clinical trials suffer from a high screen‐fail rate despite telephone pre‐screening, leading to a significant drain of time and resources. Thus, more efficient prescreening methods are required. Here, we examined whether prescreening through a brief on‐site observational study protocol could reduce clinical trial screen failure rate compared to telephone prescreening. Method: De‐identified screening data from the AHEAD study (AD prevention trial) at the Brigham and Women's Hospital (BWH) Center for Alzheimer Research and Treatment were used. Participants were referred for the AHEAD study screen either from a brief observational study protocol (Davis Memory and Aging Cohort [MAC]) or a telephone screen. MAC collects medical history, Mini‐Mental State Exam, Quick Dementia Rating System, and blood samples through a 60‐minute on‐site visit. Telephone screen uses medical history survey and Telephone Interview for Cognitive Status. We compared AHEAD screen failure rate due to (1) clinical exclusion criteria and (2) (for those with no clinical exclusion) amyloid‐β biomarker criteria (plasma, PET) between MAC and telephone screen referrals, using Fisher's exact test. Result: There was no significant difference in age, sex, race, or ethnicity between the MAC and Telephone prescreen groups (Table 1, MAC n = 61, telephone n = 55). The odds ratio (OR) for clinical screen‐fail for MAC (n = 9 out of 61, 15%) compared to telephone (n = 20 out of 55, 36%) was 0.31 (95% CI 0.12 to 0.80, p = 9.7×10−3). The OR for biomarker screen‐fail for MAC (n = 49 out of remaining 52, 94%) compared to telephone (n = 27 out of remaining 35, 77%) was 4.7 (95% CI 1.0 to 30.1, p = 0.024). The OR for randomization from MAC (n = 3 out of 61, 5%) compared to telephone (n = 8 out of 55, 15%) was not significantly different from 1 (p = 0.11). Conclusion: Our findings show that, compared to a telephone screen, an on‐site prescreen assessing cognition, medical history, and venous access may prevent clinical trial screen fails attributable to clinical exclusion criteria and save participant/staff time and resources. However, an unexplained higher biomarker screen fail rate for the on‐site group offset this benefit, requiring further investigation. [ABSTRACT FROM AUTHOR] |
| Databáze: |
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