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Cited by 60Dementia and Cognitive Impairment ResearchAlzheimer's disease research and treatmentsClinical Laboratory Practices and Quality Control

The Bio‐Hermes Study: Biomarker database developed to investigate blood‐based and digital biomarkers in community‐based, diverse populations clinically screened for Alzheimer's disease

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Mohs, Richard C., Beauregard, Douglas, Dwyer, John, Gaudioso, Jennifer, Bork, Jason, MaGee‐Rodgers, Tamiko, Key, Mickeal N., Kerwin, Diana R. +3 more·2024·Alzheimer's & Dementia
DOI 10.1002/alz.13722PMC PMC11032569
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Abstract

INTRODUCTION: Alzheimer's disease (AD) trial participants are often screened for eligibility by brain amyloid positron emission tomography/cerebrospinal fluid (PET/CSF), which is inefficient as many are not amyloid positive. Use of blood‐based biomarkers may reduce screen failures. METHODS: We recruited 755 non‐Hispanic White, 115 Hispanic, 112 non‐Hispanic Black, and 19 other minority participants across groups of cognitively normal (n = 417), mild cognitive impairment (n = 312), or mild AD (n = 272) participants. Plasma amyloid beta (Aβ)40, Aβ42, Aβ42/Aβ40, total tau, phosphorylated tau (p‐tau)181, and p‐tau217 were measured; amyloid PET/CSF (n = 956) determined amyloid positivity. Clinical, blood biomarker, and ethnicity/race differences associated with amyloid status were evaluated. RESULTS: Greater impairment, older age, and carrying an apolipoprotein E (apoE) ε4 allele were associated with greater amyloid burden. Areas under the receiver operating characteristic curve for amyloid status of plasma Aβ42/Aβ40, p‐tau181, and p‐tau217 with amyloid positivity were ≥ 0.7117 for all ethnoracial groups (p‐tau217, ≥0.8128). Age and apoE ε4 adjustments and imputation of biomarker values outside limit of quantitation provided small improvement in predictive power. DISCUSSION: Blood‐based biomarkers are highly associated with amyloid PET/CSF results in diverse populations enrolled at clinical trial sites. Highlights: Amyloid beta (Aβ)42/Aβ40, phosphorylated tau (p‐tau)181, and p‐tau 217 blood‐based biomarkers predicted brain amyloid positivity. P‐tau 217 was the strongest predictor of brain amyloid positivity. Biomarkers from diverse ethnic, racial, and clinical cohorts predicted brain amyloid positivity. Community‐based populations have similar Alzheimer's disease (AD) biomarker levels as other populations. A prescreen process with blood‐based assays may reduce the number of AD trial screen failures.

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  • Previous studies have provided evidence that p-tau217 has excellent performance in different racial and ethnic groups.

    “While p-tau217 was not available in some cohorts, previous studies have provided evidence that this biomarker also has excellent performance in different racial and ethnic groups54,55.”

    From Diagnosis of Alzheimer's disease using plasma biomarkers adjusted to clinical probability (2024) · cites this paper as [55]

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Authors
Mohs, R. C., Beauregard, D., Dwyer, J., Gaudioso, J., Bork, J., MaGee‐Rodgers, T., Key, M. N., Kerwin, D. R., Hughes, L., Cordell, C. B., & The Bio‐Hermes Collaborative Group
Affiliations
  • Global Alzheimer's Platform Foundation (US)
  • Global Alzheimer's Platform Foundation Washington District of Columbia USA
  • Kerwin Medical Center Dallas Texas USA
  • Advisor to the Global Alzheimer's Platform Foundation and IXICO plc London UK
Corresponding author
Mohs, Richard C.
ORCID
Venue
Alzheimer's & Dementia
Publisher
Wiley
Published
2024-02-28
Volume
20
Issue
4
Pages
2752-2765
ISSN
  • 1552-5260 (ISSN-L)
  • 1552-5279
DOI
10.1002/alz.13722
PMC
PMC11032569
OpenAlex
W4392239508
Cited by
60
References
4
Citations by year
2026: 22 · 2025: 23 · 2024: 15
FWCI
17.64
Type
journal article
Language
en
Open access
Licence
Locations
  • Alzheimer s & Dementia (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Funders
  • Alzheimer's Drug Discovery Foundation
  • Eli Lilly and Company
  • Biogen
  • FONDATION ALZHEIMER
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
Keywords
Alzheimer's disease, blood-based biomarkers
MeSH terms
Alzheimer Disease, Brain, Humans, Biomarkers, Amyloid beta-Peptides, tau Proteins, Positron-Emission Tomography, Cognitive Dysfunction

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