Bio‐Hermes study topline results: Aß 40/42 and p‐tau181/217/231 blood‐based biomarkers compared to amyloid PET and CSF in a diverse, community‐based population

Background Research of blood‐based biomarkers to indirectly assess amyloid presence in the brain has mainly been conducted in special populations (e.g., those enrolled in autopsy programs or single site populations selected for genetic vulnerability). To more accurately reflect clinical trial popula...

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Veröffentlicht in:Alzheimer's & dementia 2023-12, Vol.19 (S24), p.n/a
Hauptverfasser: Beauregard, Douglas W., Gaudioso, Jennifer, Mohs, Richard, Hollingshead, Sarah, Dwyer, John, Bork, Jason, Kerwin, Diana R.
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Sprache:eng
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Zusammenfassung:Background Research of blood‐based biomarkers to indirectly assess amyloid presence in the brain has mainly been conducted in special populations (e.g., those enrolled in autopsy programs or single site populations selected for genetic vulnerability). To more accurately reflect clinical trial populations and to increase diversity, the Bio‐Hermes study used 17 sites and monitored recruitment to achieve ≥19% underrepresented minorities (URM) in each of the 3 clinical trial cohorts of Cognitively Normal (CN), Mild Cognitive Impairment (MCI), and Mild AD. In addition to blood‐based biomarkers and the presence of amyloid plaques identified through brain amyloid PET and CSF, numerous digital tests and genetic assays were performed resulting in a robust Bio‐Hermes database. Method Within 18 months, 17 sites enrolled 1,001 participants (60‐85 y/o) in clinically defined cohorts of: CN (N = 417), MCI (N = 312), and Mild AD (N = 272). Traditional and digital cognitive testing, amyloid PET imaging, biospecimen collection, and speech analytics were performed. A subset of participants received a retinal exam. Blood biomarkers included Aß 42/40, p‐Tau181/217/231, NfL, GFAP, full genome sequencing, including APOE status, and proteomics. Digital biomarkers included memory recall, executive functions, and drawing‐based and speech elicitation tasks. Blood biomarkers’ relationship to amyloid PET was measured using Spearman’s rank correlation. A ROC curve analysis assessed the sensitivity and specificity of each biomarker and combination of biomarkers compared with amyloid positivity from PET and CSF. Result Brain amyloid positivity results were 21%, 34%, and 61% for the CN, MCI, and Mild AD cohorts, respectively. Initial data analysis by Global Alzheimer’s Platform Foundation® (GAP) compared results of blood Aß 42/40, t‐tau, and p‐tau181/217/231 tests with brain amyloid positivity. ROC analysis showed more favorable AUC for Aß 40/42 and p‐tau181 (0.8268), Aß 40/42 and t‐tau (0.7922), and Aß 40/42 (0.7918). For Black/African Americans, brain amyloid positivity was 24%, 23%, and 38% for the CN, MCI, and Mild AD cohorts, respectively, and for Hispanic/Latinos results were 4%, 37%, and 53%, respectively. Additional correlation and URM data will be available July 2023. Conclusion Initial topline results show blood‐based AD biomarkers are associated with brain amyloid positivity warranting further analysis of the Bio‐Hermes community‐derived database of blood‐based and digital biom
ISSN:1552-5260
1552-5279
DOI:10.1002/alz.083156