Molina-Henry Doris P, Raman Rema, Liu Andy, Langford Oliver, Braunstein Joel B, Verghese Philip B, Venkatesh Venky, Dhadda Shobha, Irrizary Michael, Grill Joshua D, Johnson Keith, Rissman Robert A, Aisen Paul, Sperling Reisa A
Alzheimer's Therapeutic Research Institute Keck School of Medicine of the University of Southern California San Diego California USA.
C2N Diagnostics, LLC, St. Louis Missouri USA.
Alzheimers Dement (Amst). 2025 Aug 22;17(3):e70164. doi: 10.1002/dad2.70164. eCollection 2025 Jul-Sep.
Consistent predictive performance across racial and ethnic groups is essential to the use of plasma biomarkers as screening tools in preclinical Alzheimer's disease trials.
Logistic regression examined racial and ethnic group differences in plasma eligibility using an algorithm that included Phosphorylated tau217 to non-phosphorylated tau217 ratio, amyloid beta 42/40, age, and apolipoprotein E to predict > 18 Centiloids on amyloid imaging in cognitively unimpaired individuals.
Among 6437 participants screened, with non-Hispanic (NH) White as the reference group, odds ratios of plasma ineligibility were 2.88 (95% confidence interval [CI]: 1.40-6.96) for Hispanic Black, 1.60 (95% CI: 1.33-1.92) for Hispanic White, 2.10 (95% CI: 1.37-3.38) for NH Asian, and 1.59 (95% CI: 1.27-2.0) for NH Black participants. Positron emission tomography (PET) eligibility rates did not differ among those who were plasma eligible.
Differential rates of plasma eligibility, but consistent PET eligibility among plasma-eligible participants, were observed, supporting the use of universal biomarker cutpoints across race and ethnic groups. Underrepresented racial and ethnic groups had lower rates of plasma eligibility compared to non-Hispanic White individuals based on a plasma screening algorithm that included the phosphorylated tau 217 ratio.Among plasma-eligible participants, amyloid positron emission tomography eligibility rates did not differ by racial and ethnic group.Plasma biomarker tests may provide equivalent effectiveness for identifying imaging biomarker eligible, cognitively unimpaired individuals across racial and ethnic groups.
在临床前阿尔茨海默病试验中，血浆生物标志物作为筛查工具，在不同种族和族裔群体中具有一致的预测性能至关重要。
采用逻辑回归分析，使用一种算法来检查血浆合格性方面的种族和族裔群体差异，该算法包括磷酸化tau217与非磷酸化tau217的比率、淀粉样蛋白β42/40、年龄和载脂蛋白E，以预测认知未受损个体淀粉样蛋白成像中>18个淀粉样蛋白成像单位。
在6437名接受筛查的参与者中，以非西班牙裔（NH）白人作为参照组，西班牙裔黑人血浆不合格的比值比为2.88（95%置信区间[CI]：1.40 - 6.96），西班牙裔白人血浆不合格的比值比为1.60（95%CI：1.33 - 1.92），NH亚裔血浆不合格的比值比为2.10（95%CI：1.37 - 3.38），NH黑人血浆不合格的比值比为1.59（95%CI：1.27 - 2.0）。血浆合格者的正电子发射断层扫描（PET）合格率无差异。
观察到血浆合格率存在差异，但血浆合格参与者的PET合格率一致，这支持在不同种族和族裔群体中使用通用的生物标志物切点。基于一种包括磷酸化tau 217比率的血浆筛查算法，与非西班牙裔白人个体相比，代表性不足的种族和族裔群体血浆合格率较低。在血浆合格的参与者中，淀粉样蛋白正电子发射断层扫描合格率在不同种族和族裔群体中无差异。血浆生物标志物检测在识别不同种族和族裔群体中符合成像生物标志物标准、认知未受损的个体方面可能具有同等效力。
