Diagnostic Performance of the Alzosure Predict Assay And Its Association With Alzheimer's Disease Biomarkers and Imaging Findings Publisher



Rajabpour Sanati A ; Nasiri H ; Khosravi F ; Ghahrieh F ; Asemanrafat A ; Bahaqiqat A K ; Saberian P ; Bakhshi R ; Rastegari F ; Ahangar Sirous R ; Shahidzadehasadi A ; Seif H ; Ghahremani M ; Gandomi Nasrabadi F Show All Authors
Source: Health Science Reports Published:2026

Abstract

Background: Early diagnosis of Alzheimer's disease (AD) is critical for improving patient outcomes. The laboratory-developed blood test of AlzoSure measures the unfolded conformational variant of p53 (U-p53AZ) in plasma and has shown promise as a screening tool for AD risk. We aimed to evaluate the association between U-p53AZ with established cerebrospinal fluid (CSF) and neuroimaging measures, and to determine its diagnostic performance in distinguishing cognitively normal (CN) individuals from those with mild cognitive impairment (MCI). Methods: Participants included CN and MCI individuals aged 55–90 years with complete baseline and 24-month follow-up assessments. Associations between U-p53AZ, CSF biomarkers, standardized uptake value ratio (SUVR) of glucose measured by fluorodeoxyglucose positron emission tomography (FDG-PET), and cognition were examined with multivariable regression models adjusted for age, sex, and APOE ε4 status. Diagnostic performance was assessed with receiver operating characteristic (ROC) analysis. Results: At baseline, no significant group differences were observed in plasma U-p53AZ, FDG SUVR, or CSF biomarkers between CN and MCI. Longitudinally, FDG SUVR significantly declined in MCI (p = 0.040), while CSF t-tau and p-tau181 increased in both groups (all p < 0.05). Higher U-p53AZ levels were independently associated with elevated CSF t-tau (β = 0.38; p = 0.033) and p-tau181 (β = 0.37; p = 0.033) at baseline, and these associations persisted at follow-up (β range 0.43–0.48; all p < 0.02). No significant associations were found with FDG SUVR or cognitive scores. The discriminative ability of U-p53AZ to distinguish CN from MCI was modest (AUC = 0.617, 95% CI 0.518–0.716). Conclusion: AlzoSure measurements are significantly associated with CSF tau values but demonstrate limited utility in differentiating CN from MCI. Although promising as a marker of tau-related neurodegeneration, AlzoSure has a modest diagnostic performance as a stand-alone assessment. © 2026 The Author(s). Health Science Reports published by Wiley Periodicals LLC.