Blood Test May Accurately Predict Progression to Alzheimer Disease 6 Years Before Diagnosis

In a retrospective longitudinal study, available as a preprint prior to peer review, a prognostic blood biomarker test (AlzoSure Predict; Diadem, Milan, Italy) identified people who progressed from normal cognition or mild cognitive impairment (MCI) to Alzheimer disease (AD). The study used a conformational variant of p53 (U-p53AZ) as blood-based biomarker to predict onset of symptomatic AD up to 6 years before diagnosis with high accuracy (area under the curve [AUC]=.99).

The p53 protein has been implicated in the pathogenesis of AD. Data evaluated were from the Australian Imaging, Biomarkers, and Lifestyle (AIBL) study cohort spanning the AD continuum from cognitive normal to fully symptomatic AD. Participants in the study were surveyed for up to 144 months. 

Tamas Bartfai, PhD, chair of Diadem's Medical Advisory Board and formerly professor and chairman of Molecular and Integrative Neurosciences and director of the Dorris Neuroscience Center at the Scripps Research Institute, noted, "These new data using samples from multiple well-known biobanks confirm that AlzoSure Predict, a blood-based, easily accessible test, can identify individuals who will progress to symptomatic Alzheimer's disease six or more years in advance. They are being published as we prepare to highlight September as Alzheimer's Disease International's World Alzheimer Month, focusing this year on the importance of early diagnosis. An accessible, accurate blood-based biomarker test like AlzoSure Predict has the potential to make possible early interventions to slow or stop disease progression and to enable more effective enrollment for the multiple clinical studies of new therapeutics. In view of the growing evidence supporting the test's utility, I am optimistic that the further validation studies that are now underway will confirm these results, paving the way for AlzoSure Predict to become available to patients and their physicians."

In earlier studies of the prognostic biomarker test, there was a consistent performance in the predicting the onset of AD dementia up to 6 years before symptoms appeared in the individuals classified as either cognitively normal or as having minor cognitive impairment at baseline, achieving AUC values of around 99% during the follow-up. The data also confirm the capability to discriminate between different stages of cognitive decline. In the 482-participant cohort study, the prognostic biomarker test also demonstrated superior predictive performance to standard PET imaging measures of amyloid b load (P.001), as well as AD-related genetic biomarkers