The performance of AlzoSure® Predict in stratifying the risk to experience a significant cognitive deterioration, due to Alzheimer’s Disease

Abstract

AbstractBackgroundTreatments for patients with Alzheimer’s Disease (AD) are now available, and are associated with certain risks. There is an increased need from providers, to have tools that will aid in clinical decision‐making.MethodThe AlzoSure® Predict test, is an IP‐LC‐MS/MS based method, to quantify the AZ284® peptide of an unfolded variant of the p53 protein (U‐p53AZ).A dataset from the Australian Imaging, Biomarkers, and Lifestyle (AIBL) study, with 479 participants, aged 60‐85, 237 being cognitively normal (CN), 98 with minimal cognitive impairment (MCI), 141 with dementia due to AD (ADD), and 3 with non‐AD dementia (OD), was used to validate the performance of AlzoSure® Predict to identify the risk individuals, to experience a significant cognitive deterioration (CN to MCI or ADD and MCI to ADD) and to stratify them according to the time frame, during which, this will occur (6 or 2 years).Result316 participants had a follow up of up to 6 years, and 294 had a follow up of up to 2 years.The performance of AlzoSure® Predict, as measured by AUC, is high, regardless of the follow‐up time frame. For prediction of deterioration within 6 years, the obtained AUC is 0.9842 with DeLong 95% CI: 0.9727‐0.9956 (68 case, who experienced a deterioration, and 248 controls), ho didn’t and for prediction of deterioration within 24 months, it is 0.9891, with DeLong 95% CI: 0.9789‐0.9994 (46 cases, and 248 controls).The cut‐off values of AlzoSure® Predict are defined to stratify individuals, at the time of testing, according to the time frame, during which they may experience a significant cognitive deterioration.AlzoSure® Predict showed high performance to identify rapid progressors to AD within 2 y, with a PPV/ NPV >90%, Sens>80%, and Spec>95%ConclusionAlzoSure® Predict has the capability to identify individuals, who are at risk to experience a significant cognitive deterioration, and stratify this risk according to the time frame, even in a period within 2 years, during which this deterioration will occur.AlzoSure® Predict can become a tool, to strengthen a personalized clinical decision‐making, with improved precision, to be used by providers, who care for patients with AD.