AlzoSure® Predict is a simple, non-invasive blood test to predict the early onset of Alzheimer’s disease (AD) with the ability to identify mild cognitive impairment (MCI) patients before the clinical symptoms are identifiable 6 years in advance of clinical diagnosis. AlzoSure® both identifies whether a patient will progress to AD and indicates their current status, such as MCI.
AlzoSure® Predict is a simple, rapid and non-invasive blood test requiring minimal blood (1ml) to generate a 25µl sample of plasma that is immunoprecipitated and digested to enable the quantification of the U-p53AZ biomarker (AZ 284®) via any mass spectrometry. The U-p53AZ biomarker is a conformational variant associated with the early stages of progression to AD.
The test readout provides a positive or negative output on a patient’s likely decline into Alzheimer’s disease and identifies MCI patients, before the clinical symptoms are identifiable 6 years in advance of clinical diagnosis, all in a single test.
HOW DOES IT WORK
The AlzoSure®Predict has been developed and designed for use in clinical laboratories to provide clinicians and general practitioners/doctors with information about the risk of individuals/patients to progress from mild or no symptoms into full-blown Alzheimer’s. This is achieved by the clinician talking a 1 ml blood sample from the individual/patient and sending it to a clinical lab for testing. The lab will process and analysis the sample in less than 3-4 days and provide the clinician with the results. These are presented as a risk factor/prognostic result allowing the clinician to better advise the individual/patient about their likely course of disease progression, six years earlier than is possible with currently available clinical diagnostic methods.
A clinical validation study has been carried out with longitudinal samples from the Australian Imaging, Biomarker & Lifestyle Flagship Study of Ageing (AIBL) study cohort containing 482 unique patients having or at risk of developing Alzheimer’s disease . From enrolment, all patients were followed for maximally 8 visits at 18-month intervals, with a maximal follow-up of approximately 144 months. During each visit, the patient’s neuropsychological (NP) status was assessed and at one time point, the AZ284® biomarker was measured. The baseline status for this analysis coincides with the timepoint at which the AZ284® biomarker was assessed (which can occur at a later visit than the study enrolment date.) The Clinical groups at baseline included cognitive normal (CN) distinguished by significant memory concern (SMC) (n=163); healthy non-memory complainers (NMC) (n=65); MCI (n=98); AD (n=141); and Other Dementia (OD) (n=3).
At the end of follow-up 16 CN progressed to MCI and 8 to AD and 60 MCI progressed to AD.
ALZOSURE® PREDICT PROGNOSTIC PERFORMANCE CONFIRMED
1. AlzoSure® Predict Prognostic Value by AUC shows the risk/probability of progression to Alzheimer’s in advance of traditional diagnostic techniques.
2. AlzoSure® Predict: PPV and NPV values for progression to Alzheimer’s over a follow up period greater than 6 years:
3. AlzoSure® Predict: also has the ability to identify MCI patients, before the clinical symptoms are identifiable (in the same test) 6 years in advance of clinical diagnosis with AUC of > 95%
ALZOSURE® PREDICT VS AMYLOID BRAIN PET IMAGING TO IDENTIFY THE COGNITIVE STATUS OF INDIVIDUALS
ALZOSURE® ACCURATELY IDENTIFIED INDIVIDUALS AT HIGH RISK OF COGNITIVE DECLINE
Ability to identify and classify MCI patients >95% in same test
AlzoSure® demonstrates the ability to identify and classify MCI patients with >95% accuracy, all in the same test
AlzoSure® Predict shows AUC=100% and AUC=97% to differentially diagnose Cognitive Normal and MCI individuals vs AD patients, further confirming its Diagnostic Clinical value.