Diadem SpA, a company developing the first blood-based test for the early prediction of progression to Alzheimer’s disease (AD), presented clinical data at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference highlighting the accuracy and clinical utility of its AlzoSure Predict prognostic blood test for Alzheimer’s Disease (AD), setting the stage for commercialization in the U.S. beginning in 2023.

In the presentation by Diadem Chief Medical Officer Sam Agus MD, he discussed how AlzoSure Predict can aid pharmaceutical and biotechnology companies for screening, enrichment, and stratification of patient populations to facilitate Alzheimer’s disease clinical trials. Use of the test enables drug developers to identify individuals who will experience a decline to Alzheimer’s dementia up to six years in advance of diagnosis with high confidence, regardless of their cognitive, amyloid, or tau measurement status at the time of testing. This type of patient stratification can improve clinical trial recruitment and the odds of success, as it ensures that patients participating in the trials have a very high probability of developing full-blown AD.

Additionally, Agus discussed the utility of the prognostic blood test as a screening tool to enable physicians to identify those individuals at high risk of developing AD very early in the disease process, when therapies may be most effective. The likely approval of new drugs such as lecanemab from Eisai and Biogen, which shows promising signs of slowing cognitive decline in early AD, highlights the need for accurate and economical screening tools to select patients most likely to benefit from early treatment.

“This is an exciting time in the battle against Alzheimer’s disease,” says Paul Kinnon, CEO of Diadem. “Advances in AD diagnosis and therapy are finally providing hope that we can begin to slow or stop the progression of this terrible disease, which impacts so many individuals and families. We see AlzoSure Predict playing a key role in this progress, with its wide potential accessibility and its ability to enhance AD clinical trials and to identify individuals at high risk for progression to AD. As we expected, global market research we are in the process of conducting is showing that both individuals and physicians indicate strong interest in early access to better diagnostic tools for Alzheimer’s.”

Kinnon continued, “Our clinical studies show that AlzoSure Predict is able to predict cognitive decline to AD dementia with an AUC greater than 90%, regardless of the cognitive, amyloid or tau status of the patient at the time of testing. AlzoSure also showed superiority compared to Pib-PET amyloid imaging in predicting decline to AD dementia in patients before, or with, early signs of cognitive deficits. We now are in the final stages of further validating these findings using longitudinal data from the U.S.-based Alzheimer’s Disease Research Centers (ADRC) and Alzheimer’s Disease Neuroimaging Initiative (ADNI) cohorts, and look forward to releasing results in the coming months. We also are preparing for the commercial launch of AlzoSure Predict in the U.S. in the new year, in collaboration with a major diagnostics partner.”

AlzoSure Predict is a non-invasive biomarker prognostic blood test that can identify with high accuracy whether individuals over the age of 50 with signs of cognitive impairment will or will not progress to Alzheimer’s disease up to six years before diagnosis. AlzoSure Predict uses a proprietary antibody (U-p53AZ) to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD. Previous studies suggest that this p53 variant has utility as a diagnostic and as a predictive biomarker to identify individuals likely to progress to AD up to six years before symptoms appear.

The utility of AlzoSure Predict is supported by clinical data from a large longitudinal study that was the basis for AlzoSure Predict’s Breakthrough Device designation from the U.S. Food & Drug Administration and its CE-IVD marking in the E.U. AlzoSure Predict requires only 1mL of blood and 4 to 5 days for analysis to detect AD at the asymptomatic and prodromal (early symptomatic) stage, with an accuracy greater than 95% up to at least 6 years in advance of the clinical onset of symptoms. Previous research also demonstrated that AlzoSure Predict can discriminate between the different kinds of dementia with high accuracy.