Diadem presents data at 22nd International Alzheimer’s Drug Discovery Conference, emphasizing that his blood biomarker test is 84% ​​concordant with amyloid brain imaging

– Further analysis of clinical validation data shows that Diadem’s AlzoSure® prediction is highly consistent with amyloid brain imaging – the current gold standard for diagnosing Alzheimer’s disease – in all patients. people tested–

Posted: October 6, 2021 at 1:00 a.m. CDT|Update: 49 minutes ago

MILAN, October 6, 2021 / PRNewswire / – Diadem LLP, a company developing the first blood test for the early prediction of Alzheimer’s disease (AD), presented data showing that its AlzoSure^® The prognostic biomarker test is 84% ​​concordant with imaging of the amyloid brain, the current gold standard for diagnosing AD. The new results of the study were presented at the 22^sd International Conference on Drug Discovery for Alzheimer’s Disease. The Diadem test uses a proprietary antibody to measure blood levels of a conformational variant of the p53 protein (U-p53^{from A to Z}) which has been implicated in the pathogenesis of AD.

The presentation highlights data from a clinical validation study showing that an elevated concentration of U-p53^{from A to Z} is already detectable at the preclinical stage, years before the onset of symptoms in the individuals in the study who progress to AD. It discusses the multiple factors that impact U-p53^{from A to Z} and to make AlzoSure an effective integrative biomarker. These include the numerous downstream interactions of p53 with p-tau and 1-40 / 1-42 amyloid, as documented in over 400 papers that have investigated the scientific rationale for these biomarkers. The presentation included these new findings and summarized data from the clinical validation study showing that:

• AlzoSure^® Predict had 84% concordance with amyloid brain imaging levels in all individuals tested (individuals with uncertain status were counted as mismatch)
• AlzoSure^® Predict is able to identify individuals in the preclinical and early stages of onset of Alzheimer’s disease with more than 95% AUC (a measure of precision) up to six years before diagnosis
• AlzoSure^® Predict clearly distinguishes between people with Alzheimer’s disease and those who don’t progress, and between those with mild cognitive impairment (MCI) and those with AD. In this study, amyloid brain imaging was not able to clearly distinguish between progressors and non-progressors or between individuals who are preclinical or have MCI and those with AD.

Data were presented on October 5, 2021, at the 2021 Alzheimer’s Drug Discovery Foundation International Conference on Drug Discovery for Alzheimer’s Disease by Simona piccirella, PhD, Vice President of Product Development and Operations at Diadem. Dr Piccirella noted: “We presented data from several studies showing that AlzoSure^® Predict can accurately identify people at high risk for progression to AD early in the disease process. These new data further confirm the accuracy of AlzoSure^®, showing that it is highly concordant with amyloid brain imaging, the current gold standard for diagnosing AD. Unlike brain imaging, which is expensive and mostly available at specialist facilities, AlzoSure^® Predict requires only a simple blood test and analysis in a clinical laboratory, which makes it potentially widely available for screening and early diagnosis of AD. “

The presentation discussed selected results and new interpretations of the large retrospective longitudinal study of AlzoSure^® Predict recently released by Diadem researchers as Medrxiv preprint. This confirms that AlzoSure^® Predict accurately identifies people without cognitive impairment or only minors who will progress to fully symptomatic Alzheimer’s disease for up to six years before symptoms of dementia are evident, reaching AUC values ​​of around 99% over the course of years of study follow-up. The data also confirmed the test’s ability to discriminate between patients at different stages of cognitive decline, from asymptomatic impairment to mild impairment to complete dementia of AD. AlzoSure prediction^® also demonstrated superior predictive performance to PET brain imaging measurements of amyloid b charge (P

In addition, Diadem announced that she will present a scientific poster at the XXVth World Congress of Neurology of the World Federation of Neurology, which will take place 3-7 October 2021. The presentation of the poster, Early onset prognosis of Alzheimer’s disease up to 6 years in advance by conformational variant of p53 (U-p53^{from A to Z}), includes key findings from Diadem’s Discovery longitudinal cohort study of 225 people who provided early confirmation of AlzoSure’s prognostic value^® Predict Alzheimer’s disease, as well as its usefulness in mapping out prognostic pathways for AD.

Diadem develops AlzoSure^® Predict the test as a simple, non-invasive plasma biomarker test to accurately predict the likelihood that a patient with asymptomatic mild cognitive impairment will progress to Alzheimer’s dementia. The company’s technology uses an analytical method that includes a proprietary antibody developed by Diadem designed to bind to the conformational variant U-p53^{from A to Z} protein and its target sequences.

The company is conducting a follow-up study using additional longitudinal data from different cohorts and centers of Europe and the United States to validate these results and compare and correlate the potential of U-p53^{from A to Z} as a blood biomarker with traditionally studied markers of AD pathology. The results are expected in the coming months.

About Alzheimer’s disease
There are approximately 50 million people with dementia worldwide. Alzheimer’s disease is the most common form and accounts for 60 to 70% of cases. Currently, there is no modifying treatment for Alzheimer’s disease, and therapies to treat symptoms are limited. There are about 10 million new cases per year, and the incidence is increasing rapidly as the population ages. The current total cost of care is enormous – estimated at 1000 billion dollars in the United States each year and is expected to double by 2030. Currently, the diagnosis of Alzheimer’s disease is slow, inconclusive, invasive and expensive. The development of effective therapies for Alzheimer’s disease has been hampered by the lack of accurate and cost-effective prognostic and diagnostic methods.

About Diadem
Diadem was founded as a spin-off from the University of Brescia (Italy). The company is developing the first blood-based prognostic test for the early detection of dementia, with a focus on Alzheimer’s disease. The lack of accurate, accessible and affordable diagnostic tools is a major contributor to the lack of effective treatments for this devastating disease. As a result, patients are not diagnosed until late in the disease, when effective treatment is no longer possible. Diadem’s fast, accurate and cost-effective blood prognostic test makes it possible for the first time to identify patients early in the disease process, when effective interventions and better outcomes are much more achievable. The usefulness of the approach has been demonstrated in the first clinical studies. Additional retrospective and prospective clinical trials are underway and planned to further validate clinical claims and support widespread adoption and use. The founding principal investor of Diadem is Milan-based at Panakes Partners, a venture capital firm that finances promising biomedical companies with high potential in Europe and Israel. Diadem is preparing for rapid commercialization of its initial Alzheimer’s prognosis via a global launch in collaboration with strategic partners. For more information, visit www.diademdx.com/.

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