The early research suggests that a new blood test that can identify the variant of the protein P53 might be able identify AD progression up to 6 years before a clinical diagnosis.
Two studies that analysed the test found that the test (AlzoSure Predict) which requires less than 1 ml of blood, has numerous advantages when compared to other blood tests that track AD pathology.
“We believe this could dramatically improve early stratification and the identification of patients who are eligible for trials that take place 6 years before the diagnosis, which could allow for faster and efficient approvals of treatments,” Paul Kinnon, CEO of Diadem the test’s maker, said in Medscape Medical News.
The findings were presented at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) conference.
Positive “Discovery” Results
Kinnon stated that P53, which is found in both the brain as well as other parts of the body “is one of the proteins that are targeted” in drug development for cancer and other ailments.
The blood test that is currently in use detects a derivative of the P53 (U-p53 AZ). Previous research suggests this derivative, which influences amyloid and oxidative stress is also involved in AD pathogenesis.
Researchers collected blood samples from people 60 years and older who were part of Australia Imaging, Biomarkers and Lifestyles (AIBL), a study that looked at the cognitive function of different levels.
They examined samples at a variety of intervals over a decade, “so we know when the marker is the most accurate at predicting decline,” Kinnon said.
The first of the two studies was an “discovery” study that included blood samples from 224 patients.
The test predicted a decline from mild cognitive impairment to AD at the age of 6 years. There was an area under the curve (AUC) that was greater than 90 percent.
Kinnon said that the results are “massive.” “It’s the most accurate test I’ve seen anywhere for predicting the decline of an individual.”
Kinnon said the test can be used to determine a patient’s level of cognition. “Not only does it enable us to predict 6 years in advance, it will also reveal whether the patient has SMC [subjective memory complaints], MCI, or AD with a 95% accuracy,” Kinnon said.
He noted that test sensitivity was greater than those obtained using conventional methods currently being employed. Kinnon stated that the positive predictive value (PPV), and negative predictive value, which were at minimum 90% are “absolutely amazing.”
“Better than Expected” Results
Researchers examined samples from 482 patients in the second validation study. The “very impressive” results showed AUCs of more than 90%, PPVs over 90% and “very high” NPVs, Kinnon said.
He said, “These are great data. More than we anticipated.”
He did however note that the test is specific for AD decline, and not for other dementias.
In addition, Kinnon noted the test is not able to check levels of amyloid beta or tau, which are more prevalent at the later stage of AD. “Amyloid and tau are signs that you’re suffering from it. We’re a long way off before these levels are visible,” he said.
Identifying patients that are likely to progress to AD years before they begin to show symptoms allows them to make medical decisions. Patients may also be able to try treatments at an earlier stage of the disease, when these treatments are most likely to be helpful, said Kinnon.
In addition, using the test could speed up the approval of potential treatment options for AD. Pharmaceutical companies currently enroll thousands of patients into studies “and they don’t know which ones will have AD,” Kinnon noted.
“This test will reveal which ones are expected to be able to continue and which ones should be included in the study. It will also inform you which ones aren’t. The study is statistically significant and precise.
Investigators can also use the test to monitor patients in the course of a study, instead of relying on expensive PET scans or painful and costly spinal fluid tests, he added.
Kinnon said that market research and prior surveys have found that general practitioners and neurologists “want the use of a blood test in screening patients earlier to better educate and inform patients.”
Additional results, which will include biobank data from more than 1000 patients across Europe and the United States, are expected to be available by the end of the year.
The company is currently in talks with the European and North American markets. Kinnon said that the company hopes to launch the product onto the market by the middle of next year on a variety of markets.
Percy Griffin (MSc PhD) commentated on the findings of Medscape Medical News. He said that it was “exciting” to discover new methods of detecting and predicting AD.
“There is an urgent need for simple, inexpensive non-invasive and accessible early detection tools for Alzheimer’s, like blood tests,” he said.
Griffin advised that the test is in its infancy and has not yet been thoroughly tested in large, varied clinical trials.
He also said that although the test can predict whether a person will make progress, it is not able to predict when.
He stated that “These preliminary results are encouraging, but more validation is needed before this test can become widespread.”
Technologies that facilitate the early detection and intervention before the brain cells are destroyed from AD “would be game-changing” for individuals, families, and the healthcare system, Griffin concluded.
14th Clinical Trials on Alzheimer’s Disease (CTAD) conference: Late-breaking (LB) presentation #3. The presentation was given on November 11, 2021.
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