A university research team and a global diagnostics company simultaneously but independently unveil two new tests that accurately identify people predisposed to Alzheimer’s at earlier stages in the disease

Medical laboratory scientists and clinical pathologists have long awaited an accurate and clinically-useful test for the predisposition and early diagnosis of Alzheimer’s disease. Now comes pioneering efforts from two organizations that suggest real progress is being made.

One organization is an academic center and the other is an in vitro company. It was a research team at Rowan University School of Osteopathic Medicine (RowanSOM) that announced development of the first blood test to use the body’s own immune system to detect mild cognitive impairment (MCI), an early stage of Alzheimer’s disease.

Similarly, research scientists for Randox Laboratories unveiled to pathologists, clinical laboratory leaders, and others attending the American Association for Clinical Chemistry (AACC) Annual Scientific Meeting, how their biochip-based technology also could be used to detect elevated risk for Alzheimer’s disease.

“We don’t know who’s going to be first. We’re working as hard as we can, as fast as we can,” said Robert Nagele, PhD, Professor of Medicine at Rowan University School of Osteopathic Medicine, Director of the Biomarker Discovery Center at Rowan’s New Jersey Institute for Successful Aging, and the study’s corresponding author, in an article published in the Courier-Post (part of the USA Today Network). Nagele was commenting, generally, about nationwide efforts to find tests for the devastating and progressive neurodegenerative disease.

More than Five Million Living with Alzheimer’s

With no current means to accurately diagnose or cure people of Alzheimer’s disease, researchers see an opportunity to help millions. About 5.2 million people over age 65 have Alzheimer’s disease, the most common form of dementia, according to the Alzheimer’s Association, which also states that number could triple to 13.8 million by 2050.

Robert Nagele, PhD (above), is Director of the Biomarker Discovery Center at Rowan’s New Jersey Institute for Successful Aging. He is also the corresponding author of a Rowan University School of Osteopathic Medicine study of a blood test that identifies with 100% overall accuracy, sensitivity, and specificity, subjects with mild cognitive impairment (MCI) caused by early stage Alzheimer’s disease. (Photo copyright: New Jersey Online/NJ.com.)

Robert Nagele, PhD (above), is Director of the Biomarker Discovery Center at Rowan’s New Jersey Institute for Successful Aging. He is also the corresponding author of a Rowan University School of Osteopathic Medicine study of a blood test that identifies with 100% overall accuracy, sensitivity, and specificity, subjects with mild cognitive impairment (MCI) caused by early stage Alzheimer’s disease. (Photo copyright: New Jersey Online/NJ.com.)

Discovery and leverage of known biomarkers could lead to therapeutic drugs or other approaches to treat Alzheimer’s patients early-on. Furthermore, the RowanSOM and Randox tests may strengthen efforts to develop drugs to prevent the disease. Once cleared by the Food and Drug Administration (FDA), these different tests for Alzheimer’s disease could provide clinical laboratories with useful tools to help physicians do a better job of diagnosing and treating Alzheimer’s patients.

Researchers Focus on Finding Alzheimer’s Early

At RowanSOM in Stratford, NJ, researchers set out to answer these questions:

1. Can Alzheimer’s be detected at an early stage before it causes too much brain devastation?

2. Is it possible to distinguish Alzheimer’s from other diseases such as Parkinson’s disease, multiple sclerosis, and breast cancer?

3. How may autoantibodies be used as blood-based biomarkers?

Making a disease distinction is important to patient care, because people could have MCI for reasons other than Alzheimer’s, the researchers explained.

“About 60% of all MCI patients have MCI caused by an early stage of Alzheimer’s disease. The remaining 40% of cases are caused by other factors including vascular issues, drug side-effects, and depression. Physicians need to know which cases of MCI are due to early Alzheimer’s and which are not,” said Cassandra DeMarshall, the study’s lead author and a doctoral candidate at Rowan University’s Graduate School of Biomedical Sciences (RowanGSBS), in a news release about the study.
100% Accuracy

According to the RowanSOM statement, in the proof-of-concept study the blood test identified—with 100% accuracy—those subjects whose MCI was caused by an early stage of Alzheimer’s disease, as opposed to other causes. An article in New Atlas (formerly GizMag) outlined the study:

• Blood samples from 236 patients were secured;

• Fifty of them were diagnosed with Alzheimer’s due to low-levels of amyloid-beta 42 peptide in cerebrospinal fluid;

• Other subjects included a control group of 50, a group of 50 with MCI, 50 with Parkinson’s, 25 with multiple sclerosis, and 11 with breast cancer;

• Blood samples were screened with human microarrays that each had 9,486 unique proteins;

• Researchers drew out antibodies indicative of different diseases and identified the top 50 autoantibody biomarkers capable of detecting early-stage Alzheimer’s.

“Our results show that a small panel of blood-borne autoantibody biomarkers can be used to distinguish subjects with Alzheimer’s disease-associated MCI from age-matched and gender-matched controls with an overall accuracy of 100%. In addition, MCI subjects were successfully differentiated from those with mild-moderate Alzheimer’s with similar overall accuracy, suggesting that this approach may also be useful for delineation of discrete disease stages,” the researchers wrote in the journal, Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring.

Biochip Technology Identifies Risk for Alzheimer’s

Meanwhile, research scientists at Randox Laboratories, a global healthcare diagnostics company, addressed how biochip technology could be used to test for increased risk of Alzheimer’s disease.

Randox research scientists say their test performs with the same accuracy as a gold standard DNA test. The biochip test reportedly allows multiple tests to run on one blood sample.

“This is the first time that we have used this biochip technology to test for an increased risk of Alzheimer’s disease,” said Emma Harte, PhD, Research Scientist at Randox Laboratories, in a company statement.

How Does the Randox Test Work?

The test detects the presence of a protein in the blood produced by a specific variation of the apolipoprotein gene—ApoE4—which is associated with increased risk of developing Alzheimer’s.

One ApoE gene is inherited from each parent. If a person inherits the ApoE4 variant from one parent, they have a three times greater risk of developing Alzheimer’s. And a child inheriting ApoE4 from both parents is eight-to-12 times more likely to develop the disease, Randox stated.

About 25% of people inherit one copy of the ApoE4 gene. Inheriting two copies increases a person’s Alzheimer’s risk by 10 times or more, noted Medical News Today.

Test Detects Alzheimer’s Risk in Three Hours

The Randox team, working with colleagues from the Medical University of Vienna, analyzed 384 samples and compared the results to those from a standard molecular diagnostic test. The results showed the two tests agreed and provided results with 100% accuracy. However, the biochip test results were available faster—within three hours—according to the company’s statement.

Is the Wait for an Alzheimer’s Test Over?

Development of an accurate and reliable blood test for diagnosing Alzheimer’s disease would be an important advance. It would give medical laboratories a tool that would be welcomed by physicians, patients, and their families as they work to diagnose the disease, select appropriate therapies, and monitor its progress.

—Donna Marie Pocius

Related Information:

Rowan-led Team Alzheimer’s Test “100%” Accurate

Researchers at AACC Annual Scientific Meeting Show Test Performs with Accuracy as Gold Standard DNA Test

Rowan Researchers Develop Blood Test That Detects Early Alzheimer’s Disease

Blood Test for Alzheimer’s Shows 100 Percent Accuracy in Early Trials

Detection of Alzheimer’s Disease at Mild Cognitive Impairment and Disease Progression Using Autoantibodies as Blood-based Biomarkers

Randox Biosciences Biochip Blood Test Detects Elevated Risk for Alzheimer’s Disease

Alzheimer’s: Biochip Blood Test Detects Disease Risk

Rowan University Researchers Announce Blood-Based Biomarkers for Early Detection, Diagnosis of Parkinson’s Disease