Most doctors in survey favor DISCERN to diagnose Alzheimer’s

Skin-sample biomarker test aims to identify disease in early stages

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by Steve Bryson, PhD |

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DISCERN, a biomarker test reported to accurately diagnose Alzheimer’s disease at its earliest stages, routinely would be used by 90% of physicians who responded to a recent survey.

With a positive test using a small skin sample, physicians were some six times more likely to diagnose Alzheimer’s and nearly three times more likely to prescribe therapies to treat symptoms of suspected dementia, the survey found.

“Our study demonstrates that the DISCERN test is an objective contributor to physician decision-making, associated with significantly higher clinician confidence in an [Alzheimer’s disease] diagnosis, especially in those recently diagnosed with dementia,” Frank Amato, CEO and president of SYNAPS Dx, which developed the test, said in a press release.

Survey findings were in the study, “Clinical Utility of a Novel Test to Diagnose Alzheimer’s Disease in Patients with Suspected Dementia,” published in the journal Annals of Clinical Cytology and Pathology. SYNAPS Dx funded the work, which was done by professionals with Boston Healthcare Associates, Semler Scientific, and Aetna.

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Alzheimer’s difficult to diagnose, especially in primary care

An Alzheimer’s diagnosis can be challenging as it relies on assessing a person’s medical history, disease symptoms, lab tests, and brain scans. Reports suggest the condition is often misdiagnosed in primary care due to a lack of objective and cost-effective tools.

With an early diagnosis, treatments are more likely to be effective at easing symptoms and slowing disease progression and may help to minimize the impact of Alzheimer’s on everyday life.

The DISCERN test was developed as an accurate and objective way of identifying those in the early stages of Alzheimer’s (within four years of a dementia diagnosis) and distinguish the disease from other forms of dementia.

It is intended to be used by primary care physicians (PCPs), neurologists, and geriatricians in patients ages 55–90 with suspected dementia. The U.S. Food and Drug Administration (FDA) has not cleared or approved DISCERN for use, its webpage noted.

“With the potential FDA-approval of drugs for [Alzheimer’s disease] coming this year, payers will be facing challenges regarding prescribing and coverage determinations for new, expensive treatments for the most appropriate patients,” said Frederick Huie, MD, an SYNAPS Dx advisory council member and study co-author.

Using a small skin sample, DISCERN measures factors directly related to the formation of synapses — the junctions where nerve cells communicate. Synaptic loss is an established indicator of cognitive decline. The test also assesses regulators of amyloid plaque and tau formation, which are considered hallmarks of Alzheimer’s.

DISCERN has been validated against autopsy findings with a 95% sensitivity, or ability to correctly detect Alzheimer’s, and a 95% specificity, or ability to correctly rule it out, SYNAPS Dx reported.

This web-based survey was designed to evaluate the clinical utility of DISCERN against other diagnostic measures and determine how physicians would use the test in a real-world setting.

Lack of definitive Alzheimer’s test among diagnostic challenges

A total of 402 physicians took part in the survey: 250 primary care physicians, 102 neurologists, and 50 geriatricians.

Overall, less than half (48%) of surveyed physicians said they were satisfied (44%) or extremely satisfied (4%) with current methods for assessing Alzheimer’s. Satisfaction was lower among primary care physicians (40%) than among neurologists (64%).

A lack of a definitive test to detect Alzheimer’s was cited as the greatest diagnostic challenge (77%), followed by the cost of standard of care (56%), and the subjectivity in interpreting current test results (54%).

The benefits of a more accurate test to detect Alzheimer’s and distinguish it from other dementias included prescribing appropriate treatments earlier on in the disease’s course (82%), avoiding the prescription of inappropriate therapies to those who do not have the condition (77%), and peace of mind for patients given a definitive diagnosis (66%).

Among respondents, 90% said they were likely to order DISCERN. They cited its ability to help with treatment decision-making (69%), high accuracy (67%), ability to provide a definitive diagnosis (66%), and lower invasiveness compared with cerebrospinal fluid sampling (66%) as the main reasons. Of note, the cerebrospinal fluid is the liquid that surrounds the brain and spinal cord.

With a positive test, physicians indicated that they were 6.45 times more likely to diagnose Alzheimer’s, 2.98 times more likely to prescribe treatments to treat symptoms of suspected dementia, and 4.12 times more likely to prescribe disease-modifying therapies for Alzheimer’s.

“Based on the results of this study,” its authors concluded, “we believe that the DISCERN test will be adopted broadly by clinicians … for evaluating patients with cognitive impairment suggestive of [Alzheimer’s disease] and it will have a significant positive impact on patients, their caregivers, and society.”