A Breakthrough in Diagnosing Alzheimer’s Disease 

A significant barrier in Alzheimer’s Disease (AD) research for decades has been the inability to identify AD in people recently diagnosed with dementia and to distinguish AD from other forms of dementia. But as presented at the 2022 Alzheimer’s Association International Conference (AAIC) July 31-August 4, data have been presented to address that barrier.

SYNAPS Dx presented new findings that further demonstrate the efficacy of its DISCERN™ diagnostic test to provide highly accurate AD diagnoses. The presenting AAIC researchers released data on the performance of the Morphometric Imaging (MI) assay of the DISCERN test. Results from this autopsy validated clinical study demonstrate that the MI assay accurately identified AD in people diagnosed with dementia, even in the presence of other co-morbid pathologies or mixed-dementias at autopsy.

Specifically, the MI biomarker demonstrated specificity and sensitivity of 100% (p<.001) in distinguishing AD from non-AD patients. Such a distinction is notable because over 50% of people with AD have other pathologies of dementia. Such co-morbidities complicate current standard diagnostic pathways and may adversely impact treatment outcomes. 

Decades of Stymied AD Research 

The government currently invests $3.5 billion a year on Alzheimer’s research. This is in addition to the billions already spent in recent decades. There is good reason for a sense of urgency around this research. Already, about 11 percentof the population age 65 and older are diagnosed with AD, and about two-thirds are women. According to Politico, without action, AD and other dementias will overwhelm the federal budget by 2050. 

To date, there hasn’t been a lot to show for the billions spent; AD drugs have delivered a 99% failure rate. After all, it’s difficult to treat what hasn’t been accurately diagnosed.

AD Management Begins with Early Diagnosis

Until DISCERN, AD diagnostics such as medical imaging (CT, MRI, PET) and blood tests were often inaccurate or difficult to support, especially in those recently diagnosed with dementia. Other diagnostics, such as interviews with family members of suspected AD patients, can be subjective and cognitive frailty can be caused by a variety of social determinants, including diet or lifestyle. The only sure way to diagnose the disease has been post-mortem through autopsy. 

DISCERN now provides highly accurate, timely and early diagnoses to mitigate safety risks, prevent complications and to better allow patient/family planning for the future. It will also help researchers to find more patients to participate in much needed clinical trials. The test has received Breakthrough Designation by the FDA and is the first AD diagnostic of its kind to earn Proprietary Laboratory Analyses (PLA) Codes 206U and 207U and has been reimbursed for people insured with Medicare Fee-For-Service.

This test was developed and its performance characteristics determined by NeuroDiagnostics Inc, dba Synaps Dx. It has not been cleared or approved by the U.S. Food and Drug Administration. NeuroDiagnostics, Inc. is regulated under the Clinical Laboratory Improvement Amendments (CLIA) as an accredited laboratory to perform high complexity clinical testing. The test is intended for patients with dementia. Test results should be interpreted in conjunction with other laboratory and clinical data available to the clinician. All rights reserved.