June 12, 2023

Donanemab Clinical Trial Data Underscores Need for DISCERN™ Accurate Diagnostic Test for Alzheimer’s Disease, Highlights Physician Shortage in Rural Areas

While patients and families anxiously await the availability of drugs to treat Alzheimer’s disease, there are caveats to physicians prescribing these new therapies, safety considerations for patients and cost considerations for payers.

There is consensus that topline clinical trial data is an exciting update for the Alzheimer’s community, but therapies can only be effective when physicians can confidently diagnose the disease. That is where diagnostic pathways fall short: currently, 50% to 70% of symptomatic Alzheimer’s patients are not correctly diagnosed in primary care due to lack of routine cognitive screenings and accurate testing.

SYNAPS Dx (SDx) is taking this opportunity to support physician prescribers, payers and patients with information that points to the value of an accurate diagnosis with DISCERN: an autopsy-validated minimally invasive skin test to identify the disease in people recently diagnosed with dementia, even when they have mixed dementia.

Here’s the Background

Following the results of a clinical trial, donanemab maker, Eli Lilly, is expected to file for FDA approval for the drug before July. In separate trials, data showed the drug slowed Alzheimer’s disease by up to 36 percent compared to 27 percent for Eisai’s lecanemab (Leqembi).

What is becoming evident is that there are significant safety considerations for all amyloid targeted therapies designed to slow the progression of Alzheimer’s disease, especially Amyloid-Related Imaging Abnormalities (ARIA) that indicate swelling and hemorrhages in the brain. Compared to lecanemab, the clinical trial for donanemab showed participants were twice as likely to have ARIA.

Finally, donanemab’s dosing is infused every four weeks vs. lecanemab’s every two weeks and unlike Leqembi, donanemab has the potential to be a fixed course regimen; those who take it could stop taking the treatment within a year if their amyloid clears.

Physician Shortage

These challenges are further amplified by physician shortages, especially in rural areas.

Experts estimate over the next decade the United States will experience a shortage of 12,500-31,100 primary care physicians. Primary care is not the only field experiencing a shortage of practitioners, with an estimated lack of 28,200-63,700 specialists, impacting access to care for people with Alzheimer’s disease, cancer and more.

A scarcity and uneven distribution of neurologists across the country is particularly troubling. A study from the American Academy of Neurology shows that of the 15,063 practicing neurologists surveyed, over 94% worked in metropolitan areas, about 5% practiced in nonmetropolitan locations and less than 1% served rural regions. These already burdened neurologists face further challenges to diagnose Alzheimer’s disease due to the lack of time- and cost-effective diagnostic tools available in the current pathway.

This shortage of clinicians and tools is happening in tandem with an increasing aging population in the United States. Analysts project that the incidence of Alzheimer’s disease is expected to rise to nearly 13 million by 2050.

Get to Know DISCERN – The Key to Supporting A Clinician’s Definitive Diagnosis

Unlike other diagnostic tests for Alzheimer’s, DISCERN is autopsy-validated to identify the disease in people recently diagnosed with dementia, even when they have mixed dementia. No other diagnostic tests have undergone this rigorous autopsy validation for early dementia and no other autopsy-validated tests are available to accurately diagnose mild cognitive impairment due to Alzheimer’s.

The DISCERN test assesses the factors directly related to the formation of synaptic connections in the brain, impacting loss of memory and cognition in people living with Alzheimer’s disease as well as regulators of amyloid plaque and tau formation, hallmarks of Alzheimer’s at autopsy.

Validated in Clinical Trials

In clinical trials, DISCERN demonstrated >95% sensitivity and specificity for identifying Alzheimer’s versus the NIH Gold Standard definition for the disease – dementia in life and the presence of plaque/tau upon autopsy.

DISCERN was tested by following patients from initial diagnosis of dementia through death – on average eight years – at which point an autopsy was performed with the pathologists blinded to the initial diagnosis, and the results of assays were compared to the NIH standard.

What Payers Need to Know about DISCERN

With over half of symptomatic patients misdiagnosed with Alzheimer’s in the generalist setting and 25%-30% misdiagnosed in specialty memory clinics, diagnostic accuracy is still a great unmet medical need.

Even in the absence of disease-modifying therapies, the ability to accurately diagnose Alzheimer’s disease in the generalist setting with DISCERN has been shown in published economic models to be cost-neutral when adding the test to the current diagnostic pathway.

When clinicians reduce reliance on expensive and invasive tests such as positron emission tomography (PET) scans and cerebrospinal fluid (CSF) punctures to identify Alzheimer’s, DISCERN can be cost-saving.

In a published clinical utility study, most primary care physicians were dissatisfied with the current diagnostic approach, citing the burden and subjectivity of the diagnostic tools. The clinicians indicated they were five times more likely to diagnose and three times as likely to prescribe disease-modifying drugs for Alzheimer’s disease, like Leqembi or donanemab, with a positive DISCERN test.

Learn more about the DISCERN test by contacting SYNAPS Dx.

* The DISCERN™ 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.