Many in the Alzheimer’s Disease (AD) community were disappointed when the Centers for Medicare & Medicaid Services (CMS) announced in late February it is not reconsidering national coverage determination (NCD) for Food and Drug Administration (FDA)-approved monoclonal antibodies directed against amyloid for the treatment of AD. Despite pressures from the AD community including patients, caregivers, families and advocacy organizations, this decision delaying access to the treatment until full FDA approval was quite disappointing on many levels.
In the near term, this pronouncement leaves an estimated 2,000 individuals aged 65 or older without medication and susceptible to transition from mild dementia due to AD to a more advanced stage of the disease where they may no longer be eligible for the new FDA-approved treatments.
CMS states it is required to determine if medication is reasonable and necessary – raising the question: who are the right patients for whom monoclonal antibodies directed against amyloid are reasonable and necessary?
AD is a complex disease and while the presence of amyloid is a hallmark of disease at death, it is not correlated with synaptic loss and neuronal death. Unfortunately, it has been difficult to diagnose AD, with 50% to 70% of symptomatic AD patients not correctly diagnosed in primary care and 25% to 30% misdiagnosed in specialized memory clinics. The reason cited by the Association is that routine cognitive screening is not consistently performed and there is a lack of easily accessible, time- and cost- effective, and accurate diagnostic tools. The problem is even worse in early stages of the disease, that is, in patients without dementia who have either subjective cognitive decline (SCD) or mild cognitive impairment (MCI). The currently available cognitive tests available in primary care are inadequate to differentiate SCD and MCI.
A Pathway Forward: Accurate Diagnosis, Lifestyle Changes
With early intervention being the key to a proper diagnosis, accurate tools are necessary for physicians to provide diagnoses that can help identify patients that would benefit most from disease modifying therapies (DMTs). To fill this diagnosis gap, tools such as the DISCERN™ test, the first highly accurate, minimally invasive skin test for AD specifically versus other forms of dementia, can support a clinician’s definitive diagnosis, even in people recently diagnosed with dementia. In a recent survey, over 90% of clinicians indicated that they would use DISCERN™ and with results from the test, be more confident in their diagnosis and potentially prescribing anti-amyloid treatments.
It is important to note, however, that 40% of Alzheimer’s disease and related dementias (ADRD), can be prevented or delayed with lifestyle changes that address modifiable risk factors.
Activities that support healthy mental aging include:
- Adopting an overall healthy lifestyle by maintaining normal blood pressure and blood sugar, being physically active and maintaining a healthy weight, avoiding drinking and smoking, caring for hearing loss and getting proper sleep.
- Maintaining a healthy diet that supports cognitive function.
- Cultivating strong social connections and maintaining a sense of community.
- Participating in light or moderate exercise.
- and avoiding head trauma.
Studies show that regular exercise can help adults at risk for AD slow cognitive decline and reducing risk factors such as physical inactivity, smoking, depression, mid-life hypertension, mid-life obesity, low education and diabetes, can reduce the prevalence of AD in the U.S.
Further, amyloid targeted agents have struggled to demonstrate a modest improvement in cognition, and AD is a complex disease with several factors contributing to synaptic loss and neuronal death. While physicians and patients consider the safety and efficacy of the drugs, those concerned with subjective cognitive decline (SCD) and mild cognitive impairment (MCI), focusing on modifiable risk factors and receiving and annual wellness exam is suitable. Those concerned with dementia can also focus on modifiable risk factors and determine if AD is the cause with a DISCERN test. If AD is detected, patients can continue with risk factor modification and evaluate the presence of amyloid consistent with AD. If AD and Amyloid are detected, monoclonal antibodies directed against amyloid may be appropriate – depending on other health related factors for the patient.
DISCERN is a CLIA certified, minimally invasive skin test that assesses the factors directly related to the formation of synaptic connections in the brain impacting loss of memory and cognition in people living with AD, as well as regulators of amyloid plaque and tau formation—hallmarks of AD at autopsy. The test is the first of its kind to earn Proprietary Laboratory Analyses (PLA) Codes 206U and 207U. Medicare-Fee-for-Service has reimbursed the cost of the DISCERN exam. DISCERN is recognized as the world’s only Gold Standard Validated benchmark to offer such clinical insight.
* 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.