Early, accurate detection impacts prescribing decisions, avoids unnecessary exposure to drugs with potential serious safety issues and patient burden

For more than 6 million seniors in America who are experiencing memory, language and thinking problems -- the first symptoms of Alzheimer's disease (AD) – news of the first FDA-approved anti-amyloid drugs to treat AD has likely been a topic for discussion. Perhaps, a physician has suggested these drugs, although there are several serious concerns about the safety, risks and potential out of pocket cost associated with these new medications.

Ensuring appropriate physician prescribing as well as health plan or Medicare reimbursement is a key issue. While these drugs are considered a step forward in treatment, they come with significant baggage. Here’s why:

The Alzheimer’s Association estimates that 50%-70% of symptomatic patients with AD are not recognized in the community setting and 25%-30% of AD patients are misdiagnosed in specialized memory clinics. 

The problem of diagnosing AD is even more dire when evaluating people with Mild Cognitive Impairment (MCI). The primary cause, according to the Alzheimer’s Association, is that routine cognitive screening is not performed and there is a lack of easily accessible, time- and cost-effective diagnostic tools available.

Studies indicate that more than 50% of people with MCI will not progress to dementia over 10 years. 

Alternative Options

Moreover, studies have shown that 40% of dementia cases could be prevented by focusing on modifiable risk factors. These include addressing social isolation and depression, inadequate control of metabolic conditions such as Type 2 diabetes and hypertension, and physical inactivity. 

In fact, the NIH has sponsored studies (SMARRT and EXERT), demonstrating that it is possible to stabilize cognition and improve quality of life by resolving non-clinical issues and Social Determinants of Health (SDoH). By initiating lifestyle changes, millions of patients can avoid exposure to the extreme risks — and costs — of these new drugs.

Prevention Strategies

There are several activities one can adopt to encourage a healthy mental state as one ages including:

• Maintaining 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.
• Eating a healthy diet that supports cognitive function.
• Engaging in social events and establishing strong social connections.
• Performing light or moderate exercise regularly.
• Avoiding head trauma.

Studies support that adopting these lifestyle changes can help reduce risk factors for cognitive decline. The EXERT study shows that regular exercise can help adults at risk for AD and the Systematic Multi-Domain Alzheimer's Risk Reduction Trial (SMARRT) study found that reducing risk factors such as physical inactivity, smoking, depression, mid-life hypertension, mid-life obesity and diabetes, can also reduce the prevalence of AD in the U.S.

These strategies can help prevent cognitive decline and slow the progression of disease. But for those who are already experiencing symptoms of AD, deciding on the next steps can be daunting for individuals and families.

Ways Forward

AD is the most common cause of dementia, a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. AD accounts for 60%-80% of dementia cases and is the most common cause of cognitive impairment or dementia in individuals age 65+. Although cognitive issues and symptoms may be new to the individual affected, the brain changes that cause them are thought to begin 20 years or more before symptoms start.

By 2050, the number of Americans over 65 with AD is expected to rise to 12.7 million from 6.5 million in 2022. This demonstrates the urgency for awareness of AD prevention and ways forward for people who experience signs of cognitive decline.

People experiencing symptoms of AD such as forgetfulness, bad judgment, forgetting the date or where they are, difficulty doing everyday tasks, or experiencing mood and personality changes should visit their doctor to discuss appropriate options.

One suggestion a physician might have is getting tested for AD. Important considerations to look for in an AD test include:

• Demonstration of high specificity and sensitivity with both early and late-stage AD and diagnosing AD for people experiencing mixed dementia.
• Easily accessible and administered by general practitioners in the community setting.
• Paid for by Medicare.
• Accuracy in identifying AD, even in people recently diagnosed with dementia.
• Autopsy-validated in prospective clinical trials.
• Assesses multiple crucial factors that directly relate to AD and that regulate memory, as well as the presence of operating synaptic connections among neurons and the level of amyloid plaques and the level of neurofibrillary tangles in the brain.

Receiving a test for AD will become increasingly important as drugs that can slow the progression of the disease become available to the public. Patients can seek cost effective, easily accessible and convenient testing for AD, allowing them to receive all resources available to them. Accurate and non-invasive testing, such as the DISCERN™ test, enables physicians and patients to receive a diagnosis and begin the most appropriate treatments.

Outlook for the Future

People can stay physically and mentally active to reduce their risk of cognitive decline. Lifestyle changes can support overall brain health and play an integral role in the health of the aging population. For those already experiencing symptoms of cognitive decline, hope is not lost and physicians can advise ways forward including testing, possible treatment and more.

About Frank Amato, CEO & president, SYNAPS Dx

Frank Amato, CEO and president of SYNAPS Dx an Alzheimer’s Disease diagnostic company. After two plus decades in the pharmaceutical and biotech industry, he became president, CEO and director of electroCore, a NASDAQ-traded bioelectronic medicine company focused on treating neurological conditions. Prior to electroCore, Frank was vice president of the Specialty Commercial Operations at Merck.

Frank was as an infantry field medic in the 82nd Airborne Division, before starting as a sales professional with the Upjohn Company. Throughout his career, Frank has worked on key initiatives in the U.S., Europe, and Japan.