November is Alzheimer’s Awareness Month, a special time dedicated to helping people understand the disease and support individuals and families who are struggling with this diagnosis. It also reminds everyone that physicians and the scientific community are continuously working towards discovering effective treatment options and ways to slow or stop this devastating disease.
Alzheimer’s disease (AD) affects an individual’s memory, thinking and language skills with symptoms ranging from changes in mood and personality to confusion on time and place and asking the same question repeatedly. As AD progresses, individuals can become delusionary, mistake a person for someone else and even struggle with completing basic abilities such as eating and walking.
There are approximately 6.2 million Americans living with AD. This is not to be confused with:
1) Dementia; AD is the most common cause of dementia, a general term for cognitive and memory loss serious enough to interfere with a person’s daily life. AD accounts for 60-80% of dementia cases.
2) Mild Cognitive Impairment (MCI): which might cause memory problems and may progress to dementia or AD over time.
More than half of AD patients also have other pathologies of dementia, further complicating the diagnostic process. Currently there is no known cure, but strides in diagnostics, research and drug commercialization are underway that will hopefully lead to valuable treatments for this fatal condition.
Importance of an Early Diagnosis
An early and accurate diagnosis can have important benefits not only for individuals living with AD, but also their families and their caregivers. By diagnosing AD early in the disease trajectory, everyone who is impacted has more time to make informed decisions about:
- Optimizing time spent with loved ones
- Helping to finalize legal and financial plans
- Introducing lifestyle changes such as addressing high blood pressure, smoking cessation, getting regular physical and mental exercise and changing one’s diet.
An early diagnosis also provides emotional benefits, lessening anxieties and questions about the onset of certain symptoms and easing the minds of both the patient and family.
Once the diagnosis is reached, therapeutic intervention can be provided. It also provides a runway to accessing resources or participating in research studies. Equally important, an early diagnosis may help to reduce medical and long-term care costs.
According to the Alzheimer’s Association, there are factors that play a part in developing AD, including:
- Age– Currently, age is still the top risk factor for developing AD, though it is not a normal part of aging. Individuals with AD are typically 65 years or older. At this age the risk of AD doubles every five years. After age 85, around one third of the older population experiences AD.
- Family History– If a family member has AD, it is more likely a patient will develop it as well.
- Genetics– It is not guaranteed that people develop AD if their family member has it, but there is an increased risk. It was discovered that less than 1% of AD cases were the product of deterministic genes.
- Other factors– Outside of age, family history and genetics, there seem to be other environmental and lifestyle factors that could contribute towards the risk of developing AD.
- Head trauma- People should keep the head as safe as possible no matter what age they are by using seatbelts, helmets and maintaining a “fall proof” home to avoid brain injuries.
- Declining heart health- When damage occurs to the heart through conditions such as high blood pressure, diabetes and high cholesterol, it could increase chances of developing AD or vascular dementia.
- Substance use- Some measures to live a healthy life are to be socially active, eat a healthy diet, exercise regularly and avoid tobacco use and excessive alcohol.
Current Diagnostic Pathways
In the early stages of AD, it is common for the symptoms to be misdiagnosed with a number of other medical issues that can bring on memory loss, such as Lyme disease, vitamin deficiencies, thyroid issues, drug interactions and various forms of dementia. This can cause a delay in detecting the presence of AD.
Clinicians, payers and patients need better tools to accurately identify AD in people recently diagnosed with dementia, even when the dementia is caused by several factors. This is especially important considering most patients with dementia are managed in primary care where due to the lack of availability of diagnostic tools, more than half are misdiagnosed.
Current AD diagnostic approaches may be inaccurate, especially in early stages of the disease and with mixed dementia. By placing focus on surrogate markers that are related to AD but not the disease itself, the distinction of AD can be difficult. An earlier diagnosis, prior to dementia, can be even more challenging because most patients never progress to AD or dementia.
While a blood biomarker (BBM), defined as measurable DNA, RNA or protein component that indicates disease, has the potential to help clinicians screen for the presence of amyloid plaque or tau — a hallmark of AD — it does not diagnose MCI or early AD dementia with high accuracy. In fact, the Alzheimer’s Association states further research is needed before widespread use of BBMs. While BBMs have the potential to help clinicians screen for the presence of amyloid plaque a hallmark of AD, they do not diagnose MCI due to AD or AD dementia.
The most promising breakthrough for identifying AD is an autopsy-confirmed, minimally invasive skin test to support clinicians’ definitive diagnoses of AD vs. other forms of dementia. This test has the potential to help patients and families get the right support or treatment path for improved quality of life.
It is predicted that by 2050, there will be approximately 153 million people globally with an AD diagnosis. This awareness month is dedicated to enhancing widespread understanding of the disease, showing compassion toward those with AD and giving patients and their families hope.
The Alzheimer’s Association enthusiastically welcomes the positive topline data reported by Eisai and Biogen on the CLARITY AD global Phase 3 clinical trial of lecanemab. They assert that these are the most encouraging results in clinical trials treating the underlying causes of AD to date.
For people in the earliest stages of AD, this treatment has the potential to change the course of the disease in a clinically meaningful way. While these are positive signals, there is still a need for accurate diagnosis so that payers can make appropriate prescribing recommendations, set policy for prior authorizations and decide upon patient copays.
Editor’s Note: Frank Amato is CEO and president of SYNAPS Dx. Previously, after two decades in the pharmaceutical and biotech industries, he was president, CEO, and director of electroCore, a NASDAQ-traded bioelectronic medicine company focused on treating neurological conditions. Frank is an accomplished leader with a track record for consistently delivering strong results.
Prior to his tenure at electroCore, Frank was vice president of the Specialty Commercial Operations Group at Merck, which comprised nine specialty therapeutic divisions. After Merck’s acquisition of Schering-Plough, he led the integration of approximately 3,000 employees into the new company. In addition to his day-to-day business responsibilities, Amato was accountable for various aspects of due diligence, negotiation, integration and launching products in neuroscience, virology and ophthalmology.
After serving as an infantry field medic in the 82nd Airborne Division, U.S. Army, Frank began his career as a sales professional in New York City with the Upjohn Company. Throughout his career, Frank has worked on key initiatives in the U.S., Europe, and Japan, managing teams of senior executives in sales, marketing, operations, finance, legal, medical, regulatory and research and development.