Imaging innovations help spur earlier Alzheimer’s intervention

Understanding Alzheimer's disease

Alzheimer's disease (AD) is an irreversible, progressive neurodegenerative disease that has a profound impact on the lives of those it affects. It's the leading cause of dementia among the aging population, accounting for 60–80% of dementia cases and is the sixth leading cause of death in the United States.¹ AD is characterized by a decline in cognitive function, including memory loss, impaired judgment and changes in personality and behavior. As the disease progresses, individuals may experience difficulties with language, problem-solving and spatial orientation, ultimately leading to a complete loss of independence.²

Around 6.5 million individuals in the United States and 30–35 million worldwide, are affected by Alzheimer’s disease. The number of cases is expected to increase, with projections suggesting it could reach 13.8 million in the U.S. and 150 million globally by 2060. Age is the most significant risk factor for developing AD, with the likelihood of developing the disease increasing with advancing years. Individuals over 65 years of age have an 11% chance of developing AD, while those over 85 years have a 33% risk.¹

Women are slightly more likely to be diagnosed with AD than men, with a 1.17 times higher prevalence among women compared to men. Moreover, certain ethnicities are disproportionately affected by AD. Hispanic and African American individuals are 1.5 to 2 times more likely to develop AD compared to their White counterparts.

Additionally, lifestyle factors such as smoking, poor diet, lack of exercise and excessive alcohol consumption can contribute to an increased risk of AD. Certain co-occurring medical conditions, including sleep disorders, diabetes, cardiovascular disease and obesity, have also been linked to a higher likelihood of developing AD.

Advancements in therapeutics expand diagnostic reimbursement

The medical landscape is experiencing a surge in therapeutic advancements, particularly in the realm of dementia care. While numerous therapeutic interventions have been explored, the recent approval of lecanemab (Leqembi) by the U.S. Food and Drug Administration (FDA) has sparked renewed hope in the fight against this debilitating condition. Leqembi, a breakthrough antibody intravenous (IV) infusion therapy, holds immense promise in effectively targeting and removing beta-amyloid from the brain, a key pathological hallmark of Alzheimer's disease.³ In addition to Leqembi, the FDA is expected to grant full approval to Donanemab in 2024.⁴ While these therapeutics represent a significant advancement in Alzheimer's treatment, it's important to note they aren't a cure for the disease.

This wave of innovation has fueled a corresponding expansion in diagnostic reimbursement, paving the way for more comprehensive evaluations of progressive neurological disorders. In 2022, the Centers for Medicare & Medicaid Services (CMS) made significant adjustments to its national coverage determination (NCD) for positron emission tomography (PET) scans in dementia and neurodegenerative diseases.⁵ This notable change enabled one scan per beneficiary during their lifetime.

In October 2023, the NCD was completely removed, eliminating the one-scan limitation and relinquishing coverage determination decisions to local Medicare administrative contractors. This represents a significant shift in the reimbursement landscape and offers several potential advantages. Firstly, it allows broader access to beta-amyloid PET scans for individuals with suspected dementia or neurodegenerative disease. By removing the one-scan limit, patients can obtain multiple scans during their lifetime, allowing for more comprehensive and accurate diagnosis and monitoring of disease progression. Secondly, it increases the likelihood of early detection of Alzheimer's disease, enabling timely intervention and management strategies. Early diagnosis can help optimize patient care, improve outcomes and potentially slow disease progression.

Thirdly, the elimination of the NCD aligns coverage policies for beta-amyloid PET scans with other diagnostic imaging techniques routinely used in clinical practice. By treating beta-amyloid PET scans similarly to other diagnostic tools, Medicare recognizes the clinical value and necessity in diagnosing Alzheimer's disease. The expanded coverage for beta-amyloid PET scans signifies a positive step forward for patients.

Amyloid imaging: visualizing the hallmarks of Alzheimer's disease

Neuroimaging is a powerful tool that doctors use to look inside the human brain to understand how it works. Among the various neuroimaging techniques, PET scans and amyloid imaging stand out as powerful modalities for visualizing brain activity and detecting the hallmarks of neurological diseases.

Amyloid imaging holds immense significance in the study and diagnosis of AD. This specialized neuroimaging technique uses radioactive tracers to specifically target and visualize the accumulation of amyloid-beta plaques in the brain. These plaques are considered a defining characteristic of AD and are intricately linked to its progression.

The ability to visualize amyloid-beta plaques in the brain has given doctors a unique window into the pathological processes underlying AD. This enables a more accurate diagnosis, empowering healthcare professionals to intervene promptly and potentially slow the progression of the disease. Furthermore, amyloid imaging serves as a valuable tool in monitoring the effectiveness of treatments, providing crucial insights into the response of the brain to various therapeutic interventions.

The capability of seeing amyloid beta plaques in the brain has revolutionized the field of AD research. It’s facilitated a deeper understanding of the disease's progression, enabling researchers to pinpoint the earliest stages of plaque accumulation and track their spread over time. This knowledge has paved the way for the development of targeted therapies aimed at combating the disease at its root cause, offering hope to millions of patients and their families.

This advanced technology is changing how doctors diagnose and treat AD. It helps them do a better job of managing the condition, leading to more accurate and effective treatments. Ultimately, it improves the lives of people affected by this terrible disease.