• Brittany Evans

Advances in Alzheimer's Treatments

The brain is commonly thought to be the most complex organ in the body and as with any other organ, the brain can develop serious diseases. Alzheimer’s disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and, eventually, the ability to carry out the simplest tasks. Because the brain is so complex, there have not been many advancements in treatment for Alzheimer's disease. No treatment can stop Alzheimer's disease completely, but current approaches focus on helping people maintain mental function, manage behavioral symptoms, and slow down the symptoms of the disease.

Caring for individuals with Alzheimer's disease is a financial burden for families and healthcare companies. An estimated 5.8 million adults over 65 years are living with AD, with the number expected to more than double by the year 2050 to approximately 14 million individuals. The total cost of care for the treatment of Alzheimer's disease in 2020 was estimated to be $305 billion. Medicare and Medicaid cover the largest proportion of these costs, estimated to be around $206 billion, while patient out-of-pocket costs are estimated to be around $66 billion. These estimates do not cover the indirect cost of Alzheimer's disease. An example of indirect cost is unpaid care provided by family or friends at the patient's home. In 2019, 16.3 million informal caregivers provided an estimated 18.6 billion hours of unpaid care. When evaluating the cost using replacement costs of care valued at $13.11 per hour, the estimated value of informal care provided in 2019 was $244 billion.

The FDA has approved several medications over the years to manage symptoms of Alzheimer's disease. Most of the drugs work by regulating the chemicals that transmit messages between neurons. They may help reduce symptoms and help with certain behavioral problems. However, these drugs don’t change the underlying disease process. And although the FDA is working on new treatments for Alzheimer's disease, there was a 99.6% failure rate for clinical trials between 2002-2012. The clinical trial environment has proven to be difficult to manage. There is limited understanding of the development of Alzheimer's disease, partly because the disease progresses so slowly, and partly because of the death rate associated with Alzheimer's disease. Additionally, the cause of Alzheimer's disease is not known creating multiple grey areas for researchers. As we move to treat earlier in the disease continuum, there is more sensitivity around risk associated with drug use; drug failures may be the result of studying too low a dose to decrease the occurrence of side effects, including amyloid-related imaging abnormalities (ARIA), which are still poorly understood.

The FDA recently approved the drug Aduhelm (aducanumab) to treat patients with Alzheimer's disease. This was the first drug approved for the treatment of Alzheimer's disease since 2003. The approval of Aduhelm was controversial. The Peripheral and Central Nervous System Drugs Advisory (PCNS) Committee met in November 2020 to discuss the trial results of Aduhelm and determined the drug had not undergone enough testing. The PCNS based their denial of the drug on three controversial trials study 103, 301, and 302. Analyzing the three studies proved difficult for PCNS, study 301 and 302 were ended prematurely, and study 103 had a smaller group of participants. The PCNS also noted that Aduhelm increased the presence of ARIA in varying degrees depending on the dosage during the trials. While ARIA resulted in serious symptoms in only .3% of patients in the trial, the PCNS feels that ARIA is the most important safety concern of the drug. Despite the concerns of the PCNS, the FDA felt that the drug was safe for use and granted accelerated approval to the drug.

In*(paywall-accessed through my university) the United States in late 2010/early 2011, the National Alzheimer’s Project Act (NAPA) was passed and signed into law. It required the creation of a national strategic plan to address the rapidly escalating AD crisis and the coordination of AD efforts across the federal government. The overarching research goal of the project is to prevent or effectively treat Alzheimer’s disease by 2025. While this plan was created a decade ago Aduhelm is the only drug that has been approved. Some of the biggest challenges to reaching this goal are clinical trial operation and design, detection of the disease, and patient recruitment. Completing all three phases of a clinical trial can take nine years or more. Reducing the study time or the number of participants could affect the integrity of the trial, voiding the results. Currently, patient recruitment is very slow because there are not many registries of people battling Alzheimer's disease. Most patients aren't diagnosed with Alzheimer's until they are in the late stages of the disease, which decreases the amount of time they can participate in trials.

Implementing changes that promote detection of the disease is vital to understanding early signs and symptoms of Alzheimer's disease. Understanding the early stages of Alzheimer's disease will provide researchers with valuable data for the prevention and elimination of the disease. Preventing Alzheimer's disease could reduce financial burdens for both the healthcare industry and loved ones of Alzheimer's patients.

Speaking Plainly:

  • Alzheimer's disease is a progressive and irreversible disease that decays a persons memory and thinking skills.

  • Medications for Alzheimer's disease only treat the symptoms, they don't cure the disease.

  • The FDA recently approved a new medication for Alzheimer's disease called Aduhelm.

  • Many clinical trials for Alzheimer's disease experience a lack of participants.

  • Researchers are trying to find ways to detect Alzheimer's disease in earlier stages of advancement to further their understanding of the disease.