Expert Q&A with Sean Rogers, MD, PhD, System Section Chief, Inova Memory Disorders Program. Dr. Rogers directs the Inova Memory Disorders Program and has extensive experience in treating Alzheimer’s disease and overseeing Alzheimer’s disease clinical trials.
Alzheimer’s disease affects 6.2. million Americans. Earlier this week, the first new drug therapy in 20 years for Alzheimer’s disease made headlines. With that new medicine comes a lot of hope, but there are many questions as well.
We asked Alzheimer’s expert Sean Rogers, MD, PhD, for an update on what our patients and their families need to know.
Q: First, Dr. Rogers, what is your reaction to the recent news of a new Alzheimer’s disease treatment?
As a physician specializing in memory disorders, I am very excited about the potential of the newest drug therapy that may be able to slow disease progression for Alzheimer’s patients.
Q: What is the name of the new FDA-approved drug for Alzheimer’s disease?
The new FDA-approved medication for Alzheimer’s is aducanumab, and it is marketed by the trademark name Aduhelm™.
Q: How does this prescription drug work differently from other Alzheimer’s disease treatments?
This medicine is unique in that it is the first disease-modifying therapy for Alzheimer’s disease. It specifically targets the amyloid, or the abnormal protein, that is found in the brains of all Alzheimer’s disease patients. Amyloid is thought to drive the death of nerve cells (neurons) in the brains of people with Alzheimer’s.
Until now, all treatments for Alzheimer’s focused on improving the symptoms, but they had no effect on the cause of the Alzheimer’s itself.
Aducanumab was designed to target the abnormal amyloid protein and potentially slow the disease’s progression by removing this damaging protein from the brain. As the goal is to slow the progression, this medicine is generally given to patients in the early stages of the disease, before they have progressed to more substantial dementia.
This medicine is also unique in that it is the only Alzheimer’s disease medication that is given as an infusion, or directly into the veins.
Q: Will it help me or my loved one in terms of quality of life?
The FDA-approved aducanumab based on two clinical trials of patients with Alzheimer’s disease who were given the new medication. Both of these studies did show that the medication can remove the abnormal protein in the brain of an Alzheimer’s patient. However, only one of these studies actually showed improvement in memory and thinking for the patients taking the medication. Therefore, it is thought that the medicine may provide some benefit for a patient’s day-to-day functioning, but exactly how much it can help is still somewhat unclear.
The hope is that the medicine can reduce the abnormal amyloid protein, which may not help immediately, but that it can slow the damage that is occurring in the brain over time.
Q: Is it safe, and are there side effects?
Aducanumab is generally considered safe. Like most medicines, there is the possibility of side effects and even the risk for some serious side effects. In some cases, after patients have been receiving the intravenous infusion for a month or more, aducanumab has been reported to cause allergic reactions or a specific reaction called ARIA-E, which is a form of fluid accumulation in the brain.
Patients who receive aducanumab will need to be closely monitored and have MRIs of their brain, especially if there is any concern for ARIA-E. Patients who are considering aducanumab will need to have a conversation with their physician to weigh the risks and benefits, and to determine whether or not this new medication is a good option for them.
Q: What kind of person is this possible drug therapy suited for?
As of now, the FDA has not specified which Alzheimer’s patients should be given aducanumab. However, since this medicine is thought to slow the progression of Alzheimer’s, it is likely best suited for patients with milder symptoms or those who are early in the disease process. In fact, in both of the studies for aducanumab, only patients with mild cognitive impairment or mild dementia related to Alzheimer’s were given the medication.
Q: How is an Alzheimer’s patient qualified for this drug therapy?
As this medication is specifically targeted to treat and remove amyloid, some patients may need specific testing to confirm the presence of amyloid in the brain. Amyloid is not found in high levels in the brain of the average person or in persons with other types of memory problems. If there is any question about the cause of the memory loss, it is important to ensure that the patient definitely has Alzheimer’s disease before proceeding with the treatment.
Q: How can underinsured Americans qualify for treatment?
The drug manufacturer, Biogen, has established programs, such as one with CVS Health’s Project Health, to aid uninsured and underinsured Americans with cognitive screenings that could help in diagnosing Alzheimer’s disease. Biogen is also working with the Veterans Health Administration to set up a program supporting access there. In the coming months, more information will become available about how more patients can potentially get this medication or any testing that is needed.
Q: Why is testing, including clinical trials continuing if the prescription drug has FDA approval?
Although the clinical trials were not conclusive as to the therapy’s effect on cognition and function, they clearly showed that aducanumab can reduce levels of beta-amyloid plaques, according to the FDA.
As a stipulation of the FDA approval, the medication’s manufacturer will be required to conduct additional clinical testing to verify the anticipated clinical benefit, known as Phase 4 confirmatory trials. If data from these trials do not verify the anticipated benefit, the FDA could remove aducanumab from the market.
Q: What else is important to know?
For those who face Alzheimer’s disease, early diagnosis has demonstrated better health outcomes. The approval of this new therapy makes early detection and diagnosis even more critical to ensure individuals receive the most benefit at the earliest point possible.