Finding an effective treatment of Alzheimer’s, a devastating disease affecting about 6.2 million people in the US, is one of the primary goals of the research world. Scientists are trying to uncover the underlying biological processes of this disease in order to discover ways to slow its progression or alleviate its symptoms. In such an attempt, the US Food and Drug Administration approved a new drug, Aduhelm (aducanumab), via an accelerated approval pathway on June 7, 2021. It is the first new treatment approved since 2003.
How does aducanumab work?
Aduhelm is the first ever disease-modifying drug or therapy to address the fundamental disease process. It is a human antibody (or immunotherapy) that targets and removes the hallmark of Alzheimer’s disease, the beta-amyloid protein. Accumulation of this protein into plaques may result in cell death and tissue loss in parts of the brain responsible for memory, reaoning, learning, and behavior. Therefore, this therapy may effectively reduce cognitive and functional impairment in people with early-stage Alzheimer’s by removing plaques from the brain.
At what stages of the disease is it prescribed?
In the clinical studies, the researchers studied the effectiveness of this new drug only in people with early-stage Alzheimer’s or mild cognitive impairment (MCI). Therefore, doctors will only prescribe it in these stages of the disease. No data is available to demonstrate its effectiveness or safety in earlier or later stages. Research is still underway to determine if this drug affects a person’s rate of cognitive decline over time.
How is aducanumab administered?
Aducanumab is an intravenous drug delivered via a 45-to-60-minute infusion every four weeks. Intravenous (IV) administration helps the drug reach the brain most effectively.
Is any diagnostic test required before its prescription?
According to the FDA, no diagnostic test is necessary before prescribing aducanumab. However, due to the fact that it targets the beta-amyloid protein in the brain, doctors may require a PET scan or a CSF (cerebrospinal fluid) analysis in order to determine the presence of plaques in the brain. These diagnostic tests assist them in making a precise diagnosis before prescribing the drug. While the patient is on aducanumab, doctors may routinely recommend MRI to oversee the possible side effects, including bleeding or swelling in the brain.
What are the side effects?
During the aducanumab treatment, there is a possibility of developing amyloid-related imaging abnormalities (ARIA) in the brain, particularly as temporary swelling in parts of the brain portions. However, the issue usually resolves itself over time, and most people do not exhibit symptoms. Some people may also experience bleeding in the brain with swelling. Other common side effects include headache, dizziness, falls, confusion, nausea, diarrhea, disorientation, and vision changes. Furthermore, there is also a potential risk of hypersensitivity reactions such as urticaria and angioedema.
Can it be taken with other medication or supplements?
It is essential to have a conversation about one’s health condition, medications, and supplements with a doctor whenever one considers any treatment, including aducanumab, in order to confirm eligibility for that treatment.