Alzheimer’s Disease is an irreversible, progressive brain disorder that affects memory, comprehension, and motor skills. Currently, Alzheimer’s affects an estimated 6.2 million Americans. This devastating illness can have a profound impact on the lives of those who are diagnosed with the disease, as well as their loved ones.
Previously, the only available treatment for symptoms of the disease included therapies targeted at helping victims of Alzheimer’s (and their loved ones) maintain their mental faculties for as long as possible. Now however, there appears to be a potential new answer on the horizon.
Earlier this month, the U.S. Food and Drug Administration approved an all-new drug designed to treat Alzheimer’s Disease during its early stages. This drug, known as “Aduhelm” (aducanumab) was approved using an accelerated approval pathway, which is typically used for drugs that are used in the treatment of serious or life-threatening illness and provide a meaningful advantage over other existing treatments.
Aduhelm is a first-of-its kind treatment and the first new treatment approved for Alzheimer’s since 2003. In addition, it is the first treatment to target the fundamental pathophysiology of the condition.
Researchers evaluated Aduhelm’s efficacy in three separate studies representing a total of 3,482 patients. The studies consisted of double-blind, randomized, placebo-controlled dose-ranging studies in patients with Alzheimer’s disease.
In the studies, patients receiving the treatment had significant dose-and-time-dependent reduction of amyloid beta plaque, which is the hard, insoluble accumulations of beta amyloid proteins that clump together between the nerve cells and cause the symptoms of Alzheimer’s disease. During the studies, patients in the control arm had no reduction of amyloid beta plaque.
These results are strong enough to support the FDA’s accelerated approval of Aduhelm, though as a condition of this designation, the drug will need to go through a new randomized, controlled clinical trial to verify its clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.
The prescribing information for Aduhelm includes a warning for amyloid-related imaging abnormalities (ARIA), which most commonly presents as temporary swelling in areas of the brain that usually resolves over time and does not cause symptoms.
Other potential side effects include headache, confusion, dizziness, vision changes, nausea, and hypersensitivity reactions, including angioedema and urticaria. The most common side effects of Aduhelm were ARIA, headache, fall, diarrhea, and confusion/delirium/altered mental status/disorientation.
Clinical trials are incredibly important in the development of new treatments for conditions and diseases like Alzheimer’s. Successful treatments depend on knowledge that comes from research. Clinical trials are integral to the development of safe, successful medications used to treat mental illness.
Clinical trials allow trial medications to be tested out on volunteer participants to determine their effectiveness, safety and side effects. These trials also determine what dosage amounts should be used to treat varying levels of illness, giving medical professionals an understanding of how best to prescribe medication.
Right now, the Lehigh Center for Clinical Research is offering free memory screenings as well as an all-new trial on Alzheimer’s Disease and is actively seeking participants. Those who qualify for the study may have access to possible new treatment options, may be eligible to consult board-certified physicians at no cost, and may receive compensation for time and travel.
At LCCR, our team sets a higher standard in delivering both quality and care to our participants and reliable, clean data to our pharmaceutical partners. Our study experience is diverse and effective, and we’d love for you to come and see that for yourself.
If you’re interested in being a part of our journey to create better lives for those suffering from mental health disorders, click here to check out how you can get involved in one of our many ongoing studies or clinical trials. We look forward to seeing you!