A new drug approved by the FDA is a promising therapy that may profoundly impact the lives of those living with this debilitating disease.

Story by Ann Butenas

Alzheimer’s is a progressive disease that affects roughly 6.2 million Americans. It destroys memory and other mental functions, such as thinking and behavior.  When the symptoms grow severe enough, they can significantly impact daily tasks. Alzheimer’s is the most common form of dementia. Although it is not a normal part of aging, the majority of individuals afflicted with this disease are 65 years of age and older.

The symptoms of Alzheimer’s typically worsen over the years. Memory loss may initially remain mild, but over time it can affect one’s ability to have a normal conversation or to carry on with the tasks of daily living.

While Alzheimer’s has no cure, there is an exciting new treatment available. The U.S. Food and Drug Administration recently approved the drug Aducanumab, marketed as Aduhelm™, for the treatment of Alzheimer’s. This is the first therapy that shows signs of removing amyloid, which is one of the hallmarks of this disease. As a result, cognitive and functional decline is “reasonably likely to be reduced.”

Is Aduhelm™ a cure for Alzheimer’s? 

No, this medication does not cure the disease, but it does address the underlying biology of it by reducing beta-amyloid plaques, which have been suggested to lead to a reduction in cognitive decline. As such, it allows patients to enjoy a more active daily life, retain independence, and have the ability to maintain memories for a longer period of time.

How does it work?

This drug targets certain forms of beta-amyloid. When this accumulates into plaque, it can lead to cell death and loss of tissue in the brain deemed necessary for thinking, memory, behaviors, and learning. The brain will continue to create beta-amyloid, but Aduhelm™ is designed to step in and decrease the amount created. However, no evidence to date suggests prior memories or lost cognitive function can be restored.

Aduhelm™ was recently granted accelerated approval as a treatment for Alzheimer’s by the U.S. Food and Drug Administration. This fast-track process was designed to expedite the review of this drug, with the goal of getting the drug to patients earlier.

A fast-track drug must show advantages over the currently available therapies as follows:

• “Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes” (“Fast Track | FDA – U.S. Food and Drug Administration”)
• Avoiding serious side effects of an available therapy
• Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
• Decreasing a clinically significant toxicity of an available therapy that is common and causes discontinuation of treatment
• Ability to address emerging or anticipated public health needs

How can I receive this treatment option?

Whether for you or a loved one, the Alzheimer’s Association strongly suggests you speak with your healthcare provider for a comprehensive evaluation and diagnosis.

How is Aduhelm™ administered?

This drug is administered intravenously (IV) every four to six weeks through a 45–60-minute infusion. It can be given at hospitals or at infusion therapy centers. It is given via IV to allow the drug to reach the brain most effectively.

A physician should perform diagnostic tests to confirm the presence of beta-amyloid plaques in the brain prior to prescribing this medication.

Are there any known side effects?

The most common side effects include headache, falling, and amyloid-related imaging abnormalities. Further, there is the risk of a serious allergic reaction.

If you are interested to learn more about this treatment option for Alzheimer’s, please consult your healthcare provider.

Sources:  alz.org, fda.gov