Aducanumab is a newly approved drug for the treatment of mild Alzheimer’s disease. However, there are many risks associated with its use, such as swelling or bleeding.

Alzheimer’s disease is a form of dementia. Dementia is an umbrella term to describe a decline in a person’s cognitive abilities. People with dementia may experience a loss in memory, language, problem-solving, and many other thinking abilities. It can affect their ability to perform daily activities.

The drug aducanumab received approval from the Food and Drug Administration (FDA) in June 2021 for the treatment of Alzheimer’s disease.

However, there has been some controversy over the use of aducanumab for treating Alzheimer’s disease. Many experts have voiced concerns about the drug’s approval — the main concern seems to be that there is not yet enough evidence to support its efficacy in treating the condition.

The brand name for aducanumab is Aduhelm.

Read on to learn more about aducanumab, including how it works, who is a candidate for treatment, safety considerations, and more.

illustration of human brainShare on Pinterest
mikroman6/Getty Images

Aducanumab is an FDA-approved monoclonal antibody. Scientists create monoclonal antibodies in a lab. It is a protein that can attach to certain targets in the body. These targets include antigens on the surface of body cells.

The FDA approved its use for treating Alzheimer’s disease in June 2021 through its accelerated approval program. This means that aducanumab was approved based on the tests that predict the benefit of the drug. The drug should still undergo further confirmatory trials to ensure it works as intended.

The drug does not cure or reverse the progression of dementia in people.

Aducanumab works by reducing the number of amyloid plaques in the brains of people with Alzheimer’s disease.

Amyloid plaques are proteins that the body naturally produces. In people with Alzheimer’s, there are more amyloid plaques than usual in the brain. They then clump together and collect between neurons — or nerve cells — disrupting cell communication.

Learn more about Alzheimer’s disease here.

Aducanumab is for people with mild cognitive impairment and early or mild Alzheimer’s disease.

Experts also recommend prescribing the drug to people with confirmed amyloid deposits and a score of more than 21 in the mini-mental state examination (MMSE) or similar cognitive test.

It is not a drug for people with advanced Alzheimer’s disease.

Learn more about cognitive tests for diagnosing dementia here.

While there is a link between amyloid plaques and cognitive decline, there is not enough evidence to confirm that reducing them can protect against dementia.

Additionally, data from Biogen’s clinical trials before approval have not been published in peer-reviewed journals. Biogen is the company that makes the aducanumab drug.

Trials involving other drugs with the same mechanism showed no significant improvement in symptoms. That said, there is promising evidence that aducanumab reduces amyloid plaque deposits. However, there is not enough data to show that this can prevent or treat Alzheimer’s disease.

Ultimately, more research would be beneficial. Despite getting accelerated approval from the FDA, Biogen must do a clinical trial to confirm whether the drug is effective. The clinical trial will likely end in 2026.

Some experts have concerns regarding the accelerated approval and note that pushing through drugs such as aducanumab may give false hope to those with Alzheimer’s and their loved ones.

It is also notable that medical approval bodies such as those in Japan and Europe have not approved the drug.

Another concern regarding aducanumab is its high risk for serious side effects. These can include swelling or bleeding in the brain.

Approximately 41% of people in clinical trials for the drug experienced swelling or bleeding.

As the drug can cause these serious effects, a doctor will order imaging tests before administering the drug to compare against future imaging. Doctors will order additional imaging 6 and 12 months after starting treatment.

Other possible side effects may include:

It is important to note that some of the above symptoms may be signs of more serious side effects.

Access to aducanumab is still limited.

People or loved ones of those with mild Alzheimer’s can ask a doctor whether they are a candidate for aducanumab.

Doctors need to confirm the presence of amyloid plaques in the brain before prescribing aducanumab. People may require PET imaging or cerebrospinal fluid analysis to check for these plaques.

Doctors administer aducanumab through a monthly intravenous (IV) infusion.

Each infusion lasts about 45–60 minutes every 4 weeks. Treatment can be at the hospital or an infusion therapy center.

Aducanumab was initially set at $56,000 USD per year. In 2022, Biogen reduced the price by half.

The high cost of the drug is another factor that makes some experts wary of its accelerated approval. If the clinical trial meant to confirm the drug’s efficacy shows it is ineffective, people will have been paying a considerable amount for treatment that does not work.

There is no cure for Alzheimer’s disease.

However, some drugs may help with mild to moderate symptoms.

There are only four other FDA-approved drugs for treating Alzheimer’s disease. These include:

Aducanumab is an FDA-approved drug for the treatment of mild or early onset Alzheimer’s disease. There is much controversy around the accelerated approval of the drug. Experts have flagged concerns over the drug’s high cost and limited evidence regarding its effectiveness.

While the drug shows a promising ability to reduce amyloid plaques in the brain, there is not enough evidence to show that this can improve symptoms or prevent disease.

More research on the effects of aducanumab and the ability to treat Alzheimer’s disease would be beneficial.