Introduction
Dementia is a condition that causes thinking and memory problems and is most common among older adults. Alzheimer’s disease is the most common cause of dementia. People with dementia have symptoms: those can include trouble remembering things, paying attention, making decisions, learning a new task, or doing everyday things like shopping or cooking. Their mood, interactions with others, and ability to communicate can also change.
We don’t know exactly why some people develop Alzheimer’s disease but having a family member with it increases your risk of getting it too. Other factors like education, diet, medical history and where someone lives could also play a role.
There is no cure for Alzheimer’s disease.
What is aducanumab?
In 2022 The Food & Drug Administration (FDA) approved aducanumab (Aduhelm) to treat Alzheimer’s Disease via its "fast track.” The FDA based its decision on studies that showed that aducanumab reduced the amount of an abnormal protein, called A-beta (or just “amyloid”) in the brain. This protein is present in abnormally large amounts in the brains of people who have Alzheimer’s disease and it starts to build up before there are noticeable changes in memory, thinking, or other symptoms. In fact, some people with extra amyloid in their brains do not develop symptoms of dementia. But we do not yet know if reducing amyloid in the brain will provide noticeable benefit to patients day-to-day or reduce the symptoms or effects of Alzheimer’s disease on peoples’ lives.
The FDA is requiring a new clinical trial of aducanumab because the existing data did not show that it slowed the progression of the symptoms of Alzheimer’s Disease – what individuals experience and what families and others might notice. In early 2022, the Centers for Medicare & Medicaid Services issued a Medicare coverage decision that requires people to be participating in a clinical trial for Medicare to pay for this new drug.
Both the FDA ‘fast track’ and the Medicare coverage decisions reflect the uncertainty that still exists about aducanumab’s benefits to people living with Alzheimer’s Disease.
Does aducanumab work?
Right now, there is not enough information to know if aducanumab will help people who receive this treatment.
Until more information is available, aducanumab should be used with caution and only in consultation with your physician and family.
Aducanumab can cause serious side effects. More studies are being done to see if it is safe and effective.
Who can take aducanumab?
Aducanumab was approved only for patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease, as indicated by the presence of cognitive changes AND the presence of extra amyloid found on special brain imaging studies. People with more advanced stages of dementia are not eligible for this treatment.
The American Geriatrics Society has advised that clinicians should do the following before prescribing aducanumab:
- Test the patient to be sure the patient has mild cognitive impairment or mild dementia due to Alzheimer’s disease.
- Measure levels of amyloid proteins in the brain or spinal fluid. This is measured by a positive amyloid Positron Emission Tomography (PET) scan of the brain, or a spinal tap (lumbar puncture).
- Obtain a brain Magnetic Resonance Imaging (MRI). – a study of brain structure – before starting treatment
- Discuss what matters most to the patient and whether aducanumab is the right treatment for them. Patient and caregivers should be informed of all the potential harms and benefits of treatment and actively participate in all decisions about treatment.
How is aducanumab treatment given?
Aducanumab is given through monthly infusions, directly into a vein through a needle or catheter.
The infusions:
- take about one hour
- are given every month for 12-24 months or longer
- are done at hospitals or infusion therapy centers
Clinicians need to make sure that aducanumab is not causing harm and is helping the patients who take it, so they will order the following tests:
- MRI scans before the 7th and the 12th infusions to monitor for a condition called amyloid-related imaging abnormalities (ARIA). These are considered ‘side effects’ of treatment.
- Regular assessments (at least once a year) to see if aducanumab treatment is helping with memory and thinking.
What are the possible side effects?
In studies, some people developed:
- Brain swelling and bleeding
- Headaches
- Changes in mental state
- Confusion
- Vomiting
- Nausea
- Tremors
- Trouble walking
What does aducanumab cost?
Aducanumab will cost at least $28,000 per year for the medication. The infusions and tests will add to the cost of treatment.
There are strict rules about who qualifies for Medicare coverage of aducanumab treatment. Medicare only covers aducanumab for people who are taking part in a clinical trial (a specific research study). Contact your insurance company to determine its coverage policy if you have private insurance.
Last Updated November 2022