Aducanumab Patient Information Guide

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With the FDA’s accelerated approval of aducanumab (Aduhelm™) — the first treatment to address the underlying biology of Alzheimer’s disease, rather than only addressing symptoms — early detection and diagnosis are more critical than ever.

As a clinician, you play a key role in ensuring early and accurate diagnosis, access to treatment and quality care so that individuals who may benefit from all available treatments can do so at the earliest point possible. Learn more about aducanumab and what it means for health systems.

The Alzheimer’s Association offers information, tools and resources to help you understand this new treatment.

Download our Aducanumab Summary Guide for Primary Care Physicians for detailed information to keep on hand, or Understanding Aducanumab: An Information Guide for Patients to share with your patients.

 


Therapeutic usage

Based on their review, the FDA determined that there is substantial evidence that aducanumab reduces amyloid plaques, one of the hallmarks of Alzheimer’s, and that the reduction in these plaques is reasonably likely to reduce cognitive and functional decline in people living with early Alzheimer’s.

We recognize that as with all drug therapies, this drug may work differently for everyone who takes it, and may not work for some individuals.

Who is eligible to receive the treatment?

Appropriate Use Recommendations for Aducanumab

These four key recommendations cover the appropriate population and dose for the drug, monitoring for side effects, and clinician communication.

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The FDA specified that aducanumab should be initiated in patients in the Alzheimer’s disease stage studied in clinical trials — people with mild cognitive impairment (MCI) or mild dementia stage of disease.

Aducanumab was studied in people living with early Alzheimer’s dementia and MCI due to Alzheimer’s who showed evidence of a buildup of amyloid plaques in the brain. The therapy has not yet been tested on people with more advanced cases of dementia due to Alzheimer's disease or those without clinical symptoms.

A physician should confirm the presence of amyloid plaques in the brain before prescribing this anti-amyloid plaque treatment. Confirmatory tests like cerebrospinal fluid analysis or amyloid PET imaging should be a part of the diagnostic process to determine eligibility for the treatment.

Are there any contraindications?

There are no contraindications listed on the FDA label.

Though not listed as a contraindication, some vascular comorbidities and some antithrombotic medications were exclusion criteria for clinical trials and may prohibit prescription due to risk of amyloid-related imaging abnormalities (ARIA). A thorough evaluation by a qualified physician will be needed to determine benefit versus risk for side effects.

Are PET/MRI scans required?

A physician should confirm the presence of amyloid plaques in the brain via PET imaging or CSF analysis before prescribing this anti-amyloid plaque treatment.

In addition, as part of the treatment and monitoring for ARIA in patients receiving this therapy, MRI scans are required by the FDA. The drug’s label tells doctors that patients will need to obtain a recent (within one year) brain MRI prior to initiating treatment. Additional MRI scans will be needed prior to the seventh and 12th treatment infusions.

What are the warnings and precautions?

CME Course: Learn How to Identify and Manage ARIA

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In the FDA label, the most common side effects include ARIA, headache and fall. Another potentially serious side effect is allergic reaction.

ARIA is a common side effect that does not usually cause any symptoms but can be serious. It is typically a temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain with the swelling, although most people with swelling in areas of the brain do not have symptoms. Some may have symptoms of ARIA such as headache, dizziness, nausea, confusion and vision changes.

As part of the treatment and monitoring for ARIA in patients receiving this therapy, MRI scans are required by the FDA prior to beginning treatment and before the seventh and 12th infusion. Enhanced clinical vigilance for ARIA is also recommended during the first eight doses of treatment with aducanumab, particularly during titration. If a patient experiences symptoms which could be suggestive of ARIA, clinical evaluation should be performed, including MRI testing if indicated.

Evidence from clinical trials

In the Phase III clinical trials, EMERGE and ENGAGE, aducanumab was administered intravenously once every four weeks over a period of 78 weeks using titration protocols.

The clinical trials for aducanumab exclusively enrolled participants with MCI due to Alzheimer's disease and early Alzheimer's dementia, and abnormal amyloid buildup confirmed through PET imaging. This allowed researchers to monitor participants’ amyloid levels and measure changes over the course of the trial to determine whether the treatment reduced amyloid.

Just as critical, researchers used a variety of cognitive assessments, participant reports and caregiver reports, as well as medical examinations, to learn whether aducanumab would provide a clinical benefit.

Data collected during the EMERGE trial suggest that exposure to the highest dose of aducanumab over 18 months led to reduced levels of amyloid in the brain. Researchers also saw reduced symptoms of cognitive and functional decline, along with reduced decline associated with activities of daily living.

Treatment process

The role of primary care clinicians

Primary care clinicians may not be able to prescribe the treatment, but play an important role in early detection and diagnosis. Regardless of whether a patient may be a candidate for aducanumab, early and accurate diagnosis have long demonstrated better health outcomes for individuals living with Alzheimer’s and their caregivers.

Detecting possible cognitive impairment is the first step in determining whether or not a patient needs further evaluation. The Alzheimer’s Association offers a number of tools to help, including a Cognitive Assessment Toolkit. For a definitive diagnosis, individuals whose cognitive assessments indicate that their memory or cognition is consistent with MCI or early Alzheimer's dementia should be evaluated further or referred to a specialist.

The role of specialists

Specialists will need to conduct a thorough cognitive assessment and confirm the presence of amyloid in order to consider treatment with aducanumab. This process may include amyloid PET or CSF testing.

When considering any treatment, it is important for patients and clinicians to have a conversation to determine if the patient is a candidate, and make an informed decision to determine if the treatment is an option. Not all patients with amyloid will be good candidates for the treatment, depending on the stage of the disease and other risk factors.

Once aducanumab has been prescribed, it is administered intravenously via a 45- to 60-minute infusion every four weeks. While we do not yet have information on specific locations, in general, infusions can be done at hospitals and infusion therapy centers.

It is unclear how many doses any individual will need to take over the course of their treatment. The clinical trial tested this drug over the course of 18-months and many trial participants have been treated for years, however the therapy has not been tested on people with more advanced Alzheimer’s dementia.

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