Leqembi and Beyond: Racial Disparities That Affect Anti-Amyloid Medications in Alzheimer’s Disease
Key takeaways:
Anti-amyloid medications, such as Leqembi (lecanemab), target protein clusters called beta-amyloid plaques. These are a potential underlying cause of Alzheimer’s disease. But Black adults may not have enough of these plaques for these treatments to work. More studies are needed to confirm if these medications are beneficial for several racial and ethnic groups.
In general, Alzheimer's disease clinical trials lack diverse representation. Mistrust in the healthcare system and limited access to healthcare services may be two reasons why.
Diversity in clinical trials has room for improvement. For example, researchers could pick more strategic locations for their clinical trial sites. They can also recruit more diverse clinical trial teams to connect with participants in local communities.
Table of contents
Navigating Alzheimer’s disease can be challenging. There is currently no cure for the condition. But some recent FDA approvals — alongside ongoing efforts in over 100 new Alzheimer’s clinical trials — give us some hope.
These new treatments show promise. However, it's important to recognize that not everyone may benefit equally. Clinical trials often don’t have enough diversity in their population samples. In fact, only about 3% of participants in global clinical trials for the newest Alzheimer’s medication, Leqembi (lecanemab), were Black. It’s a glaring statistic, especially since Black adults are up to twice as likely as white adults to develop Alzheimer’s disease.
Here, we’ll explore how certain racial and ethnic groups with Alzheimer’s disease face additional challenges. We’ll also look at strategies for promoting racial equality in Alzheimer's disease clinical trials.
How do anti-amyloid medications treat Alzheimer’s disease?
Anti-amyloid medications are monoclonal antibodies that target a buildup of proteins in the brain. These proteins are called beta-amyloid plaques.
Beta-amyloid plaques block your brain cells from communicating with each other. They can also trigger your immune system to mistakenly destroy your brain cells. This process may lead to dementia symptoms such as memory loss, speech issues, and mood changes.
Anti-amyloid medications attach to these beta-amyloid plaques. This alerts your immune system to remove these harmful protein clusters. They can help in early-stage Alzheimer’s disease, but studies are ongoing to confirm their long-term effectiveness and use in more severe stages of Alzheimer’s disease.
Important: Leqembi is the only anti-amyloid medication currently available in the U.S. Aduhelm (aducanumab), which is made by the same company as Leqembi, will be voluntarily removed from the market. The company will focus their efforts on the development and marketing of Leqembi.
Do newer Alzheimer’s treatments benefit all people equally?
No. Anti-amyloid medications may not benefit everyone equally. Some data suggests that Black and Hispanic adults with Alzheimer’s disease generally don’t have as many beta-amyloid plaques in their brain. So anti-amyloid treatments may not work as well compared to white adults. This suggests that Alzheimer’s disease may begin and progress differently among racial and ethnic groups.
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Are anti-amyloid medications safe and effective for Black adults?
We don’t know for sure. More research is needed to fully understand if anti-amyloid medications are safe and effective for Black adults.
It’s also important to consider the potential side effects of anti-amyloid medications. Especially when they may not be effective for Black adults.
Anti-amyloid medications carry a boxed warning — the FDA’s most serious type of medication warning — about a side effect called amyloid-related imaging abnormalities (ARIA). This side effect can cause fluid buildup and/or small bleeds in the brain.
ARIA typically happens early on in treatment and resolves within 4 months. There often isn’t long-term damage, but your healthcare professional (HCP) will schedule routine MRIs to proactively monitor for this risk. They will also check for symptoms of ARIA. If your MRI shows signs of ARIA, your HCP may postpone or stop your infusions.
Other possible side effects of anti-amyloid medications include:
Confusion
Headache
Infusion-related reactions, such as flu-like symptoms, trouble breathing, and dizziness
Increased risk of falls
Nausea
How are new Alzheimer’s medications affected by racial disparities?
To date, Alzheimer’s medication clinical trials haven’t sufficiently studied the safety and efficacy differences between diverse racial and ethnic groups. They haven’t been set up in a way that would make this comparison possible.
What’s more, the FDA approved anti-amyloid medications to treat adults with early-stage Alzheimer's disease specifically. In many cases, HCPs diagnose Black adults with Alzheimer's at later stages compared to white adults. This means Black adults may miss the window for qualifying for these treatments. This is due to many potential factors, including:
Limited access to healthcare or insurance
Discrimination when seeking care
Social belief that memory loss is a normal part of aging
New Alzheimer's medications are expensive, too. Leqembi’s list price may be as high as $26,500 per year. So even if you or a loved one qualify for these new treatments, the medication’s affordability may be a deal breaker.
Why is there a lack of diversity in Alzheimer’s clinical trials?
Historically, clinical trials haven’t been diverse. They don’t reflect the demographics of the real world. And this problem certainly isn’t unique to Alzheimer’s clinical trials.
The National Institutes of Health Revitalization Act of 1993 requires women and people of color to be included in clinical trials. But according to a 2022 report from the FDA, enrollment for people of color is still low.
Here are some potential reasons why there’s a lack of diversity in Alzheimer clinical trials:
Lack of education about Alzheimer’s disease
Mistrust of healthcare and clinical trial systems
Limited access to physical clinical trial sites
Less spare time due to work or family commitments
Stigmas around being the first one to try a new experimental treatment
How can diversity in clinical trials be improved?
Diversity in clinical trials is important. This helps ensure treatments are safe and effective for the general population — not just a few select groups.
Government organizations and primary medical organizations are beginning to recognize this priority, too. In 2022, the FDA gave advice to researchers on how to make clinical trials more inclusive. Some potential solutions include:
Picking strategic locations: Selecting trial locations with diverse populations gives them an opportunity to take part. Volunteers are more likely to go to a clinical trial site that is nearby.
Recruiting diverse clinical research staff: A diverse research team naturally makes it easier to connect with and recruit participants. It also builds trust in the clinical trial if the staff speaks the same language, or understands their cultural background.
Exploring financial support: Financial help, such as compensation for time and travel, can encourage volunteers to participate in clinical research.
Planning for ongoing community engagement: Involving local communities and leaders into clinical trial opportunities can build awareness. Researchers can reach out to health workers or patient advocacy groups in the area.
Setting specific goals for enrollment: A clear set of objectives can help researchers achieve their participation criteria.
Good to know: The New IDEAS study aims to improve diversity in Alzheimer’s clinical trials. Over half the participants in this study will be Black or African American and Hispanic or Latino. This study will use PET scans (brain imaging) to examine beta-amyloid plaques. The results of these scans will be shared with other researchers and clinicians in order to bridge the gap of demographic underrepresentation.
The bottom line
Anti-amyloid medications, such as Leqembi (lecanemab), aim to slow down Alzheimer’s disease progression by targeting an underlying cause of the condition. But they may not benefit everyone equally. The majority of past clinical trial participants for Leqembi and other related medications were white adults. The good news is there are more diverse Alzheimer’s clinical trials currently in progress.
If you’re interested in learning more about Alzheimer’s clinical trials, check for clinical trial sites near you. You can also reach out to your healthcare professional — they can potentially connect you to a study.
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References
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