Skip to main content.

Minority Report

University of Kansas Alzheimer’s researchers are recruiting more Hispanics and African Americans for clinical trials

Minority Report banner image of lightbulb

Aduhelm (aducanumab), a new drug for the treatment of Alzheimer's disease, has been embroiled in controversy from the moment it was approved by the Food and Drug Administration (FDA) in June 2021. Although clinical trials of Aduhelm did not meet statistical standards for efficacy, the FDA approved the drug over the objections of its advisory panel. But the approval of Aduhelm has given a glimmer of hope to some of the more than 5 million Americans diagnosed with Alzheimer's disease. 

A much less-publicized controversy around Aduhelm was the lack of participants from underrepresented minority populations in its clinical trials. Increasing the number of minority participants in clinical trials is a matter of great urgency to members of those communities, because they are also more vulnerable to Alzheimer's.  

The Centers for Disease Control and Prevention (CDC) reported in 2018 that among people aged 65 and older, African Americans have the highest prevalence of Alzheimer's disease and related dementias (13.8 percent), followed by Hispanics (12.2 percent). The corresponding percentage for non-Hispanic whites was 10.3 percent. 

By 2060, researchers estimate there will be 3.2 million Hispanics and 2.2 million African Americans with Alzheimer's disease and related dementias, the CDC said. Yet researchers and community members report that Hispanics and African Americans are less likely than whites to enroll in Alzheimer's clinical drug trials, or to engage with programs that disseminate information about Alzheimer's and related dementias.  

The reasons for this include lack of trust, lack of adequate health coverage, language barriers and acceptance of cognitive barriers as a normal part of aging to be managed within the family. 

"There is urgency to this," said Jeffrey Burns, M.D., a professor of neurology and co-director of the University of Kansas Alzheimer's Disease Research Center.  

"We have a new drug hitting the market, but very few African Americans and Latinos were in the studies that led to its approval. We have to ensure that drugs and the knowledge we're gaining don't exacerbate these health disparities, but instead close the gap. The last thing we want is a drug that works for white folks and doesn't work for everyone else." 

The disparities also include lower access to dementia care and dementia detection services. 

"Together with being under-represented in research, that makes the situation so much worse," said Jaime Perales-Puchalt, Ph.D., an assistant professor with the KU Alzheimer's Disease Research Center. 

These alarming disparities have spurred the KU Alzheimer's Disease Research Center to reach out to Hispanics and African Americans in an effort to close the gaps that have plagued their communities. 

James Perales-Puchalt talking to person
James Perales-Puchalt, Ph.D., Assistant Professor
University of Kansas Alzheimer's Disease Research Center

HOW TO EFFECTIVELY REACH OUT

Eric Vidoni, Ph.D., an associate professor of neurology and director of the Outreach, Recruitment and Education Core for the KU Alzheimer's Disease Research Center, said minority community members are too often blamed for their lack of participation. 

"Many medical researchers often don't consider what it takes for someone to participate in a clinical trial," Vidoni said. "They haven't listened to the two communities (Hispanic and African American) about addressing some of the barriers preventing them from participating." 

One major barrier is the well-documented history of the unethical treatment of African Americans in clinical research. Many in the community recall with horror the Tuskegee Study of Untreated Syphilis in the Negro Male. This abusive study was conducted in Alabama between 1932 and 1972 by the U.S. Public Health Service and the Centers for Disease Control and Prevention on a group of nearly 400 African Americans with syphilis. The participants were not told about the nature of the experiment, which resulted in more than 100 deaths. 

Vidoni said the mistrust in minority communities about scientific research is justified. 

"So many things have been done to people of color without them being told what was going on. I think nearly everybody is open to participating and advancing our medical knowledge when they're fully informed," Vidoni said. "You look someone in the eye and tell them what the research is and why you're asking them to do it." 

Ashley Shaw, Ph.D., a research assistant professor at the KU Alzheimer's Disease Research Center, said entities such as Institutional Review Boards have enacted regulations to prevent abusive studies and to protect participants from being taken advantage of in medical research. 

"But it's still necessary to build trust," Shaw said. "Everyone is entitled to know what the risks are before they agree to participate in a clinical trial." 

Perales-Puchalt said for studies to be appealing to minority communities, researchers need to demonstrate the study's value to the community, show more flexibility when it comes eligibility criteria and ensure the study is accessible. Studies also should not be perceived as overly complicated or painful. 

"Studies that don't have something as burdensome as a spinal tap are going to get many more people," Perales-Puchalt said. 

Messaging around research studies must be specifically tailored to the people researchers are trying to reach. To address this, Perales-Puchalt and Vidoni have developed Envejecimiento Digno (Dignified Aging), a curriculum to increase Alzheimer's disease research participation among Latinos. 

"Educational presentations aimed at the Latino community must be given in a language they understand ― and in a culturally appropriate way," Perales-Puchalt said. "The Latino community asked me to present information from a positive perspective, instead of focusing on the devastating impact of Alzheimer's and other forms of dementia." 

Similarly, Ashley Shaw created the Aging with Grace educational program in partnership with the African American community. The program aims to reduce the risk of developing Alzheimer's disease through lifestyle modification, while addressing stigmas around clinical research participation. 

The KU Alzheimer's Disease Research Center is also committed to grassroots outreach to the two communities. Before the COVID-19 pandemic, researchers from the KU Alzheimer's Disease Research Center visited churches and community centers on a regular basis. They were able to spread the word about KU's Alzheimer's trials and programs to large groups of people and developed crucial relationships with community leaders. 

The pandemic put a halt to many of those face-to-face meetings and conversations, but the KU Alzheimer's Disease Research Center stepped up efforts to communicate and disseminate information through other means, such as e-mail, text messaging, webinars and social media. 

One outreach tool includes the program MyAlliance for Brain Health, which sends participants weekly communications on Alzheimer's-related topics including healthy eating, exercise, caregiver support and easy access to research study opportunities. 

Dr Shaw talking to person
Ashley Shaw, Ph.D., Research Assistant Professor
University of Kansas Alzheimer's Disease Research Center

CLINICAL TRIALS

KU's proving grounds for Alzheimer's research are its clinical trials. A research trial that the KU Alzheimer's Disease Research Center recently launched is the Bio-Hermes study, which is designed to determine the validity of certain blood biomarkers in accurately diagnosing Alzheimer's disease at an early stage. 

Bio-Hermes is one of the first Alzheimer's clinical trials designed to ensure representation of groups at higher risk of developing the disease. 

Leading the Bio-Hermes study at KU is Samantha Fikru, MSN, a nurse practitioner in the Memory Care Clinic, who also is the medical monitor for research at the KU Alzheimer's Disease Research Center. 

"We want to see how these blood biomarkers compare in different ethnic and racial groups," Fikru said. "We have already discovered that there might be some differences based on race and ethnicity. It's important to know that the diagnostics work for everybody." 

KU is partnering with several entities on the Bio-Hermes study, including the Washington-based Global Alzheimer's Platform Foundation. Fikru said the study will also generate diagnostic information that will determine participants' eligibility for the drug, Aduhelm. 

"We started screening our first patients at the beginning of August 2021. Our goal is to enroll 60 people by mid-2022. Our recruitment efforts are geared towards African Americans and Hispanic Americans." 

In the Kansas City area, Fikru said she and her colleagues work with groups such as the Black Health Care Coalition to recruit participants. 

"For example, we disseminated information about Bio-Hermes and screening for Alzheimer's disease at their annual Juneteenth celebration." 

Two other clinical trials at the KU Alzheimer's Disease Research Center — AHEAD and IGNITE ― also are focusing on diversity. AHEAD is looking at an investigational treatment that could help delay memory decline for up to 20 years before symptoms arise. IGNITE is examining the connection between brain health and exercise in older adults and is particularly interested in including older African American males. 

Vidoni said because of efforts like these, the level of African American and Hispanic participation in KU Alzheimer's Disease Research Center clinical trials has more than doubled in the last few years. 

"The reason I'm in this research is I believe it helps affirm the dignity of each individual," he said. "Oftentimes it breaks down on racial and socio-economic lines. Hopefully, doing this helps affirm that dignity and makes our science better."

Aging with grace 

According to the Alzheimer's Association, vascular disease may be a particularly powerful factor in the prevalence of Alzheimer's among African Americans. The association has reported that persons with a history of high blood pressure or high cholesterol levels are twice as likely to get Alzheimer's. Those with both risk factors are four times as likely to become demented. 

Shaw's Aging with Grace program highlights the importance of lifestyle interventions such as a healthier diet. 

"There is research to suggest that diet is strongly linked to cognitive health outcomes," Shaw said. "Following the Mediterranean diet has been shown to be a strong factor when you're thinking about a protective way to reduce your risk of developing Alzheimer's disease." 

Shaw noted that the Mediterranean diet, which includes high consumption of vegetables and olive oil and moderate consumption of protein, can be a new concept for some in minority communities. 

"The Mediterranean diet isn't necessarily congruent with African American culture." Shaw said. "My role is to incorporate African American culture within the design of the intervention, so the community is more receptive to making changes." 

Shaw said African American culinary culture includes many healthy foods, but a change in preparation would make them healthier. She cited examples such as air-frying fish instead of frying fish in a skillet with unhealthy oils. 

Shaw also conducts clinical cohort trials, in which participants undergo annual assessments regarding their memory. Participants in Shaw's programs include Freddie Mae Hill, a 65-year-old African American woman. Hill, who has a family history of dementia, learned about the trials when Shaw visited her church in 2019. 

"I'm very conscious about what I eat anyway, so it just kind of motivated me to stay on the right track, maybe increasing my veggies a little more and making sure they're balanced out with my carbohydrates, and not eating a lot of sugars," Hill said. 

Hill took a cognitive skills test as a participant in Shaw's clinical cohort assessment and found it challenging but motivating. 

"It made me think about making sure that I stay in tune with my environment, and being involved," Hill said.

Shaw's programs also have drawn the participation of Bedelia Frizell, a 73-year-old African American woman. Frizell said Aging with Grace made her more conscious of her diet, which formerly brimmed with items such as cereal, milk, hamburger, pork, white bread and canned vegetables. 

"I upgraded my diet after the study," she said. "Now I make more of an effort to eat frozen vegetables, tuna, frozen salmon patties and turkey and less beef. I don't eat any pork, and I drink water." 

GET INVOLVED

Hill and Frizell encourage others to get involved and participate in Alzheimer's trials and programs. 

"Many people are afraid of things that happened in the past among our people, for good reason," Hill said. "Listening to Dr. Shaw when she came to the church, I didn't feel like there was anything to fear. You won't know until you try it. You don't have to stay in the study, you have the freedom to remove yourself at any time. It's a great experience, and I've learned a lot." 

Frizell said members of her community need to be involved in studies because of ongoing concerns about physical and cognitive health.

"If we continue to ignore them, we will have a decline," Frizell said. "I think researchers being more transparent helps, because that's one of the biggest things we've been concerned about. If they are upfront about what's going on and your results, that's what is important."

KU'S LONG-TERM COMMITMENT

Burns said he is proud of the KU Alzheimer's Disease Research Center's success in boosting recruitment from vulnerable minority communities.

"We have more and more African Americans and Latinos participating in our studies every year. We can show that the drugs we're developing and the advances we're making don't just apply to Caucasians." 

Burns foresees ongoing success for minority recruitment efforts, but he's not ready to take a victory lap.

"It's a long-term commitment. It's not something you solve in a day, a week or a year," Burns said. "The diversity in our leadership and diversity in our scientists helps us make that long-term commitment and make sure we're not widening disparities as we move the field forward." 


University of Kansas Medical Center

Office of Communications
3901 Rainbow Boulevard
Mailstop 3013
Kansas City, KS 66160

Media inquiries: 913-617-8698
Staff Contacts