Clinical research needs to reflect the Alzheimer’s population – Boston, Massachusetts

Boston, Massachusetts 2021-07-29 15:00:29 –

NSData from the National Institute on Aging (NIA), which is part of the National Institute of Health, show how to design and fund Alzheimer’s disease research and clinical trials to overcome the challenges of urgent health inequalities. Need to change to.

Alzheimer’s disease—a progressive brain disorder that slowly erodes memory and executive function over time—disproportionately affects people of color, Health inequalities in the treatment of Alzheimer’s disease And research is not yet fully undertaken.

Black Americans are about Double chance, And Hispanic Americans 1.5 times more likely More developed than non-Hispanic Caucasians with Alzheimer’s disease Their number can increase.. However, these groups make up less than 10% of the currently enrolled NIA-funded Alzheimer’s disease study participants.


Researchers and industry often point to distrust and participant interest as a major recruitment challenge, but help people of color and low socioeconomic status lead to better treatments and interventions. There are systematic barriers that make it difficult to participate in studies designed for. The country’s sixth leading cause of death.

The new NIA data show that the eligibility criteria set by researchers (known as inclusion and exclusion criteria) may work for people from different backgrounds participating in clinical trials. I emphasize it.


analysis Presented by NIA Clinical Research Coordinator Alexandra Mitchell and colleagues. Alzheimer’s Association International Conference On Thursday, 60% of NIA-funded Alzheimer’s disease trials had at least exclusion criteria that could affect black and Hispanic participants disproportionately compared to non-Hispanic white participants. It was shown that there is one. These include:

  • 20% of trials focused on dementia associated with Alzheimer’s disease are of color More likely Living with chronic depression that lasts longer than non-Hispanic White Americans.
  • 70% of trials have at least one “broad” exclusion category that is too general for the researchers conducting the study to objectively define, and the process that should be transparent and scientifically justified is gray. The area has been introduced.
  • Fifty-five percent of federally funded exams are “English only,” effectively demonstrating that seven percent of non-English-speaking Americans and about eight percent of English-speaking Americans are not “very good.” It is shut off. US Census..
  • Eleven percent of NIA-funded trials exclude individuals with diabetes, and the same percentage exclude individuals with transportation problems. Both are known barriers to low-income communities.

NIA data show that clinical trial systems are directed to specific demographics that do not reflect the Alzheimer’s disease patient population.

Jennifer Manly, Andrea Gilmore Bikovsky, Casey Ditters do it Commentary In the case of JAMA Network Open for a major trial of Alzheimer’s disease known as the A4 study, “white, well-educated and well-resourced participants focused on each step of the design and execution process. rice field.”

This direction can also be seen in the 31 NIA-funded distributions across the country. Alzheimer’s Disease Research Center..according to analysis Access to these marquee research sites, led by researchers at the University of Wisconsin, “winds towards the wealthiest areas.”

As people working in the area of ​​Alzheimer’s disease, we know that communities that are strongly affected by the disease are not “enough resources.” NS analysis UsAgainstAlzheimer’s and Urban Institute found that the counties with the highest prevalence of Alzheimer’s disease among black and Hispanic Americans in the Medicare program tend to have worse socioeconomic conditions than the counties with the lowest prevalence of Alzheimer’s disease. I found that there is.

Families living in these counties were less likely to have health insurance, less access to exercise opportunities, and less likely to earn a bachelor’s degree or higher. At the same time, they were more likely to report lower incomes and poor health than families living in counties with low levels of Alzheimer’s disease.

Although inclusion in the study cannot solve the root cause of brain health inequality, proper expression is that taxpayer money is more equitable and responsible in the competition to solve this pressing health challenge. It helps to ensure that it is used with. We believe there are three steps that fields, especially NIA, can take to put this data into action.

Improve accountability for trial designs. Follow these steps: National Cancer Institute, NIA, in collaboration with patient advocacy groups and the Food and Drug Administration, to ensure that the eligibility criteria set by researchers are scientifically justified and their impact on the exclusion of underestimated populations in the study is continuously assessed. need to do it.

Increase access to your site in an underserved community. NIA needs to extend its reach beyond traditional academic medical centers by launching research sites in areas where the burden of Alzheimer’s disease is high. for example, Practice-based research network By training healthcare providers and community health centers to be part of the research team and providing incentives to do so, we can help extend research to poorly serviced communities with a high incidence of Alzheimer’s disease. increase. Eight other NIH laboratories, including the National Cancer Institute, are currently using such networks to support their research activities.

Address language access gaps. The Covid-19 pandemic has taught us that telemedicine can be a powerful tool to help ensure continuity of care and address disparities in access to care. NIA needs to apply these lessons and invest in a centralized telemedicine program that connects language-savvy professionals to research sites through secure and secure video conferencing solutions. This zoom-based approach can be of great help in addressing obvious access gaps affecting millions of potential participants.

Without studies that represent American diversity, the Alzheimer’s disease research community will continue to provide innovations that are better suited to some groups than others, by race and income rather than need and impartiality. The line will continue to be drawn. We all have to do better.

Jason Resendez is the secretary-general of UsAgainst Alzheimer’s Center for Brain Health Disparities. Stephanie Monroe is Executive Director of AfricanAmericansAgainstAlzheimer’s, a network of UsAgainstAlzheimer’s.

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