{"id":6880,"date":"2024-04-17T09:06:23","date_gmt":"2024-04-17T16:06:23","guid":{"rendered":"https:\/\/keck.usc.edu\/news\/?p=6880"},"modified":"2025-12-17T15:12:06","modified_gmt":"2025-12-17T23:12:06","slug":"usc-study-links-lack-of-diversity-in-alzheimers-disease-clinical-trials-to-differences-in-amyloid-levels","status":"publish","type":"post","link":"https:\/\/keck.usc.edu\/news\/usc-study-links-lack-of-diversity-in-alzheimers-disease-clinical-trials-to-differences-in-amyloid-levels\/","title":{"rendered":"USC study links lack of diversity in Alzheimer\u2019s disease clinical trials to differences in amyloid levels"},"content":{"rendered":"\n \n \n\n\n\n\n\n\n\n
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USC study links lack of diversity in Alzheimer\u2019s disease clinical trials to differences in amyloid levels<\/h1>\n\n\n<\/div>\n \n \n
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Researchers from the Keck School of Medicine of USC found that individuals from certain racial and ethnic groups may be ineligible for some Alzheimer\u2019s disease clinical trials because of lower levels of brain amyloid buildup at early stages of the disease.<\/p>\n\n\n\n<\/div>\n \n

\n Zara Abrams<\/span>\n \n April 17, 2024<\/span>\n <\/div>\n \n \n
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Amyloid plaques between neurons. Image\/iStock<\/p>\n<\/figcaption>\n <\/figure>\n \n \n \n\n<\/div>\n \n\n <\/div><\/div>\n\n\n\n\n \n \n\n\n\n\n\n\n\n

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It\u2019s long been recognized that some of the groups most likely to get dementia, including African Americans and Hispanics, are greatly underrepresented in clinical trials. Now a new USC study shows that people from certain racial and ethnic groups may be ineligible for Alzheimer\u2019s disease clinical trials because they have lower levels of amyloid protein at early stages of the disease. The study also suggests that Alzheimer\u2019s may progress differently in different populations.<\/p>\n

Funded in part by the National Institutes of Health, researchers from the Keck School of Medicine of USC<\/a> collected blood tests and brain scans from 4,905 participants, ages 55 to 80. Based on blood tests designed to detect levels of amyloid, the protein known to disrupt brain activity in Alzheimer\u2019s disease, people who identified as non-Hispanic whites were most likely to meet eligibility cutoffs for clinical trials. People who identified as Hispanic Black, Hispanic white, non-Hispanic Asian and non-Hispanic Black were significantly less likely to be eligible for studies based on amyloid levels in the blood when compared to non-Hispanic white counterparts.<\/p>\n

Participants who were eligible based on blood tests also underwent positron emission tomography (PET) scans, brain scans that are used to directly measure amyloid buildup in the brain. Among \u201cplasma eligible\u201d participants (those who met the blood test cutoff), individuals from all racial and ethnic groups were equally likely to be eligible to participate based on PET scan data. The study was just published in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association<\/a>.<\/p>\n

\u201cIn these early stages, we see that the amyloid levels are different across racial and ethnic groups. That may be an important contributor to the underrepresentation of some groups in amyloid-lowering trials,\u201d said Doris P. Molina-Henry, PhD<\/a>, an assistant professor of research neurology at the Alzheimer\u2019s Therapeutic Research Institute<\/a> (ATRI) at the Keck School of Medicine and lead author of the study.<\/p>\n

Participants in the study were considered preclinical, meaning they did not have cognitive impairment characteristic of Alzheimer\u2019s disease or another form of dementia, but did have some biological changes related to the condition (in this case, amyloid proteins in the blood). A growing number of clinical trials seek to intervene during this stage, either by removing amyloid protein from the brain or preventing it from building up.<\/p>\n

The findings add to existing research suggesting that in different populations, different factors may contribute to cognitive decline. Unknown factors may make some individuals more vulnerable to symptoms of dementia, even if their amyloid levels remain low, and future research should aim to understand why, said Molina-Henry.<\/p>\n

\u201cThis opens up further questions: If it\u2019s not amyloid that\u2019s driving Alzheimer\u2019s disease, what is it? Or if amyloid is driving this, what is making the brain of someone from a group at higher risk for dementia much more susceptible?\u201d she said.<\/p>\n

Clinical trial eligibility<\/strong><\/p>\n

As part of the AHEAD 3-45 study, a clinical trial designed to test the safety and efficacy of the medication lecanemab, researchers had access to preclinical Alzheimer\u2019s disease participants at 75 sites across the country. The research team placed a special emphasis on recruiting and enrolling individuals from racial and ethnic groups that are traditionally underrepresented in Alzheimer\u2019s research.<\/p>\n

The study included 4,905 adults, ages 55 to 80, without cognitive impairment or dementia: 60 Hispanic Blacks, 671 Hispanic whites, 101 non-Hispanic Asians, 381 non-Hispanic Blacks and 3,692 non-Hispanic whites.<\/p>\n

The researchers collected blood from each participant and calculated amyloid levels, using a liberal threshold to determine who was considered eligible for inclusion in the clinical trial. The trial requires a participant to have 20 centiloids or more of amyloid, but researchers lowered the cutoff to 11 centiloids to avoid excluding participants who might be just below the typical threshold. Centiloids are units in a standardized method of measuring amyloid plaque in the brain based on PET imaging.<\/p>\n

Of the 4905 adults tested, 1,724 (35.1%) were \u201cplasma eligible\u201d to participate in a clinical trial, meaning they met the 11-centiloids blood test cutoff. Broken down by racial and ethnic group, non-Hispanic whites had the highest rate of eligibility at 38.9%. All other groups were significantly less likely to meet eligibility criteria: just 13.3% of Hispanic Blacks, 24.7% of Hispanic whites, 20.8% of non-Hispanic Asians and 24.7% of non-Hispanic Blacks surpassed the 11-centiloids threshold.<\/p>\n

Then, the researchers collected and analyzed PET scans from the 1,724 participants who were deemed plasma-eligible for the clinical trial. All racial and ethnic groups in the study were equally likely to meet inclusion criteria based on PET scans.<\/p>\n

\u201cThis suggests that the cutoffs for eligibility are adequate, but also point to a paradox where some groups may have a higher risk of dementia but lower levels of amyloid, and treating those groups may require a different approach,\u201d Molina-Henry said.<\/p>\n

Improving access<\/strong><\/p>\n

The study raises several questions about what factors may impact Alzheimer\u2019s disease progression in various racial and ethnic groups. For example, are some groups more vulnerable to dementia, even with lower levels of amyloid? Do comorbid conditions, such as cardiovascular disease, play a key role in Alzheimer\u2019s disease progression among these groups? What role do social determinants of health play in aging disparities?<\/p>\n

Molina-Henry said the findings also highlight the need for better access to Alzheimer\u2019s disease pre-screening and screening opportunities in communities across the United States. ATRI\u2019s Alzheimer\u2019s Prevention Trials Program<\/a> allows people to take quarterly online cognitive tests that can flag those who may be eligible for future clinical trials, while the institute\u2019s AlzMatch program collects blood tests in community settings for the same purpose.<\/p>\n

\u201cMore than ever\u2014particularly for groups who are underrepresented in research\u2014it\u2019s important to participate in screening efforts, to have your blood drawn and if eligible, to join a clinical trial,\u201d Molina-Henry said. \u201cContributing to research in this way adds critical diversity and helps us answer questions about this very devastating disease.\u201d<\/p>\n

About this research<\/strong><\/p>\n

In addition to Molina-Henry, the study\u2019s other authors are Rema Raman, Andy Liu, Oliver Langford, Leona K. Shum, Gustavo Jimenez-Maggiora, Robert A. Rissman and Paul Aisen from the Alzheimer\u2019s Therapeutic Research Institute, Keck of Medicine of USC, University of Southern California; Keith Johnson and Reisa A. Sperling from Massachusetts General Hospital, Harvard Medical School and Brigham and Women\u2019s Hospital; Crystal M. Glover from Rush Alzheimer\u2019s Disease Center and the Department of Psychiatry and Behavioral Sciences, Rush University Medical College; Shobha Dhadda and Michael Irizarry from Eisai Inc.;\u00a0 Joel B. Braunstein, Kevin Yarasheski, Venky Venkatesh, Tim West and Philip B. Verghese from C2N Diagnostics; and Joshua D. Grill from the Institute for Memory Impairments and Neurological Disorders, University of California Irvine.<\/p>\n

This work was supported by the National Institute on Aging, National Institutes of Health (U24AG057437, R01AG054029, R01AG061848), Eisai Inc., the GHR Foundation, the Alzheimer\u2019s Association (SG-22-877415-AHEAD) and other philanthropists.<\/p>\n

To find out more about AHEAD, including who is eligible for the study, visit aheadstudy.org<\/a>.<\/p>\n\n\n\n<\/div>\n <\/div>\n\n\n <\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":128,"featured_media":6881,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[6],"tags":[476,394,80,20,103],"class_list":["post-6880","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-press-release","tag-brain-health","tag-inclusive-excellence","tag-neurology","tag-research","tag-alzheimers-therapeutic-research-institute"],"acf":[],"yoast_head":"\nUSC study links lack of diversity in Alzheimer\u2019s disease clinical trials to differences in amyloid levels<\/title>\n<meta name=\"robots\" content=\"index, follow, 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