Clinical trial hoping to speed up Alzheimer’s diagnoses for minorities
Black people are twice as likely as white people to develop Alzheimer’s disease — Latinx people, 1.5 times as likely. But barriers including access to health care, timely diagnoses and transportation often keep clinical trials — designed to test new treatments and diagnostic techniques — out of reach.
Clinical trials are also sometimes the only way for people to access diagnostic tools such as PET scans, which determine if amyloid plaques — a hallmark of Alzheimer’s — are present in the brain. These scans are generally free to patients in a clinical trial but can otherwise cost several thousand dollars and are not typically covered by health insurance or Medicare.
A clinical trial called Bio-Hermes is testing cheaper alternatives to PET scans with an emphasis on increasing minorities’ access to early diagnoses.
In partnership with the Global Alzheimer’s Platform Foundation, research centers including K2 Medical Research in Maitland are comparing blood and digital biological marker diagnostic tests, including digital cognitive and voice assessments, to PET scans and traditional cognitive tests. The goal is to one day make these cheaper, easier tests commonplace in places like clinics or primary care doctor’s offices.
“If these biomarkers, these blood plasma tests, can be used instead of going to an imaging center [for a PET scan], they’ll spend less money and they’ll take less time to find out whether they can benefit from the drugs that are coming on the market, which is really important,” said John Dwyer, president of the Global Alzheimer’s Platform Foundation.
The trial, still seeking participants, will not stop enrollment until at least 20% of its volunteers are Black or Latinx, Dwyer said. Only 1% of all clinical trial participants are Latinx and 5% are Black, according to the Alzheimer’s Impact Movement, an advocacy affiliate of the Alzheimer’s Association, a nonprofit that supports Alzheimer’s care and research.
“We’re not excluding folks that are Caucasian. We’re just making sure that the Orlando Latino and African American communities know they are welcomed with
open arms,” Dwyer said.
Black and Latinx people have higher rates of hypertension and diabetes, which both increase risk factors for Alzheimer’s by impacting brain function over time. Life stressors such as low socioeconomic status also increase Alzheimer’s risk, according to the National Institute on Aging.
Dwyer noted it’s important to include diverse samples in biomarker studies because evidence suggests racial differences in biological markers of Alzheimer’s, with one 2017 study from Emory University School of Medicine finding these differences could even contribute to an underdiagnosis of Black patients.
Keith Gibson, director of diversity, equity, and inclusion at the Alzheimer’s Association Florida chapter, said diverse samples in Alzheimer’s clinical trials are crucial to ensure that diagnosis and treatment techniques work on everyone, not just white people.
Research needs to evolve from a “one size fits all” perspective, he added.
“We need to understand that the biology of a Black person is different from the biology of a Hispanic person and the biology of a white person,” Gibson said. “If we don’t look at infusing diversity in our research and our clinical trials, we’re going to see this disparity continue to grow.”
Along with increasing the understanding of the biological basis of Alzheimer’s in Black and Latinx communities, access to diagnostic services and health care needs to be improved, as does education about the signs and risk factors of Alzheimer’s, Gibson added. Even though Black and Latinx people are more likely to get Alzheimer’s than white people, they are less likely to be diagnosed, according to a March 2020 fact sheet from the Alzheimer’s Association.
“In these cultures, it’s not a matter of changing. We have to pretty much deconstruct and reconstruct a system that’s going to be inclusive,” Gibson said.
The Institutional Review Board-approved study is supported by partners such as the Alzheimer’s Drug Discovery Foundation, Lilly, and Merck. Lilly will provide full genomic sequencing of each Bio-Hermes Study volunteer, which will be used to research connections between genetics and the biomarkers of Alzheimer’s disease.
“We are excited to partner with the Global Alzheimer’s Platform Foundation and other leaders in the field on this landmark study as the utilization of biomarkers is critical to the advancement of Alzheimer’s research and clinical practice,” said Mark Mintun, senior vice president of pain and neurodegeneration research and development at Eli Lilly and Company. “We are hopeful that this partnership will result in diverse representation so that future treatments have broad relevance for all families battling this disease and improve health equity.”
The study will administer PET scans, cognitive tests, and blood and digital biological marker diagnostic tests to 1,000 people, ranging from healthy people to people with mild cognitive impairment — often the first stage of Alzheimer’s — or mild Alzheimer’s disease, Dwyer said.
Participation requires two visits with the research study staff and one visit to a local imaging site over approximately three months, with the potential for a follow-up phone call.
The study is still looking for as many as 100 volunteers aged 60 to 85 with significant memory concerns or an Alzheimer’s diagnosis in the Orlando area, Dwyer said. K2 Medical Research, the main site looking for participants, can be reached at 407-500-5252.
Dwyer expects the study to wrap up by the end of June.