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KU Alzheimer’s Disease Research Center part of global study deploying blood biomarker testing for dementia diagnoses

Blood biomarkers have the potential to accelerate diagnoses for dementia and identify people most likely to benefit from the new drugs for Alzheimer’s disease.

photo of a gloved hand holding a test tube with a label that says Alzheimer - Test
The Accurate Diagnosis project is the first-ever global implementation research program to study the use of blood biomarkers as part of the diagnostic process for dementia.

The University of Kansas Alzheimer’s Disease Research Center is one of seven institutions in the world participating in the first global initiative to assess how integrating blood tests for Alzheimer’s disease impacts the speed and accuracy of dementia diagnoses. The initiative, known as the Accurate Diagnosis project, was launched June 13 by the Davos Alzheimer’s Collaborative (DAC), an international organization seeking to cure Alzheimer’s and dementia.

For decades, doctors diagnosed Alzheimer’s disease through a combination of cognitive testing, individual and family histories and physical exams and laboratory tests that can rule out other conditions. But in the past few years, physicians also have begun use PET scans and cerebrospinal fluid tests that can detect biomarkers that indicate Alzheimer’s, including amyloid-beta, a protein that builds up in the brain and is a hallmark of the disease.

A less expensive and more accessible alternative to brain scans and spinal taps, blood biomarker tests, which are currently used in research studies, have shown promise in diagnosing Alzheimer’s early and accurately. Early diagnosis is critical for enabling physicians to identify patients that stand to benefit most from the new drugs for Alzheimer’s disease, such as lecanemab (brand name, Leqembi), that remove amyloid plaques in the brain to help slow cognitive decline. (A panel of advisors to the Food and Drug Administration recommended approval of another anti-amyloid drug, donanemab, on June 10.)

“These new drugs work best for those who are diagnosed in the earliest stages,” said Jeffrey Burns, M.D., co-director of KU Alzheimer’s Disease Research Center. “They appear to have their biggest impact and biggest effect on patients the earlier we treat them. In fact, there’s a time window; if we don’t diagnose early, they are no longer eligible for the drug.”

For people who do not meet the criteria for these drugs, early diagnosis is still important, Burns pointed out. Patients and their families adjust better and can plan more effectively for the future when they have identified the disease.

Blood biomarker testing also can be done in the offices of primary care physicians, who are typically the first doctors to whom patients report memory problems and thus often the first to diagnose dementia. And there simply are not enough specialists to manage all the patients with cognitive decline.

The number of people in the world living with dementia is expected to reach 139 million by 2050, but only three out of four people with dementia are ever diagnosed, according to the DAC. The Alzheimer’s Association estimates that one in nine Americans over 65 have Alzheimer’s and the number of new cases is expected to double by 2050, making the role of primary care physicians and early diagnosis critical to meet the demand for care.

With funding from the DAC, KU Alzheimer’s Disease Research Center will study the impact of using Alzheimer’s blood biomarkers across different clinical settings at The University of Kansas Health System, including primary care, neurology and memory care. They will look at the rates of these blood tests and confirmatory testing (amyloid PET scans or lumbar punctures) in these settings and examine the differences across testing in the time it takes to complete testing, make diagnoses, refer study participants to specialists and begin anti-amyloid drug treatment for those participants who had a blood test versus those who did not. Data will be collected at up to 18 ambulatory clinic sites across the health system.

KU Alzheimer’s Disease Research Center will also work to help clinicians implement the blood biomarker testing into their practices. They will provide education on using the testing effectively, develop enhanced cognitive screening and support primary care physicians.

“We are trying to improve everything so that we can better serve this population. It's not as simple as tripling or quadrupling the size of our memory clinic,” said Burns. “We have to have new models. This project is trying to develop all that.”

 Other sites participating in the Accurate Diagnosis project include Icahn School of Medicine at Mount Sinai, Wake Forest University School of Medicine, Alzheimer Center Amsterdam at Amsterdam UMC, Imperial College London and Imperial College Healthcare NHS Trust, Ludwig-Maximilians University (LMU) Hospital Munich – Alzheimer’s Therapy and Research Center, Tokyo Metropolitan Institute for Geriatrics and Gerontology. The sites were selected on the basis of their scientific and clinical capabilities as well as their ability to reach patients across ages, racial and ethnic backgrounds, education levels, socioeconomic status and geographic settings.

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