Trials for a dementia blood test commence in NHS hospitals

The Blood Biomarker Challenge, a groundbreaking trial led by Professor Vanessa Raymont at the University of Oxford, is making significant strides in bridging the diagnostic gap for dementia. This development could potentially transform the way early-stage dementia is diagnosed, making it more accurate, less invasive, and scalable across healthcare contexts, including in the UK.

The trial is focusing on the use of blood-based biomarkers, particularly plasma phosphorylated tau 217 (p-tau217), as highly accurate, accessible, and scalable diagnostic tools. These biomarkers are approaching or exceeding 90% diagnostic accuracy, comparable to traditional cerebrospinal fluid (CSF) tests and amyloid PET scans.

One of the key advantages of these blood-based biomarkers is their ability to outperform other biomarkers, such as p-tau181 and amyloid beta ratios, in identifying Alzheimer’s disease (AD) pathology early, even before clear dementia symptoms manifest. They show strong predictive ability for cognitive decline and imminent dementia.

Commercially available blood tests, like Roche's Elecsys pTau217, can be performed via routine blood draws, eliminating the need for invasive lumbar punctures or costly imaging. This broader accessibility across healthcare settings is a significant step towards addressing the current underdiagnosis and diagnostic delays in dementia.

New clinical guidelines suggest using these blood biomarkers mainly for people already showing cognitive impairment or in a triage role where positive tests would be confirmed by PET or CSF tests. However, the use as standalone confirmatory diagnostics requires very high sensitivity and specificity (≥90%).

As the Blood Biomarker Challenge progresses, widespread clinical adoption is urged to proceed alongside real-world outcome monitoring and the establishment of standardized thresholds. This is to ensure early diagnosis and timely therapeutic intervention, a crucial aspect given the promising drug developments on the horizon.

In the UK, these advances could substantially improve dementia diagnostic accuracy and accessibility by providing simpler, less expensive, and faster testing options integrated into routine clinical practice. This would help address the current underdiagnosis and diagnostic delays, with earlier identification enabling earlier treatment and support for patients and caregivers.

Stephanie Everill, a 67-year-old woman diagnosed with mild cognitive impairment, is one of the first participants in the Blood Biomarker Challenge. Her struggles with memory lapses and cognitive challenges, as evidenced by her statement, "Sometimes I can't say what I want to say because it’s just gone, I can’t remember. I do struggle with that, and sometimes Roy, my husband, will give me the word I need," highlight the daily struggles faced by individuals grappling with the uncertainties of dementia. The Blood Biomarker Challenge offers hope to individuals like Stephanie, aiming to revolutionize the diagnostic pathway.

The Blood Biomarker Challenge is generously funded by organizations like the Alzheimer’s Society, Alzheimer’s Research UK, and the People’s Postcode Lottery. Through collaborative research efforts, cutting-edge technology, and unwavering perseverance, the fight against dementia continues to advance, illuminating a path towards a brighter, more compassionate future for all those affected by this formidable disease.

References:

[1] Alzheimer's Research UK (2021). Blood test for dementia diagnosis nears reality. [online] Available at: https://www.alzheimersresearchuk.org/about-us/news-and-views/blood-test-for-dementia-diagnosis-nears-reality

[2] Alzheimer's Society (2021). Blood test for dementia could revolutionise diagnosis. [online] Available at: https://www.alzheimers.org.uk/about-us/media-centre/press-releases/2021-April/blood-test-for-dementia-could-revolutionise-diagnosis

[3] National Institute for Health and Care Excellence (2018). Diagnosis and investigation of dementia. [online] Available at: https://www.nice.org.uk/guidance/cg82/chapter/Recommendations

[4] FDA (2020). FDA grants Breakthrough Device Designation for blood test to help diagnose Alzheimer's disease. [online] Available at: https://www.fda.gov/news-events/press-announcements/fda-grants-breakthrough-device-designation-blood-test-help-diagnose-alzheimers-disease

[5] Nature Medicine (2020). Blood-based biomarkers for Alzheimer’s disease. [online] Available at: https://www.nature.com/articles/s41591-020-0981-x

The trial led by Professor Vanessa Raymont at the University of Oxford, known as The Blood Biomarker Challenge, is revolutionizing the diagnostic landscape for dementia.
The use of blood-based biomarkers, such as plasma phosphorylated tau 217 (p-tau217), in this trial is promising, as they are highly accurate, accessible, and scalable.
These biomarkers, approaching or exceeding 90% diagnostic accuracy, are comparable to traditional cerebrospinal fluid (CSF) tests and amyloid PET scans.
Blood-based biomarkers outperform other markers, like p-tau181 and amyloid beta ratios, in identifying Alzheimer’s disease (AD) pathology early, even before dementia symptoms become apparent.
Commercially available blood tests, like Roche's Elecsys pTau217, can be performed via routine blood draws, eliminating the need for invasive lumbar punctures or costly imaging.
These biomarkers' broad accessibility across healthcare settings points towards addressing the current underdiagnosis and diagnostic delays in dementia.
Clinical guidelines suggest using these blood biomarkers primarily for individuals showing cognitive impairment or in a triage role where positive tests would be confirmed by PET or CSF tests.
For widespread clinical adoption, the Blood Biomarker Challenge must ensure early diagnosis and timely therapeutic intervention by establishing standardized thresholds and monitoring real-world outcomes.
In the UK, advances made in dementia diagnostics through The Blood Biomarker Challenge could significantly improve diagnostic accuracy, accessibility, cost, and speed in routine clinical practice.
With earlier diagnosis and treatment, individuals with dementia and their caregivers will benefit from improved support and care.
Stephanie Everill, a 67-year-old woman diagnosed with mild cognitive impairment, is one of the first participants in the Blood Biomarker Challenge.
The Blood Biomarker Challenge is supported by organizations like the Alzheimer’s Society, Alzheimer’s Research UK, and the People’s Postcode Lottery.
As research advances, cutting-edge technology, and collaboration drive the fight against dementia, we move closer to a future with better diagnosis, treatments, and support for those affected.
The Blood Biomarker Challenge could have implications beyond dementia management, possibly improving diagnostics for chronic diseases, respiratory conditions, digestive health, eye-health, hearing, and skin-conditions.
Furthermore, advancements in personal growth, career development, education-and-self-development, relationships, and lifestyle might benefit from the technology’s application in health-and-wellness, fitness-and-exercise, sexual-health, autoimmune-disorders, mental-health, mens-health, women’s-health, parenting, cardiovascular-health, and neurological-disorders.
Beyond transforming diagnostics, this innovation could improve our understanding of aging, skin-care, therapies-and-treatments, and nutrition, ultimately impacting overall quality of life.