Unlocking the Future of Alzheimer’s Diagnosis & Care

Recent advancements in Alzheimer's disease (AD) focus on earlier detection and more effective treatments. New blood tests are being developed to identify AD before symptoms become severe, potentially replacing more invasive tests like spinal taps and brain scans. Excitingly, new drugs have been approved that target the disease's progression, with several more in clinical trials showing promise. These innovations offer hope for earlier diagnosis and better management of AD, making it a hopeful time for people living with a diagnosis of AD and their family members.

Although these recent achievements are promising, commercially available diagnostic tests using blood-based biomarkers (BBM) are still scratching the surface for early detection of AD. Researchers have found that p-tau 217 levels are elevated in individuals with AD and can be detected in both cerebrospinal fluid (CSF) and blood plasma. This biomarker best correlates with the presence of amyloid plaques in the brain, making it a promising tool for triaging and confirmation of amyloid pathology.

BBM tests serve two primary purposes: triaging and confirming amyloid pathology. When triaging, a negative test result indicates that individuals are unlikely to have amyloid pathology and should be assessed for other causes of cognitive impairment. A positive result suggests a higher likelihood of amyloid pathology, necessitating further accurate testing. Triaging tests are most suitable for people with a pre-test probability of amyloid positivity of 50% or less, as a negative result in this context provides high confidence that amyloid pathology is not present. However, when the pre-test probability exceeds 50%, a negative BBM result is less reliable for ruling out amyloid pathology. Clinicians must still consider Alzheimer's disease as a possible cause in people with negative BBM results but who show symptoms of AD.1

Our Current Status

What is Veravas doing to address the current challenges?

“Biomarkers are indicators – pathology measures what is”

At Veravas, we have pioneered a differentiated and more clinically specific and sensitive blood-based approach to diagnosing AD by targeting tau pathology which helps distinguish cognitive decline resultant of neurodegeneration from other types of dementia. Currently, tau pathology in the brain, or neurofibrillary tangles (NFTs), is measured by a Positron Emission Tomography (PET) scan, which is costly and offers limited accessibility. Veravas' VeraBIND™ Tau Pathology assay requires a noninvasive plasma sample. Measuring tau pathology, particularly the binding of normal tau to VeraBIND purified hyperphosphorylated tau (HPT), is critical in diagnosing and understanding AD.

Veravas is also using its VeraBIND technology and proprietary antibodies to develop a more specific and sensitive blood-based VeraBIND™ pTau217 assay to detect amyloid pathology or amyloid plaque in the brain. Our VeraBIND Clean Beads clean and condition plasma samples to mitigate and remove substances in the blood that can cause false positive or false negative results, and our antibody coated VeraBIND Capture Beads capture and purify a specific form of p-Tau 217 peptide for measurement of its levels.

  • Early Detection: Elevated levels of p-tau, such as p-tau 217 or tau pathology activity, can be detected even in the early stages of Alzheimer's, often before significant cognitive symptoms appear, which allows for earlier diagnosis and intervention. 2

  • Disease Differentiation: Measuring p-Tau 217 and tau pathology helps distinguish cognitive decline resultant of neurodegeneration from other types of dementia, and since tau pathology is a hallmark of AD it can provide a more accurate diagnosis compared to other biomarkers. 3

  • Treatment Planning: By understanding if dementia is resultant of neurodegeneration, clinicians can develop personalized treatment plans, including selecting appropriate therapies and monitoring their effectiveness over time. 4

Measuring tau pathology can be used as an adjunct to other clinical diagnostic evaluations to help establish a diagnosis of AD or other cognitive disorders.

Measuring p-Tau 217 can help identify amyloid plaque in the brain and those who may be candidates for the new FDA approved amyloid plaque clearing therapeutics designed to delay onset or progression of cognitive decline.

How is Veravas’ approach different?

The Veravas AD assay portfolio is powered by our patented VeraBIND™ technology which purifies and concentrates key biomarkers from the patient sample to improve test sensitivity and specificity to deliver unprecedented accuracy. This innovative platform uses magnetic beads and proprietary antibodies to remove the interfering substances from blood-based samples that can result in uncertainty and confusion in AD testing.

What does the approach mean for clinicians and people living with AD?

Veravas Alzheimer’s assays provide clear, easy-to-understand results so clinicians can focus on preserving brain function instead of analyzing results.

Clear, easy-to-understand results

Our VeraBIND AD assays are designed to assist clinicians dedicated to making informed decisions for current and future brain health. With clear, actionable information, they can provide more definitive answers about conditions, helping individuals transition from uncertainty to prevention or management.

Better decision making

Clinicians need simple, accurate, and actionable tests to manage the rapidly growing burden of AD and make a difference as early as possible. The VeraBIND AD assays can reduce challenges and eliminate the need for invasive testing to diagnose AD by providing clinicians with more definitive information earlier in the diagnostic process. This allows clinicians to start the appropriate interventions earlier when they are most effective.

Improved care as early as possible

What is the outlook for our aging population?

More than ever, society is investing more time and resources into the accurate and early diagnosis and treatment of AD. With more than 120 therapeutics in development 5, new blood-based tests are becoming more readily available, and a better understanding of the impact of lifestyle changes, the future is bright to treat or prevent cognitive decline resultant of AD.

1. Schindler, S.E., Galasko, D., Pereira, A.C. et al. Acceptable performance of blood biomarker tests of amyloid pathology — recommendations from the Global CEO Initiative on Alzheimer’s Disease. Nat Rev Neurol (2024). https://doi.org/10.1038/s41582-024-00977-5

2. https://www.alz.org/media/Documents/alzheimers-dementia-biomarkers-and-alzheimers-disease-ts.pdf

3. https://www.alz.org/media/Documents/alzheimers-facts-and-figures-special report.pdf#:~:text=URL%3A%20https%3A%2F%2Fwww.alz.org%2Fmedia%2FDocuments%2Falzheimers

4. Singh H, Das A, Khan MM, Pourmotabbed T. New insights into the therapeutic approaches for the treatment of tauopathies. Neural Regen Res. 2024 May;19(5):1020-1026. doi: 10.4103/1673-5374.385288. PMID: 37862204; PMCID: PMC10749630.

5. Cummings J, Zhou Y, Lee G, Zhong K, Fonseca J, Cheng F. Alzheimer's disease drug development pipeline: 2024. Alzheimer’s Dement (N Y). 2024 Apr 24;10(2):e12465. Dutch. doi: 10.1002/trc2.12465. PMID: 38659717; PMCID: PMC11040692.