During mid-summer, the Alzheimer’s Association released its first-ever clinical practice guideline on the use of blood-based biomarkers (BBMs) in diagnosing Alzheimer disease (AD). Developed through a rigorous evidence-based process, the recommendations provide a framework for specialists to incorporate BBM tests into the diagnostic workup of patients with cognitive impairment, emphasizing when these tests can serve as triaging tools or confirmatory alternatives to established methods such as cerebrospinal fluid analysis or PET imaging.
As part of a new iteration of NeuroVoices, NeurologyLive® sat down with Rebecca Edelmayer, PhD, vice president of scientific engagement at the Alzheimer’s Association, to overview the guidelines and the takeaways clinicians should have. Edelmayer spoke on the considerations around accuracy, test selection, and appropriate patient populations for BBM tests, while stressing that these guidelines are an early step in a rapidly evolving field. Furthermore, she reflected on the next research priorities needed to expand use of these biomarkers beyond specialty care, aiming for more equitable access to AD diagnosis worldwide.
NeurologyLive: What went into the need for these guidelines?
Rebecca Edelmayer, PhD: We recognize that the field around blood-based biomarkers in diagnosing Alzheimer’s disease is moving very, very rapidly, and it was critical to gather all of the evidence in a systematic way to inform recommendations. Clinicians need clarity on how to use these new tools in their practice when evaluating patients with suspected Alzheimer’s disease. It’s not just about having the test available—it’s about understanding how to select the right test, for the right patient, at the right time. Without that structured guidance, we run the risk of variability in practice and uneven care. These guidelines help create a more consistent framework for clinicians who are encountering patients concerned about their memory or thinking.
What were the biggest takeaways from these recommendations?
Some of the key parts of the recommendations include synthesizing all the available evidence to understand the accuracy of the tests and identifying which may be appropriate to use as triaging tools or initial screens. For example, in some patients, a blood-based test might be used to determine whether further confirmatory testing—such as CSF analysis or PET imaging—is warranted.
In other scenarios, the evidence suggests blood-based biomarkers could be used as confirmatory tools themselves, potentially substituting for CSF or PET in confirming the presence of amyloid or tau pathology in the brain. These are big steps forward. Having blood-based biomarkers serve different roles in the diagnostic pathway—whether as screening, triage, or confirmation—gives clinicians more flexibility. But it also underscores the importance of using the right test in the right clinical context, since accuracy and performance may vary across different platforms and patient populations.
What considerations and precautions should clinicians have about diagnostic and commercially available tests? Are there times when blood-based biomarker tests are not appropriate?
This first iteration of the guidelines was developed specifically for clinicians evaluating patients with suspected cognitive impairment. The panel’s recommendations reflect where the evidence currently stands and focus on specialized care settings, not on primary care or general screening.
We emphasized that not all tests have the same level of accuracy. Some of the assays available in clinics today are better validated than others. That’s why the recommendations are based on careful review of sensitivity and specificity data within cognitively impaired populations.
It’s important to point out what these guidelines are not: they are not yet recommendations for using blood-based biomarkers in cognitively unimpaired individuals, or for broad population-level screening. Those questions are still unanswered. Similarly, we do not yet have recommendations for use in primary care settings. These are areas where the evidence is still building, and updates will come as data mature.
Clinicians should also be cautious about assuming all blood tests are interchangeable. Some may be more appropriate for triaging, while others may be appropriate for confirmation. The key takeaway is that accuracy and context matter, and tests should be selected accordingly.
What considerations are needed as these tools are integrated into clinical care?
Education is absolutely critical. Guidelines themselves are only one part of the process—they provide the rigor, but clinicians need accessible educational resources and clinical tools to put them into practice. We use rigorous methodology—GRADE methodology—to synthesize the evidence and create the recommendations. But then we need to translate that into real-world use.
The Alzheimer’s Association has already created an executive summary of these guidelines, available on our ALZPRO website, which helps distill the findings. But that’s just a starting point. What comes next is more implementation support: things like micro-learning tools, case-based examples, or checklists that clinicians can use in practice.
Another key part of integration is ensuring that clinical judgment remains central. Biomarker results must be interpreted in the broader context of patient history, clinical exam, and other findings. These are not standalone tests. Shared decision-making with patients is also essential, so patients understand both the benefits and the limitations of testing.
What are the next steps in research to advance these guidelines and address unanswered questions?
One of the most important needs is that data be published in peer-reviewed journals in formats that allow systematic review. For guidelines to be rigorous, the underlying evidence must be accessible and analyzable.
The field is moving incredibly quickly, which is both exciting and challenging. On the positive side, we are at a point where blood-based biomarkers are realistic tools for clinical practice. On the challenging side, evidence is still uneven. We need more data across diverse patient populations, across different care settings, and from global cohorts to understand how these biomarkers perform outside of specialized centers.
Another gap is around use in cognitively unimpaired individuals. Could these biomarkers be used for very early detection, before symptoms emerge? Could they be incorporated into primary care settings to broaden access? Those questions aren’t yet answered. Similarly, issues of equity and access remain critical. CSF and PET, while considered gold standards, are not accessible to everyone. Blood-based biomarkers have the potential to level the playing field, but only if implemented in ways that are equitable and supported by the right infrastructure.
Ultimately, the goal is to create a future where patients can receive earlier and more accurate diagnoses, no matter where they live or what resources their clinic has. That’s what will allow us to connect patients with treatments, clinical trials, and support services sooner. The guidelines will evolve alongside the evidence, and the Alzheimer’s Association will continue to update them as new data emerge.
Transcript edited for clarity. To review the newly published guidelines,