Blood-based biomarkers for Alzheimer’s disease: Current state and future use in a transformed global healthcare landscape
Open accessAbstract
Timely detection of the pathophysiological changes and cognitive impairment caused by Alzheimer's disease (AD) is increasingly pressing because of the advent of biomarker-guided targeted therapies that may be most effective when provided early in the disease. Currently, diagnosis and management of early AD are largely guided by clinical symptoms. FDA-approved neuroimaging and cerebrospinal fluid biomarkers can aid detection and diagnosis, but the clinical implementation of these testing modalities is limited because of availability, cost, and perceived invasiveness. Blood-based biomarkers (BBBMs) may enable earlier and faster diagnoses as well as aid in risk assessment, early detection, prognosis, and management. Herein, we review data on BBBMs that are closest to clinical implementation, particularly those based on measures of amyloid-β peptides and phosphorylated tau species. We discuss key parameters and considerations for the development and potential deployment of these BBBMs under different contexts of use and highlight challenges at the methodological, clinical, and regulatory levels.
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BBMs have not been recommended as standalone diagnostic tests due to a lack of studies demonstrating their equivalence to clinically used CSF and PET methods.
“Despite BBMs being used in clinical practice in some countries, including the United States, they have not been recommended as standalone diagnostic tests due to a lack of studies demonstrating their equivalence to clinically used CSF and PET methods16,35–37.”
From Highly accurate blood test for Alzheimer's disease is similar or superior to clinical cerebrospinal fluid tests (2024) · cites this paper as [16]
The paper’s Future directions and conclusions section says blood-based biomarkers do not currently provide a standalone AD diagnosis. Its Diagnosis section discusses comparisons with CSF and PET, but the cited passages do not say that a lack of studies demonstrating equivalence is the reason standalone tests have not been recommended. (LLM, conf=0.85)
Experimental — accuracy not yet measuredBlood-based markers capable of detecting AD pathology have been developed.
“In the last several years, blood-based markers (BBMs) capable of detecting AD pathology have been developed16–18.”
From Highly accurate blood test for Alzheimer's disease is similar or superior to clinical cerebrospinal fluid tests (2024) · cites this paper as [16]
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Self-citationComparison of plasma and CSF biomarkers across ethnoracial groups in the ADNI
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Self-citationAdvances in Brain Amyloid Imaging
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Using Alzheimer's disease blood tests to accelerate clinical trial enrollment
Schindler, S. E., Li, Y., Li, M., Despotis, A., Park, E., Vittert, L., Hamilton, B. H., Womack, K. B., Saef, B., Holtzman, D. M., et al. (2023) · Alzheimer's & Dementia · doi:10.1002/alz.12754 · Cited by 38 · see citing works
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“Despite BBMs being used in clinical practice in some countries, including the United States, they have not been recommended as standalone diagnostic tests due to a lack of studies demonstrating their equivalence to clinically used CSF and PET methods 16,35–37 .”
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Self-citation
- Authors
- Hampel, H., Hu, Y., Cummings, J., Mattke, S., Iwatsubo, T., Nakamura, A., Vellas, B., O’Bryant, S., Shaw, L. M., Cho, M., Batrla, R., Vergallo, A., Blennow, K., Dage, J., & Schindler, S. E.
- Affiliations
- Eisai (United States) (US)
- University of Nevada, Las Vegas (US)
- University of Southern California (US)
- The University of Tokyo (JP)
- National Center for Geriatrics and Gerontology (JP)
- Inserm (FR)
- University of North Texas Health Science Center (US)
- University of Pennsylvania (US)
- Sahlgrenska University Hospital (SE)
- Indiana University School of Medicine (US)
- Washington University in St. Louis (US)
- Corresponding author
- Hampel, Harald
- Hu, Yan
- ORCID
- Venue
- Neuron
- Publisher
- Elsevier BV
- Published
- 2023-09
- Volume
- 111
- Issue
- 18
- Pages
- 2781-2799
- ISSN
- 0896-6273 (ISSN-L)
- PMC
- PMC10720399
- OpenAlex
- W4379880742
- Cited by
- 283
- References
- 159
- Citations by year
- 2026: 99 · 2025: 87 · 2024: 92 · 2023: 4
- FWCI
- 12.87
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- www.elsevier.com/legal/tdmrep-license (tdm)
- www.elsevier.com/open-access/userlicense/1.0/ (vor, 385 d)
- doi.org/10.15223/policy-017 (stm-asf)
- doi.org/10.15223/policy-037 (stm-asf)
- doi.org/10.15223/policy-012 (stm-asf)
- doi.org/10.15223/policy-029 (stm-asf)
- doi.org/10.15223/policy-004 (stm-asf)
- Locations
- Neuron (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- IUScholarWorks (Indiana University) (submittedVersion)
- Funders
- Alzheimer's Drug Discovery Foundation (P20GM109025)
- Eli Lilly and Company (P20GM109025)
- Biogen (P20GM109025)
- University of Pennsylvania
- Cure Alzheimer's Fund
- Japan Agency for Medical Research and Development (20dk0207027h0005, JP22ae0101077, JP22dk0207052)
- Sage Therapeutics
- Prothena
- Eisai (P20GM109025)
- Novo Nordisk
- National Center for Geriatrics and Gerontology
- Siemens Healthineers
- Servier (P20GM109025)
- H. Lundbeck A/S (P20GM109025)
- Grifols
- Julius Clinical
- National Institutes of Health (ADNI4)
- Genentech (P20GM109025)
- National Institute on Aging (R01AG053798, P20AG068053, P01AG003991, R35AG71476, R01AG058533, P30AG066444, U19AG024904, P30AG072959, R01AG070941, P30AG072979, U19AG078109, P01AG026276, R35AG071476)
- National Institute of General Medical Sciences (P20GM109025)
- National Institute of Neurological Disorders and Stroke (U01NS093334)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Keywords
- Alzheimer's disease, blood-based biomarkers, amyloid-beta, phosphorylated tau, early diagnosis, liquid biopsy, cerebrospinal fluid biomarkers, risk assessment, prognosis, regulatory challenges, clinical implementation
- MeSH terms
- Alzheimer Disease, Delivery of Health Care, Humans, Peptide Fragments, Biomarkers, Amyloid beta-Peptides, tau Proteins, Cognitive Dysfunction
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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