Considerations for widespread implementation of blood-based biomarkers of Alzheimer's disease.
Alzheimer's disease
amyloid
biomarker
blood‐based biomarkers
clinical implementation
clinical practice
cognitive impairment
disease‐modifying treatment
ethics
patient journey
primary care
secondary care
Journal
Alzheimer's & dementia : the journal of the Alzheimer's Association
ISSN: 1552-5279
Titre abrégé: Alzheimers Dement
Pays: United States
ID NLM: 101231978
Informations de publication
Date de publication:
06 Oct 2024
06 Oct 2024
Historique:
revised:
01
07
2024
received:
24
04
2024
accepted:
02
07
2024
medline:
6
10
2024
pubmed:
6
10
2024
entrez:
6
10
2024
Statut:
aheadofprint
Résumé
Diagnosing Alzheimer's disease (AD) poses significant challenges to health care, often resulting in delayed or inadequate patient care. The clinical integration of blood-based biomarkers (BBMs) for AD holds promise in enabling early detection of pathology and timely intervention. However, several critical considerations, such as the lack of consistent guidelines for assessing cognition, limited understanding of BBM test characteristics, insufficient evidence on BBM performance across diverse populations, and the ethical management of test results, must be addressed for widespread clinical implementation of BBMs in the United States. The Global CEO Initiative on Alzheimer's Disease BBM Workgroup convened to address these challenges and provide recommendations that underscore the importance of evidence-based guidelines, improved training for health-care professionals, patient empowerment through informed decision making, and the necessity of community-based studies to understand BBM performance in real-world populations. Multi-stakeholder engagement is essential to implement these recommendations and ensure credible guidance and education are accessible to all stakeholders.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024 The Author(s). Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.
Références
Hansson O. Biomarkers for neurodegenerative diseases. Nat Med. 2021;27:954‐963. doi:10.1038/s41591‐021‐01382‐x
Villemagne VL, Burnham S, Bourgeat P, et al. Amyloid β deposition, neurodegeneration, and cognitive decline in sporadic Alzheimer's disease: a prospective cohort study. Lancet Neurol. 2013;12:357‐367. doi:10.1016/S1474‐4422(13)70044‐9
2023 Alzheimer's disease facts and figures. Alzheimers Dement. 2023;19:1598‐1695. doi:10.1002/alz.13016
Drabo EF, Barthold D, Joyce G, Ferido P, Chang Chui H, Zissimopoulos J. Longitudinal analysis of dementia diagnosis and specialty care among racially diverse Medicare beneficiaries. Alzheimers Dement. 2019;15:1402‐1411. doi:10.1016/j.jalz.2019.07.005
Paczynski MM, Day GS. Alzheimer disease biomarkers in clinical practice: a blood‐based diagnostic revolution. J Prim Care Community Health. 2022;13:21501319221141178. doi:10.1177/21501319221141178
Health Resources and Services Administration, National Center for Health Workforce Analysis. Health workforce projections: neurology physicians and physician assistants. Health Resources and Services Administration. 2017. https://bhw.hrsa.gov/sites/default/files/bureau‐health‐workforce/data‐research/bhw‐factsheet‐neurology.pdf
2020 Alzheimer's disease facts and figures. Alzheimers Dement. 2020;16:391‐460. doi:10.1002/alz.12068
Gauthier S, Rosa‐Neto P, Morais JA, Webster C. World Alzheimer report 2021: journey through the diagnosis of dementia. Alzheimer's Disease International. 2021. https://www.alzint.org/u/World‐Alzheimer‐Report‐2021.pdf
Gauthier S, Webster C, Servaes S, Morais JA, Rosa‐Neto P. World Alzheimer Report. Life after diagnosis: navigating treatment, care and support. Alzheimer's Disease International. Alzheimer's Disease International. 2022. https://www.alzint.org/u/World‐Alzheimer‐Report‐2022.pdf
Hansson O, Edelmayer RM, Boxer AL, et al. The Alzheimer's Association appropriate use recommendations for blood biomarkers in Alzheimer's disease. Alzheimers Dement. 2022;18:2669‐2686. doi:10.1002/alz.12756
Mattke S, Jun H, Chen E, Liu Y, Becker A, Wallick C. Expected and diagnosed rates of mild cognitive impairment and dementia in the U.S. Medicare population: observational analysis. Alzheimers Res Ther. 2023;15:128. doi:10.1186/s13195‐023‐01272‐z
Hampel H, Hu Y, Cummings J, et al. Blood‐based biomarkers for Alzheimer's disease: current state and future use in a transformed global healthcare landscape. Neuron. 2023;111:2781‐2799. doi:10.1016/j.neuron.2023.05.017
Schindler SE, Atri A. The role of cerebrospinal fluid and other biomarker modalities in the Alzheimer's disease diagnostic revolution. Nat Aging. 2023;3:460‐462. doi:10.1038/s43587‐023‐00400‐6
LEQEMBI. Prescribing information. Eisai Inc. and Biogen. 2023. https://www.leqembi.com/‐/media/Files/Leqembi/Prescribing‐Information.pdf
Mintun MA, Lo AC, Duggan Evans C, et al. Donanemab in early Alzheimer's disease. N Engl J Med. 2021;384:1691‐1704. doi:10.1056/NEJMoa2100708
Hansson O, Blennow K, Zetterberg H, Dage J. Blood biomarkers for Alzheimer's disease in clinical practice and trials. Nat Aging. 2023;3:506‐519. doi:10.1038/s43587‐023‐00403‐3
The Global CEO Initiative on Alzheimer's Disease. UsAgainstAlzheimer's. 2013. https://www.usagainstalzheimers.org/our‐enterprise/CEOi
Schindler SE, Galasko D, Pereira AC, 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;20(7):426‐439. doi:10.1038/s41582‐024‐00977‐5
Mielke MM, Anderson M, Ashford JW, et al. Recommendations for clinical implementation of blood-based biomarkers for Alzheimer's disease. Alzheimers Dement. 2024. Epub ahead of print. doi:10.1002/alz.14184
White L, Ingraham B, Larson E, Fishman P, Park S, Coe NB. Observational study of patient characteristics associated with a timely diagnosis of dementia and mild cognitive impairment without dementia. J Gen Intern Med. 2022;37:2957‐2965. doi:10.1007/s11606‐021‐07169‐7
Lin PJ, Daly AT, Olchanski N, et al. Dementia diagnosis disparities by race and ethnicity. Med Care. 2021;59:679‐686. doi:10.1097/mlr.0000000000001577
Mattke S, Batie D, Chodosh J, et al. Expanding the use of brief cognitive assessments to detect suspected early‐stage cognitive impairment in primary care. Alzheimers Dement. 2023;19:4252‐4259. doi:10.1002/alz.13051
Centers for Medicare and Medicaid Services. Annual wellness visits providing personalized prevention plan services: conditions for limitations on coverage. Accessed June 18, 2024. https://www.govinfo.gov/content/pkg/CFR‐2012‐title42‐vol2/pdf/CFR‐2012‐title42‐vol2‐sec410‐15.pdf
2019 Alzheimer's disease facts and figures. Alzheimers Dement. 2019;15:321‐387.
Jacobson M, Thunell J, Zissimopoulos J. Cognitive assessment at Medicare's annual wellness visit in fee‐for‐service and medicare advantage plans. Health Aff. 2020;39:1935‐1942. doi:10.1377/hlthaff.2019.01795
Mattke S, Cho SK, Bittner T, Hlávka J, Hanson M. Blood‐based biomarkers for Alzheimer's pathology and the diagnostic process for a disease‐modifying treatment: projecting the impact on the cost and wait times. Alzheimers Dement. 2020;12:e12081. doi:10.1002/dad2.12081
Angioni D, Delrieu J, Hansson O, et al. Blood biomarkers from research use to clinical practice: what must be done? A report from the EU/US CTAD Task Force. J Prev Alzheimers Dis. 2022;9(4):569‐579. doi:10.14283/jpad.2022.85
Borson S, Frank L, Bayley PJ, et al. Improving dementia care: the role of screening and detection of cognitive impairment. Alzheimers Dement. 2013;9:151‐159. doi:10.1016/j.jalz.2012.08.008
Cordell CB, Borson S, Boustani M, et al. Alzheimer's Association recommendations for operationalizing the detection of cognitive impairment during the Medicare Annual Wellness Visit in a primary care setting. Alzheimers Dement. 2013;9:141‐150. doi:10.1016/j.jalz.2012.09.011
Go Annual Website. Go Annual. Accessed June 18, 2024. https://goannualga.com/
Leuzy A, Mattsson‐Carlgren N, Cullen NC, et al. Robustness of CSF Aβ42/40 and Aβ42/P‐tau181 measured using fully automated immunoassays to detect AD‐related outcomes. Alzheimers Dement. 2023;19:2994‐3004. doi:10.1002/alz.12897
Cullen NC, Janelidze S, Mattsson‐Carlgren N, et al. Test‐retest variability of plasma biomarkers in Alzheimer's disease and its effects on clinical prediction models. Alzheimers Dement. 2023;19:797‐806. doi:10.1002/alz.12706
Brum WS, Cullen NC, Janelidze S, et al. A two‐step workflow based on plasma p‐tau217 to screen for amyloid beta positivity with further confirmatory testing only in uncertain cases. Nat Aging. 2023;3:1079‐1090. doi:10.1038/s43587‐023‐00471‐5
Teunissen CE, Verberk IMW, Thijssen EH, et al. Blood‐based biomarkers for Alzheimer's disease: towards clinical implementation. Lancet Neurol. 2022;21:66‐77. doi:10.1016/s1474‐4422(21)00361‐6
Janelidze S, Stomrud E, Palmqvist S, et al. Plasma β‐amyloid in Alzheimer's disease and vascular disease. Sci Rep. 2016;6:26801. doi:10.1038/srep26801
Mattsson‐Carlgren N, Janelidze S, Palmqvist S, et al. Longitudinal plasma p‐tau217 is increased in early stages of Alzheimer's disease. Brain. 2020;143:3234‐3241. doi:10.1093/brain/awaa286
Khalil M, Pirpamer L, Hofer E, et al. Serum neurofilament light levels in normal aging and their association with morphologic brain changes. Nat Commun. 2020;11:812. doi:10.1038/s41467‐020‐14612‐6
Mielke MM, Syrjanen JA, Blennow K, et al. Plasma and CSF neurofilament light: relation to longitudinal neuroimaging and cognitive measures. Neurology. 2019;93:e252‐e260. doi:10.1212/wnl.0000000000007767
Mielke MM, Dage JL, Frank RD, et al. Performance of plasma phosphorylated tau 181 and 217 in the community. Nat Med. 2022;28:1398‐1405. doi:10.1038/s41591‐022‐01822‐2
Janelidze S, Barthélemy NR, He Y, Bateman RJ, Hansson O. Mitigating the associations of kidney dysfunction with blood biomarkers of Alzheimer disease by using phosphorylated tau to total tau ratios. JAMA Neurol. 2023;80:516‐522. doi:10.1001/jamaneurol.2023.0199
Syrjanen JA, Campbell MR, Algeciras‐Schimnich A, et al. Associations of amyloid and neurodegeneration plasma biomarkers with comorbidities. Alzheimers Dement. 2022;18:1128‐1140. doi:10.1002/alz.12466
Morris JC, Schindler SE, McCue LM, et al. Assessment of racial disparities in biomarkers for Alzheimer disease. JAMA Neurol. 2019;76:264‐273. doi:10.1001/jamaneurol.2018.4249
Gottesman RF, Schneider AL, Zhou Y, et al. The ARIC‐PET amyloid imaging study: brain amyloid differences by age, race, sex, and APOE. Neurology. 2016;87:473‐480. doi:10.1212/wnl.0000000000002914
Windon C, Iaccarino L, Mundada N, et al. Comparison of plasma and CSF biomarkers across ethnoracial groups in the ADNI. Alzheimers Dement. 2022;14:e12315. doi:10.1002/dad2.12315
Langbaum JB, Zissimopoulos J, Au R, et al. Recommendations to address key recruitment challenges of Alzheimer's disease clinical trials. Alzheimers Dement. 2023;19:696‐707. doi:10.1002/alz.12737
National Institutes of Health. All of Us. Accessed June 18, 2024. https://allofus.nih.gov
Vanderschaeghe G, Dierickx K, Vandenberghe R. Review of the ethical issues of a biomarker‐based diagnoses in the early stage of Alzheimer's disease. J Bioeth Inq. 2018;15:219‐230. doi:10.1007/s11673‐018‐9844‐y
Arias JJ, Tyler AM, Oster BJ, Karlawish J. The proactive patient: long‐term care insurance discrimination risks of Alzheimer's disease biomarkers. J Law Med Ethics. 2018;46:485‐498. doi:10.1177/1073110518782955
Karlawish J. Addressing the ethical, policy, and social challenges of preclinical Alzheimer disease. Neurology. 2011;77:1487‐1493. doi:10.1212/WNL.0b013e318232ac1a
Largent EA, Bradbury AR. Bringing Alzheimer disease testing and results disclosure into the 21st Century Cures Act. JAMA Neurol. 2022;79:219‐220. doi:10.1001/jamaneurol.2021.4851
Lerner AJ. Biomarkers and mindfulness: a way forward. J Alzheimers Dis. 2022;90:993‐996. doi:10.3233/jad‐215592