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Diagnostic Workup

Adding biomarker evidence to your existing algorithm may help increase your confidence in diagnosing Alzheimer's disease6,16

Major advances in Alzheimer's disease (AD) research have included the development of biomarkers initially in CSF, followed by PET tracers, and more recently, in blood that can detect key pathologies, including the abnormal buildup of amyloid and tau.1,2,4,5

Blood-based biomarkers could be a key step in a diagnostic process that begins in primary care and helps to identify individuals who should be referred to specialists for further evaluation, including PET imaging or CSF analysis.7

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Other routine diagnostic tools used in the assessment of patients include3,12:

  • Routine labs (such as CBC, metabolic panel, LFTs, TSH, vitamin B12, folate)
  • Structural imaging (CT scan, MRI)
  • Neuropsychological assessment
  • FDG-PET scan

Biomarker testing may increase the confidence in your AD diagnosis in patients with cognitive impairment and help inform patient care.13,14

Biomarker testing in the diagnosis of AD13-15:

  • Is designed to identify neuropathological components of AD, in order to differentiate it from other neurodegenerative diseases and normal aging
  • May help provide a neuropathological diagnosis of AD and make services available for patients with suspected AD
  • Could increase clinician confidence in diagnosing AD*

*Based on a comparison of diagnostic confidence pre- and post-amyloid PET scans in a study of patients with cognitive impairment of unknown etiology or suspected AD.6,16

Diagnostic uncertainty 16 to 72 PET scan

Diagnostic uncertainty was reduced from 72% prior to amyloid PET to 16% post-amyloid PET scan6,16

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*This article was published prior to the FDA approval of amyloid targeting therapies.

Aβ=amyloid beta; CBC=complete blood count; CSF=cerebrospinal fluid; CT=computed tomography; FDG-PET=fluorodeoxyglucose-positron emission tomography; LFT=liver function test; MRI=magnetic resonance imaging; NFT=neurofibrillary tangle; PET=positron emission tomography; TSH=thyroid-stimulating hormone.

References:

  1. McDade E, Bednar M, Brashear HR, et al. The pathway to secondary prevention of Alzheimers Dement (N Y). 2020;6(1):1-9.
  2. Aisen PS, Cummings J, Jack CR. et al. On the path to 2025: understanding the Alzheimer's disease continuum. Alzheimers Res Ther. 2017;9(1): 1-10. https://alzres.biomedcentral.com/track/pdf/10.1186/s13195-017-0283-5.pdf . Accessed August 13, 2021.
  3. Hort J, O'Brien JT, Gainotti G, et al. EFNS guidelines for the diagnosis and management of Alzheimer’s disease.Eur J Neurol. 2010;17(10):1236-1248.
  4. Grundman M, Pontecorvo MJ, Salloway SP, et al. Potential impact of amyloid imaging on diagnosis and intended management in patients with progressive cognitive decline.Alzheimer Dis Assoc Disord. 2013:27(1):4-15.
  5. Counts SE, lkonomovic MD, Mercado N, et al. Biomarkers for the early detection and progression of Alzheimer’s disease. Neurotherapeutics. 2017;14(1):35-53.
  6. McKhann GM, Knopman DS, Chertkow H, et al. The diagnosis of dementia due to Alzheimer's disease: recommendations from the national institute on aging Alzheimer's association workgroups on diagnostic guidelines for Alzheimer’s disease.Alzheimers Dement.2011;7(3):263-269.
  7. Hampel H, O’Bryant SE, Molinuevo JL, et al. Blood-based biomarkers for Alzheimer’s disease: mapping the road to the clinic. Nat Rev Neurol. 2018;14(11):639-652.
  8. Johnson KA, Minoshima S, Bohnen NI, et al. Appropriate use criteria for amyloid PET: A report of the Amyloid Imaging Task Force, the Society of Nuclear Medicine and Molecular Imaging, and the Alzheimer's Association. Alzheimers Dement. 2013;9(1):e1-16.
  9. Teunissen CE, Verberk IMW, Thijssen EH, et al. Blood-based biomarkers for Alzheimer’s disease: towards clinical implementation. Lancet Neurol. 2022;21(1):66-77.
  10. Hansson O, Edelmayer RM, Boxer AL, et al. The Alzheimer’s Association appropriate use recommendations for blood biomarkers in Alzheimer’s disease. Alzheimer’s Dement. 2022. doi:10.1002/alz.12756
  11. Shaw LM, Arias J, Blennow K, et al. Appropriate use criteria for lumbar puncture and cerebrospinal fluid testing in the diagnosis of Alzheimer's disease. Alzheimers Dement. 2018;11:1505-1521.
  12. Albert MS, DeKosky ST, Dickson D, et al. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dement. 2011;7(3):270-279.
  13. Andersen E, Casteigne B, Chapman WD, et al. Diagnostic biomarkers in Alzheimer’s disease. Biomark Neuropsychiatry. July 15, 2021. Accessed June 27, 2022. https://doi.org/10.1016/j.bionps.2021.100041 doi:10.1016/j.bionps.2021.100041
  14. Leuzy A, Mattsson-Carlgren N, Palmqvist S, et al. Blood-based biomarkers for Alzheimer’s disease. EMBO Mol Med. 2022;14(1):e14408.
  15. Porteri C, Albanese E, Scerri C, et al; Geneva Task Force for the Roadmap of Alzheimer’s Biomarkers. The biomarker-based diagnosis of Alzheimer’s disease. 1—ethical and societal issues. Neurobiology of Aging. 2017;(52):132-140
  16. Rabinovici GD, Gatsonis C, Apgar C, et al. Association of amyloid positron emission tomography with subsequent change in clinical management among Medicare beneficiaries with mild cognitive impairment or dementia. JAMA. 2019;321(13):1286-1294.