Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers
The diagnosis of Alzheimer's disease can be improved by the use of biological measures. Biomarkers of functional impairment, neuronal loss, and protein deposition that can be assessed by neuroimaging (ie, MRI and PET) or CSF analysis are increasingly being used to diagnose Alzheimer's dise...
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| Veröffentlicht in: | Lancet neurology 2017-08, Vol.16 (8), p.661-676 |
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| creator | Frisoni, Giovanni B Boccardi, Marina Barkhof, Frederik Blennow, Kaj Cappa, Stefano Chiotis, Konstantinos Démonet, Jean-Francois Garibotto, Valentina Giannakopoulos, Panteleimon Gietl, Anton Hansson, Oskar Herholz, Karl Jack, Clifford R Nobili, Flavio Nordberg, Agneta Snyder, Heather M Ten Kate, Mara Varrone, Andrea Albanese, Emiliano Becker, Stefanie Bossuyt, Patrick Carrillo, Maria C Cerami, Chiara Dubois, Bruno Gallo, Valentina Giacobini, Ezio Gold, Gabriel Hurst, Samia Lönneborg, Anders Lovblad, Karl-Olof Mattsson, Niklas Molinuevo, José-Luis Monsch, Andreas U Mosimann, Urs Padovani, Alessandro Picco, Agnese Porteri, Corinna Ratib, Osman Saint-Aubert, Laure Scerri, Charles Scheltens, Philip Schott, Jonathan M Sonni, Ida Teipel, Stefan Vineis, Paolo Visser, Pieter Jelle Yasui, Yutaka Winblad, Bengt |
| description | The diagnosis of Alzheimer's disease can be improved by the use of biological measures. Biomarkers of functional impairment, neuronal loss, and protein deposition that can be assessed by neuroimaging (ie, MRI and PET) or CSF analysis are increasingly being used to diagnose Alzheimer's disease in research studies and specialist clinical settings. However, the validation of the clinical usefulness of these biomarkers is incomplete, and that is hampering reimbursement for these tests by health insurance providers, their widespread clinical implementation, and improvements in quality of health care. We have developed a strategic five-phase roadmap to foster the clinical validation of biomarkers in Alzheimer's disease, adapted from the approach for cancer biomarkers. Sufficient evidence of analytical validity (phase 1 of a structured framework adapted from oncology) is available for all biomarkers, but their clinical validity (phases 2 and 3) and clinical utility (phases 4 and 5) are incomplete. To complete these phases, research priorities include the standardisation of the readout of these assays and thresholds for normality, the evaluation of their performance in detecting early disease, the development of diagnostic algorithms comprising combinations of biomarkers, and the development of clinical guidelines for the use of biomarkers in qualified memory clinics. |
| doi_str_mv | 10.1016/S1474-4422(17)30159-X |
| format | Article |
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Biomarkers of functional impairment, neuronal loss, and protein deposition that can be assessed by neuroimaging (ie, MRI and PET) or CSF analysis are increasingly being used to diagnose Alzheimer's disease in research studies and specialist clinical settings. However, the validation of the clinical usefulness of these biomarkers is incomplete, and that is hampering reimbursement for these tests by health insurance providers, their widespread clinical implementation, and improvements in quality of health care. We have developed a strategic five-phase roadmap to foster the clinical validation of biomarkers in Alzheimer's disease, adapted from the approach for cancer biomarkers. Sufficient evidence of analytical validity (phase 1 of a structured framework adapted from oncology) is available for all biomarkers, but their clinical validity (phases 2 and 3) and clinical utility (phases 4 and 5) are incomplete. To complete these phases, research priorities include the standardisation of the readout of these assays and thresholds for normality, the evaluation of their performance in detecting early disease, the development of diagnostic algorithms comprising combinations of biomarkers, and the development of clinical guidelines for the use of biomarkers in qualified memory clinics.</description><identifier>ISSN: 1474-4422</identifier><identifier>EISSN: 1474-4465</identifier><identifier>DOI: 10.1016/S1474-4422(17)30159-X</identifier><identifier>PMID: 28721928</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>1984 ; 1992 ; 5-phase development framework ; Algorithms ; Alzheimer Disease - diagnosis ; Alzheimer's disease ; amyloid pet ; association workgroups ; Biomarkers ; Brain research ; Cancer ; Cerebrospinal fluid ; cerebrospinal-fluid biomarkers ; clinical ; Clinical Medicine ; Clinical trials ; Cognitive ability ; Dementia ; Diagnosis ; Early Diagnosis ; heltens p ; Humans ; Interdisciplinary aspects ; journal of neurology neurosurgery and psychiatry ; khann g ; Klinisk medicin ; Magnetic resonance imaging ; Medical and Health Sciences ; Medical diagnosis ; Medical imaging ; Medicin och hälsovetenskap ; mild cognitive impairment ; national institute ; Neurodegenerative diseases ; Neuroimaging ; Neurologi ; Neurology ; Neurosciences & Neurology ; p939 ; p967 ; Physicians ; Positron emission tomography ; Regulatory approval ; Task forces ; task-force ; tau pathology ; v34 ; v55 ; Validation Studies as Topic ; Validity</subject><ispartof>Lancet neurology, 2017-08, Vol.16 (8), p.661-676</ispartof><rights>2017 Elsevier Ltd</rights><rights>Copyright © 2017 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Aug 1, 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c703t-548509a490014835d1dbdfa3bb526e8b11ce37eda29d0f2347207249162ddef83</citedby><cites>FETCH-LOGICAL-c703t-548509a490014835d1dbdfa3bb526e8b11ce37eda29d0f2347207249162ddef83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S147444221730159X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28721928$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://gup.ub.gu.se/publication/255677$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttps://lup.lub.lu.se/record/145259c1-a2ac-476e-b62d-d030e8e18779$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:136182913$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Frisoni, Giovanni B</creatorcontrib><creatorcontrib>Boccardi, Marina</creatorcontrib><creatorcontrib>Barkhof, Frederik</creatorcontrib><creatorcontrib>Blennow, Kaj</creatorcontrib><creatorcontrib>Cappa, Stefano</creatorcontrib><creatorcontrib>Chiotis, Konstantinos</creatorcontrib><creatorcontrib>Démonet, Jean-Francois</creatorcontrib><creatorcontrib>Garibotto, Valentina</creatorcontrib><creatorcontrib>Giannakopoulos, Panteleimon</creatorcontrib><creatorcontrib>Gietl, Anton</creatorcontrib><creatorcontrib>Hansson, Oskar</creatorcontrib><creatorcontrib>Herholz, Karl</creatorcontrib><creatorcontrib>Jack, Clifford R</creatorcontrib><creatorcontrib>Nobili, Flavio</creatorcontrib><creatorcontrib>Nordberg, Agneta</creatorcontrib><creatorcontrib>Snyder, Heather M</creatorcontrib><creatorcontrib>Ten Kate, Mara</creatorcontrib><creatorcontrib>Varrone, Andrea</creatorcontrib><creatorcontrib>Albanese, Emiliano</creatorcontrib><creatorcontrib>Becker, Stefanie</creatorcontrib><creatorcontrib>Bossuyt, Patrick</creatorcontrib><creatorcontrib>Carrillo, Maria C</creatorcontrib><creatorcontrib>Cerami, Chiara</creatorcontrib><creatorcontrib>Dubois, Bruno</creatorcontrib><creatorcontrib>Gallo, Valentina</creatorcontrib><creatorcontrib>Giacobini, Ezio</creatorcontrib><creatorcontrib>Gold, Gabriel</creatorcontrib><creatorcontrib>Hurst, Samia</creatorcontrib><creatorcontrib>Lönneborg, Anders</creatorcontrib><creatorcontrib>Lovblad, Karl-Olof</creatorcontrib><creatorcontrib>Mattsson, Niklas</creatorcontrib><creatorcontrib>Molinuevo, José-Luis</creatorcontrib><creatorcontrib>Monsch, Andreas U</creatorcontrib><creatorcontrib>Mosimann, Urs</creatorcontrib><creatorcontrib>Padovani, Alessandro</creatorcontrib><creatorcontrib>Picco, Agnese</creatorcontrib><creatorcontrib>Porteri, Corinna</creatorcontrib><creatorcontrib>Ratib, Osman</creatorcontrib><creatorcontrib>Saint-Aubert, Laure</creatorcontrib><creatorcontrib>Scerri, Charles</creatorcontrib><creatorcontrib>Scheltens, Philip</creatorcontrib><creatorcontrib>Schott, Jonathan M</creatorcontrib><creatorcontrib>Sonni, Ida</creatorcontrib><creatorcontrib>Teipel, Stefan</creatorcontrib><creatorcontrib>Vineis, Paolo</creatorcontrib><creatorcontrib>Visser, Pieter Jelle</creatorcontrib><creatorcontrib>Yasui, Yutaka</creatorcontrib><creatorcontrib>Winblad, Bengt</creatorcontrib><title>Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers</title><title>Lancet neurology</title><addtitle>Lancet Neurol</addtitle><description>The diagnosis of Alzheimer's disease can be improved by the use of biological measures. Biomarkers of functional impairment, neuronal loss, and protein deposition that can be assessed by neuroimaging (ie, MRI and PET) or CSF analysis are increasingly being used to diagnose Alzheimer's disease in research studies and specialist clinical settings. However, the validation of the clinical usefulness of these biomarkers is incomplete, and that is hampering reimbursement for these tests by health insurance providers, their widespread clinical implementation, and improvements in quality of health care. We have developed a strategic five-phase roadmap to foster the clinical validation of biomarkers in Alzheimer's disease, adapted from the approach for cancer biomarkers. Sufficient evidence of analytical validity (phase 1 of a structured framework adapted from oncology) is available for all biomarkers, but their clinical validity (phases 2 and 3) and clinical utility (phases 4 and 5) are incomplete. To complete these phases, research priorities include the standardisation of the readout of these assays and thresholds for normality, the evaluation of their performance in detecting early disease, the development of diagnostic algorithms comprising combinations of biomarkers, and the development of clinical guidelines for the use of biomarkers in qualified memory clinics.</description><subject>1984</subject><subject>1992</subject><subject>5-phase development framework</subject><subject>Algorithms</subject><subject>Alzheimer Disease - diagnosis</subject><subject>Alzheimer's disease</subject><subject>amyloid pet</subject><subject>association workgroups</subject><subject>Biomarkers</subject><subject>Brain research</subject><subject>Cancer</subject><subject>Cerebrospinal fluid</subject><subject>cerebrospinal-fluid biomarkers</subject><subject>clinical</subject><subject>Clinical Medicine</subject><subject>Clinical trials</subject><subject>Cognitive ability</subject><subject>Dementia</subject><subject>Diagnosis</subject><subject>Early Diagnosis</subject><subject>heltens p</subject><subject>Humans</subject><subject>Interdisciplinary aspects</subject><subject>journal of neurology neurosurgery and psychiatry</subject><subject>khann g</subject><subject>Klinisk medicin</subject><subject>Magnetic resonance imaging</subject><subject>Medical and Health Sciences</subject><subject>Medical diagnosis</subject><subject>Medical imaging</subject><subject>Medicin och hälsovetenskap</subject><subject>mild cognitive impairment</subject><subject>national institute</subject><subject>Neurodegenerative diseases</subject><subject>Neuroimaging</subject><subject>Neurologi</subject><subject>Neurology</subject><subject>Neurosciences & Neurology</subject><subject>p939</subject><subject>p967</subject><subject>Physicians</subject><subject>Positron emission tomography</subject><subject>Regulatory approval</subject><subject>Task 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Pharma Collection</collection><collection>Lancet Titles</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Göteborgs universitet</collection><collection>SWEPUB Lunds universitet</collection><jtitle>Lancet neurology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Frisoni, Giovanni B</au><au>Boccardi, Marina</au><au>Barkhof, Frederik</au><au>Blennow, Kaj</au><au>Cappa, Stefano</au><au>Chiotis, Konstantinos</au><au>Démonet, Jean-Francois</au><au>Garibotto, Valentina</au><au>Giannakopoulos, Panteleimon</au><au>Gietl, Anton</au><au>Hansson, Oskar</au><au>Herholz, Karl</au><au>Jack, Clifford R</au><au>Nobili, Flavio</au><au>Nordberg, Agneta</au><au>Snyder, Heather M</au><au>Ten Kate, Mara</au><au>Varrone, Andrea</au><au>Albanese, Emiliano</au><au>Becker, Stefanie</au><au>Bossuyt, Patrick</au><au>Carrillo, Maria C</au><au>Cerami, Chiara</au><au>Dubois, Bruno</au><au>Gallo, Valentina</au><au>Giacobini, Ezio</au><au>Gold, Gabriel</au><au>Hurst, Samia</au><au>Lönneborg, Anders</au><au>Lovblad, Karl-Olof</au><au>Mattsson, Niklas</au><au>Molinuevo, José-Luis</au><au>Monsch, Andreas U</au><au>Mosimann, Urs</au><au>Padovani, Alessandro</au><au>Picco, Agnese</au><au>Porteri, Corinna</au><au>Ratib, Osman</au><au>Saint-Aubert, Laure</au><au>Scerri, Charles</au><au>Scheltens, Philip</au><au>Schott, Jonathan M</au><au>Sonni, Ida</au><au>Teipel, Stefan</au><au>Vineis, Paolo</au><au>Visser, Pieter Jelle</au><au>Yasui, Yutaka</au><au>Winblad, Bengt</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers</atitle><jtitle>Lancet neurology</jtitle><addtitle>Lancet Neurol</addtitle><date>2017-08-01</date><risdate>2017</risdate><volume>16</volume><issue>8</issue><spage>661</spage><epage>676</epage><pages>661-676</pages><issn>1474-4422</issn><eissn>1474-4465</eissn><abstract>The diagnosis of Alzheimer's disease can be improved by the use of biological measures. Biomarkers of functional impairment, neuronal loss, and protein deposition that can be assessed by neuroimaging (ie, MRI and PET) or CSF analysis are increasingly being used to diagnose Alzheimer's disease in research studies and specialist clinical settings. However, the validation of the clinical usefulness of these biomarkers is incomplete, and that is hampering reimbursement for these tests by health insurance providers, their widespread clinical implementation, and improvements in quality of health care. We have developed a strategic five-phase roadmap to foster the clinical validation of biomarkers in Alzheimer's disease, adapted from the approach for cancer biomarkers. Sufficient evidence of analytical validity (phase 1 of a structured framework adapted from oncology) is available for all biomarkers, but their clinical validity (phases 2 and 3) and clinical utility (phases 4 and 5) are incomplete. To complete these phases, research priorities include the standardisation of the readout of these assays and thresholds for normality, the evaluation of their performance in detecting early disease, the development of diagnostic algorithms comprising combinations of biomarkers, and the development of clinical guidelines for the use of biomarkers in qualified memory clinics.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>28721928</pmid><doi>10.1016/S1474-4422(17)30159-X</doi><tpages>16</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1474-4422 |
| ispartof | Lancet neurology, 2017-08, Vol.16 (8), p.661-676 |
| issn | 1474-4422 1474-4465 |
| language | eng |
| recordid | cdi_swepub_primary_oai_swepub_ki_se_495341 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | 1984 1992 5-phase development framework Algorithms Alzheimer Disease - diagnosis Alzheimer's disease amyloid pet association workgroups Biomarkers Brain research Cancer Cerebrospinal fluid cerebrospinal-fluid biomarkers clinical Clinical Medicine Clinical trials Cognitive ability Dementia Diagnosis Early Diagnosis heltens p Humans Interdisciplinary aspects journal of neurology neurosurgery and psychiatry khann g Klinisk medicin Magnetic resonance imaging Medical and Health Sciences Medical diagnosis Medical imaging Medicin och hälsovetenskap mild cognitive impairment national institute Neurodegenerative diseases Neuroimaging Neurologi Neurology Neurosciences & Neurology p939 p967 Physicians Positron emission tomography Regulatory approval Task forces task-force tau pathology v34 v55 Validation Studies as Topic Validity |
| title | Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-03T23%3A32%3A42IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_swepu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Strategic%20roadmap%20for%20an%20early%20diagnosis%20of%20Alzheimer's%20disease%20based%20on%20biomarkers&rft.jtitle=Lancet%20neurology&rft.au=Frisoni,%20Giovanni%20B&rft.date=2017-08-01&rft.volume=16&rft.issue=8&rft.spage=661&rft.epage=676&rft.pages=661-676&rft.issn=1474-4422&rft.eissn=1474-4465&rft_id=info:doi/10.1016/S1474-4422(17)30159-X&rft_dat=%3Cproquest_swepu%3E1920395361%3C/proquest_swepu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1919451405&rft_id=info:pmid/28721928&rft_els_id=S147444221730159X&rfr_iscdi=true |