NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease
In 2011, the National Institute on Aging and Alzheimer's Association created separate diagnostic recommendations for the preclinical, mild cognitive impairment, and dementia stages of Alzheimer's disease. Scientific progress in the interim led to an initiative by the National Institute on...
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| Published in | Alzheimer's & dementia Vol. 14; no. 4; pp. 535 - 562 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
01.04.2018
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| Subjects | |
| Online Access | Get full text |
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| Abstract | In 2011, the National Institute on Aging and Alzheimer's Association created separate diagnostic recommendations for the preclinical, mild cognitive impairment, and dementia stages of Alzheimer's disease. Scientific progress in the interim led to an initiative by the National Institute on Aging and Alzheimer's Association to update and unify the 2011 guidelines. This unifying update is labeled a “research framework” because its intended use is for observational and interventional research, not routine clinical care. In the National Institute on Aging and Alzheimer's Association Research Framework, Alzheimer's disease (AD) is defined by its underlying pathologic processes that can be documented by postmortem examination or in vivo by biomarkers. The diagnosis is not based on the clinical consequences of the disease (i.e., symptoms/signs) in this research framework, which shifts the definition of AD in living people from a syndromal to a biological construct. The research framework focuses on the diagnosis of AD with biomarkers in living persons. Biomarkers are grouped into those of β amyloid deposition, pathologic tau, and neurodegeneration [AT(N)]. This ATN classification system groups different biomarkers (imaging and biofluids) by the pathologic process each measures. The AT(N) system is flexible in that new biomarkers can be added to the three existing AT(N) groups, and new biomarker groups beyond AT(N) can be added when they become available. We focus on AD as a continuum, and cognitive staging may be accomplished using continuous measures. However, we also outline two different categorical cognitive schemes for staging the severity of cognitive impairment: a scheme using three traditional syndromal categories and a six-stage numeric scheme. It is important to stress that this framework seeks to create a common language with which investigators can generate and test hypotheses about the interactions among different pathologic processes (denoted by biomarkers) and cognitive symptoms. We appreciate the concern that this biomarker-based research framework has the potential to be misused. Therefore, we emphasize, first, it is premature and inappropriate to use this research framework in general medical practice. Second, this research framework should not be used to restrict alternative approaches to hypothesis testing that do not use biomarkers. There will be situations where biomarkers are not available or requiring them would be counterproductive to the specific research goals (discussed in more detail later in the document). Thus, biomarker-based research should not be considered a template for all research into age-related cognitive impairment and dementia; rather, it should be applied when it is fit for the purpose of the specific research goals of a study. Importantly, this framework should be examined in diverse populations. Although it is possible that β-amyloid plaques and neurofibrillary tau deposits are not causal in AD pathogenesis, it is these abnormal protein deposits that define AD as a unique neurodegenerative disease among different disorders that can lead to dementia. We envision that defining AD as a biological construct will enable a more accurate characterization and understanding of the sequence of events that lead to cognitive impairment that is associated with AD, as well as the multifactorial etiology of dementia. This approach also will enable a more precise approach to interventional trials where specific pathways can be targeted in the disease process and in the appropriate people. |
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| AbstractList | In 2011, the National Institute on Aging and Alzheimer's Association created separate diagnostic recommendations for the preclinical, mild cognitive impairment, and dementia stages of Alzheimer's disease. Scientific progress in the interim led to an initiative by the National Institute on Aging and Alzheimer's Association to update and unify the 2011 guidelines. This unifying update is labeled a “research framework” because its intended use is for observational and interventional research, not routine clinical care. In the National Institute on Aging and Alzheimer's Association Research Framework, Alzheimer's disease (AD) is defined by its underlying pathologic processes that can be documented by postmortem examination or in vivo by biomarkers. The diagnosis is not based on the clinical consequences of the disease (i.e., symptoms/signs) in this research framework, which shifts the definition of AD in living people from a syndromal to a biological construct. The research framework focuses on the diagnosis of AD with biomarkers in living persons. Biomarkers are grouped into those of β amyloid deposition, pathologic tau, and neurodegeneration [AT(N)]. This ATN classification system groups different biomarkers (imaging and biofluids) by the pathologic process each measures. The AT(N) system is flexible in that new biomarkers can be added to the three existing AT(N) groups, and new biomarker groups beyond AT(N) can be added when they become available. We focus on AD as a continuum, and cognitive staging may be accomplished using continuous measures. However, we also outline two different categorical cognitive schemes for staging the severity of cognitive impairment: a scheme using three traditional syndromal categories and a six-stage numeric scheme. It is important to stress that this framework seeks to create a common language with which investigators can generate and test hypotheses about the interactions among different pathologic processes (denoted by biomarkers) and cognitive symptoms. We appreciate the concern that this biomarker-based research framework has the potential to be misused. Therefore, we emphasize, first, it is premature and inappropriate to use this research framework in general medical practice. Second, this research framework should not be used to restrict alternative approaches to hypothesis testing that do not use biomarkers. There will be situations where biomarkers are not available or requiring them would be counterproductive to the specific research goals (discussed in more detail later in the document). Thus, biomarker-based research should not be considered a template for all research into age-related cognitive impairment and dementia; rather, it should be applied when it is fit for the purpose of the specific research goals of a study. Importantly, this framework should be examined in diverse populations. Although it is possible that β-amyloid plaques and neurofibrillary tau deposits are not causal in AD pathogenesis, it is these abnormal protein deposits that define AD as a unique neurodegenerative disease among different disorders that can lead to dementia. We envision that defining AD as a biological construct will enable a more accurate characterization and understanding of the sequence of events that lead to cognitive impairment that is associated with AD, as well as the multifactorial etiology of dementia. This approach also will enable a more precise approach to interventional trials where specific pathways can be targeted in the disease process and in the appropriate people. In 2011, the National Institute on Aging and Alzheimer's Association created separate diagnostic recommendations for the preclinical, mild cognitive impairment, and dementia stages of Alzheimer's disease. Scientific progress in the interim led to an initiative by the National Institute on Aging and Alzheimer's Association to update and unify the 2011 guidelines. This unifying update is labeled a “research framework” because its intended use is for observational and interventional research, not routine clinical care. In the National Institute on Aging and Alzheimer's Association Research Framework, Alzheimer's disease (AD) is defined by its underlying pathologic processes that can be documented by postmortem examination or in vivo by biomarkers. The diagnosis is not based on the clinical consequences of the disease (i.e., symptoms/signs) in this research framework, which shifts the definition of AD in living people from a syndromal to a biological construct. The research framework focuses on the diagnosis of AD with biomarkers in living persons. Biomarkers are grouped into those of β amyloid deposition, pathologic tau, and neurodegeneration [AT(N)]. This ATN classification system groups different biomarkers (imaging and biofluids) by the pathologic process each measures. The AT(N) system is flexible in that new biomarkers can be added to the three existing AT(N) groups, and new biomarker groups beyond AT(N) can be added when they become available. We focus on AD as a continuum, and cognitive staging may be accomplished using continuous measures. However, we also outline two different categorical cognitive schemes for staging the severity of cognitive impairment: a scheme using three traditional syndromal categories and a six-stage numeric scheme. It is important to stress that this framework seeks to create a common language with which investigators can generate and test hypotheses about the interactions among different pathologic processes (denoted by biomarkers) and cognitive symptoms. We appreciate the concern that this biomarker-based research framework has the potential to be misused. Therefore, we emphasize, first, it is premature and inappropriate to use this research framework in general medical practice. Second, this research framework should not be used to restrict alternative approaches to hypothesis testing that do not use biomarkers. There will be situations where biomarkers are not available or requiring them would be counterproductive to the specific research goals (discussed in more detail later in the document). Thus, biomarker-based research should not be considered a template for all research into age-related cognitive impairment and dementia; rather, it should be applied when it is fit for the purpose of the specific research goals of a study. Importantly, this framework should be examined in diverse populations. Although it is possible that β-amyloid plaques and neurofibrillary tau deposits are not causal in AD pathogenesis, it is these abnormal protein deposits that define AD as a unique neurodegenerative disease among different disorders that can lead to dementia. We envision that defining AD as a biological construct will enable a more accurate characterization and understanding of the sequence of events that lead to cognitive impairment that is associated with AD, as well as the multifactorial etiology of dementia. This approach also will enable a more precise approach to interventional trials where specific pathways can be targeted in the disease process and in the appropriate people. In 2011, the National Institute on Aging and Alzheimer’s Association created separate diagnostic recommendations for the preclinical, mild cognitive impairment, and dementia stages of Alzheimer’s disease. Scientific progress in the interim led to an initiative by the National Institute on Aging and Alzheimer’s Association to update and unify the 2011 guidelines. This unifying update is labeled a “research framework” because its intended use is for observational and interventional research, not routine clinical care. In the National Institute on Aging and Alzheimer’s Association Research Framework, Alzheimer’s disease (AD) is defined by its underlying pathologic processes that can be documented by postmortem examination or in vivo by biomarkers. The diagnosis is not based on the clinical consequences of the disease (i.e., symptoms/signs) in this research framework, which shifts the definition of AD in living people from a syndromal to a biological construct. The research framework focuses on the diagnosis of AD with biomarkers in living persons. Biomarkers are grouped into those of β amyloid deposition, pathologic tau, and neurodegeneration [AT(N)]. This ATN classification system groups different biomarkers (imaging and biofluids) by the pathologic process each measures. The AT(N) system is flexible in that new biomarkers can be added to the three existing AT(N) groups, and new biomarker groups beyond AT(N) can be added when they become available. We focus on AD as a continuum, and cognitive staging may be accomplished using continuous measures. However, we also outline two different categorical cognitive schemes for staging the severity of cognitive impairment: a scheme using three traditional syndromal categories and a six-stage numeric scheme. It is important to stress that this framework seeks to create a common language with which investigators can generate and test hypotheses about the interactions among different pathologic processes (denoted by biomarkers) and cognitive symptoms. We appreciate the concern that this biomarker-based research framework has the potential to be misused. Therefore, we emphasize, first, it is premature and inappropriate to use this research framework in general medical practice. Second, this research framework should not be used to restrict alternative approaches to hypothesis testing that do not use biomarkers. There will be situations where biomarkers are not available or requiring them would be counterproductive to the specific research goals (discussed in more detail later in the document). Thus, biomarker-based research should not be considered a template for all research into age-related cognitive impairment and dementia; rather, it should be applied when it is fit for the purpose of the specific research goals of a study. Importantly, this framework should be examined in diverse populations. Although it is possible that β-amyloid plaques and neurofibrillary tau deposits are not causal in AD pathogenesis, it is these abnormal protein deposits that define AD as a unique neurodegenerative disease among different disorders that can lead to dementia. We envision that defining AD as a biological construct will enable a more accurate characterization and understanding of the sequence of events that lead to cognitive impairment that is associated with AD, as well as the multifactorial etiology of dementia. This approach also will enable a more precise approach to interventional trials where specific pathways can be targeted in the disease process and in the appropriate people. In 2011, the National Institute on Aging and Alzheimer's Association created separate diagnostic recommendations for the preclinical, mild cognitive impairment, and dementia stages of Alzheimer's disease. Scientific progress in the interim led to an initiative by the National Institute on Aging and Alzheimer's Association to update and unify the 2011 guidelines. This unifying update is labeled a "research framework" because its intended use is for observational and interventional research, not routine clinical care. In the National Institute on Aging and Alzheimer's Association Research Framework, Alzheimer's disease (AD) is defined by its underlying pathologic processes that can be documented by postmortem examination or in vivo by biomarkers. The diagnosis is not based on the clinical consequences of the disease (i.e., symptoms/signs) in this research framework, which shifts the definition of AD in living people from a syndromal to a biological construct. The research framework focuses on the diagnosis of AD with biomarkers in living persons. Biomarkers are grouped into those of β amyloid deposition, pathologic tau, and neurodegeneration [AT(N)]. This ATN classification system groups different biomarkers (imaging and biofluids) by the pathologic process each measures. The AT(N) system is flexible in that new biomarkers can be added to the three existing AT(N) groups, and new biomarker groups beyond AT(N) can be added when they become available. We focus on AD as a continuum, and cognitive staging may be accomplished using continuous measures. However, we also outline two different categorical cognitive schemes for staging the severity of cognitive impairment: a scheme using three traditional syndromal categories and a six-stage numeric scheme. It is important to stress that this framework seeks to create a common language with which investigators can generate and test hypotheses about the interactions among different pathologic processes (denoted by biomarkers) and cognitive symptoms. We appreciate the concern that this biomarker-based research framework has the potential to be misused. Therefore, we emphasize, first, it is premature and inappropriate to use this research framework in general medical practice. Second, this research framework should not be used to restrict alternative approaches to hypothesis testing that do not use biomarkers. There will be situations where biomarkers are not available or requiring them would be counterproductive to the specific research goals (discussed in more detail later in the document). Thus, biomarker-based research should not be considered a template for all research into age-related cognitive impairment and dementia; rather, it should be applied when it is fit for the purpose of the specific research goals of a study. Importantly, this framework should be examined in diverse populations. Although it is possible that β-amyloid plaques and neurofibrillary tau deposits are not causal in AD pathogenesis, it is these abnormal protein deposits that define AD as a unique neurodegenerative disease among different disorders that can lead to dementia. We envision that defining AD as a biological construct will enable a more accurate characterization and understanding of the sequence of events that lead to cognitive impairment that is associated with AD, as well as the multifactorial etiology of dementia. This approach also will enable a more precise approach to interventional trials where specific pathways can be targeted in the disease process and in the appropriate people.In 2011, the National Institute on Aging and Alzheimer's Association created separate diagnostic recommendations for the preclinical, mild cognitive impairment, and dementia stages of Alzheimer's disease. Scientific progress in the interim led to an initiative by the National Institute on Aging and Alzheimer's Association to update and unify the 2011 guidelines. This unifying update is labeled a "research framework" because its intended use is for observational and interventional research, not routine clinical care. In the National Institute on Aging and Alzheimer's Association Research Framework, Alzheimer's disease (AD) is defined by its underlying pathologic processes that can be documented by postmortem examination or in vivo by biomarkers. The diagnosis is not based on the clinical consequences of the disease (i.e., symptoms/signs) in this research framework, which shifts the definition of AD in living people from a syndromal to a biological construct. The research framework focuses on the diagnosis of AD with biomarkers in living persons. Biomarkers are grouped into those of β amyloid deposition, pathologic tau, and neurodegeneration [AT(N)]. This ATN classification system groups different biomarkers (imaging and biofluids) by the pathologic process each measures. The AT(N) system is flexible in that new biomarkers can be added to the three existing AT(N) groups, and new biomarker groups beyond AT(N) can be added when they become available. We focus on AD as a continuum, and cognitive staging may be accomplished using continuous measures. However, we also outline two different categorical cognitive schemes for staging the severity of cognitive impairment: a scheme using three traditional syndromal categories and a six-stage numeric scheme. It is important to stress that this framework seeks to create a common language with which investigators can generate and test hypotheses about the interactions among different pathologic processes (denoted by biomarkers) and cognitive symptoms. We appreciate the concern that this biomarker-based research framework has the potential to be misused. Therefore, we emphasize, first, it is premature and inappropriate to use this research framework in general medical practice. Second, this research framework should not be used to restrict alternative approaches to hypothesis testing that do not use biomarkers. There will be situations where biomarkers are not available or requiring them would be counterproductive to the specific research goals (discussed in more detail later in the document). Thus, biomarker-based research should not be considered a template for all research into age-related cognitive impairment and dementia; rather, it should be applied when it is fit for the purpose of the specific research goals of a study. Importantly, this framework should be examined in diverse populations. Although it is possible that β-amyloid plaques and neurofibrillary tau deposits are not causal in AD pathogenesis, it is these abnormal protein deposits that define AD as a unique neurodegenerative disease among different disorders that can lead to dementia. We envision that defining AD as a biological construct will enable a more accurate characterization and understanding of the sequence of events that lead to cognitive impairment that is associated with AD, as well as the multifactorial etiology of dementia. This approach also will enable a more precise approach to interventional trials where specific pathways can be targeted in the disease process and in the appropriate people. |
| Author | Montine, Thomas Siemers, Eric Rowe, Christopher C. Karlawish, Jason Ryan, Laurie Sperling, Reisa Bennett, David A. Rankin, Katherine P. Jack, Clifford R. Silverberg, Nina Molinuevo, Jose Luis Haeberlein, Samantha Budd Phelps, Creighton Holtzman, David M. Snyder, Heather M. Masliah, Eliezer Jagust, William Dunn, Billy Jessen, Frank Elliott, Cerise Blennow, Kaj Liu, Enchi Carrillo, Maria C. Scheltens, Philip |
| AuthorAffiliation | a Department of Radiology, Mayo Clinic, Rochester, MN, USA j Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA q Department of Neurology, VU University Medical Center, Amsterdam, Netherlands l BarcelonaBeta Brain Research Center, Pasqual Maragall Foundation and Hospital Clinic-IDIBAPS, Barcelona, Spain o Department of Neurology, University of California San Francisco, San Francisco, CA, USA p Department of Molecular Imaging, Austin Health, University of Melbourne, Melbourne, Australia b Department of Neurological Sciences, Rush University, Chicago, IL, USA h Department of Public Health and Neuroscience, University of California Berkeley, Berkeley, CA, USA c Department of Psychiatry and Neurochemistry, University of Gothenburg, Gothenburg, Sweden i Department of Psychiatry, University of Cologne, Medical Faculty, Cologne, Germany n Formerly at National Institute on Aging, Bethesda, MD, USA f Biogen, Cambridge, MA, USA g Department of Neurology, Washington University, St. Lou |
| AuthorAffiliation_xml | – name: g Department of Neurology, Washington University, St. Louis, MO, USA – name: m Department of Pathology, Stanford University, Standford, CA, USA – name: n Formerly at National Institute on Aging, Bethesda, MD, USA – name: c Department of Psychiatry and Neurochemistry, University of Gothenburg, Gothenburg, Sweden – name: p Department of Molecular Imaging, Austin Health, University of Melbourne, Melbourne, Australia – name: j Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA – name: o Department of Neurology, University of California San Francisco, San Francisco, CA, USA – name: i Department of Psychiatry, University of Cologne, Medical Faculty, Cologne, Germany – name: b Department of Neurological Sciences, Rush University, Chicago, IL, USA – name: a Department of Radiology, Mayo Clinic, Rochester, MN, USA – name: h Department of Public Health and Neuroscience, University of California Berkeley, Berkeley, CA, USA – name: q Department of Neurology, VU University Medical Center, Amsterdam, Netherlands – name: s Department of Neurology, Brigham and Women’s Hospital, Boston, MA, USA – name: f Biogen, Cambridge, MA, USA – name: l BarcelonaBeta Brain Research Center, Pasqual Maragall Foundation and Hospital Clinic-IDIBAPS, Barcelona, Spain – name: d Medical & Scientific Relations, Alzheimer’s Association, Chicago, IL, USA – name: e Office of Drug Evaluation, FDA, Silver Spring, MD, USA – name: k Prothena Biosciences, Inc., San Francisco, CA, USA – name: r Formerly at Eli Lilly and Company, Indianapolis, IN, USA |
| Author_xml | – sequence: 1 givenname: Clifford R. surname: Jack fullname: Jack, Clifford R. email: jack.clifford@mayo.edu organization: Department of Radiology, Mayo Clinic, Rochester, MN, USA – sequence: 2 givenname: David A. surname: Bennett fullname: Bennett, David A. organization: Department of Neurological Sciences, Rush University, Chicago, IL, USA – sequence: 3 givenname: Kaj surname: Blennow fullname: Blennow, Kaj organization: Department of Psychiatry and Neurochemistry, University of Gothenburg, Gothenburg, Sweden – sequence: 4 givenname: Maria C. surname: Carrillo fullname: Carrillo, Maria C. organization: Medical & Scientific Relations, Alzheimer's Association, Chicago, IL, USA – sequence: 5 givenname: Billy surname: Dunn fullname: Dunn, Billy organization: Office of Drug Evaluation, FDA, Silver Spring, MD, USA – sequence: 6 givenname: Samantha Budd surname: Haeberlein fullname: Haeberlein, Samantha Budd organization: Biogen, Cambridge, MA, USA – sequence: 7 givenname: David M. surname: Holtzman fullname: Holtzman, David M. organization: Department of Neurology, Washington University, St. Louis, MO, USA – sequence: 8 givenname: William surname: Jagust fullname: Jagust, William organization: Department of Public Health and Neuroscience, University of California Berkeley, Berkeley, CA, USA – sequence: 9 givenname: Frank surname: Jessen fullname: Jessen, Frank organization: Department of Psychiatry, University of Cologne, Medical Faculty, Cologne, Germany – sequence: 10 givenname: Jason surname: Karlawish fullname: Karlawish, Jason organization: Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 11 givenname: Enchi surname: Liu fullname: Liu, Enchi organization: Prothena Biosciences, Inc., San Francisco, CA, USA – sequence: 12 givenname: Jose Luis surname: Molinuevo fullname: Molinuevo, Jose Luis organization: BarcelonaBeta Brain Research Center, Pasqual Maragall Foundation and Hospital Clinic-IDIBAPS, Barcelona, Spain – sequence: 13 givenname: Thomas surname: Montine fullname: Montine, Thomas organization: Department of Pathology, Stanford University, Standford, CA, USA – sequence: 14 givenname: Creighton surname: Phelps fullname: Phelps, Creighton organization: Formerly at National Institute on Aging, Bethesda, MD, USA – sequence: 15 givenname: Katherine P. surname: Rankin fullname: Rankin, Katherine P. organization: Department of Neurology, University of California San Francisco, San Francisco, CA, USA – sequence: 16 givenname: Christopher C. surname: Rowe fullname: Rowe, Christopher C. organization: Department of Molecular Imaging, Austin Health, University of Melbourne, Melbourne, Australia – sequence: 17 givenname: Philip surname: Scheltens fullname: Scheltens, Philip organization: Department of Neurology, VU University Medical Center, Amsterdam, Netherlands – sequence: 18 givenname: Eric surname: Siemers fullname: Siemers, Eric organization: Formerly at Eli Lilly and Company, Indianapolis, IN, USA – sequence: 19 givenname: Heather M. surname: Snyder fullname: Snyder, Heather M. organization: Medical & Scientific Relations, Alzheimer's Association, Chicago, IL, USA – sequence: 20 givenname: Reisa surname: Sperling fullname: Sperling, Reisa organization: Department of Neurology, Brigham and Women's Hospital, Boston, MA, USA – sequence: 21 givenname: Cerise surname: Elliott fullname: Elliott, Cerise – sequence: 22 givenname: Eliezer surname: Masliah fullname: Masliah, Eliezer – sequence: 23 givenname: Laurie surname: Ryan fullname: Ryan, Laurie – sequence: 24 givenname: Nina surname: Silverberg fullname: Silverberg, Nina |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29653606$$D View this record in MEDLINE/PubMed https://gup.ub.gu.se/publication/267444$$DView record from Swedish Publication Index |
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| Copyright | 2018 The Authors 2018 The Alzheimer's Association Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved. |
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| Issue | 4 |
| Keywords | Alzheimer's disease diagnosis Amyloid PET Tau PET Preclinical Alzheimer's disease CSF biomarkers Alzheimer's disease Biomarkers Alzheimer's disease Alzheimer's disease imaging |
| Language | English |
| License | This is an open access article under the CC BY-NC-ND license. Attribution-NonCommercial-NoDerivs Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
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| Notes | The listed National Institute on Aging program staff are acknowledged for their key contributions in leadership and scientific guidance on this project. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 ObjectType-Review-3 content type line 23 Contributors†: Cerise Elliott, Eliezer Masliah, Laurie Ryan, and Nina Silverberg |
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