{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:49:06Z","timestamp":1792788546235,"version":"4.5.0"},"reference-count":191,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,10,12]],"date-time":"2018-10-12T00:00:00Z","timestamp":1539302400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["U19-AG024904"],"award-info":[{"award-number":["U19-AG024904"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000049","name":"National Institute on Aging","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000049","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["alz-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Alzheimer's &amp;amp; Dementia"],"published-print":{"date-parts":[[2019,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The overall goal of the Alzheimer's Disease Neuroimaging Initiative (ADNI) is to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI is a multisite, longitudinal, observational study that has collected many biomarkers since 2004. Recent publications highlight the multifactorial nature of late\u2010onset AD. We discuss selected topics that provide insights into AD progression and outline how this knowledge may improve clinical trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We used standard methods to identify nearly 600 publications using ADNI data from 2016 and 2017 (listed in Supplementary Material and searchable at\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/adni.loni.usc.edu\/news-publications\/publications\/\">http:\/\/adni.loni.usc.edu\/news\u2010publications\/publications\/<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      (1) Data\u2010driven AD progression models supported multifactorial interactions rather than a linear cascade of events. (2) \u03b2\u2010Amyloid (A\u03b2) deposition occurred concurrently with functional connectivity changes within the default mode network in preclinical subjects and was followed by specific and progressive disconnection of functional and anatomical networks. (3) Changes in functional connectivity, volumetric measures, regional hypometabolism, and cognition were detectable at subthreshold levels of A\u03b2 deposition. 4. Tau positron emission tomography imaging studies detailed a specific temporal and spatial pattern of tau pathology dependent on prior A\u03b2 deposition, and related to subsequent cognitive decline. 5. Clustering studies using a wide range of modalities consistently identified a \u201ctypical AD\u201d subgroup and a second subgroup characterized by executive impairment and widespread cortical atrophy in preclinical and prodromal subjects. 6. Vascular pathology burden may act through both A\u03b2 dependent and independent mechanisms to exacerbate AD progression. 7. The\n                      <jats:italic>APOE<\/jats:italic>\n                      \u03b54 allele interacted with cerebrovascular disease to impede A\u03b2 clearance mechanisms. 8. Genetic approaches identified novel genetic risk factors involving a wide range of processes, and demonstrated shared genetic risk for AD and vascular disorders, as well as the temporal and regional pathological associations of established AD risk alleles. 9. Knowledge of early pathological changes guided the development of novel prognostic biomarkers for preclinical subjects. 10. Placebo populations of randomized controlled clinical trials had highly variable trajectories of cognitive change, underscoring the importance of subject selection and monitoring. 11. Selection criteria based on A\u03b2 positivity, hippocampal volume, baseline cognitive\/functional measures, and\n                      <jats:italic>APOE<\/jats:italic>\n                      \u03b54 status in combination with improved cognitive outcome measures were projected to decrease clinical trial duration and cost. 12. Multiple concurrent therapies targeting vascular health and other AD pathology in addition to A\u03b2 may be more effective than single therapies.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>ADNI publications from 2016 and 2017 supported the idea of AD as a multifactorial disease and provided insights into the complexities of AD disease progression. These findings guided the development of novel biomarkers and suggested that subject selection on the basis of multiple factors may lower AD clinical trial costs and duration. The use of multiple concurrent therapies in these trials may prove more effective in reversing AD disease progression.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1016\/j.jalz.2018.08.005","type":"journal-article","created":{"date-parts":[[2018,10,13]],"date-time":"2018-10-13T02:02:22Z","timestamp":1539396142000},"page":"106-152","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":457,"title":["Understanding disease progression and improving Alzheimer's disease clinical trials: Recent highlights from the Alzheimer's Disease Neuroimaging Initiative"],"prefix":"10.1002","volume":"15","author":[{"given":"Dallas P.","family":"Veitch","sequence":"first","affiliation":[{"name":"Department of Veterans Affairs Medical Center Center for Imaging of Neurodegenerative Diseases San Francisco CA USA"},{"name":"Northern California Institute for Research and Education (NCIRE) Department of Veterans Affairs Medical Center San Francisco CA 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of Public Health Sciences University of California Davis CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nigel J.","family":"Cairns","sequence":"additional","affiliation":[{"name":"Knight Alzheimer's Disease Research Center Washington University School of Medicine Saint Louis MO USA"},{"name":"Department of Neurology Washington University School of Medicine Saint Louis MO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert C.","family":"Green","sequence":"additional","affiliation":[{"name":"Division of Genetics Department of Medicine Brigham and Women's Hospital and Harvard Medical School Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danielle","family":"Harvey","sequence":"additional","affiliation":[{"name":"Division of Biostatistics Department of Public Health Sciences University of California Davis CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr.","given":"Clifford 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