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individuals with IWG-1 defined prodromal AD. Based on centrally analyzed baseline biomarkers, participants were classified according to the IWG-2 and National Institute on Aging\u2013Alzheimer\u2019s Association (NIA-AA) 2011 and 2018 criteria. Linear mixed models were used to investigate the 2-year change in cognitive and functional performance (Neuropsychological Test Battery NTB <jats:italic>Z<\/jats:italic> scores, Clinical Dementia Rating-Sum of Boxes CDR-SB) (criteria \u00d7 time interactions; baseline score, randomization group, sex, Mini-Mental State Examination (MMSE), and age also included in the models). Cox models adjusted for randomization group, MMSE, sex, age, and study site were used to investigate the risk of progression to dementia over 2 years.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>In total, 88%, 86%, and 69% of participants had abnormal cerebrospinal fluid (CSF) \u03b2-amyloid, total tau, and phosphorylated tau, respectively; 64% had an A+T+N+ profile (CSF available for <jats:italic>N<\/jats:italic>\u2009=\u2009107). Cognitive-functional decline appeared to be more pronounced in the IWG-2 prodromal AD, NIA-AA 2011 high and intermediate AD likelihood, and NIA-AA 2018 AD groups, but few significant differences were observed between the groups within each set of criteria. Hazard ratio (95% CI) for dementia was 4.6 (1.6\u201313.7) for IWG-2 prodromal AD (reference group no prodromal AD), 7.4 (1.0\u201354.7) for NIA-AA 2011 high AD likelihood (reference group suspected non-AD pathology SNAP), and 9.4 (1.2\u201372.7) for NIA-AA 2018 AD (reference group non-Alzheimer\u2019s pathologic change). Compared with the NIA-AA 2011 high AD likelihood group (abnormal \u03b2-amyloid and neuronal injury markers), disease progression was similar in the intermediate AD likelihood group (medial temporal lobe atrophy; no CSF available).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Despite being less restrictive than the other criteria, the IWG-1 criteria reliably identified individuals with AD pathology. More pragmatic and easily applicable selection criteria might be preferred due to feasibility\u00a0in certain situations, e.g., in multidomain prevention trials that do not specifically target \u03b2-amyloid\/tau pathologies.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>Netherlands Trial Register, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.trialregister.nl\/trial\/1620\">NL1620<\/jats:ext-link>. Registered on 9 March 2009<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13195-021-00799-3","type":"journal-article","created":{"date-parts":[[2021,3,25]],"date-time":"2021-03-25T18:41:25Z","timestamp":1616697685000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Research diagnostic criteria for Alzheimer\u2019s disease: findings from the LipiDiDiet randomized controlled trial"],"prefix":"10.1186","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1456-7991","authenticated-orcid":false,"given":"Anna","family":"Rosenberg","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alina","family":"Solomon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hilkka","family":"Soininen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pieter Jelle","family":"Visser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaj","family":"Blennow","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias","family":"Hartmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miia","family":"Kivipelto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the LipiDiDiet clinical study group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hilkka","family":"Soininen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilona","family":"Hallikainen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Merja","family":"Hallikainen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seppo","family":"Helisalmi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tarja","family":"Lappalainen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yawu","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teemu","family":"Paajanen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miia","family":"Kivipelto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alina","family":"Solomon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars-Olof","family":"Wahlund","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yvonne","family":"Freund-Levi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G\u00f6ran","family":"Hagman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaj","family":"Blennow","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias","family":"Hartmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Klaus","family":"Fassbender","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Riemenschneider","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcus O. 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Approval was obtained from the following committees: Ethics committee of the Hospital District of Northern Savo in Finland (Pohjois-Savon sairaanhoitopiirin tutkimuseettinen toimikunta), the Stockholm Regional Ethical Review Board in Sweden (Regionala etikpr\u00f6vningsn\u00e4mnden i Stockholm), the Medical Ethical Committee of the VU University Medical Center Amsterdam in the Netherlands (Medisch Ethische Toetsingscommissie VU medisch centrum), and the ethical committees of University of Regensburg (Fakult\u00e4t Medizin Ethikkommission Universit\u00e4t Regensburg), Eberhards-Karls-University of T\u00fcbingen and T\u00fcbingen University Hospital Clinic (Ethik-Kommission an der Medizinischen Fakult\u00e4t der Eberhard-Karls-Universit\u00e4t und am Universit\u00e4tsklinikum T\u00fcbingen), Heidelberg University (Ethikkommission Medizinische Fakult\u00e4t Heidelberg), the Medical faculty in Mannheim (Medizinische Fakult\u00e4t Mannheim Medizinische Ethik-Kommission II), and Saarland University (Ethik-Kommission \u00c4rtzekammer des Saarlandes) in Germany.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The LipiDiDiet consortium received funding by Danone Nutricia Research for the intervention period from 25 to 96 months, and the consortium distributed the funding to their members to conduct the trial and analysis. HS reports personal fees from ACI and MERCK (advisor), outside the submitted work. KB has served as a consultant, at advisory boards, or at data monitoring committees for Abcam, Axon, Biogen, JOMDD\/Shimadzu, Julius Clinical, Lilly, MagQu, Novartis, Roche Diagnostics, and Siemens Healthineers and is a co-founder of Brain Biomarker Solutions in Gothenburg AB (BBS), which is a part of the GU Ventures Incubator Program (disclosures not relevant for the submitted work). AR, AS, PJV, TH, and MK report no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"64"}}