Exploring cognitive and biological correlates of sleep quality and their potential links with Alzheimer's disease (ALFASleep project). Protocol for an observational study

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• dc.contributor.author Fauria, Karine
• dc.contributor.author Minguillón, Carolina
• dc.contributor.author Sánchez Benavides, Gonzalo
• dc.contributor.author Arenaza Urquijo, Eider M.
• dc.contributor.author Suárez-Calvet, Marc
• dc.contributor.author Domingo Gispert, Juan
• dc.contributor.author Grau-Rivera, Oriol
• dc.date.accessioned 2023-02-27T07:17:50Z
• dc.date.available 2023-02-27T07:17:50Z
• dc.date.issued 2022
• dc.description.abstract Introduction: the growing worldwide prevalence of Alzheimer's disease (AD) and the lack of effective treatments pose a dire medical challenge. Sleep disruption is also prevalent in the ageing population and is increasingly recognised as a risk factor and an early sign of AD. The ALFASleep project aims to characterise sleep with subjective and objective measurements in cognitively unimpaired middle/late middle-aged adults at increased risk of AD who are phenotyped with fluid and neuroimaging AD biomarkers. This will contribute to a better understanding of the pathophysiological mechanisms linking sleep with AD, thereby paving the way for the development of non-invasive biomarkers and preventive strategies targeting sleep. Methods and analysis: we will invite 200 participants enrolled in the ALFA+ (for ALzheimer and FAmilies) prospective observational study to join the ALFASleep study. ALFA+ participants are cognitively unimpaired middle-aged/late middle-aged adults who are followed up every 3 years with a comprehensive set of evaluations including neuropsychological tests, blood and cerebrospinal fluid (CSF) sampling, and MRI and positron emission tomography acquisition. ALFASleep participants will be additionally characterised with actigraphy and CSF-orexin-A measurements, and a subset (n=90) will undergo overnight polysomnography. We will test associations of sleep measurements and CSF-orexin-A with fluid biomarkers of AD and glial activation, neuroimaging outcomes and cognitive performance. In case we found any associations, we will test whether changes in AD and/or glial activation markers mediate the association between sleep and neuroimaging or cognitive outcomes and whether sleep mediates associations between CSF-orexin-A and AD biomarkers. Ethics and dissemination: the ALFASleep study protocol has been approved by the independent Ethics Committee Parc de Salut Mar, Barcelona (2018/8207/I). All participants have signed a written informed consent before their inclusion (approved by the same ethics committee). Study findings will be presented at national and international conferences and submitted for publication in peer-reviewed journals.
• dc.description.sponsorship This work was supported by a grant from the Alzheimer’s Association (2019-AARF-644568) awarded to OG-R. The ALFASleep study also receives funding from the Instituto de Salud Carlos III through the project PI19/00117 (cofunded by European Regional Development Fund, 'A Way to Make Europe') awarded to OG-R. Additional funding has been received from F. Hoffmann-La Roche. The ALFA+ study is funded by 'la Caixa' Foundation (ID 100010434), under agreement LCF/PR/GN17/50300004 and the Alzheimer's Association and an international anonymous charity foundation through the TriBEKa Imaging Platform project (TriBEKa‐17‐519007). OG-R is supported by the Spanish Ministry of Science, Innovation and Universities (IJC2020-043417-I). HZ is a Wallenberg Scholar supported by grants from the Swedish Research Council (#2018-02532), the European Research Council (#681712 and #101053962), Swedish State Support for Clinical Research (#ALFGBG-71320), the Alzheimer Drug Discovery Foundation (ADDF), USA (#201809-2016862), the AD Strategic Fund and the Alzheimer's Association (#ADSF-21-831376-C, #ADSF-21-831381-C and #ADSF-21-831377-C), the Olav Thon Foundation, the Erling-Persson Family Foundation, Stiftelsen för Gamla Tjänarinnor, Hjärnfonden, Sweden (#FO2019-0228), the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement number 860197 (MIRIADE), the European Union Joint Programme–Neurodegenerative Disease Research (JPND2021-00694) and the UK Dementia Research Institute at UCL (UKDRI-1003). KB is supported by the Swedish Research Council (#2017-00915), the ADDF, USA (#RDAPB-201809-2016615), the Swedish Alzheimer Foundation (#AF-930351, #AF-939721 and #AF-968270), Hjärnfonden, Sweden (#FO2017-0243 and #ALZ2022-0006), the Swedish state under the agreement between the Swedish government and the County Councils, the ALF-agreement (#ALFGBG-715986 and #ALFGBG-965240), the European Union Joint Program for Neurodegenerative Disorders (JPND2019-466-236), the National Institutes of Health, USA, (grant #1R01AG068398-01) and the Alzheimer’s Association 2021 Zenith Award (ZEN-21-848495).
• dc.format.mimetype application/pdf
• dc.identifier.citation Fauria K, Minguillon C, Knezevic I, Tort-Colet N, Stankeviciute L, Hernández L, et al. Exploring cognitive and biological correlates of sleep quality and their potential links with Alzheimer's disease (ALFASleep project). Protocol for an observational study. BMJ Open. 2022 Dec 30; 12(12): e067159. DOI: 10.1136/bmjopen-2022-067159
• dc.identifier.doi http://dx.doi.org/10.1136/bmjopen-2022-067159
• dc.identifier.issn 2044-6055
• dc.identifier.uri http://hdl.handle.net/10230/55928
• dc.language.iso eng
• dc.publisher BMJ Publishing Group
• dc.relation.projectID info:eu-repo/grantAgreement/ES/2PE/IJC2020-043417-I
• dc.rights Copyright © Fauria K, Minguillon C, Knezevic I, Tort-Colet N, Stankeviciute L, Hernández L, et al. 2022. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: http://creativecommons.org/licenses/by/4.0/.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword Dementia
• dc.subject.keyword Neurology
• dc.subject.keyword Sleep medicine
• dc.title Exploring cognitive and biological correlates of sleep quality and their potential links with Alzheimer's disease (ALFASleep project). Protocol for an observational study
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion