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Framework for clinical trials in cerebral small vessel disease (FINESSE)

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dc.contributor.authorMarkus, Hugh S.
dc.contributor.authorvan Der Flier, Wiesje M.
dc.contributor.authorSmith, Eric E.
dc.contributor.authorBath, Philip
dc.contributor.authorBiessels, Geert Jan
dc.contributor.authorBriceno, Emily
dc.contributor.authorBrodtman, Amy
dc.contributor.authorChabriat, Hugues
dc.contributor.authorChen, Christopher
dc.contributor.authorde Leeuw, Frank-Erik
dc.contributor.authorEgle, Marco
dc.contributor.authorGanesh, Aravind
dc.contributor.authorGeorgakis, Marios K.
dc.contributor.authorGottesman, Rebecca F.
dc.contributor.authorKwon, Sun
dc.contributor.authorLauner, Lenore
dc.contributor.authorMok, Vincent
dc.contributor.authorO’Brien, John
dc.contributor.authorOttenhoff, Lois
dc.contributor.authorPendlebury, Sarah
dc.contributor.authorRichard, Edo
dc.contributor.authorSachdev, Perminder
dc.contributor.authorSchmidt, Reinhold
dc.contributor.authorSpringer, Melanie
dc.contributor.authorTiedt, Stefan
dc.contributor.authorWardlaw, Joanna M.
dc.contributor.authorVerdelho, Ana
dc.contributor.authorWebb, Alastair
dc.contributor.authorWerring, David
dc.contributor.authorDuering, Marco
dc.contributor.authorLevine, Deborah
dc.contributor.authorDichgans, Martin
dc.date.accessioned2024-07-24T11:19:12Z
dc.date.available2024-07-24T11:19:12Z
dc.date.issued2022
dc.description© 2022 American Medical Association. All rights reserved.pt_PT
dc.description.abstractImportance: Cerebral small vessel disease (SVD) causes a quarter of strokes and is the most common pathology underlying vascular cognitive impairment and dementia. An important step to developing new treatments is better trial methodology. Disease mechanisms in SVD differ from other stroke etiologies; therefore, treatments need to be evaluated in cohorts in which SVD has been well characterized. Furthermore, SVD itself can be caused by a number of different pathologies, the most common of which are arteriosclerosis and cerebral amyloid angiopathy. To date, there have been few sufficiently powered high-quality randomized clinical trials in SVD, and inconsistent trial methodology has made interpretation of some findings difficult. Observations: To address these issues and develop guidelines for optimizing design of clinical trials in SVD, the Framework for Clinical Trials in Cerebral Small Vessel Disease (FINESSE) was created under the auspices of the International Society of Vascular Behavioral and Cognitive Disorders. Experts in relevant aspects of SVD trial methodology were convened, and a structured Delphi consensus process was used to develop recommendations. Areas in which recommendations were developed included optimal choice of study populations, choice of clinical end points, use of brain imaging as a surrogate outcome measure, use of circulating biomarkers for participant selection and as surrogate markers, novel trial designs, and prioritization of therapeutic agents using genetic data via Mendelian randomization. Conclusions and relevance: The FINESSE provides recommendations for trial design in SVD for which there are currently few effective treatments. However, new insights into understanding disease pathogenesis, particularly from recent genetic studies, provide novel pathways that could be therapeutically targeted. In addition, whether other currently available cardiovascular interventions are specifically effective in SVD, as opposed to other subtypes of stroke, remains uncertain. FINESSE provides a framework for design of trials examining such therapeutic approaches.pt_PT
dc.description.sponsorshipThe workshops were supported by an LMU-University of Cambridge joint funding initiative. Profs Markus and O’Brien are supported by the National Institutes of Health Research Cambridge Biomedical Research Centre (grant BRC-1215-20014) and Dr Pendlebury is supported by the National Institutes of Health Research Oxford Biomedical Research Centre. Dr Tiedt is supported by the Corona Foundation and received funding from the Deutsche Forschungsgemeinschaft (grant 413635475) and the Munich Clinician Scientist Program of LMU Munich. Dr Levine was supported by the National Institutes of Health (grants R01 NS102715, R01 AG051827, and RF1 AG068410). Dr Launer is supported by the Intramural Research Program, National Institute on Aging. Dr van der Flier is supported by the Pasman stichting. Ms Ottenhoff is appointed on OTAPA, a collaboration cofunded by the PPP Allowance made available by Health~Holland and Brain Research Center (grant LSHM19051). Dr Ganesh reports funding from Alberta Innovates, the Canadian Institutes of Health Research, the Canadian Cardiovascular Society, the Sunnybrook Research Institute INOVAIT program, and the University of Calgary. Prof Wardlaw is supported by the UK Dementia Research Institute, which receives its funding from DRI Ltd, funded by the UK Medical Research Council, Alzheimer’s Society and Alzheimer’s Research UK and by the British Heart Foundation, the Stroke Association, the Fondation Leducq, the EU Horizon 2020, and Row Fogo Charitable Trust. Dr Chen is funded by the National Medical Research Council of Singapore. Dr Georgakis is supported by a Walter-Benjamin fellowship from the German Research Foundation (grant 3461/1-1). Dr Springer is funded by the National Institute of Neurological Disorders and Stroke (grant K01 NS117555). Dr Chabriat is funded by RHU TRT_cerebral small vessel diseases (Agence Nationale de la Recherche grant, Recherche Hospitalo-Universitaire TRT_cSVD; ANR:16-RHUS-0004) and Association de Recherche en Neurologie Vasculaire. Dr Dichgans is supported by the European Union’s Horizon 2020 research and innovation program No 666881, SVDs@target, the Munich Cluster for Systems Neurology (EXC 2145 SyNergy [ID 390857198]), and the Vascular Dementia Research Foundation.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationJAMA Neurol. 2022 Nov 1;79(11):1187-1198pt_PT
dc.identifier.doi10.1001/jamaneurol.2022.2262pt_PT
dc.identifier.eissn2168-6157
dc.identifier.issn2168-6149
dc.identifier.urihttp://hdl.handle.net/10451/65437
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherAmerican Medical Associationpt_PT
dc.relation666881pt_PT
dc.relation.publisherversionhttps://jamanetwork.com/journals/jamaneurologypt_PT
dc.titleFramework for clinical trials in cerebral small vessel disease (FINESSE)pt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage1198pt_PT
oaire.citation.issue11pt_PT
oaire.citation.startPage1187pt_PT
oaire.citation.titleJAMA Neurologypt_PT
oaire.citation.volume79pt_PT
person.familyNameVerdelho
person.givenNameAna
person.identifier.ciencia-idFC14-938F-EBBD
person.identifier.orcid0000-0003-4945-4946
person.identifier.scopus-author-id6602902026
rcaap.rightsrestrictedAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublication11ec545d-3044-4ffd-b658-578d00f82d2a
relation.isAuthorOfPublication.latestForDiscovery11ec545d-3044-4ffd-b658-578d00f82d2a

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