Developing blood-brain barrier arterial spin labelling as a non-invasive early biomarker of Alzheimer’s disease (DEBBIE-AD): a prospective observational multicohort study protocol

Author:

Padrela BeatrizORCID,Mahroo Amnah,Tee Mervin,Sneve Markus H,Moyaert Paulien,Geier OliverORCID,Kuijer Joost P A,Beun Soetkin,Nordhøy Wibeke,Zhu Yufei David,Buck Mareike A,Hoinkiss Daniel C,Konstandin Simon,Huber Jörn,Wiersinga Julia,Rikken Roos,de Leeuw Diederick,Grydeland Håkon,Tippett Lynette,Cawston Erin E,Ozturk-Isik Esin,Linn Jennifer,Brandt Moritz,Tijms Betty M,van de Giessen Elsmarieke M,Muller Majon,Fjell Anders,Walhovd Kristine,Bjørnerud Atle,Pålhaugen Lene,Selnes Per,Clement Patricia,Achten Eric,Anazodo Udunna,Barkhof Frederik,Hilal Saima,Fladby Tormod,Eickel Klaus,Morgan Catherine,Thomas David L,Petr Jan,Günther Matthias,Mutsaerts Henk J M MORCID

Abstract

IntroductionLoss of blood-brain barrier (BBB) integrity is hypothesised to be one of the earliest microvascular signs of Alzheimer’s disease (AD). Existing BBB integrity imaging methods involve contrast agents or ionising radiation, and pose limitations in terms of cost and logistics. Arterial spin labelling (ASL) perfusion MRI has been recently adapted to map the BBB permeability non-invasively. The DEveloping BBB-ASL as a non-Invasive Early biomarker (DEBBIE) consortium aims to develop this modified ASL-MRI technique for patient-specific and robust BBB permeability assessments. This article outlines the study design of the DEBBIE cohorts focused on investigating the potential of BBB-ASL as an early biomarker for AD (DEBBIE-AD).Methods and analysisDEBBIE-AD consists of a multicohort study enrolling participants with subjective cognitive decline, mild cognitive impairment and AD, as well as age-matched healthy controls, from 13 cohorts. The precision and accuracy of BBB-ASL will be evaluated in healthy participants. The clinical value of BBB-ASL will be evaluated by comparing results with both established and novel AD biomarkers. The DEBBIE-AD study aims to provide evidence of the ability of BBB-ASL to measure BBB permeability and demonstrate its utility in AD and AD-related pathologies.Ethics and disseminationEthics approval was obtained for 10 cohorts, and is pending for 3 cohorts. The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

Funder

Netherlands Organisation for health Research and Development

DEBBIE

European Union

Research Council of Norway

EU Joint Program for Neurodegenerative Disease Research

FWO in Belgium, Canadian Institutes of Health Research (CIHR) in Canada, BMBF

The Scientific and Technological Research Council of Turkey

the National Center for Advancing Translational Sciences, National Institutes of Health

ZonMw

National Medical Research Council

New Zealand Dementia Prevention Trust

Joint Programme on Neurodegenerative Disease Research

NIHR Biomedical Research Centre, Royal Marsden NHS Foundation Trust/Institute of Cancer Research

Heart Foundation

VIDI

Publisher

BMJ

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