Rombach, Ines http://orcid.org/0000-0003-3464-3867
Iftikhar, Marvi
Jhuti, Gurleen S.
Gustavsson, Anders
Lecomte, Pascal
Belger, Mark
Handels, Ron
Castro Sanchez, Amparo Y.
Kors, Jan
Hopper, Louise http://orcid.org/0000-0002-9382-5241
Olde Rikkert, Marcel
Selbæk, Geir
Stephan, Astrid
Sikkes, Sietske A. M.
Woods, Bob
Gonçalves-Pereira, Manuel
Zanetti, Orazio
Ramakers, Inez H. G. B.
Verhey, Frans R. J.
Gallacher, John
Actifcare Consortium,
LeARN Consortium,
Landeiro, Filipa
Gray, Alastair M.
,
Funding for this research was provided by:
Fuel Cells and Hydrogen Joint Undertaking (116020)
University of Oxford
Article History
Accepted: 3 October 2020
First Online: 17 October 2020
Compliance with ethical standards
:
: The authors declare the following conflict of interest: Gurleen S Jhuti is an employee of F. Hoffmann-La Roche Ltd. Anders Gustavsson is a partner of Quantify Research, providing consultancy services to pharmaceutical companies and other private and public organisations and institutions. Anders Gustavson’s contribution to ROADMAP was on behalf of Roche Pharmaceuticals. Pascal Lecomte is a full-time employee of Novartis and holds stocks of Novartis. Mark Belger is an employee and shareholder of Eli Lilly and Company. Ron Handels reports the following to conduct this study: grants from ROADMAP (IMI2; public-private collaboration; 2016–2019); Ron Handels reports the following outside this study: consulting fees from Piramal, Roche and Eisai; grants from Horizon 2020, JPND Joint Programming Neurodegenerative Disease Research, IMI Innovative Medicines Initiative, and national, European and patient charity funding organizations and private-public collaborations (ZonMw Netherlands; Alzheimer Netherlands; Dutch Flutemetamol Study; Alzheimer Research UK; Swedish National study on Aging and Care; European Brain Council). Yovanna Castro: Yovanna Castro is an employee of F. Hoffmann-La Roche Ltd. F. Hoffmann-La Roche Ltd. is an industry partner in the ROADMAP project. Ines Rombach, Filipa Landeiro and Alastair M Gray report grants from Innovative Medicines Initiative 2 Joint Undertaking during the conduct of the study. The remaining authors have no conflict of interest to declare.
: Appropriate ethical approvals were obtained by the Actifcare and LeARN study teams. For Actifcare, all individual countries applied for medical ethical approval in their own country. Ethical consideration differs between countries: Medischeethische toetsingscommissie (NL), Wales Research Ethics Committee 5, Bangor (UK), Ethics committee of the Medical Faculty, Martin Luther University Halle-Wittenberg (DE), Regional committee for medical and health research ethics, South-East B (NO), the Regional Ethics Review Board (SW), Dublin City University Research Ethics Committee (IE), Ethics Committee of the Nova Medical School, Ethics Committee of Centro Hospitalar de Lisboa Ocidental, Ethics Committee of ARSLVT, Ethics Committee of ARSA, Comissão Nacional de Protecção de Dados (PT). Comitato Etico, IRCCS San Giovanni di Dio-Fatebenefratelli (IT). This project recruited people with dementia, and aimed to ask the patient for informed consent, in case the patient was still able to give consent for themselves. When a patient was not able to give informed consent, the legal procedures in the specific country were followed. Generally, this meant that where persons with dementia lacked capacity, or lost capacity during the study, their carer (personal consultee) was consulted regarding participants of the person with dementia. Sometimes, legal representatives or close family members were consulted. For the LeARN study, ethical approval was granted by the medical ethics committee “MedischEthischeCommissieazM/UM”. Only participants capable of deciding on their participation were recruited.