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Article History

Received: 15 May 2018

Accepted: 10 September 2018

First Online: 12 October 2018

Ethics approval and consent to participate

: Twenty-one centers in Europe (Belgium, Finland, France, Germany, Spain, Sweden and The Netherlands) participated in the study. The independent ethic committees at each site approved the protocol and amendments and the informed-consent documentation. All subjects and their caregiver provided written informed consent to participate in the study. The study was conducted in compliance with the declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines.

: All authors approved the final version of the manuscript for submission.

: PS has received consultancy/speaker fees (paid to the institution) from Eli-Lilly, GE Healthcare, Novartis, Probiodrug, Biogen, Roche, TauRx and EIP Pharma; he holds no stocks or options in Probiodrug. TG reported as an investigator and the national coordinating investigator for Germany in this trial; outside the submitted work he received consulting fees from Actelion, Eli Lilly, MSD, Novartis, Quintiles and Roche Pharma, lecture fees from Biogen, Lilly, Parexel and Roche Pharma, and grants to his institution from Actelion and PreDemTech. AAG received research support from Probiodrug and received research support from Boehringer Ingelheim via the VUmc Alzheimer Center. CET has functioned on advisory boards of Fujirebio and Roche, received nonfinancial support in the form of research consumables from ADxNeurosciences and Euroimmun, and performed contract research or received grants from Janssen Prevention Center, Boehringer, Brainsonline, AxonNeurosciences, EIP farma and Roche which are all unrelated to the present work. JH has in the past 2 years received honoraria and/or consulting fees from 23andMe, AbbVie, Access to Quality, AlzCure, Amgen, Anavex, Astellas Pharma, AstraZeneca, Avonex, Avraham, Axon, Axovant, Biogen Idec, Boehringer Ingelheim, Bracket, C4X Discovery, Cambridge Brain Sciences, Catenion, Cognitive Therapeutics, Compass Pathways, DeNDRoN, Enzymotec, Eisai, Eli Lilly, Forum Pharma, Fresh Forward, GfHEu, Heptares, Janssen AI, Johnson & Johnson, Kaasa Health, Kyowa Hakko Kirin, LivaNova PLC, Lundbeck, MedAvante, Merck, MyCognition, Neurocog, Neurotrack, Novartis, Nutricia, Pfizer, Prana Biotech, Probiodrug, Prophase, ProStrakan, Regeneron, Reviva, Roche, Sanofi, Servier, Shire, Takeda, TCG, TransTech Pharma and Velacor. IL is an employee and shareholder of Probiodrug. NDP serves on the advisory board of Boehringer Ingelheim and Probiodrug, and is a member of the DSMB of Abbvie’s M15-566 trial; he has received consultancy or speaker fees from Sanofi, Takeda, Janssen and Novartis; and he is CEO and co-owner of the Brain Research Center, Amsterdam. The remaining authors declare that they have no conflicts of interest.

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