The EPAD LCS is an ongoing prospective, multicentre, pan-European longitudinal cohort study. Participants are recruited mainly from existing parent cohorts across Europe to form a ‘probability-spectrum’ population covering the entire continuum of anticipated probability for Alzheimer’s dementia development. The primary objective of the EPAD LCS is to be a readiness cohort for the EPAD PoC trial though a second major objective is to generate a comprehensive and large data set for disease modelling of preclinical and prodromal Alzheimer’s disease. The number of research participants is 1991 (Last update January 2020). The LCS is led by University of Edinburgh. For more information, please visit:

http://ep-ad.org/open-access-data/overview/

The EPAD LCS data is made available in secure online Workspaces in order to facilitate collaboration between people and teams with similar research aims. The dataset definition document can be accessible on the ERAP page of the EPAD website along with the different versions of the EPAD protocol, videos and tutorial to access the data. For more information, please visit:

http://ep-ad.org/erap/

The EPAD LCS is an ongoing prospective, multicentre, pan-European longitudinal cohort study. Participants are recruited mainly from existing parent cohorts across Europe to form a ‘probability-spectrum’ population covering the entire continuum of anticipated probability for Alzheimer’s dementia development. The EPAD LCS study has collected CSF, blood, urine and saliva samples in its BioBank, currently located at the Roslin Research Institute at the University of Edinburgh. These samples will be used for future biomarker assessments (emerging AD biomarkers). For more information please see:

https://bmjopen.bmj.com/content/8/12/e021017

The EPAD Trial Delivery Centre (TDC) network is formed by the TDCs contributing to the EPAD LCS study and intending to participate in the EPAD PoC study. EPAD currently has 28 study sites and plans to initiate 40 TDCs prior to the end of the IMI funding period (June 2020). The TDCs that are part of the TDC network have been certified and approved by the Chief Investigator (CI) & the Sponsor (UEDIN). For more information please visit:

http://ep-ad.org/for-research-participants/why-participate-in-epad/trial-locations/

The EPAD register is a pan-European register of over half a million people across the risk spectrum for dementia, led by VUMC and Pfizer. It has been developed to function as a reservoir of potential research participants for the EPAD LCS study. It is made up of a set of collaborating Parent Cohorts (PCs) across Europe that remain independent and secure, but simultaneously constitute a ‘virtual’ collection of subjects from which suitable participants can be discovered and selected, on the basis of known risk factors and markers, for the trial-ready LCS. The EPAD Register will also be the main source of recruitment to EPAD PoC from 2021. For more information please visit:

https://doi.org/10.1016/j.jalz.2018.02.010

http://ep-ad.org/the-epad-platform/the-epad-platform/

The EPAD PoC trial platform is available to any pharmaceutical company or biotech interested in testing a compound in PhII for the prevention of AD. It uses the TDC network, recruits from EPAD LCS and EPAD Register. The PoC Platform facilitates for different Intervention Owners to run their Appendix on the PoC trial, with the University of Edinburgh as the trial Sponsor and IQVIA as the Trial CRO. The PoC trial platform is based on a Master PoC Protocol and Intervention Owner-specific Appendices. The PoC trial allows an adaptive design including an equal randomisation across Appendices and a 3:1 randomisation within each Appendix to active treatment and placebo. Within the PoC trial, placebo arms can be shared across different Intervention Owners. Intervention Owners can approach EPAD by email epad.poc@ed.ac.uk. For more information, please visit:

http://ep-ad.org/for-intervention-owners/epad-benefits/ 

Creation of the EPAD register has also generated an array of software tools and processes, including the PREPAD tool for federated discovery of suitable subjects (‘Participant Registry in EPAD’). In addition, Aridhia has created a monitoring application for batch-level tracking of all pre-screening steps two databases for checking and integration of all Registry activities at the subject level (the ‘Central Archive’ and ‘Current Status’ databases), as well as custom scripts for data transformation and harmonisation. For more information, please visit:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318591/

Creation of the EPAD register has also generated an array of software tools and processes, including the DerIDIOM tool for ID encryption and matching ('DerID Input Output Management'). In addition, Aridhia has created a monitoring application for batch-level tracking of all pre-screening steps two databases for checking and integration of all Registry activities at the subject level (the ‘Central Archive’ and ‘Current Status’ databases), as well as custom scripts for data transformation and harmonisation. For more information, please visit:

http://ep-ad.org/?mdocs-file=958

Creation of the EPAD register has also generated an array of software tools and processes, including the VEEPAD tool for rapid controlled registration of high-value subjects (‘VElocity for EPAD’). In addition, Aridhia has created a monitoring application for batch-level tracking of all pre-screening steps two databases for checking and integration of all Registry activities at the subject level (the ‘Central Archive’ and ‘Current Status’ databases), as well as custom scripts for data transformation and harmonisation. For more information, please visit:

http://ep-ad.org/

Creation of the EPAD register has also generated an array of software tools and processes, including the SEEPAD tool for semi-real-time and historical visual exploration of the Register and enrolment activities (‘Subject Enrolment in EPAD’ or SEEPAD). In addition, Aridhia has created a monitoring application for batch-level tracking of all pre-screening steps two databases for checking and integration of all Registry activities at the subject level (the ‘Central Archive’ and ‘Current Status’ databases), as well as custom scripts for data transformation and harmonisation. For more information, please visit:

http://ep-ad.org/?wysija-page=1&controller=email&action=view&email_id=29&wysijap=subscriptions

One of the objectives of EPAD is to investigate the ethical, legal and social implications of disclosure of biomarker results and the associated risk of AD dementia. This work has been reported in WP8 Deliverable 8.4 – Interim report on ethical and social implications of biomarker disclosure: approaches to disclosure in EPAD and in a number of scientific publications. For more information, please visit:

http://ep-ad.org/mdocs-posts/wp8-deliverable-d8-4-interim-report-on-ethical-and-social-implications-of-biomarker-disclosure-approaches-to-disclosure-in-epad/

EPAD WP4 focuses on the selection and certification of the EPAD trial delivery centres, and the EPAD Cohort protocol early in the project, as well as the design and execution of the Proof-of-Concept (PoC) study. The team also oversees the execution of the protocols for the EPAD cohort and trials and work with National/Regional Leads and Clinical Research Organisations (CROs) on qualification, establishment and training of the EPAD trial delivery centres. For more information, please visit:

http://ep-ad.org/mdocs-posts/wp4-deliverable-4-14-update-on-epad-trial-delivery-centres-and-pi-network-activities/

EPAD has established an open dialogue with participants in the EPAD studies, giving them an active role in influencing the design, conduct and reporting of research. The research participant panel involves a small group of EPAD research participants from several European countries who participate in regular meetings to identify issues associated with participation, disclosure, consent and privacy. The Participant Panel provides feedback on the study experience, reviewing study documentation and acting as participant representatives in decision-making processes that directly affect them. For more information, please visit:

http://ep-ad.org/for-research-participants/epad-cohort-study/the-research-participant-panel/

ttps://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/approaches-to-the-communication-of-alzheimers-disease-risk-acar/

The EPAD Academy aims to efficiently leverage EPAD resources to foster and develop academic research capacity and output in AD across Europe for maximum global impact. Mission: (1) to help create the next generation of AD researchers and thought leaders, by creating and facilitating opportunities for junior researchers’ career advancement, (2) to create fair and efficient procedures for EPAD and non-EPAD research teams to access EPAD data, samples and research participants with the objective of deepening the understanding of AD onset and progression, and the factors contributing to underlying processes and (3) to support the EPAD academic output in terms of scientific publications, participation in conferences and development of guidelines and studies, and to maximise their visibility and impact. It is led by CHUT. For more information, please visit: 

http://ep-ad.org/epad-academy/