EPAD members report on important advances and progress

The past years were very productive and efficient for the EPAD project. In this piece, we wanted to reflect back on some of the important advances and major achievements made by each Work Package (WP).

WP1 (Scientific challenges)

Creation of 5 Scientific Advisory Groups (SAGs) – Clinical and Cognitive Outcomes, Fluid Biomarkers, Genetics, Imaging and Life Style/Non-Pharmacological Interventions
Development of recommendations/advices by the SAGs for the EPAD Register, Longitudinal Cohort Study (LCS) and the Proof of Concept (PoC) trial in order to recruit patients on a “risk spectrum”
Establishment of the EPAD LCS Research Access Committee and the EPAD Research Access Process (ERAP) for data and sample access requests through the WizeHive Zengine tool
Preparation of a state of the art report on the role of lifestyle as protective or risk factor for Alzheimer’s disease and on the perspective of non-pharmacological interventions (Lifestyle and non-pharmacological interventions SAG)
Creation of a proposed protocol for a Primary Prevention EPAD Cohort as a post-IMI sustainability strategy

WP2 (Statistical/Methodology Engine Room)

Disease modelling work focused on the development of Alzheimer’s disease risk models using historical/existing data, with the ultimate aim of translating and tailoring these models to the EPAD LCS
Development of an efficient analysis method for clinical trials and using LCS data to demonstrate the improvements
Analyses of the EPAD LCS data
Delivery of the V500.0, V1500.0 and V500.1 data releases

WP3 (Parent Cohorts and EPAD Register)

Creation of the EPAD Register built from a collaborating set of Parent Cohorts
Creation of software and platform to support the discovery and/or proposing of suitable participants and provide an alternative recruitment route for rapid inclusion of certain high-value participants
Development of an online graphic tool called ‘Subject Enrolment in EPAD’ (SEEPAD), so EPAD partners could visualise many aspects of the whole research participant recruitment process
Publication of several manuscripts on the EPAD Registry and the prescreening for EPAD Trial-Ready Cohort

WP4 (EPAD Cohort and EPAD Trials)

May 2016: First participant screened for the LCS
December 2017: 10 Trial Delivery Centers opened
February 2018: 500 participants screened for the LCS
June 2018: First letter of intent signed by an intervention owner and first appendix writing group kick-off meeting for the PoC Platform
July 2018: Launched PoC platform and had first EPAD booth at AAIC in Chicago
September 2018: 1000 participants screened for the LCS
April 2019: Second letter of intent signed by an intervention owner to join the PoC Platform
December 2019: The number of trial ready participants (Amy + and CDR 0.5) had increased to 9.7% from 5% at the beginning of 2019.
December 2019: 30 TDCs had been opened compared to 21 at the beginning of 2019
March 2020: Over 2000 participants screened for the LCS before closure

WP5 (Project Management)

9 amendments of the IMI Grant Agreement, including 2 project no-cost extensions
2 amendments of the Project Agreement
Organisation of 5 General Assembly meetings
Coordination of 4 Periodic Reports
Coordination of production – including formal review process – and submission of 63 deliverables
Work Plan monitoring and follow up on milestones achievement
Maintenance of internal repository platform (TeamworkPM), distribution lists and internal bulletin production

WP6 (Dissemination)

Communication activities were carried out in line with the strategy outlined in the Dissemination and Communication Plan with regular updates to the EPAD website, mailing of a quarterly external newsletter and active presence on social media channels
Numerous dissemination opportunities to present the project and its progress were taken at an increasing number of scientific conferences and events
More than 30 EPAD videos have been uploaded on the EPAD YouTube channel (i.e. videos, webinars)
Development of an EPAD Research Gate page to share and download EPAD publications
Development of 5 press releases and several flyers/brochures

WP7 (Business Model and Sustainability)

Creation of the 5-component model
Funding secured for the maintenance of LCS data and samples
Funding secured for communications, including maintenance of the website
International Site Network (GAP-EPAD) & Registers– Business plan in place (funding application to happen by end 2020)
EPAD Academy to potentially expand across the IMI Neurodegeneration portfolio with support from Neuronet

WP8 (Ethical, Legal and Social Implications)

Developing an ethical framework for the project
Developing a procedure and supporting materials for the communication of research results to participants as part of clinical trial recruitment
Conducting research on ethical questions related to risk communication and the experience of EPAD research participants
Working with sites across the project to set-up the EPAD Participants’ Panel

We would like to thank all the EPADistas and research participants for their work, enthusiasm and dedication to the EPAD initiative.