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European Prevention of Alzheimer's Dementia Consortium
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EPAD Project Structure

EPAD was coordinated by Serge Van der Geyten and Craig Ritchie.
The success of this Project was underpinned by the coordinated activity of the different Work Packages (WPs). Although the 8 WPs are described separately below, to achieve the Project’s goals, close collaboration and cross-cutting actions of the different WPs were crucial.

Work Package 1: Scientific Challenges

Description

Integrates the scientific input to the project and addresses the central questions in AD disease modification that will drive the design of the EPAD adaptive clinical trial: who the subjects are, how should they be assessed, and with what should they be treated?

Objectives
  • To define a spectrum of individuals at risk of developing dementia due to AD.
  • To define the evaluation criteria for inclusion of participants into the EPAD Register, EPAD Cohort and EPAD Trial, and the relevant biomarkers, clinical assessments and endpoints.
  • To assess and select potential trial mechanisms and compounds, through a Clinical Candidate Selection Committee.
  • To establish and coordinate four Scientific Advisory Groups (SAGs) referring to key scientific areas that gather the needed, high-level scientific knowledge to support decisions made in WP1.
Leads

José Luis Molinuevo (BBRC)
Gary Romano (Janssen)

Deliverables
Name Downloads Version Owner Last Modified Rating
Name Downloads Version Owner Last Modified Rating
WP1 Deliverable 1.1 - Evaluation of pre-clinical and prodromal diagnostic criteria, risk spectrum and inclusion criteria for Register and Cohort
  • » epad_d1.1_evaluationcriteria.pdf
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1433 downloads 1.0 EPAD Administrator 11-02-2015
WP1 Deliverable 1.2 - Description of Compound Selection criteria and decision tree for Proof of Concept trial
  • » epad_d1.2_compoundcriteriadecisiontree.pdf
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1666 downloads 1.0 EPAD Administrator 22-12-2015
WP1 Deliverable 1.3 - Interim Report on Biomarkers, Clinical Assessments, and Outcome Measures
  • » epad_d1.3_interimreportbiomarkclinout.pdf
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1052 downloads 1.0 EPAD Administrator 02-02-2016
WP1 Deliverable 1.4 - Scientific report on compound inclusion for trial
  • » epad_d1.4_compoundselection.pdf
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904 downloads 1.0 EPAD Administrator 12-07-2016
WP1 Deliverable 1.5- Interim Report on the Scientific Recommendations and Key Outcomes
  • » 115736_epad_d1.5_reportrecomendationsoutcomeslcs.pdf
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862 downloads 1.0 EPAD Administrator 10-08-2017
WP1 Deliverable 1.6- Interim report on evaluation of biomarker and clinical assessments and outcomes from existing and acquired data
  • » 115736_EPAD_D1.6_Interim report on evaluation of biomarker and clinical assessments and outcomes from existing and acquired data_Final.pdf
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719 downloads 1.0 EPAD Administrator 30-01-2019
WP1 Deliverable 1.7- Final assessment for sustained EPAD Cohort and Trials
  • » WP1 Deliverable 1.7- Final assessment for sustained EPAD Cohort and Trials.pdf
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162 downloads 1.0 EPAD Administrator 06-07-2020
WP1 Deliverable 1.8 - Establishment of the EPAD LCS Research Access Committees
  • » 115736_EPAD_D1.8_Establishment of the EPAD LCS Research Access Committees.pdf
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384 downloads 1.0 EPAD Administrator 24-01-2020
WP1 Deliverable 1.9 - EPAD Research Access Process (ERAP) Operational Report
  • » 115736_EPAD_D1.9_ERAP_Operations_Report_Final_V2.0.pdf
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117 downloads 1.0 EPAD Administrator 04-09-2020

Work Package 2: Statistical/Methodology Engine Room

Description

The anchor for knowledge management, this WP receives all data from the EPAD register, cohort and trial for analysis to continually inform disease modelling and adaptive trial design decisions. It gathers the tools and resources that will be used for disease modelling, assessing and preparing them for exploitation and setting up procedures to design the adaptive trial.

Objectives
  • To develop and optimize disease modelling and simulation software supporting risk modelling and adaptive clinical trial design and updates.
  • To develop disease and risk modelling capacity based on existing and acquired data via EPAD Cohort and Trial activities informing scientific assessment in WP1 and trial design updates.
  • To build the interventional adaptive trial design and needed methodology, providing updates to the design, analysis of new interventions and of existing compounds.
Leads

Scott Berry (Berry Consultants)
Shobha Dhadda (Eisai)
Adrian Mander (MRC)
Philip Hougaard (Lundbeck)

Deliverables
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WP2 Deliverable 2.1 - Report on resources to be used for Disease modelling
  • » epad_d2.1_modellingresources_abstract.pdf
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1066 downloads 1.0 EPAD Administrator 14-09-2015
WP2 Deliverable 2.10- Final report on integrative data mining, including software updates
  • » WP2 Deliverable 2.10- Final report integrative data mining incl sofware updates.pdf
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153 downloads 1.0 EPAD Administrator 13-07-2020
WP2 Deliverable 2.2 - Initial skeleton design
  • » epad_d2.2_skeletondesign_abstract.pdf
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943 downloads 1.0 EPAD Administrator 18-11-2015
WP2 Deliverable 2.3 - Initial version of optimized model fitting software
  • » epad_d2.3_modelfittingsoftware_abstract.pdf
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1014 downloads 1.0 EPAD Administrator 21-06-2016
WP2 Deliverable 2.4 - Draft Design Report complete for finalized design from the simulation process
  • » epad_d2.4_simulationsreport_abstract.pdf
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937 downloads 1.0 EPAD Administrator 10-10-2016
WP2 Deliverable 2.5- Operational Process Document
  • » WP2 Deliverable 2.5- Operational Process Document.pdf
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669 downloads 1.0 EPAD Administrator 31-10-2018
WP2 Deliverable 2.6- Disease Risk Modelling
  • » wp2deliverable2.6-diseaseriskmodelling.pdf
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876 downloads 1.0 EPAD Administrator 13-07-2017
WP2 Deliverable 2.7- Update to the design based on disease-risk model and scientific reassessment
  • » 115736_EPAD_115736_EPAD_D2.7_Update Design based on disease risk-model and scientific re-assessment.pdf
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96 downloads 1.0 EPAD Administrator 01-10-2020
WP2 Deliverable 2.8- Disease risk Modelling Report V2
  • » wp2deliverable2.8-diseaseriskmodellingv2.pdf
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806 downloads 1.0 EPAD Administrator 13-02-2018

Work Package 3: Parent Cohorts and EPAD Register

Description

Creates and maintains the EPAD register in the form of full “fingerprinting” of parent cohorts.

Objectives
  • To provide the methods and tools to identify, characterise and select Parent Cohorts suitable for contributing to the EPAD Register.
  • To provide the methods and tools to identify and select suitable participants from Parent Cohorts to build the EPAD Register, enabling the appropriate data discovery/sharing capacity and underpinning policies.
  • To define operational processes and arrangements for maintenance and replenishment of the EPAD Register.
Leads

Pieter-Jelle Visser (VUmc)
Gerald Luscan (Pfizer)

Deliverables
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Name Downloads Version Owner Last Modified Rating

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Work Package 4: EPAD Cohort and EPAD Trials

Description

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. This 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.

Objectives
  • To establish certified EPAD TDCs across Europe capable of recruiting the needed number of subjects for the EPAD Cohort and Trial.
  • To establish the EPAD Cohort and related data flows, databasing infrastructure, quality control/assurance and monitoring procedures.
  • To sign off the EPAD Cohort Protocol and implement it.
  • To sign off the EPAD Trial Master Protocol and Appendices implement them.
  • To establish a Principal Investigators Network supporting EPAD Cohort and Trial activities.
Leads

Lisa Ford (Janssen)
Craig Ritchie (University of Edinburgh)
Catherine Debove (Boehringer)
Miia Kivipelto (Karolinska Institutet)

Deliverables
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Name Downloads Version Owner Last Modified Rating

No files found in this folder.

Work Package 5: Project Management

Description

Provides professional project management to EPAD.

Objectives
  • To set-up a project management structure that ensures efficient operational and timely execution of the Project.
  • To guarantee project is executed according to the work plan and scientific activities are managed efficiently.
  • To manage resources, procedures and tools for ensuring that all expected results are delivered on time, with an adequate quality level and within cost, including risk management and quality control procedures on deliverables.
  • To ensure effective communication and work dynamics between Participants to help drive the whole Consortium as a team towards successful completion of the Project.
Leads

Carlos Diaz (Synapse)
Serge Van der Geyten (Janssen)

Deliverables
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WP5 Deliverable 5.1 - Restricted Website and Tools for Internal Collaboration and Communication
  • » epad_d5.1_internalcollaborationplatform.pdf
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1328 downloads 1.0 EPAD Administrator 23-02-2015
WP5 Deliverable 5.2 - EPAD Project Handbook
  • » epad_d5.2_projecthandbook_abstract.pdf
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897 downloads 1.0 EPAD Administrator 19-06-2015
WP5 Deliverable 5.5 - Project Assessment
  • » WP5 Deliverable 5.5-Project Assessment.pdf
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422 downloads 1.0 EPAD Administrator 23-01-2018

Work Package 6: Dissemination

Description

Leads and coordinates external dissemination activities, outreach to specific external stakeholders and a public health campaign with special emphasis on the importance of AD prevention. The WP6 team also assesses the impact and effectiveness of dissemination activities.

Objectives
  • To develop a dissemination and communication plan including objectives, target audiences, tools and activities.
  • To develop and update the needed tools to implement the planned dissemination activities.
  • To carry out a variety of dissemination activities aiming at maximising exposure of the project while optimising the project’s perception among the different target audiences.
Leads

Sean Knox (Biogen)
Jean Georges (Alzheimer Europe)

Deliverables
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Name Downloads Version Owner Last Modified Rating
WP6 Deliverable 6.1 - Initial Communication Plan, including project branding and policies
  • » epad_d6.1_commsplan_abstract.pdf
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953 downloads 1.0 EPAD Administrator 29-07-2015
WP6 Deliverable 6.2 - Initial Report on communication tools and material
  • » epad_d6.2_report_comms_tools_abstract.pdf
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843 downloads 1.0 EPAD Administrator 29-02-2016
WP6 Deliverable 6.3- Interim report on dissemination activities
  • » wp6deliverable6.3-interimreportondisseminationactivities.pdf
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761 downloads 1.0 EPAD Administrator 17-07-2017
WP6 Deliverable 6.4- Updated communications plan, tools and materials
  • » WP6 Deliverable 6.4- Updated communications plan tools and materials.pdf
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412 downloads 1.0 EPAD Administrator 29-03-2018
WP6 Deliverable 6.5- Impact and Evaluation Report
  • » WP6 Deliverable 6.5- Impact and evaluation report.pdf
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53 downloads 1.0 EPAD Administrator 03-11-2020

Work Package 7: Business Model and Sustainability

Description

Analyses markets, stakeholders, incentives and schemes for pre-competitive intellectual property handling in order to develop a viable business plan for sustainability of the EPAD ‘machine’ and network of centres beyond the project’s timeframe.

Objectives
  • To study existing and emerging public-private partnership collaborative models that can be useful for the EPAD sustainability.
  • To analyse the stakeholder types intervening in EPAD, their interests and incentives towards sustainability.
  • To analyse and develop procedures for a pre-competitive space that caters to a variety of companies and therapies.
  • To analyse and develop procedures that enable the EPAD infrastructure of TDCs to be sustained over time.
  • To develop a solid business plan that enables transition of EPAD to the post-project phase for long term sustainability.
Leads

Serge Van der Geyten (Janssen)
José Luis Molinuevo (BBRC)
Saira Ramasastry (Synapse)

Deliverables
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WP7 Deliverable 7.1 - Establishment of a Business Leadership Committee
  • » epad_d7.1_blc.pdf
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1344 downloads 1.0 EPAD Administrator 16-04-2015
WP7 Deliverable 7.2 - Analysis of existing public-private partnerships
  • » epad_d7.2_publicprivatepartnershipsanalysis_abstract.pdf
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957 downloads 1.0 EPAD Administrator 21-12-2015
WP7 Deliverable 7.3 - Stakeholder Analysis
  • » epad_d7.3_stakeholderanalysis_abstract.pdf
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866 downloads 1.0 EPAD Administrator 27-06-2016
WP7 Deliverable 7.4- Configuration of a Pre-Competitive Space, IPR Handling and Business Flows
  • » wp7deliverable7.4-configurationofapre-competitivespaceiprhandlingandbusinessflows.pdf
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730 downloads 1.0 EPAD Administrator 04-12-2017
WP7 Deliverable 7.5 - Workflows and Procedures of the EPAD Network Centers
  • » epad_d7.5_workflows_procedures_network_centers_abstract.pdf
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807 downloads 1.0 EPAD Administrator3 15-05-2017
WP7 Deliverable 7.6- Business Plan v1
  • » WP7 Deliverable 7.6- Business Plan v1.docx
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549 downloads 1.0 EPAD Administrator 19-12-2018
WP7 Deliverable 7.7-Business Plan v2
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130 downloads 1.0 EPAD Administrator 02-07-2020
WP7 Deliverable 7.8 - Report on the EPAD Academy, including ERAP
  • » WP 7 Deliverable 7.8-Report on the EPAD Academy including ERAP.pdf
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252 downloads 1.0 EPAD Administrator 09-01-2020

Work Package 8: Ethical, Legal and Social Implications

Description

Studies the critical ethical, legal and social issues (ELSI) pertaining to the project and provides guidance on informed consent, privacy, disclosure of findings and data sharing.

Objectives
  • Define an EPAD ethics and information governance framework for recruiting from existing cohort studies.
  • Develop a robust strategy for involving research subjects in the development of ethics procedures and research protocols.
  • Investigate the ethical, legal and social implications of disclosure of biomarker results and the associated risk of AD dementia.
  • Evaluate and compare the feasibility and impact of large-scale biomarker-testing within national health care systems.
  • Investigate and advise on the recruitment of subjects for Phase 2 trials from existing cohort studies.
Leads

Shirlene Badger (University of Cambridge)
Edo Richard (RUMC)
Carol Brayne (University of Cambridge)

Deliverables
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Latest News
  • The final EPAD dataset is now available to the entire research community
    2020-11-30
  • ALZFORUM
    Alzforum conference blog mentions EPAD
    2020-11-30
  • EPAD v1500 dataset
    New webpage dedicated to EPAD data and samples on the EPAD website
    2020-11-18
  • ADDI launches new Workbench to foster greater global research innovation and accelerate breakthroughs in Alzheimer’s disease and related dementias
    2020-11-17
  • New paper investigating the prediction of Alzheimer’s disease biomarker status
    2020-11-12
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We would like to thank all our followers! A massive thanks also goes to our research participants & members for all their support! Looking back on the years of the @IMI_EPAD project, here's key pictures took at major events. Have a safe & Happy New Year! youtu.be/FeYsOBOhCeo

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8:55 am · 2021-01-18
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The videos from #30AEC are online! Check out the @IMI_EPAD presentations on #data sharing by @rodrigobarnes (@aridhia) & Colin Veal (@uniofleicester). Thanks @IMI2_NEURONET and @AlzheimerEurope for giving us the opportunity to present our work. imi-neuronet.org/2020-virtual… twitter.com/IMI2_NEURONET/…

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8:43 am · 2021-01-15
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Authors investigated #data from nine studies, including @IMI_EPAD, comprising a total of 60,004 assessed participants. If you want to explore the #Alzheimer's disease data landscape, visit adata.scai.fraunhofer.de @BirkenbihlC @ApitiusHofmann @ddomingof @Simon_Lovestone @TVB_cloud

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7:56 am · 2021-01-11
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Numerous studies have collected #Alzheimer's disease cohort #data sets. @BirkenbihlC and colleagues have evaluated the Alzheimer's disease data landscape from a patient‐level data‐centric perspective. @IMI_EPAD @IMI_EMIF @NACCALZ alz-journals.onlinelibrary.wi…

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7:48 am · 2021-01-11
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The final @IMI_EPAD dataset is now available to the entire research community | News | @CORDIS_EU | European Commission europa.eu/!dj89jY

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12:55 pm · 2021-01-08
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