The AMYPAD project structure

The overall project consists of six functional work streams. Three are central representing the core scientific work and can be directly mapped onto the main objectives described in the previous section. Another three are instrumental pieces supporting the core scientific work. Although the six functional work streams are described separately below, to achieve the project’s goals, close collaboration and cross-cutting actions between them are crucial.

1. Overall project governance and management
 
Leads:
Carlos Diaz<br />(SYNAPSE Research Management Partners)
Carlos Diaz
(SYNAPSE Research Management Partners)
Gill Farrar<br />(GE Healthcare Ltd)
Gill Farrar
(GE Healthcare Ltd)

The purpose is to provide scientific oversight and management support to the project, ensuring adequate dovetailing with EPAD.

Objectives:

  • To establish governance and management structure to both steer the efforts optimally towards the desired results and to provide a structure for decision making.
  • To ensure full alignment with EPAD, to maximally exploit synergy, achieve efficiency and optimise/harmonise performance.
  • To guarantee that the project is appropriately implemented according to the work plans and scientific activities are managed efficiently, with special attention to cross activities and dependencies.
  • 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 promote synergies with other EU/international project and initiatives, including the IMI Alzheimer‘s Disease Platform.
2. Tracer delivery, PET scanning and image analysis
 
Leads:
Juan Domingo Gispert<br />(Barcelonaβeta Brain Research Center)
Juan Domingo Gispert
(Barcelonaβeta Brain Research Center)
Chris Foley<br />(GE Healthcare Ltd)
Chris Foley
(GE Healthcare Ltd)

This part of the work will be devoted to all technical and logistic operations needed to support the correct development of the AMYPAD project.

Objective:
To deals with the tracer delivery, scan acquisition, QC, transfer, quantification and, ultimately, sharing of image data across the 3 main aims of the study.

3. Diagnostic and patient management study
 
Leads:
Giovanni Battista Frisoni<br />(Université de Genève)
Giovanni Battista Frisoni
(Université de Genève)
Andrew Stephens<br />(Piramal Imaging Ltd)
Andrew Stephens
(Piramal Imaging Ltd)

The diagnostic study will determine, in a real-life clinical setting, for whom diagnostic Aß imaging is appropriate, when this is best performed and how the resulting information is influencing diagnostic thinking, patient management and ultimately decision trees and cost-effectiveness of dementia care.

Objective:
AMYPAD will select and follow-up a memory clinic population investigated for memory complaints or possible AD. Patients with subjective cognitive decline (SCD), mild cognitive impairment (MCI) and dementia possibly due to AD but with unclear aetiology will be studied to estimate the impact of β-amyloid imaging on change of diagnosis, diagnostic confidence, treatment decisions, and management changes.

4. Risk stratification: natural history and enrichment strategies
 
Leads:
Craig Ritchie<br />(The University of Edinburgh)
Craig Ritchie
(The University of Edinburgh)
Serge Van der Geyten<br />(Janssen Pharmaceutica NV)
Serge Van der Geyten
(Janssen Pharmaceutica NV)

This work stream in AMYPAD is ultimately tasked with ensuring efficiencies in delivering the interaction with the EPAD Programme. PET-Amyloid imaging in 3200 subjects enrolled in the EPAD LCS will be undertaken. A sub-population of these subjects will have a repeat PETAmyloid scan conducted 2 years later. The PET-Amyloid imaging represents an additional important biomarker amongst a multitude of cognitive, imaging and CSF biomarkers already funded in the EPAD project.

Objective:
To focus on understanding natural history of AD, defining the window for intervention and trial-readiness population in conjunction with EPAD’s protocol for the Longitudinal Cohort Study.

5. Monitoring treatment: quantifying patient-specific efficacy
 
Leads:
Frederik Barkhof<br />(Stichting VUmc)
Frederik Barkhof
(Stichting VUmc)
Mark Schmidt<br />(Janssen Pharmaceutica NV)
Mark Schmidt
(Janssen Pharmaceutica NV)

This unit will focus on the full quantitative data generated in AMYPAD to go beyond the analyses planned in the diagnostic and prognostic studies that both focus on global amyloid status as a dichotomous measure. This group will work closely with EPAD, which focuses on risk prediction modelling and development of adaptive trial methodology for intervention studies.

Objective:
The ultimate goal is to establish predictors of decline by using quantitative baseline and longitudinal PET measurements and determine how this can be best used to plan and monitor treatment.

6. Ethics, communication and dissemination
 
Leads:
Jean-Georges<br />(Alzheimer Europe)
Jean-Georges
(Alzheimer Europe)
Anja Mett<br />(GE Healthcare Ltd)
Anja Mett
(GE Healthcare Ltd)

This team will lead and coordinate external dissemination activities (including publication and dissemination strategy), will address liaison with external stakeholders, including regulators and patients, and will examine ethical issues and data access policies.

Objectives:

  • To report and provide guidance on ethical issues raised by the development and establishment of AMYPAD in close collaboration with other Work Packages and the EPAD project
  • To understand experiences of research participants and consequences of disclosure of biomarker results.
  • To liaise with external stakeholders including regulators, payers, policy makers and the wider dementia community.
  • To design a plan that allows for optimal communication within the project Consortium and the dissemination of information and knowledge generated by the project to the scientific community, other relevant stakeholders and the society at large.
  • To design and produce the communication tools that will be needed to implement the communication plan.