The overall project consisted of six functional work streams. Three were central representing the core scientific work and directly mapped onto the main objectives described in the previous section. Another three were 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 were crucial.
Gill Farrar
(GE Healthcare)
Sandra Pla
(SYNAPSE Research Management Partners)
The purpose was 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.
- To develop a long-term sustainability plan for AMYPAD and its components.
Juan Domingo Gispert
(Barcelonaβeta Brain Research Center)
Chris Buckley
(GE Healthcare)
This part of the work was devoted to all technical and logistic operations needed to support the clinical activities of the AMYPAD project. It coordinated tracer production and delivery to the imaging sites, all the tasks to set-up the clinical imaging network, the development of image acquisition and analysis protocols, the deployment of a centralized solution for image management infrastructure for both studies. In addition, the team provided technical support for data sharing and dissemination policies for amyloid PET data. Finally, the team was responsible for the data harmonization of the historical and prospectively collected PET imaging data, to ensure data quality and joint analyses between all collaborating cohorts.
Objective:
To deal with the tracer production and distribution, scan acquisition, QC, transfer, quantification and, ultimately, sharing of image data across the 3 main aims of the study.
Giovanni Battista Frisoni
(Université de Genève)
Andrew Stephens
(Life Molecular Imaging)
The diagnostic study determined, in a real-life clinical setting, for whom diagnostic Aß imaging ws appropriate, when this was best performed and how the resulting information was influencing diagnostic thinking, patient management and ultimately decision trees and cost-effectiveness of dementia care.
Objective:
AMYPAD selected and followed 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 were studied to estimate the impact of β-amyloid imaging on change of diagnosis, diagnostic confidence, treatment decisions, and management changes.
Lisa Ford
(Janssen Pharmaceutica NV)
Pieter Jelle Visser
(Stichting VUmc)
This work stream in AMYPAD was ultimately tasked with ensuring efficiencies in delivering the interaction with the EPAD Programme and other deep phenotyped European cohorts of cognitively unimpaired participants, now including EMIF-AD, ALFA+, FACEHBI, Microbiota, FPACK, and UCL-cohort. Amyloid PET imaging wascollected and prospectively performed in up to 2000 subjects enrolled in one of the parent cohorts. A sub-population of these subjects had a repeat amyloid PET scan conducted at least 1 year after the previous scan. The amyloid PET scan represented an additional important biomarker amongst a multitude of cognitive, imaging and CSF biomarkers already performed in the parent cohorts.
Objective:
Further unravel the natural history of AD, defining the window for intervention and trial-readiness population in conjunction with a range of European Cohorts.
Frederik Barkhof
(Stichting VUmc)
Mark Schmidt
(Janssen Pharmaceutica NV)
This unit was focusing 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.
Objective:
The ultimate goal was to establish predictors of decline by using quantitative baseline and longitudinal PET measurements and determined how this can be best used to plan and monitor treatment.
Jean-Georges
(Alzheimer Europe)
Anja Mett
(GE Healthcare)
This team was leading and coordinating external dissemination activities (including publication and dissemination strategy), addressing liaison with external stakeholders, including regulators and patients, and examining 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.