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.
The purpose was to provide scientific oversight and management support to the project, ensuring adequate dovetailing with EPAD.
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.
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.
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.
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.
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.
Further unravel the natural history of AD, defining the window for intervention and trial-readiness population in conjunction with a range of European Cohorts.
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.
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.
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.