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.
The purpose is to provide scientific oversight and management support to the project, ensuring adequate dovetailing with EPAD.
This part of the work is devoted to all technical and logistic operations needed to support the clinical activities of the AMYPAD project. It coordinates 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 provides technical support for data sharing and dissemination policies for amyloid PET data. Finally, the team is 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 deals 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 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.
AMYPAD selects and follows 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 are 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 is 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 will be collected and prospectively performed in up to 2000 subjects enrolled in one of the parent cohorts. A sub-population of these subjects will have a repeat amyloid PET scan conducted at least 1 year after the previous scan. The amyloid PET scan represents 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 is 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 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.
This team is 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.