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AMYPAD Report Summary

Project ID: 115952
Funded under: H2020-EU.3.1.7.

Periodic Reporting for period 1 - AMYPAD (Amyloid imaging to Prevent Alzheimer’s Disease – Sofia ref.: 115952)

Reporting period: 2016-10-01 to 2017-09-30

Summary of the context and overall objectives of the project

AMYPAD aims to determine the value of β-amyloid imaging as a diagnostic and therapeutic marker for Alzheimer’s disease. β-amyloid deposition is a necessary - but not sufficient - step on the path towards development of Alzheimer’s disease (AD). Depiction of brain β-amyloid in vivo can therefore improve an early diagnosis of AD, and, when recognized in a pre-symptomatic population, even provides an opportunity for secondary prevention of AD. Understanding the value of imaging of β-amyloid using a positron emission tomography (PET) provides a unique opportunity to achieve 3 major goals: 1) Diagnostic study: First, the project aims at better understanding the impact of amyloid PET imaging utilization on diagnostic thinking and patient management. AMYPAD will scan a large population cohort (n=900) suspected of possible Alzheimer’s disease, to determine the usefulness of β-amyloid PET imaging regarding diagnostic confidence, decision trees, change in diagnosis, and patient management plans. The primary objective is to measure the impact of early vs late knowledge of amyloid status via PET imaging on the physician’s confidence in an etiological diagnosis, 2) Prognostic study: Second, the project wants to better understand the natural history of Alzheimer’s disease in its preclinical and prodromal stages.
To that aim, AMYPAD will leverage a Europe-wide network in close collaboration with EPAD to study the earliest stages of Alzheimer’s disease in a longitudinal fashion. 3) Monitoring Treatment: Finally, AMYPAD will support EPAD in the selection of subjects for proof-of-concept treatment trials aiming at preventing Alzheimer’s disease by ensuring more homogeneous and appropriate enrolment. The ultimate goal is to establish predictors of decline to help in the planning and monitoring of treatment. Through engagement with regulators, the AMYPAD consortium will also maximize the value of its findings for pharmaceutical companies, healthcare providers, and patients.
AMYPAD will address the above goals in close collaboration with IMI project EPAD,EMIF-AD and AETIONOMY .

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Since the official start of the project, AMYPAD has been highly active in establishing the framework for its activities. First, the protocol for the Diagnostic Study was extensively discussed amongst partners to ensure a seamlessly integration of the study with each and every clinical practice. In addition, the study leads requested advice on the design and outcomes of the study to regulatory agencies and the result was a robust study protocol which has been approved at the Sponsor site in Geneva. Similarly, significant work has been put into operationalizing the integration between EPAD and the AMYPAD Prognostic Study. The study protocol is at its final stages and after important decisions regarding governance are made, it shall be ready for ethical and regulatory submissions.
In parallel, technical and operational aspects of the study have been established and optimized. Some critical aspects of this large study are the efficient and balanced supply of radiotracers to participating sites, the harmonization of data across radiotracers and scanners at the different sites, their qualifications, and the optimization of data accuracy for high-quality standard of results. In this period, a dedicated team has mapped out the optimal radiotracer delivery and distribution, defined the optimal scanning protocols to maximize data quality, certified participating sites and developed pipelines for the harmonization of results. In addition, substantial work was put into setting up collaborations with external groups to enable disease modelling work from the beginning of the project. Several data donors expressed interest and provided access to data, and AMYPAD researchers have started preliminary work to understand the natural history of AD and improve risk-profiling methodologies, which will improve community knowledge but also support better subject selection for the project itself.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The recent regulatory approval of β-amyloid PET tracers for clinical use suggests its relevance as a non-invasive tool to study one of the key molecules associated with the development of Alzheimer’s Diseases – an untreatable illness estimate to cost society 1% of global GDP. However, the potential of amyloid PET to improve patient outcomes and support the development of new treatments for AD hasn’t quite been realized. β-amyloid PET is not reimbursed in any major market, meaning very few patients receive it, and while β-amyloid PET has become widely used in clinical trials and research, results from recent studies (e.g. Roche and Janssen) suggest that the way in which β-amyloid biomarkers are used in clinical trial protocols needs to be improved.
AMYPAD will perform amyloid PET scans on an unprecedented scale of patients suspected to be in the early stages of AD. Data will be collected to determine the clinical added value in diagnosis and patient monitoring, by determining when and in whom β-amyloid PET makes a cost-effective contribution to advance patient care for patients suspected of dementia. Longitudinal data will be used to develop novel combination of biomarkers for use in clinical trials, by establishing how β-amyloid PET measurements, in combination with demographics and other measurements such as assessments of neurodegeneration, vascular disease and cognition, can better stratify patients to select targeted treatment populations, and to provide an early read-out of treatment effects.
Novel elements of AMYPAD include longitudinal imaging in up to 50% of subjects and improved quantitative analyses by performing dynamic scans in a large subset of participants. It is differentiated from other initiatives both by its large scale, and by focussing on subjects with very early stages of Alzheimer’s disease. In doing so, it will also bridge a gap between US and Australian initiatives that study either healthy aging (A4 and AIBL) or focus on more established disease stages (ADNI and IDEAS), often in elderly subjects.
Moreover, by serving as a registry of subjects qualified to enter intervention trials, AMYPAD may be able to identify subjects at the very earliest stages of disease progression when secondary prevention may offer the greatest benefit to society.

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