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The 3^rd Loyalty Meeting for research participants and collaborators of the Barcelonaβeta Brain Research Center (BBRC) took place on April 18^th in Barcelona, Spain. The aim of these annual meetings, organised by the Pasqual Maragall Foundation, is to share their knowledge with their research participants and collaborators, as well as to increase their loyalty. Over 1,500 people attended this edition, entitled “The brain uncovered: Neuroimaging & Alzheimer’s”.

The event was divided into two main conferences, led by the Clinical Director, José Luis Molinuevo, and the Head of the Neuroimaging Unit, Juan Domingo Gispert. José Luis Molinuevo gave a presentation on the chronology of the major advances in Alzheimer’s research and neuroimaging. He cited the launch of the EPAD project as one of these major advances. Then, Juan Domingo Gispert explained and illustrated the Magnetic resonance imaging (MRI) using the example of a radio and a violoncello. Finally, a video was presented in which two research participants pointed out the reasons they are involved in this research.

“Collaboration in Alzheimer’s disease and beyond: the present and future of IMI initiatives in neurodegeneration” was the theme of the meeting organised by the Innovative Medicines Initiative. It brought together the complete portfolio of IMI projects in the Alzheimer’s/dementia fiels, as well as other key stakeholder organisations and initiatives from Europe and beyond. The goal of the meeting was to discuss existing collaboration and explore future opportunities to work together to advance Alzheimer’s research.

During the first day, senior representatives of all currently funded IMI projects in the Alzheimer’s field attended to provide an overview of the aims and achievements to date of their projects. The following projects were represented making for a truly impressive portfolio in the field of Alzheimer’s research:

• ADAPTED (Alzheimer’s Disease Apolipoprotein Pathology for Treatment Elucidation and Development)
• AETIONOMY (Organising mechnistic knowledge about neurodegenerative diseases for the improvement of drug development and therapy)
• AMYPAD (Amyloid imaging to prevent Alzheimer’s disease)
• EMIF-AD (European Medical Information Framework – Alzheimer’s disease)
• EPAD (European prevention of Alzheimer’s dementia)
• IMPRIND (Inhibiting misfolded protein propagation in neurodegenerative diseases)
• MOPEAD (Models of patient engagement for Alzheimer’s disease)
• PHAGO (Inflammation and AD: modulating microglia function – focussing on TREM2 and CD33)
• PRISM (Psychiatric Ratings using Intermediate Stratified Markers)
• ROADMAP (Real world outcomes across the AD specturm for better care: multi-modal data access platform)

These presentations were followed by an open lecture for a broader IMI audience in which Jean Georges from Alzheimer Europe gave an overview of current European research initiatives and presented Alzheimer Europe’s campaign to see dementia recognised as a European priority. Craig Ritchie (pictured) from the University of Edinburgh presented a scientific update with the latest research findings and new understanding of the development of Alzheimer’s disease and possible prevention strategies.

The second day was an internal meeting where the different project representatives continued their discussions about potential synergies between projects as well as areas for future research.

On 10 March, the European Prevention of Alzheimer’s Dementia (EPAD) project launched its first video – an introduction to the project.
The three and a half minute animated video is available on the EPAD website homepage: https://alzheimer.noemi.lu/
EPAD is a collaborative research effort to improve the chance of successfully preventing Alzheimer’s dementia and to better understand early aspects of Alzheimer’s disease before dementia develops. The goal of the initiative is the prevention of dementia in people with evidence of the disease (such as biomarker abnormalities), who still may have little or no complaints or clinical symptoms.
The EPAD project has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115736, resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.

Summary:

There is growing interest in the development of novel approaches to secondary prevention trials in Alzheimer’s disease to facilitate screening and recruitment of research participants and to reduce the time and costs associated with clinical trials. Several international research collaborations are setting up research infrastructures that link existing research cohorts, studies or patient registries to establish ‘trial-ready’ or ‘readiness’ cohorts. From these cohorts, individuals are recruited into clinical trial platforms. In setting up such research infrastructures, researchers must make ethically challenging design decisions in at least three areas: re-contacting participants in existing research studies, obtaining informed consent for participation in a readiness cohort, and disclosure of Alzheimer’s disease-related biomarkers. These ethical considerations have been examined by a dedicated workgroup within the European Prevention of Alzheimer’s Dementia (EPAD) project, a trans-European longitudinal cohort and adaptive proof-of-concept clinical trial platform. This paper offers recommendations for the ethical management of re-contact, informed consent and risk disclosure which may be of value to other research collaborations in the process of developing readiness cohorts for prevention trials in Alzheimer’s disease and other disease areas.

Read more on: http://dx.doi.org/10.14283/jpad.2017.5

Professor Craig Ritchie, EPAD coordinator and Director of the University of Edinburgh’s Centre for Dementia Prevention, gave his Inaugural Lecture on 20th February 2017, entitled “Could a dementia-free world become a reality?”

The sold-out event was attended by academics, policy makers, research participants and school students, and provided a fascinating insight into the global landscape of dementia research and prevention.

There has been virtually no progress in developing new interventions to manage the symptoms of dementia over the last 20 years. This has forced a fundamental re-think of our scientific, clinical and epidemiological approach to the condition, culminating in massive, coordinated global initiatives targeting the prevention of dementia and maintenance of brain health.

During his Inaugural Lecture, Professor Ritchie provided a brief historical perspective of dementia that formed the foundation for a very optimistic vision of the near future (relatively speaking) of how we can rid the world of dementia.

A recording of Professor Craig Ritchie’s Inaugural Lecture is now online:

https://media.ed.ac.uk/media/1_h7l15jph

Members of the European Prevention of Alzheimer’s Dementia (EPAD) Work Package 6 (WP6) communication and dissemination team met on the Novartis Campus in Basel on 13 and 14 February. The team discussed the project’s communication strategy, focus plan and activities for 2017, and made plans for the EPAD General Assembly planned in May.

The meeting was attended by Sean Knox (Novartis), Lennert Steukers (Janssen), Ana Belen Collado Gill (BBRC), Jean Georges (Alzheimer Europe), Kate Boor Ellis (Alzheimer Europe) and Cindy Birck (Alzheimer Europe).

What is your current role in EPAD?
I work on ethical and social questions related to the development of the EPAD project, conducting qualitative research and coordinating the work of the EPAD ‘ELSI’ (Ethical, Legal and Social Implications) group. This group, led by Shirlene Badger, Edo Richard, Luc Truyen and Carol Brayne, consists of clinicians, philosophers, social scientists and biomedical researchers. Over the first two years of EPAD, our main role was to produce guidance related to ethical considerations associated with setting up and running such a novel project. These cover the whole EPAD ‘journey’, from recruiting from existing studies, to explaining the project to potential participants and the return of results from EPAD research – particularly the disclosure of Alzheimer’s disease biomarker information as part of clinical trials recruitment.  We have also carried out qualitative research related to the potential implications of learning biomarker test results related to Alzheimer’s disease.

I’m now working on putting some of our recommendations into practice, and I’m particularly focussed on getting the EPAD Participant Panel up and running in the next few months. EPAD already includes representatives of patients’organisations as partners in the study, and we want to take this further to make sure that the voices of EPAD participants themselves are represented in the running of the project, and that we can learn from their experience.

What did you do prior to joining EPAD?
I’m a social scientist by background, and my research interests focus on social and ethical implications of developments in the biosciences, particularly related to genetic technologies.  I’m really interested in the interplay between research (whether in the public and private sector), regulation and the public. Immediately before EPAD, I was doing ethnographic research examining how developments in neuroscience research move from lab to clinic, the barriers and facilitators associated with this process, and its social and ethical consequences – for example related to how we understand disease or healthy ageing.

Tell us a bit about the institution/company/organisation you work for?
I’m part of a group of social scientists based in the Institute of Public Health at the University of Cambridge, led by Shirlene Badger.  Our work examines social and ethical questions associated with biomedical research, particularly in dementia and Alzheimer’s disease. The Institute of Public Health itself is a multidisciplinary endeavour, working across the academic, health service and policy arenas. One particular area of strength is in non- communicable diseases and diseases of ageing; how they reduce well-being in populations in the UK and internationally; and how prevention, treatments, interventions and services can reduce the impact of these disorders and improve health.

What are your expectations from the EPAD project?

EPAD is a really ambitious effort to develop a new structure and way of working around Alzheimer’s clinical trials, so it’s a fascinating project to work on. From my perspective, it’s been great to see the commitment within EPAD to working through the ethical and social implications of this novel approach to research, and hopefully the work that we have done on these questions will be valuable for future initiatives elsewhere. I’d also hope that ultimately some of our work on ethical and social questions will add to the findings from the EPAD cohort and adaptive trials to give us a better understanding of what the future of Alzheimer’s disease could, but also should, look like in clinical practice.

What is your current role in EPAD?

With Carlos Díaz, we are co-leads of WP5 (Project Management) together with Janssen, being responsible for monitoring compliance to the work plan, planned resources and time schedule, deliverables and tracking milestone achievements, risk management, overall financial management (budget and costs/payments control) and administration. I am also participating in the EPAD dissemination strategy lead by WP6 and; from last year, I am also a member of the Algorithm Running Committee.

As an additional note, I am also participating in the Project Management of the sister initiative led by Prof. Frederik Barkhof – AMYPAD (www.amypad.eu) – IMI2 project which officially started in October 2016.

I guess that as Project Manager, my main responsibility is to make sure that the EPAD partners are not too much bothered about administrative issues, and allowing them, therefore, more time to be devoted to science.

What did you do prior to joining EPAD?

Previous to the EPAD project, I have been managing research projects in the EC Framework for regional governments, universities and research centres, responsible of the administrative and financial issues, including cost budgeting, cost reporting and audit procedures, especially in the framework of IMI projects. Since 2009 I am teaching courses in European R+D project management for a variety of institutions at the national and European level.

Tell us a bit about the institution/company/organisation you work for.

SYNAPSE (www.synapse-managers.com) is a company specialized in the high quality management of complex research and development projects in the biomedical sector, partnering with national and international organizations, both public and private (pharmaceutical and biotechnology companies, research institutes, academia, hospitals, etc.). SYNAPSE has a track record on research projects that are highly innovative (open innovation, public private partnerships), large (>10 million Euros), distributed (built on the collaboration of several institutions) and internationally oriented, with broad expertise in projects funded by the European Commission and Innovative Medicines Initiative JU.

Synapse goes beyond classical project management and brings in added value capabilities in team management, vision management, strategic thinking and project intelligence.

In addition to EPAD and AMYPAD projects, SYNAPSE is currently managing other IMI projects: eTOX (www.etoxproject.eu), EMIF (www.emif.eu), ADVANCE (www.advance-vaccines.eu), iPiE (www.i-pie.org), ROADMAP (http://www.roadmap-alzheimer.org/), RESCEU (www.resc-eu.org), TranQST (www.transqst.org), HARMONY.

What are your expectations from the EPAD project?

I am expecting that the EPAD project will help to advance research, treatment and management of persons suffering from AD (and their families), but most importantly, progress significantly in the prevention of this disease which affects the lives of millions of people worldwide.

I am proud of being part of the EPAD “Family”, who gathers the expertise of the best professionals out there to work on the project delivery. I hope that my contribution will be a worthy part of this major effort in understanding and preventing Alzheimer’s disease.

Another EPAD year has passed and we are proud to look back at a lot of successful deliveries and established relationships and look forward to 2017. To celebrate turning two, we list herein some of our key achievements of the past 12 months.

January

At the turn of the year, we welcomed the 36^th EPAD partner to the project. Aridhia and its AnalytiXagility system will develop and manage the LCS data and analytics platform.

May

May 10^th, a date we will not easily forget, as the first EPAD Research Participant has joined the EPAD family by volunteering to participate in the EPAD Longitudinal Cohort Study (LCS). Achieving this milestone officially announced the start of one of the greatest endeavours in the Alzheimer’s Community – building one of the largest predementia research cohorts ever.

Also in May, the second EPAD General Assembly took place in Barcelona. The meeting, hosted by EPAD partners the Barcelonaβeta Brain Research Center and sponsored by EPAD partner Eisai, was dedicated to discussing the initiation and delivery of the EPAD study platform as core objectives of the project.

July

During the AAIC conference, EPAD organized, together with its American counterpart the Global Alzheimer’s platform, a joint session to discuss and present the global collaborative efforts in Alzheimer’s research. Similar initiatives are being developed as we speak in Australia, Canada & Japan. With this, EPAD wants to reinforce its commitment to global alignment and collaboration in Alzheimer’s prevention.

October

EPAD publishes breakthrough recommendations for detection of early preclinical Alzheimer’s disease. In a time when prevention studies are becoming increasingly important, these recommendations were welcomed by the AD community. As EPAD will undertake large-scale proof-of-concept trials in predementia Alzheimer’s disease, the monitoring of cognitive trajectories in the preclinical period will constitute a central outcome measure.

Also in October, we welcomed our sister IMI project – IMI Amypad. Amypad will investigate the value of β-amyloid using PET imaging as a diagnostic and therapeutic marker for Alzheimer’s dementia. It may improve an early diagnosis of AD, and, when recognized in a pre-symptomatic population, even provide an opportunity for secondary prevention of AD. Especially for the latter, EPAD & Amypad will closely work together.

November

WP8 within EPAD recognizes the importance of considering the ethical, legal and social implications of research initiatives and the inclusion of research participant voices within the medical research process. A systematic review by EPAD has been published and examined the effects of disclosing genetic and nongenetic AD-related biomarkers to cognitively healthy research participants.

Also in November, EPAD was delighted and honoured to have been involved in a conference organized by the Slovak Presidency of the European Union on “Alzheimer’s disease – epidemic of the third millennium: Are we ready to face it?” in Bratislava, which brought together over 100 experts from different EU Member States and provided an opportunity to highlight policy and research initiatives at global, European and national level.

About EPAD

EPAD aims to improve the chance of successfully preventing Alzheimer’s dementia and to better understand early aspects of Alzheimer’s disease before dementia develops. The goal of the initiative is the prevention of dementia in people with evidence of the disease (such as biomarker abnormalities) who still may have little or no complaints or clinical symptoms. EPAD will establish a European-wide register of approximately 24,000 participants, of which 1,500 will be invited to participate in a trial to test new treatments for prevention of Alzheimer’s dementia. The five year programme is part of the Innovative Medicines Initiative, a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations, EFPIA.

We are pleased to announce the arrival of a new project partner, Roche. We say a warm welcome to Roche and look forward to our collaboration.

The EPAD project has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115736, resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.