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The first quarter of 2016 started with great intensity! We were busy working towards recruiting the very first research participant into our study and should reach this important milestone early next month. A serious engagement of the entire EPAD family was also needed for the mandatory scientific and financial progress report to the Innovative Medicines Initiative.

Here are some of the team’s major achievements during the past period:

The operational aspects of the Longitudinal Cohort Study are now finalised

Next to the requirements for Good Clinical Practice (GCP) and ethical considerations, organising the study itself from an operational perspective takes time. The EPAD operations team has successfully established all required service contracts (clinical assessments, bio-banking etc.), coordinated local Ethics Committee submissions and prepared best practices for sample management.

Six trial delivery centres are now certified and staff trained and ready for action

On 21 March, site personnel from the first six certified EPAD Trial Delivery Centres (TDCs) were trained during the first EPAD Investigator Meeting in Edinburgh.

Our communication strategy has been updated

A new year and ever-evolving project needs calls for a 2016 Communication Action Plan and that’s exactly what WP6 developed. Emphasis has been placed on generating awareness of the project itself and its expected results, rallying stakeholders as well as the general public around EPAD’s cause in order to create an EPAD community and educating the broader public about the fundamental concepts EPAD is built on.

Our first progress report has been submitted to the Innovative Medicines Initiative

With the first project year of EPAD completed, a first official annual report about the project scientific and financial progress of each individual partner and the consortium as a whole was submitted to IMI. Approval of this report is a prerequisite for future milestone payments to Beneficiary Partners in EPAD.

Four cohorts are now connected in the EPAD Register with five additional ones to follow shortly

An initial set of nine Parent Cohorts (PCs) have been selected for inclusion in the Register, of which four are already connected to the ‘Participant Register for EPAD’ (PREPAD) software tool, and hence the present day Register encompasses >4000 potential research participants without dementia. The other five PCs will be incorporated in the next few months. In total, 23 PCs have been fingerprinted, representing >500,000 research participants.

Sound ethical recommendations will guide the next steps of the EPAD project

The EPAD ethics team (WP8) created an extensive recommendations document that tackles topics in the following areas:

• Informed consent through the EPAD journey
• Return of results and disclosure of Alzheimer’s risk
• Incidental findings
• The experience of participation in EPAD
• Data sharing and governance
• Continuity between the Longitudinal Cohort Study and the Proof-of-Concept (PoC) Studies

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 cohort of over 6,000 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.

What is your current role in EPAD?

I am a member of the Legal & IP (intellectual property) Committee (LIPC), representing Barcelonaβeta Brain Research Centre (BBRC) that is co-leading the project and provides the Iberian Lead and a Trial Delivery Centre. The LIPC is composed of six members who are experts in legal, business, or intellectual property matters. We participate in regular discussions by conference calls, and at least once a year we meet face-to-face preferably during the General Assembly Meeting. Our mission is to assist the Steering Committee and the General Assembly in ensuring the correct application of IP ownership and access right clauses in relation to the Associated Trial Delivery Centres, Associated Scientific Collaborators, and Accession of new Participants to the Agreement, and other potential areas where legal or intellectual property advice is useful.

What did you do prior to joining EPAD?

I am part of the BBRC team from its very beginning, assuming the Managing Director Role. I am responsible for directing and controlling the institution’s operations as well as giving strategic guidance and direction to the General Director and the Board to ensure that the BBRC achieves its mission and objectives. To highlight some of my annual functions I would mention that I am responsible of preparing, gaining acceptance, and monitoring the implementation of the yearly budget to ensure its targets are met. In addition, I also lead the processes to develop and maintain an effective marketing and public relations strategy to promote fundraising opportunities.

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

The Pasqual Maragall Foundation (PMF) for research in Alzheimer’s disease (AD) was established in April 2008, as the result of the public engagement of Pasqual Maragall, former mayor of Barcelona and president of the Government of Catalonia, when he announced he had been diagnosed with the disease. The PMF is affiliated to the Pompeu Fabra University in Barcelona (UPF) and develops its research in a joint center venture with UPF, the Barcelonaβeta Brain Research Center (BBRC).

BBRC addresses the challenges AD poses from a scientific point of view, with the decisive commitment to provide solutions and improve the welfare of persons affected by the disease. Its activity is directed at obtaining new scientific knowledge with the objectives of reducing the number of patients, delaying disease progression and providing solutions that improve the quality of life of both patients and their caregivers.

We also campaign to improve public understanding of AD and the devastating impact it can have, and make sure it is taken seriously and acted on by our governments.

Finally, the Foundation through its research centre, BBRC, is conducting the ALFA project for the prospective follow-up of a cohort of cognitively normal participants, many of them first-degree descendent of AD patients, with the aim of increasing our knowledge of the pathophysiology and pathogenic factors emerging at early preclinical AD stages. Within this project, the ALFA parent cohort is composed of 2743 cognitively healthy participants representing the whole spectrum of risk of developing AD that will leverage with different projects. One of these, the longitudinal ALFA+ cohort study will serve, through deep phenotyping, to untangle the natural history of the disease and to model its earliest stages to develop successful trials. Our most ambitious aim is to follow ALFA study participants throughout their lives.

BBRC is working for a future without AD: nowhere is it written that it is invincible.

What are your expectations from the EPAD project?

It is becoming increasingly more evident that many of the changes in the brain that lead to AD dementia start decades before symptoms appear. We therefore need to know how to identify these changes in middle-aged persons and also work out how we can intervene to stop them from progressing. We may be able to stop progression through specific pharmacological and non-pharmacological interventions.

My expectations are,

1. To have an extensive pan-European cohort of persons at risk of developing Alzheimer’s dementia that will provide an extraordinary opportunity to better understand human biology behavior and compile enough information about risk factors to develop AD. Hopefully, this will allow us to,

2. Find a treatment capable of preventing or delaying the evolution of the disease and the appearance of AD dementia.

3. Finally, BBRC involvement in the EPAD project together with leading experts in the AD prevention research field, will enable collaborations between us and other groups similarly determined to fight against AD.

What is your current role in EPAD?

In EPAD, I am co-leading the WP3 (EPAD register and Parent Cohorts) with Dr. Pieter Jelle Visser. I also represent WP3 on the Steering committee and the Data Oversight Committee. I am lucky to have many talented people in WP3 with different expertise.  My role is to organize interactions within WP3 and also with other WPs to meet our goals. WP3, with the help of National Leads has defined and characterized the parent cohorts that will feed the EPAD register. We have created PREPAD, a tool that will select participants to be invited to participate in the LCS.

EPAD is a very innovative project that may create uncertainties and raise questions. That’s why our job at WP3 is also to create confidence with each stakeholder. We are at a very special moment where the first register participants are about to be invited to participate in the LCS. We have learned a lot and there is still a lot to do to finely tune and streamline our processes.

What did you do prior to joining EPAD?

I contribute to EPAD only for a part of my time. I am clinical lead at Pfizer working in the Global Product Development Group mainly in phase 3 trials. In the AD field, I have been working for several years on the Bapineuzumab phase 3 program, an anti-amyloid antibody, as a clinical scientist. Before that I worked as a Clinical Trial Project Manager in a variety of therapeutic areas. I have a background in neuroscience.

Tell us a bit about your organisation

Our purpose at Pfizer is to bring therapies to patients that significantly improve their lives. That, essentially, has been our goal since our founding in Brooklyn in 1849 and remains at the heart of our business. In 2015, with more than 97,000 Pfizer colleagues around the world we advanced some 39 proposed therapies in our R&D pipeline (Neuroscience & Pain, Oncology, Inflammation & Immunology, Cardiovascular & Metabolic Diseases, Rare Disease and and Vaccines).

What are your expectations from the EPAD project?

The EPAD collaborative approach is very exciting. It is so refreshing to see people from various horizons, even from competing companies, working together to speed scientific progress and share the risks and rewards of developing the most promising ideas. I think it is a great success of the EU through IMI to create this collaborative framework.

EPAD offers an unprecedented approach in characterization of potential participants to a clinical trial, first with the register and then with the longitudinal cohort study. This will certainly help addressing the heterogeneity in recruitment that has hampered many clinical trials. I make the wish that EPAD will receive proposals from valuable candidates compounds for the POC study.

One of the scientists working on the European Prevention of Alzheimer’s Dementia (EPAD) project, Professor Kaj Blennow, has been awarded the Söderberg Prize for his work on Alzheimer’s disease. Prof. Blennow, of the University of Gothenburg, was awarded the prize of one million SEK (EUR 110,000) for his “uniquely innovative research” on 7 April during a ceremony at the Swedish Society of Medicine seminar.

“I am extremely happy! It is a great honour to receive the Söderberg Prize in Medicine,” said Prof. Blennow (pictured), who will be performing cerebrospinal fluid (CSF) analyses for the EPAD Longitudinal Cohort Study (LCS).

“It is also very gratifying that this type of clinically tied biochemical research receives attention. Currently there are a number of highly promising drugs that are in the final phase of their clinical trials, and on the day they hopefully become available for patients, there will be an enormous need to be able to diagnose Alzheimer’s early in the course of the disease.”

The Söderberg Prize in Medicine rewards clinical medicine researchers whose results have been recognised for the past ten years. The prize, which has been awarded since 1986 by the Torsten Söderberg Foundation, is given to Laureates chosen in cooperation with the Swedish Society of Medicine.

Professor Miia Kivipelto, EPAD WP4-lead, also gave a lecture during the seminar, called “Is Alzheimer’s Preventable?”

http://sahlgrenska.gu.se/english/research/news-article//kaj-blennow-receives-the-soderberg-prize-in-medicine.cid1346942

On 21 March, between 40 and 50 representatives of the European Prevention of Alzheimer’s Dementia (EPAD) project met in Edinburgh, to launch the largest ever specific pre-dementia cohort. Participants at the “1^st wave Investigator meeting” included representatives from Clinical Research Organisations (CROs) and six dedicated teams from France, Italy, the Netherlands, Spain, Sweden, Switzerland and the UK. The objective of the meeting, which took place at St Leonard’s Hall, was to prepare attendees from trial delivery centres (TDCs) to put the EPAD Longitudinal Cohort Study (LCS) into action.

Day one of the two-day meeting mainly focused on explaining how the LCS works conceptually. Tony Brooks, Graciela Muniz Terrera and Craig Ritchie amongst others explained the purpose of the protocol and how the LCS is different from other cohort studies. Ray French also spoke about the role and responsibilities of ACCORD (The Academic and Clinical Central Office for Research and Development – a partnership between the University of Edinburgh and NHS Lothian Health Board) in the LCS, and Judi Syson closed the first day of the meeting with a few words on progress m

On 21 March, between 40 and 50 representatives of the European Prevention of Alzheimer’s Dementia (EPAD) project met in Edinburgh, to launch the largest ever specific pre-dementia cohort. Participants at the “1^st wave Investigator meeting” included representatives from Clinical Research Organisations (CROs) and six dedicated teams from France, Italy, The Netherlands, Spain, Sweden, Switzerland and The UK. The objective of the meeting, which took place at St Leonard’s Hall, was to prepare attendees from trial delivery centres (TDCs) to put the EPAD Longitudinal Cohort Study (LCS) into action.

Day one of the two-day meeting mainly focused on explaining how the LCS works conceptually. Tony Brooks, Graciela Muniz Terrera and Craig Ritchie amongst others explained the purpose of the protocol and how the LCS is different from other cohort studies. Ray French also spoke about the role and responsibilities of ACCORD (The Academic and Clinical Central Office for Research and Development – a partnership between the University of Edinburgh and NHS Lothian Health Board) in the LCS, and Judi Syson closed the first day of the meeting with a few words on progress made with the Ethics Committee (EC) approvals for the different sites.

Day two focused on the truly operational aspects of the project, and included training for all site personnel on monitoring and data management (Quintiles) sample handling (The Roslin Institute), the procedure for taking and processing MRI images (IXICO) and how cognitive tests work, including a hands-on session using tablets (Medavante). To close the day, a few words were said by Mila Etropolski from WP4, on how the LCS will continue into the Proof-of-Concept (PoC) study.

Lisa Vermunt, based at the VU University Medical Center Amsterdam (VUMC), is involved in WP3, helping to set up the EPAD Register and the TDC in Amsterdam. “Since the beginning I am looking forward to the start of the cohort – actually seeing participants for our investigations – and now we are really almost there!” she enthused after attending the Edinburgh meeting.

Samuel Rabanaque, based at the Fundación Pasqual Maragall, is mainly working on WP4 and will be involved in running the trial at the Barcelona site. “The Investigator meeting allowed us to review in a concentrated way all materials and procedures involving EPAD-LCS protocol. Besides, it gave us the opportunity to share our doubts and expectations with colleagues from other centres”, he said.

The goal of the EPAD 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’s European-wide cohort will consist of over 6,000 participants, of which 1,500 will be invited to participate in a trial to test new treatments for the prevention of Alzheimer’s dementia. The five year programme is part of the Innovative Medicines Initiative.

Follow EPAD on Twitter @IMI_EPAD and keep up to date with the cohort via the hashtag #EPADCohort.

Members of the EPAD WP6 communication team held a one day meeting in Luxembourg on 10 March to review the project’s communication strategy.

The participants discussed external communication goals and expectations and paid particular attention to communication with and retention of research participants. The team also took this opportunity to plan activities around EPAD’s 2016 General Assembly, which will take place from 17 to 19 May in Barcelona, Spain.

The meeting was attended by Serge van der Geyten and Lennert Steukers (Janssen), Karine Fauria (Pasqual Maragall Foundation), Jean Georges, Alex Teligadas and Kate Boor Ellis (Alzheimer Europe).

European Prevention of Alzheimer’s Dementia (EPAD) project researchers Edo Richard and Maartje Schermer have obtained a new grant from the Dutch Organisation for Health Research and Development, to delve deeper into some of the ethical and conceptual issues around early diagnosis in dementia.

Their project is entitled “Early diagnosis of Alzheimer’s disease: conceptual considerations and ethical guidance” and will be executed in close collaboration with other EPAD members.

On 19 January, the EPAD consortium elected to use AnalytiXagility as its data and analytics platform. AnalytiXagility belongs to Scottish clinical and translational informatics company Aridhia.

The platform combines analytical, collaboration and audit tools to support and accelerate data-driven projects. It will be accessible to all of the consortium partners, and is able to carry out advanced data analytics for any type of data.

The University of Edinburgh is now working with Aridhia to trial the EPAD cohort.

What is your current role in EPAD?

I’m currently working full time as project manager for Janssen on the IMI-EPAD project. My main role, as member of the EPAD Project Management office and WP5, is to provide overall management to the project including supporting the coordinator in liaising with IMI, work plan & schedule control, stakeholder management, team communication, supporting the Executive Committee and WP leaders in day-to-day management, assurance of timely submission of deliverables and so on. One might say it’s the glue that holds the team together. In addition to that, I’m also actively involved in EPAD’s External Communication activities, governed by WP6.

What did you do prior to joining EPAD?

Prior to joining the EPAD project, I worked in academia at the University of Ghent pursuing a PhD (Microbiology/Veterinary Sciences). My research focused on early events in the pathogenesis of human and animal herpes viruses, more specific on which mechanisms they apply to invade the host. People always ask me why, given my training in Veterinary Medicine, I never became a practitioner. To be honest, although I initially did and still clearly see the many rewarding aspects, I always have been very passionate about the bigger picture of health improvement instead of individual (animal) health and want to be part of driving innovation in the health sector. You can imagine that I’m therefore very pleased to have been given such an opportunity with EPAD.

Tell us a bit about your organisation

At my current assignment at Janssen, I’m part of the Project Management Office across all therapeutic areas specifically dedicated in providing support to the external funding portfolio. Janssen Pharmaceutica N.V., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas and have the main research facilities for Janssen Research & Development in Europe located in Beerse, Belgium, with research focused around the therapeutic areas of neuroscience, oncology, and infectious diseases. The company to which I’m affiliated to is called CMAST BVBA and provides Consultancy, Project Management & Supporting Technology services in the focus process domains of life sciences, strategic collaborations and supply chain in order to enable customers to achieve their strategic goals. CMAST professionals, based in Belgium, Poland and USA, offer sound expertise and a solid track record in Project & Portfolio Management for over 30 IMI projects, 11 FP7 grants and 7 IWT studies related to public health. For me, both companies strive for innovation and quality. It is a pleasure working in such an inspiring environment.

What are your expectations from the EPAD project?

EPAD equals innovation to me. If you think about it, we’re trying to change so many aspects of our way of thinking/doing in AD treatment & management; identification of persons very early in the course of the disease with an increasing accuracy based on knowledge we generate in the project, earlier intervention in this pre-clinical population tested in a proof-of-concept clinical trial environment allowing faster go/no-go decisions in intervention development but also go for a research participant-centred approach by giving persons participating in our studies, their caregivers and families a voice in setting priorities for the project. Sharing, learning from one another in this partnership is crucial. The inspiration/ideation is there, let’s work together on its implementation!

What is your current role in EPAD?

I’m the International Coordinator for WP4 (EPAD cohort and proof of concept studies) based at the University of Edinburgh with Professor Craig Ritchie. I also represent WP4 on the Clinical Development Group as the Operational Manager. The roles involve working with the Trial Delivery Centres to get them certified as EPAD centres, set up the cohort study and plan for the proof of concept study programme. I also maintain the detailed project plan and activity monitoring for WP4 to help keep everyone on track and help manage the interactions between work packages. I also work with all the service providers to develop their ways of working with EPAD to deliver our studies and the all-important EPAD data.

What did you do prior to joining EPAD?

I worked as a Clinical Research Director in AstraZeneca in a variety of roles and therapy areas. I have a background in neuroscience and have also worked in quality management as well as all phases of clinical research. I wanted to stay in Edinburgh when AZ moved their UK R&D HQ to Cambridge so I was really pleased to be able to make use of this experience in this new role in EPAD at the University of Edinburgh.

Tell us a bit about your organisation 

I work in the Department of Psychiatry at the University of Edinburgh which is a modern forward looking university with a long history and many fine buildings – old and new. We are part of an exciting new centre within the Medical School, the Centre for Dementia Prevention, which brings together clinical science – lead by Professor Craig Ritchie, basic science – lead by Professor Jean Manson and social science – lead by Prof Charlotte Clarke, to understand and reduce risk associated with dementia. University of Edinburgh has taken on some key roles in EPAD – providing laboratory services for the cohort study and as the Managing Agent supporting the flow of funds to partners and collaborators. Our R&D office, ACCORD is also taking on the role of Sponsor for the cohort study so we are busy putting arrangements for the GCP activities this requires. I am really enjoying the collaborative spirit within EPAD and the University so the challenges are shared and this is a fun place to work too. 

What are your expectations from the EPAD project?

I think the EPAD project will deliver an amazing amount of data and innovative approaches to modelling that data to explore approaches to dementia prevention. I am very excited about the Proof of Concept study and generating a pipeline of different interventions. My expectation is that there will be big efficiencies in the study process for the proof of concept interventions through having the LCS study set-up and running, having the study participants enthusiastic and ready to take part and having expert Trial Delivery Centres at the heart of the EPAD machine to deliver the data. It’s complex to set-up but the rewards are clear and I have high expectations that we can all work together to make EPAD a success.