Category: News

Our project leader Professor Craig Ritchie (pictured) is the new Chair of the Scottish Dementia Research Consortium (SDRC).

SDRC is a membership based organisation which aims to support the development and expansion of high quality, co-ordinated, collaborative dementia research throughout Scotland.

On 29 November, Alzheimer Scotland published an article on its website entitled “Help shape dementia research in Scotland” where Craig tells us about the aims and objectives of the SDRC and invites you to join.

“Our members are the bedrock of our success and we currently have 345 members representing people living with dementia and their caregivers, professionals working in our field as well as early career and senior academics of international repute. In 2017 we relaunched SDRC with even greater ambition and will be looking to invest heavily to ensure that SDRC helps Scottish Researchers achieve and grow their potential.”

You can read the full article here.

The Barcelonaβeta Brain Research Center hosted the first meeting of the Research Participant Panel of the European Prevention of Alzheimer’s Dementia Consortium (EPAD) in Barcelona. The panel is composed of 8 members who will represent and ensure the interests of the Spanish participants in the project.

Their mission is to suggest ideas in order to improve their experience in the study, to discuss topics of their interest, to review the information provided to the participants, and to act as an independent board between participants and the international scientific board of the study.

The next meeting will take place on spring of 2018, and will be focused on the topics that they will present at the EPAD General Assembly.

With more than 110 cognitively healthy participants, the BBRC is leading the recruitment of the EPAD project, which has now recruited over 400 participants within 10 European Trial Delivery Centres.

The European Prevention of Alzheimer’s Dementia Consortium (EPAD) is recruiting research participants at six new sites, bringing the total to ten centres in six European countries.

People in France, the Netherlands, Spain, Sweden, Switzerland and UK can now take part in the study, which aims to develop tests to identify early signs of Alzheimer’s disease that may indicate when a person is at risk of dementia before symptoms appear.

Researchers are developing a Europe-wide cohort of study participants, drawing on information from existing cohort studies, patient registers and other European studies that have identified potential participants.

The Europe-wide study aims to recruit thousands of people, of which many may be selected to participate in trials to test new treatments for the prevention of Alzheimer’s dementia. Volunteers will provide samples for genetic analysis and will undergo tests to assess their thinking skills. Detailed images of their brains will be captured using magnetic resonance imaging.

The EPAD Longitudinal Cohort Study began recruitment in May 2016, with the first centre opening in Edinburgh (UK). Three sites opened later in 2016 in Amsterdam (Netherlands), Barcelona (Spain) and Toulouse (France).

An additional six centres are now recruiting volunteers in Geneva (Switzerland), Lille (France), Montpellier (France), Nantes (France), San Sebastian (Spain) and Stockholm (Sweden).

Its ultimate goal is to develop new medicines and interventions that prevent or delay the onset of Alzheimer’s dementia.

For further information, please contact:

Jen Middleton
University of Edinburgh
+44-131-650-6514
jen.middleton@ed.ac.uk

 
For more information on the EPAD initiative and to keep up to date with our progress, follow @IMI_EPAD on Twitter and visit https://alzheimer.noemi.lu/

To see our videos, visit our YouTube channel (IMI EPAD).

About IMI

The Innovative Medicines Initiative (IMI) is Europe’s largest public-private initiative aiming to speed up the development of better and safer medicines for patients. IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe. IMI is a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations, EFPIA.

More information at www.imi.europa.eu

Acknowledgment

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

You can download the press release here.

The Association for Project Management (APM) was formed in 1972, with the mission to “Inspire communities to deliver meaningful change for societal benefit by advancing the art, science, theory and practice of project management”. This award-winning association has over 23,000 individual and 570 corporate members making it the largest professional body of its kind in Europe. The APM Project Management Awards recognise the very best the profession has to offer, grouped into four different categories. Under the Project and Programme Awards, EPAD LCS was selected to compete with other 5 finalists as the Social Project of the Year for 2017. This category is for the projects with the specific aim of developing solutions that deliver benefits to society and seek to address the concerns of 21st century society.

The APM Project Manager Awards 2017 were held on November 20^th, at Old Billingsgate, London. Renowned BBC correspondent John Pienaar was hosting the glamorous evening. The event was attended by more than 600 experienced project professionals. The EPAD project was the only finalist among all category finalists, representing a research project in the medical sector, a ground-breaking research initiative in the field on Alzheimer. IQVIA, The University of Edinburgh and Synapse representatives attended the APM Awards evening.

To learn more about the APM Awards program and to see the list of winners, visit the APM website.

The final submission we made for the entry is available here.

Joseph Milne (IQVIA): It was a great achievement being selected as a finalist, considering that the association informed me that this was a highly popular category in which they received several applications.  Although on the night we did not win, this was a great accomplishment for the EPAD project and hopefully has increased awareness and importance of medical projects within the other industries present.  Attending was a special experience, listening and meeting with other professionals managing a range of projects and has inspired me to submit again next year (if the chance arises) given the importance and potential of the EPAD project’

Fiona Ramage (IQVIA): It is a tremendous honour to be the only medical project represented as a finalist for an APM Project Management award.  We are incredibly proud of our work in Alzheimer’s disease, and to be positioned among an impressive range of projects from across industries is an amazing achievement!

Lynne Hughes (IQVIA): “It is a tremendous honour to be selected as a finalist at the APM.  Every other finalist, and the vast majority (if not all) submissions were from the construction and / or engineering field.  Thus, we are the only medical project which reached the final which is an amazing achievement!”

Judi Syson (UEDIN): “This was a great opportunity for us to showcase the partnership working involved in the EPAD project, demonstrating how great project management adds significant value to this collaboration between industry and academia.  It was an honour for me to represent the academic community at this event.”

Sandra Pla (Synapse): “It is an enormous accomplishment for EPAD to be one of the finalists, we felt very proud to be able to present our project at such distinguished occasion.”

On 20 November, members of the EPAD WP6 communication team held a one day meeting in Amsterdam to update the communication plan for the final two years of the project. The team discussed the updated project’s communication strategy, focus plan and activities for 2018-2019.

The participants started to review the communication activities undertaken from 2015-2017. The team also took this opportunity to analyse the project through a SWOT analysis evaluating its strengths, weaknesses, opportunities and threats. Then, the participants discussed external communication goals and expectations.

The meeting was attended by Sean Knox (Novartis), Jean Georges (Alzheimer Europe), Cindy Birck (Alzheimer Europe), Laura Carrera Carballes (Janssen), Vanessa Bosmans (Janssen), Ana Belén Callado Gill (BBRC), Anna Borthwick (The University of Edinburgh), Stina Saunders (The University of Edinburgh) and Pamela Brankin (Aridhia).

On 3^rd November, we presented the first analysis of the EPAD data at CTAD (Clinical Trials on Alzheimer’s Disease) in Boston, USA. This analysis was primarily illustrative as did not come from the first data wave officially to be released when we have full baseline data from our first 500 research participants (due early in the New Year).

We sought to understand how many people in the LCS are currently Amyloid Positive (CSF Ab levels <1,000pg/ml) and what key factors might drive this. In the accompanying slides it was shown that about 65/232 (28%) of the entire sample of 229 Research Participants were Amyloid Positive, with a further 25/232 (11%) being in what is described as the ‘grey zone’ just above the threshold for amyloid positivity (CSF Ab levels between 1,000pg/ml and 1,200pg/ml). With the advent and delivery of PrePAD Velocity we expect the number of people who are CDR=0.5 to increase substantially in the months ahead.

Importantly increasing age [OR=1.08 (95%CI=1.01-1.15); p=0.01], carrying an ApoEe4 allele [OR=2.6 (95% CI=1.27-5.48); p=0.001] and having a first degree relative with a diagnosis of Alzheimer’s dementia [OR=3.1 (95% CI=1.29-8.01); p=0.01] were all significantly associated with amyloid positivity. Hippocampal volume and baseline CDR score were not; though there was a trend suggesting that with increasing RBANS total score (indicating better cognitive function) there were reduced odds of being amyloid positive [OR=0.97 (95% CI=0.94-0.99) p=0.09].

If we were to increase the likelihood of someone being recruited from a parent cohort as being amyloid positive and then being eligible for the interventions in the EPAD pipeline the current data show the combination of CDR=0.5 and ApoEe4 carriage would predict almost 75% of amyloid positivity. We acknowledge these are very early data derived from analysing a small data set. In the months to come as more research participants enter the LCS and more data becomes available we should be able to refine the selection algorithm for parent cohorts, which in turn will allow us to identify opportunities to help enhance parent cohorts with new tests that will help with selecting the right research participants into the EPAD LCS.

The main outcome from the analysis and presentation was that we have demonstrated the potential that EPAD LCS will bring to our understanding of Alzheimer’s dementia in the preclinical and prodromal phase. As the cohort grows in size and research participants continue to be followed up we will contribute more and more to the knowledge required to design and deliver the EPAD Proof of Concept trial.

Early next year, with the formal release of the first wave of data, we anticipate several analyses to be presented at AAIC in Chicago and published in peer-reviewed journals. EPAD has now entered the important phase of data analysis and the delivery of new knowledge. This presentation and subsequent academic outputs are only possible and will only be possible due to the dedication over the last 3 years of literally hundreds of researchers, academics, operational staff and industry experts as well as of course the research participants we partner with to generate the data in a structure which allows rapid analyses, presentation and impact.

Well done to the Epadistas!!!

Craig Ritchie, EPAD Project Co-coordinator

What is your current role in EPAD?

I wear two hats within EPAD. Firstly I work for WP3, which is led by Pieter Jelle Visser at VUmc and Gerald Luscan at Pfizer. Together with a great team of colleagues, I’m involved in the process of informing new cohorts and getting them connected to the Registry. What makes this interesting is that no two cohorts are the same, and we continually have to work together with different parties and adapt to local situations. Secondly, I have a coordinating role for the Amsterdam TDC. When I joined the VUmc team our site had not yet started recruiting, so I’ve also assisted in setting up the logistics. As such I’ve been able to witness and contribute to the whole process from getting ethical approval to recruiting and seeing participants.

What did you do prior to joining EPAD?

This is my first fulltime job. I have a background in psycholinguistics, and I was a research assistant in projects about Theory of Mind development in children and affective language processing. I moved into neuropsychology because I was interested in brain pathology and wanted to work in a clinical setting. To my luck, the EPAD team had a vacancy directly after my clinical internship at VUmc ended. I must say I’m proud to work on a project with such enormous societal relevance.

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

The VUmc Alzheimer Center is one of the four centers in the Netherlands specialized in the diagnosis and treatment of dementia, with a special focus on young-onset dementia. Scientific research is fully integrated in the healthcare pathway, and our memory clinic cohort contains data of more than 5,000 patients. This cohort forms the basis of most of our research, which focuses on four major research lines: 1) variability in manifestation, 2) early diagnosis, 3) vascular factors, and 4) interventions. The Alzheimer Center also recently co-launched a national population-based cohort, inspired by the U.S. Brain Health Registry.

I’ve experienced the Alzheimer Center as a very nurturing environment for young researchers. I’ve learned a great deal in the past year and a half, and it’s been rewarding to be part of a group of colleagues who are so passionate about what they do. There are ample opportunities to learn from each other’s expertise and to grow as a researcher, which I thoroughly enjoy.

What are your expectations from the EPAD project?

In my view the Registry can already be called a success, but I’m expecting many more cohorts to get connected in the months and years to come. Now that we’re more than a year into the LCS, it will be exciting to start evaluating the Registry in terms of its efficiency. This will offer a wealth of information on recruitment for preclinical Alzheimer’s dementia trials. The architecture of the EPAD project is of course unique, and I’m hoping that we’ll be able to reap the harvest of that in the future. A more efficient way of conducting trials means that we can move towards preventing Alzheimer’s dementia more quickly – this is the promise that EPAD carries.

What is your current role in EPAD?
I am a member of the Executive committee, the CDEx clinical Mitterrand and balancing committee.

What did you do prior to joining EPAD?
I have been working in neuroscience drug development for nearly 16 years, at Merck and at Janssen.   

Tell us a bit about the institution/company/organisation you work for.
The Janssen Neuroscience therapeutic area in which I work is highly committed to develop treatments for devastating neuropsychological disorders, such has as mood disorders, schizophrenia, chronic pain and neurodegenerative diseases such as Alzheimer’s disease. As a team we bring a diverse group together with multiple talents and experience.

What are your expectations from the EPAD project?
My expectation is that EPAD will eventually become a self-sustaining platform trial with which companies will test proof of concept for compounds that target Alzheimer’s disease. These are still early days and there are many challenges to be met before we realize this goal.  The first deliverable will be the Longitudinal Cohort Study which will provide well characterized , trial-ready participants for the EPAD PoC trial. The second EPAD deliverable will be the collection of longitudinal data from the LCS and PoC trial which together will provide a learning engine which will provide important data that will help identify predictors of clinical response. The third deliverable will be to use those predictive biomarkers of clinical response to conduct highly efficient PoC trials that enable shorter, faster and more predictive PoC trials. And this will accelerate drug development for Alzheimer’s disease.

On 18-19 October, IMI organised its Stakeholder Forum 2017 in Brussels under the theme ‘Open innovation’. On the first day of the event, IMI was looked through the lens of open innovation and the results that IMI is delivering were discussed. The day was focused on the IMI’s public-private partnership model, some IMI flagship projects and the IMI future strategies. On the second day of the Stakeholder Forum, two parallel tracks focused on examples of IMI’s open innovation in practice. The first track was on patient forum co-developed by IMI and the European Patients’ Forum (EPF) and was focused on patient engagement and collaboration. The second track was on the microbiome, with a view to seeing how IMI could best work in this area.

We’re very thankful that Eileen, a Member of the EPAD Research Participant Panel, was willing to come along to the IMI Stakeholder Forum to talk about her actual involvement in the research and her contribution via the panel.

Here are Eileen’s impressions about the EPAD project and its Research Participant Panel:

“The Participant Panel is in the early stages. We have met with each other and Prof. Craig Ritchie twice, to begin asking questions about the EPAD project, the role of the Participant Panel and how that can be achieved.
To go back to the beginning, I think the invitation to become a volunteer in the EPAD project came by letter or phone (I assumed I had been asked to participate because my parents had Alzheimer’ disease). Previously, I had taken part in Generation Scotland and The Million Women Study.
Subsequent contact was always helpful, with parking space arranged for us and one of the EPAD team even coming out to open a barrier which we couldn’t get to operate!

The first visit to Edinburgh for the first tests was fascinating. All of the volunteers agreed that the young team tried their best to be welcoming and reassuring. The NHS personnel were also impressive, kind and so competent. The MRI scan let me have a lie down and a rest and the lumbar puncture was done in textbook fashion with the young doctor talking me through the procedure. We even managed an interesting conversation.
I was familiar with the cognitive tests (e.g. picture recognition, recall of information). Although the computer screen tests were trickier, I found out later that other people had thought the same, so that was OK.

All the participants had thorough medical examinations – 4 out of 7 discovered previously unidentified conditions which could then be treated – 1 out of 7 was already taking medication as a result of being on a clinical trial for another condition. We were all grateful to the EPAD team’s prompt response to the apprehension about having a lumber puncture done. A video was put on the website to demonstrate the procedure in the hope that more information would help people feel more relaxed.

These were unlooked for positive outcomes to taking part in research. From the brief conversations with other volunteers, we all feel that this research to help prevent Alzheimer’s dementia is very important and we are very glad to be able to contribute. Some of us have watched loved ones disappear before our eyes, while still alive with this disease. We want to stand with the young academics and researchers helping to find a cure or amelioration for it.
Research has done so much to advance treatment in heart disease and cancers. Hopefully EPAD’s assault on the prevention and cure of Alzheimer’s dementia will bring similar results.

Attending the 3rd EPAD General Assembly Meeting in Stockholm as the first Research Participant was a wonderful opportunity to see and hear the hardworking application and enthusiasm of the EPAD family, as Prof Ritchie calls us.
There was so much debate and discussion, sharing of data and encouragement to meet targets.
Several people came forward to thank me for taking part but all I wanted to do was thank them for being part of this huge endeavour. Knowing we are listened to gives us a great deal of faith in the team.

I look forward to the next conference in Brussels and to sharing news from that with everyone when I get back.”

On 16-18 October, the European Prevention of Alzheimer’s dementia (EPAD) project organised its first IMI-AD Platform Disease Modelling Workshop in Edinburgh, UK. The aim of the meeting was to bring together the modelling community within IMI funded projects to facilitate and encourage interactions between the overlapping communities.

On the first day, the chair of the workshop Graciela Muniz-Terrera (University of Edinburgh) welcomed the attendees. The event gathered 20 participants from several IMI projects (AMYPAD, EPAD, ROADMAP and AETIONOMY). The workshop consisted of three sessions divided by area: clinical perspective, drug discovery and systems/molecular biology.

The workshop gave the opportunity to the majority of the attendees to present their research topics throughout the three sessions. Attendees working on the different knowledge areas briefly introduced their models and the challenges they encounter when working on them, which inspired discussions amongst methodologists who had used different quantitative approaches in the area. One of the most discussed and challenging topic was data storage, data access and data sharing.

The last day concluded the workshop with a wrap up and definition of plans for the future, among which it is worth mentioning the creation of a cross-IMI Alzheimer’s Disease modelling working group with the aim of creating synergies between this group of experts and their IMI-founded projects.