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Lynne Hughes, VP and head of medical CNS strategy at IQVIA, talked about EPAD accomplishments and challenges in an interview article. She provided insights on how EPAD and IQVIA are contributing to advance Alzheimer’s disease research.

EPAD is celebrating five years since its inception. What has it accomplished?

We have 23 European sites enrolling subjects to the longitudinal cohort study, and they have screened 1,867 research participants and 1,554 are currently enrolled into our registry. In the next few weeks, we will have 30 sites open and actively recruiting subjects. This is the largest cohort trial in the world in this subject population. Our cohort contains data from all the subjects and covers cognition, biomarkers, genetics and imaging, and we have already published a number of articles, posters and papers regarding this cohort.

The aim of EPAD is to provide a trial-ready cohort of screened and eligible subjects for participation in an adaptive proof-of-concept clinical trial. By using the registry participants, recruitment is faster and more efficient, allowing us to expedite clinical testing of potential investigational products through the PoC stage of clinical development. In addition, we are able to gather data showing the natural history of the early development of AD — characterized via the ongoing biomarker, imaging and cognitive assessments — which will aid in our understanding of the etiology of the disease. We have currently undertaken more than 20 analyses on our data set to date with more planned, and EPAD is making the data available to researchers globally.

How is IQVIA contributing to this effort?

EPAD selected IQVIA as the only CRO to project manage the EPAD longitudinal cohort study. The project management team formalized holistic and integrated stage gate reviews to optimize engagement of key internal stakeholders at pivotal points in the project lifecycle, improve up-front delivery strategy, plan development prior to study start-up, and execute according to plans during conduct. These SGRs established a formal structured review and oversight process and have become an integral part of the project culture, fostering more transparency, communication and collaboration. This has helped remediate potential roadblocks, challenge assumptions and proactively identify and mitigate risks before they can escalate into issues, thereby improving predictability and reducing surprise for stakeholders.

Our global reporting tools are also being used to drive continuing compliance with agreed schedule and quality commitments and form the basis for reporting to stakeholders on status and progress versus plan.

In addition to managing the LCS trial, IQVIA was also selected to execute all the subsequent PoC trials, which will utilize the LCS subject registry and assess the efficacy and safety of investigational products submitted through this innovative trial system. This unique design will utilize a master protocol — a ratio of 3:1 active IP: placebo — for each arm of the trial, and we will combine the placebo arms across different IOs to increase the power of the trial for each assessed IP. This design has been developed by Scott Berry, a PhD statistician and president at Berry Consultants, a statistical consulting company specializing in designing adaptive and innovative trial designs, and is a first in the field of AD clinical trials. IQVIA will be managing this entire trial for all the IOs, and we will be copying the database for each IO to ensure confidentiality while still allowing sufficient functionality for the placebo arms to be combined for each client.

What are some of the ongoing challenges of this project?

One key challenge is ensuring sustainability and continuity of the funding to allow the research sites to recruit subjects into the LCS, which will feed subjects into the adaptive PoC trial. Another challenge is ensuring that we have a clinical trial, in a reasonable timeframe, for qualified subjects to enter. If they are diagnosed with preclinical AD, we do not want to delay them from participating in a clinical trial, because they could potentially benefit.

What is the hope for the future of EPAD? What is the goal?

We are moving into EPAD 2.0, which will see the start of the first intervention owner submitting their IP for the adaptive PoC trial. All the sites will then move into clinical trial mode and will be recruiting their suitably qualified registry participants into the clinical trial, testing the first IP through the EPAD system. The first IO has already been identified, and the sites are ensuring that future registry participants are recruited who are likely to fulfill the trial entry criteria for this new trial. In addition, there are a few more pharma/biotech companies who have also submitted their IPs for review by the EPAD executive to see whether they would be suitable as the second IO for this trial.

The full interview is available here.

The EPAD project, originally scheduled to end in December 2019, has been extended. We are pleased to share that IMI has officially approved our request for a 6-month no-cost extension to the project, setting the end date in June 2020. This extension will allow the delivery of the start of the first EPAD Proof of Concept (PoC) appendix within the official lifetime of the project as well as the implementation of a sustainability model that allows EPAD to continue its activities after June 2020.

The project started in January 2015 with the goal of streamlining the testing and development of preventative treatments for Alzheimer’s disease. To this end, EPAD has been developing a platform on which new compounds can be tested in an efficient way, delivering more effective, targeted interventions that can slow or stop dementia.

By combining knowledge and expertise from 39 organisations across multiple sectors, EPAD has been able to accomplish a lot over the last 4.5 years. Examples of these accomplishments are the EPAD Register, the EPAD Longitudinal Cohort Study currently recruiting in several European sites and with more than 1900 research participants screened and the establishment of the PoC framework. Good progress has been made on the PoC pipeline and the contract negotiations with the upcoming Intervention Owners. The team is looking forward to the inclusion of the first participant in the first PoC appendix in Q2 2020.

In addition, over the past months the EPAD sustainability work package has made significant progress in making sure that EPAD can continue running during the post IMI period, renamed as EPAD2.0, as of July 2020.

We are confident that this 6-month extension is a fantastic opportunity to successfully implement what we have been working so hard on, the first PoC appendix and EPAD 2.0. We would like to thank all the EPADistas and research participants for their enthusiasm and dedication to the EPAD initiative. We are looking forward to the upcoming months!

The Neuronet (Efficiently Networking European Neurodegeneration Research) communication team is proud to announce the launch of the official project website: http://imi-neuronet.org/

Neuronet is a three-year coordination and support action that kicked off in March 2019.  The aim of Neuronet is to set up an efficient platform to boost collaboration across research projects focusing on neurodegenerative diseases, including but not limited to Alzheimer’s disease. These projects have all been launched by the world’s biggest public-private partnership in the life sciences, the Innovative Medicines Initiative (IMI). Neuronet aims to assist in identifying gaps in research, multiply the impact of findings and enhance project visibility, whilst also facilitating connections with related initiatives in Europe and worldwide.

Neuronet has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 821513. The JU receives support from the European Union’s Horizon 2020 research and innovation programme, EFPIA and Parkinson’s UK.

Members of the EPAD team attended the Alzheimer’s Association International Conference (AAIC) held on 14-18 July. They travelled to Los Angeles (US) from across Europe for the biggest event in dementia research.

The event featured a number of key symposia, focused topic sessions and poster presentations and highlighted significant progress, results and theories that will help bring the world closer to breakthroughs in dementia science.  The five-day scientific conference brought together nearly 6,000 leaders in dementia research including academics, clinical researchers, clinicians, investigators and the care research community.

This is the second year that we exhibited the EPAD studies with our EPAD branded green and white booth in the exhibition area. We are delighted that more than 350 people stopped by at the EPAD booth to learn more about the project and discuss further topics such as the EPAD data access process, the Longitudinal Cohort Study (LCS) set up and, of course, the Proof of Concept (PoC) study. It was also a great opportunity to meet many current and future EPAD collaborators.  

“It was as a real pleasure to attend AAIC in Los Angeles. It was my first AAIC and I really enjoyed the whole experience. Our booth was popular and it was great to be able to chat with so many attendees about the work we do in EPAD and establish new connections.” – Natalia Reglinska-Matveyev

EPAD also had a business suite at the exhibition area where many engaging meetings with potential interventional owners and other world experts on Alzheimer’s disease prevention took place. Altogether, the conversations we had at the booth and the business suite generated a rich exchange of ideas and we are excited that various collaborations are being considered.

“It was great to return to AAIC 2019 after the success of last year’s booth. This year we had even more visitors to the EPAD booth, with increases in both industry and academics. Many of the people I spoke with came to the booth as they had heard about the work EPAD was doing and wanted to find out more about how they could get involved. Hot topics once again included data access, and I’m looking forward to seeing what questions the EPAD data is going to be able to help the scientific community answer.” – Sarah Gregory

At AAIC 2019, the aim of the EPAD booth was twofold. Our first aim was to showcase the EPAD PoC trial platform and engage the pharma and biotech industry. To support this a new high quality animated video was created to highlight the key benefits of the EPAD approach to develop drugs for Alzheimer’s disease (you can watch it here). Our second aim was to show all the benefits that EPAD has to offer to the scientific community. In order to do so, the EPAD booth included an interactive screen on which attendees could browse their topics of interest including the LCS and PoC studies, the EPAD Academy, the data access process and upcoming data batches, disease modelling, the statistical study design and interviews and testimonials of many EPADistas and collaborators.

“AAIC was a fantastic opportunity to show to the AD world what EPAD has done in the last 4,5 years. After reading the name of the project, many people came to the booth asking what we had in mind to prevent Alzheimer´s dementia. Their reaction was often a “Wow”. – Laura Carrera Carballés. 

Additionally, we are glad that the EPAD team had two oral presentations at AAIC on different aspects of the project. Both generated a great deal of interest from researchers outside the project: 

• “Associations between Multimorbidity and CSF Amyloid: Cross-Sectional Analysis of the European Prevention of Alzheimer’s Dementia (EPAD) Cohort” from Lucy Stirland (UEDIN)
• “Prescreening for European Prevention of Alzheimer Dementia (EPAD) Trial-Ready Cohort: Impact of AD risk factors and recruitment settings” from Lisa Vermunt (VUmc).

AAIC enabled the EPAD team to network and catch up with a lot of our colleagues and AAIC attendees. We would like to thank all the EPAD members who made this possible. We are very proud of the dedicated people working in our consortium spanning public and private sector organisations across Europe.

“Introducing EPAD to new people was very enjoyable; they are astonished by our vast network of sites and the sheer volume of data & samples we collect under the LCS. Many people specifically came to the EPAD booth to ask how they could access our data. We are looking forward to November to see how many data access request we receive once version V500.0 is released to external researchers. Everyday Craig and Kristy had positive meetings with potential, known and new Intervention Owners. The EPAD booth, our networking at the Universal Studio’s and throughout the conference was a real team effort which I have no doubt will bare autumn fruits.” – Emilie Delpon

 

Pictured: The EPAD team at the AAIC booth – From left to right, Craig Ritchie (UEDIN), Kristy Draper (UEDIN), Laura Carrera Carballés (Janssen), Kathryn Carruthers (UEDIN), Natalia Reglinska-Matveyev (UEDIN),  Sarah Gregory (UEDIN) and Emilie Delpon (UEDIN).

What is your current role in EPAD?

Within the Geneva University, I act as a project manager for both EPAD and the AMYPAD Prognostic Natural History Study (PNHS). This includes all the tasks incumbent to this function, ranging from the submissions to the Ethics committee, the follow up of the speed of recruitment, the identification of some deviations and the proposal and implementation of corrective measures, but also the coordination of the integration of new sites in Switzerland and Italy. Among these activities, the organisation of the last EPAD General Assembly presented no minor challenges.

What did you do prior to joining EPAD?

My background is quite atypical: once my law degree obtained at the University of Geneva. I spent more than 20 years in the banking industry, both in Geneva and Zurich I acted as a relationship manager first for banking institutions located in Western Europe, then as a senior client adviser for wealthy individuals from the Unites Arab Emirates. This gave me a unique opportunity to interact with various cultures and people as well as to develop a robust knowledge of all kinds of products useful to my clientele. Besides, I was involved in several projects, one of them being the set-up of a dedicated data management system for our department. After having managed to help my former customers to surf on the tsunami of the banking crisis, I decided that it was high time not only to take care of the financial welfare of individuals, but also of their physical welfare. I hoped I could make a small contribution to that end. I had the chance to come across Professor Frisoni’s path. His passionate and visionary mind and his commitment decided me to join this flagship. The idea of being part of a European initiative where efforts and dedication of so many people are put in common appealed to me and I was confident that I could happily transfer some of my former competences in this new environment. 

What are your expectations from the EPAD project?

My expectation on EPAD are high. To paraphrase Alice in the beautiful film “Still Alice”, I hope that all these efforts will mean that one day, no one will have to say: “I used to know how the mind handled language, and I could communicate what I knew. I used to be someone who knew a lot. No one asks for my opinion or advice anymore. I miss that. I use to be curious and independent and confident. I miss being sure of things.” I cannot believe that so much time and effort will be spent in vain.

What is your current role in EPAD? 

I am a Project Manager at IXICO plc, and I manage the delivery of Magnetic Resonance Imaging (MRI) analysis results on EPAD Longitudinal Cohort Study. IXICO data analysis algorithms quantitatively analyse brain scans, to maximise the information extracted and increase chances of detecting therapy-induced changes in clinical trials. IXICO’s artificial intelligence data analytics will be used to combine imaging with other data captured from EPAD participants, to predict the rate of disease progression in individual participants and identify those people who could benefit from enrolment in clinical trials aimed at preventing Alzheimer’s disease.

What did you do prior to joining EPAD?

I joined the EPAD study on 2016, when the first participants started to be recruited and having MRIs. I have a background on Biomedical Engineering and started working at IXICO in 2014, right after my MSc, in a more technical role. I developed an expertise on the complexities of set-up and training of MRI centres for data acquisition, and used that experience to set-up the majority of the MRI scanners in the study. In 2018 I moved into a position of managing a team that sets up sites and analyses the patient images, which led me to my current role on EPAD.

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

IXICO is a company that provides neuroscience expertise and global operations to deliver imaging and digital biomarker analytical services for clinical development, within a framework of regulatory compliance. IXICO values the relationships it has with academia, business and charitable organisations. Only by working together we can advance treatment for neurological diseases. IXICO’s expertise and TrialTracker™ digital platform is being used to standardise the collection and analysis of MRI data on EPAD (as well as PET data on the sister project AMYPAD).

What are your expectations from the EPAD project?

My expectations are that the foundations built/lessons learned from the Longitudinal Cohort Study across the interactions with the impressive number of academic and industry partners will allow for a solid and successful implementation of the adaptive studies. Furthermore, I hope that the output of the work performed by IXICO will have a very positive impact in the set-up and success of the adaptive studies.

This month, we get to know the North Bristol centre behind EPAD. The team of Elizabeth Coulthard (principal investigator of the EPAD project in North Bristol) began recruiting in June 2018 and has currently recruited 40 participants in the EPAD Longitudinal Cohort Study (LCS). We caught up with her team and asked them a few questions about their best practices and recruitment strategies.

Any top tips for running the LCS efficiently at your site? The key to managing this is having staff that know the study well and have good explanation of the Lumbar Puncture procedure. We have weekly meetings to discuss screening appointments and know study doctor / rater / nurse availability to plan visits accordingly.

How are you able to find suitable subjects for the cohort? We have a good database of healthy volunteers interested in research, close working links with Bristol BDR (Brains for dementia research) which has been very good for recruitment, inviting screen failures from another big study to take part in EPAD has worked well (captive audience!). We have used Join Dementia Research (national database of people interested in dementia research). We plan to increase our MCI (Mild Cognitive Impairment) recruitment in the future by recruiting from the MCI clinic that is run by our service. We have an annual newsletter which goes to all of our healthy volunteer database at Christmas time so we included a piece about EPAD in that last year (2018). BRACE (a local dementia charity who we have close working links with) have also promoted our research opportunities on their website, social media and newsletters.

Any country teleconferences/meetings you are organizing and how frequent? Our study coordinator attends monthly teleconferences for England coordinators organised by Delia Gheorghe in Oxford. Some of the EPAD team attended the EPAD Investigator meeting and the Proof of Concept kick off meeting held in Berlin in February and plan to attend the EPAD England meeting in Oxford this July.

Any past or future events/conference which have been beneficial for recruitment into EPAD? We attend the BRACE annual conference in Bristol each year and have a stall to promote our research opportunities.

Any activities in terms of participant engagement? We recently had a stand in the atrium of the main hospital building here at Southmead Hospital for Clinical Trials Day and signed up healthy volunteers to our research database.

“The participants that we see have a really keen interest in Alzheimer’s disease; it’s really rewarding to work on something that both staff and participants are really passionate and motivated about”, said Rebecca Cousins.

Pictured: From left to right: Elena Bellavia, Catherine Watkins, Dr Victoria Sanderson, Beccy Pracownik, Natalie Rosewell, Rebecca Cousins (missing staff: Bethan Owen)

EPAD Update:

We are pleased that Fundació ACE (Spain) became the latest addition to the EPAD family and recruited their first research participants. We currently have 22 sites across Europe enrolling and more than 1,750 research participants screened. There was a total of 99 new research participants enrolled in the EPAD study in May. This month, special mentions go to Pablo Martinez-Lage’s team in San Sebastian (Spain) who recruited 54 new research participants in May.

From 15-17 May 2019, the EPAD project hosted its annual General Assembly meeting in Geneva (Switzerland). We were delighted that the event brought together EPAD delegates to discuss progress, latest developments and future plans. In attendance were scientists, researchers, representatives from pharmaceutical companies, patient organisations, SMEs, EPAD study site members, other experts and research participants from across many different countries, who make up the EPAD family (also referred to as “Epadistas”!). The meeting was hosted by the Centre de la mémoire of the Geneva University Hospital, the University of Geneva and the Centre Leenaards de la mémoire of the Centre Hospitalier Universitaire Vaudois de Lausanne and kindly co-sponsored by MSD and Janssen.

The General Assembly meeting commenced with Giovanni Frisoni, Serge Van der Geyten and Craig Ritchie welcoming almost 200 attendees (exceeding any of our past General Assembly meetings). They reflected the evolution of EPAD and introduced the agenda for the coming days. Craig Ritchie then briefly introduced the EPAD project, explained the EPAD flow and its crucial components. The EPAD Proof-of-Concept (PoC) platform has been developed to speed up the development of effective, safe medicines which slow down or prevent the development of Alzheimer’s dementia. Craig stated that the recruitment into the EPAD PoC is exclusively from the EPAD Longitudinal Cohort Study (LCS). It was interesting to hear that the EPAD PoC team is being directly approached by many potential Intervention Owners.

We have now entered the final year of EPAD, with the project officially ending by the end of December 2019. However, there was an exciting announcement that EPAD will formally request IMI to grant a no-cost 6-month extension to the project. 2019 is going to be a year of transition for EPAD as we look forward to the post-IMI period, named EPAD 2.0.
The next session was then dedicated to the EPAD sustainability Work-Package. The team behind WP7 has made significant progress with the aim to help create a sustainable EPAD platform for the prevention of Alzheimer’s dementia which would continue the work already undertaken during the IMI funding of EPAD. Different scenarios and approaches for the project’s future were shared and punctuated by lively discussions.

The second day was full with a variety of talks from Work Package leads and members. Project outcomes were presented to the Consortium together with the updates on the current activities. It’s amazing to think that we have entered the final year of EPAD and there are a lot of incredible achievements to look back at! As a start, the current LCS status and the progress done so far were reported. We were glad to see the EPAD family of Trial Delivery Centres (TDCs) growing – we currently have 23 sites open of which 21 are already enrolling across 7 European countries and more than 1,600 research participants screened. We just welcomed two new sites on board that were activated in May 2019 – Fundacio ACE (Barcelona, Spain) and Centre Hospitalier Universitaire Vaudois (Lausanne, Switzerland). Additionally, over the next weeks and months we will open additional sites since TDCs from a total of 11 European countries are identified for participation in EPAD.  It was interesting to hear from Kristy Draper, EPAD Global Trial Lead (the University of Edinburgh), who introduced the potential PoC appendices and the progress towards the first PoC Trial. All vendors have been selected and the necessary processes are in place. The contract negotiations and appendix drafting are ongoing and the team is aiming for a start next year with the inclusion of the first candidate for the PoC in Q2 2020. We were pleased to witness how EPAD enables researchers from all over Europe to collaborate and share findings to pull together a world-leading project that aims to prevent Alzheimer’s dementia. Following the Work Package updates, Elisabetta Vaudano IMI Principal Scientific Officer, gave a presentation on IMI and shared some recommendations.

After an energetic coffee break, the afternoon session focused around workshops, giving everyone the opportunity to attend parallel sessions of interest. These breakout sessions on amyloid disclosure, online registries, sample management and data access were hugely valuable. One of the highlights was the presentation of the EPAD Research Access Process, designed to give academic researchers and institutions from all over the world a way of accessing the data, samples and imaging data collected during the EPAD LCS. The study data is made available in secure online workspaces in order to facilitate collaboration between people and teams with similar research aims. Another exciting announcement came on the second day that we now have released the first wave of data (v500.0) from our research participants. The data are now available for EPAD researchers only until November when access will be opened to the entire research community. That said, EPAD members can now begin the application process. The second day was concluded with a nice networking dinner at a typical Swiss restaurant. Before that, the EPAD’s team were lucky enough to enjoy a pleasure cruise on Lake Geneva (Lac Léman) with great views of the lake and mountains around.

The third and final day of the meeting hosted a question & answer session where all delegates had the opportunity to interact with the EPAD leadership. They received some great questions from the audience. Engaging discussions were held on the PoC platform, EPAD data, sustainability and future activities. Finally, the EPAD Consortium gathered for an EPAD Academy session. 60 young researchers (EPAD fellows) are now part of the EPAD Academy that aims to efficiently leverage EPAD resources to foster and develop academic research capacity and output in Alzheimer’s disease across Europe for maximum global impact. We heard from six EPAD fellows about their respective work covering pre-screening for EPAD trial-ready cohort, cognitive disease progression modelling, staging cortical amyloid deposition, fluid biomarkers in preclinical Alzheimer’s disease, theory of change methodology and cognitive decline prediction through structural MRI biomarkers.  The EPAD fellows’ talks were an engaging end to an overall fascinating General Assembly meeting. The meeting was then brought to a close by Craig Ritchie and Serge Van der Geyten. We are very thankful to everyone who came along and we would like to thank all Epadistas for their enthusiasm and dedication.

During the three days, research participants were in the spotlight. It is important to the EPAD team that we build a conversation with our participants. We are committed to involving research participants as much as possible in the development of the project, empowering everyone to play an active role in our progress. Our participants are our partners in this project too. We’re very thankful that nine research participants from France, Scotland, Spain and the Netherlands were willing to come to the General Assembly. During the second day of the meeting, they had the opportunity to meet together within the breakout session organised for the research participant panels. We were truly humbled that they took the floor to kick start the last and final day of the event to share their views and experiences of being a research participant in EPAD. We wish to say a huge thank you to all of the participants again – we can’t do any of this without you!

It is a really exciting time for EPAD and for the PoC in specific. We look forward to the next months ahead!

This month, we get to know the Karolinska Institutet centre behind EPAD. The team of Miia Kivipelto (principal investigator of the EPAD project in Karolinska Institutet) began recruiting in August 2017 and has currently recruited 32 participants in the EPAD Longitudinal Cohort Study (LCS). We caught up with her team and asked them a few questions about their best practices and recruitment strategies.

Any top tips for running the LCS efficiently at your site? Our LCS site integrates research and routine clinical activities (i.e. the Clinical Trials Unit and Memory Clinic are very closely connected). There is a continuous flow of patients coming from the routine memory clinic setting into a variety of clinical research studies, the majority of which are pharmaceutical randomized controlled trials. EPAD is a great fit for this set-up, given the focus of our site on rapid identification of individuals who are actually trial-ready.
We have also closely followed the recent major developments at Karolinska University Hospital, both in terms of a new clinical operational model, and a newly built additional hospital location with specific focus on highly specialized medical care and clinical research. We have recently opened an additional Memory Clinic with a “fast-track” clinical operational model. Where the full routine assessments are completed within one week, and the patient flow can be directed more seamlessly and accurately towards the most suitable ongoing clinical research studies. The EPAD team is also interacting much more closely with the clinic team.

How are you able to find suitable subjects for the cohort? Recruitment at our site targets memory clinic patients. Due to the highly specialized profile of the Karolinska memory clinics, about two thirds of the patients do not have dementia at referral, and a significant proportion are also relatively young (e.g. below 70 years).

The routine memory clinic assessment protocol also helps. In addition to extensive cognitive and clinical assessments, both brain MRI scans and CSF sampling for Alzheimer biomarkers are done for all referred patients (unless they have contraindications). While this is unusual for many other European countries, it’s not unusual for memory clinics in Sweden, and it definitely gives us an advantage for EPAD since we can be extremely specific about recruitment, and ensure that we actually include trial-ready EPAD participants.

Another important factor is that the EPAD team is part of the weekly diagnostic conferences of the clinical team, which increases the accuracy of the recruitment process, and ensures that EPAD updates are continuously shared with the clinical team.

Any country teleconferences/meetings you are organizing and how frequent? We have weekly and monthly site-specific EPAD meetings, where any arising issues can be highlighted and discussed to make sure they are addressed in time. We also have an ongoing regular monthly contact with the new Swedish site in Gothenburg, to bring them onboard the project and help out where needed, given that the set-up in Gothenburg is very similar to the one in Karolinska.

Any past or future events/conference which have been beneficial for recruitment into EPAD? EPAD team members have been participating in several local and national meetings in Sweden targeting clinicians but also the older general public (including patients and their families). A description of EPAD has been included in oral presentations to make sure information is spread through a broader network of memory clinics that could contribute to recruitment.   

Any activities in terms of participant engagement? Participant engagement and motivation levels tend to be higher in a memory clinic-based cohort compared with the general population, and we see this in our EPAD participants too, they come to us already very committed to contribute to this research. The EPAD design is in itself attractive for our target population, especially the alignment of the LCS with the PoC, which is eagerly awaited.

Our Clinical trials Unit team (including the EPAD team) is very experienced in working longer-term with this group of research participants. In recent years we had several qualitative research projects focusing on factors related to motivation and engagement in Alzheimer clinical trials, so we already have routines in place for maintaining the EPAD participants’ motivation and engagement during the face to face visits and phone calls.

“We are of course delighted about this international collaboration between so many research groups across Europe, and between academia and industry. Working closely together is the best way to find innovative solutions to address Alzheimer’s disease and prevent dementia”, said Miia Kivipelto

EPAD Update:

We currently have 21 sites across Europe enrolling and more than 1,600 research participants screened. There was a total of 50 new research participants enrolled in the EPAD study in April. We are pleased that Pablo Martinez-Lage’s team in San Sebastian (Spain) and Alasdair Lawrie‘s team in Grampian (UK) screened respectively 8 and 7 new research participants.

On 4 April, the CHU de Toulouse (CHUT) hosted the first meeting of the Research Participant Panel of the European Prevention of Alzheimer’s Dementia Consortium (EPAD) in France. We caught up with a French Research participant to know what it is like to take part in a research study and find out about his experiences.

What motivates you to be a research participant in a research project like EPAD? What motivated me first was my personal anxiety about my memory loss. I thought that it would be very interesting to participate in this project. On the other hand, we need motivated people willing to take part in research and keep things moving.

You have joined the EPAD project for a year now. Could you please tell us about your experience? First of all I was very surprised by some study assessments such as saliva tests. Apart from that, I find the experiment very interesting. On the health front, the participation consists of regular assessments including MRI, cognitive and biological tests. This experience offers me reassurance.

What is it like to have a lumbar puncture? Although, I was very scared for my first lumbar puncture, I really wanted to do it to be reassured and to know if I have biomarkers of Alzheimer’s disease. The second time I took a drug and everything went very well, without pain and concerns.

You are now a member of the EPAD Participant Panel in Toulouse, of which the first meeting has just held. What are your expectations and the topics you would like to raise with the participant group? I do not have any particular expectations. I would like, through these meetings, be able to know more about the conducted research. I find interesting that we can stay informed about the study and its results. I would also like to take advantage of these meetings to share my experience within EPAD and in the service.

What message would you like to send to the researchers and partners of the project? The research team is really nice. It is really important to see this collective commitment. They know how to put us in confidence and to set us at our ease. This is really appreciate and key for all the exams. For that, I would like to express my gratitude to them. I feel anxious very quickly and the involvement and professionalism of the team is thus really appreciable.

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French:

Le 4 avril, le CHU de Toulouse (CHUT) a accueilli la première réunion du panel de participants à la recherche du projet EPAD en France. Nous avons discuté avec un participant à la recherche pour savoir ce que cela représente de participer à une étude de recherche et découvrir ses expériences.

Quelles ont été les motivations qui vous ont amené à participer au projet EPAD? Ce qui m’a motivé en premier c’est mon angoisse personnelle concernant mes pertes de mémoire et je me suis dit qu’il était très intéressant pour moi de participer à ce projet. D’autre part, il faut des personnes volontaires et motivées pour participer à la recherche et faire avancer les choses.

Vous êtes dans le protocole EPAD depuis 1 an maintenant, pouvez-vous nous parler un peu de votre expérience? Tout d’abord j’ai été très surprise par certains tests, comme les prélèvements de salive par exemple ! A part cela, je trouve l’expérience intéressante, sur le plan médical étant donné qu’on bénéficie d’un IRM et de tests cognitifs et biologique chaque année. Cette expérience m’a rassurée.

Vous avez eu des ponctions lombaires, pouvez-vous nous dire quel effet cela fait? J’avais très peur, mais j’ai voulu absolument faire cette ponction lombaire pour être rassurée et pouvoir savoir si j’avais des biomarqueurs de la maladie d’Alzheimer. La première fois, j’ai eu vraiment très peur, la seconde fois j’ai pris un décontractant et tout s’est très bien passé, sans douleur !

Vous faîtes partie du participant panel, dont la première réunion s’est tenue aujourd’hui, quelles sont vos attentes et les thèmes que vous souhaiteriez aborder? Je n’ai pas d’attentes particulières. J’aimerai, à travers ces réunions, pouvoir connaitre un peu l’évolution de la recherche. Je trouve intéressant qu’on puisse nous donner l’évolution de l’étude et ses résultats. J’aimerai aussi profiter de ces réunions pour pouvoir faire un retour sur mon expérience dans EPAD et dans le service.

Quel message souhaiteriez-vous faire passer aux équipes de recherche et aux partenaires du projet? L’équipe de recherche est vraiment sympathique et c’est très important car cela aide beaucoup ! Ils nous mettent en confiance ce qui est c’est essentiel pour tous les examens. Ils savent nous mettre à l’aise et rien que pour cela je voudrais les remercier. Je suis quelqu’un qui s’angoisse très vite et pour moi tout cela est appreciable.