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On 4 December, our partner Aridhia announced that its digital research platform AnalytiXagility used in the health, biomedical research and precision medicine sectors, is to move all its work to Azure, including treatment studies by the European Prevention of Alzheimer’s Dementia Consortium (EPAD).

Aridhia will use Microsoft’s service to offer medical experts, such as those at EPAD, a secure, efficient and safe way of sharing data to improve patient outcomes, accelerate clinical research and contribute to the development of new drugs.

“We have created a safe space for researchers to work with highly privileged data associated with patients across all types of conditions,” said David Sibbald, Chief Executive of Aridhia. “It allows research groups to work and collaborate with other medical centres across the world, as well as bring in bio-pharmaceutical companies, in a secure environment.

Aridhia is planning to give some customers early access to their Digital Research Platform running on Azure in January.

Check out the joint release between Aridhia and Microsoft here.

Want to find our more? Rodrigo Barnes, Chief Technology Officer at Aridhia, wrote an insightful blog on the Aridhia website.

This month, we get to know the Tayside centre behind EPAD. The site began recruiting in February 2018, with its first participant enrolled on 22nd February. The team has currently recruited 50 participants and still has 6 participants due in for baselines this month, taking the total to 56 participants by the end of November. We are glad to hear that 5 (so far) research participants are booked in for December!

“We have thoroughly enjoyed running EPAD here within Tayside. The study thus far, has been no easy feat, but we enjoy a challenge”, said Kate Ferguson, the EPAD study coordinator in Tayside.

We caught up with the Tayside centre and asked them a few questions about their best practices and recruitment strategies.

Do you have any top tips to share for running the EPAD Longitudinal Cohort Study (LCS) efficiently at your site? Tayside: Building rapport with participants is key! Here in Tayside, we pride ourselves on our ability to communicate within the team and also to our participants. Right from the get go we try and establish a good rapport with potential participants, finding out as much information as possible during the screening calls. We like to take our time when recruiting participants to the study, encouraging them to ask as many questions as they want and express any concerns they may have in regards to the study (usually lumbar puncture!). Communication between the team allows us to streamline and run visits smoothly within the site.

How are you able to find suitable subjects for the cohort? Tayside: We continue to use HIC (Health Information Tracker) to recruit participants. This is a parent cohort which finds participants who have previously taken part in Generation Scotland studies. We also continue to recruit from Velocity and we find word of mouth is a wonderful thing for EPAD. The positive feedback we have had from participants, in relation to staff approach and professionalism, has been echoed in the amount of friends and family members we have recruited from participants already in EPAD.
Additionally, we use SHARE as a means of velocity recruitment and we also have access to JDR (Join Dementia Research), however we have not needed to tap into this resource at present, due to the continual flow of participants.
We are based in Ninewells hospital in Dundee and have on occasion put up a stall with study information on it and have seen a few interested individuals, one of which signed up to the study! Various members of our team attend conferences and events, handing out study information in the hopes this will boost recruitment.

Are you organising teleconferences with other EPAD sites in Scotland? Tayside: In Scotland there is usually a monthly teleconference which is held on the last Thursday of the month. We use this to discuss any issues or potential issues we have been experiencing to see if other sites can provide support and solutions. At present, Tayside, Edinburgh, Glasgow and Aberdeen are all a part of this.

“We hope to get a Tayside participant on the PPI in Edinburgh by the end of the year.” Kate Ferguson

Pictured: From left to right: Kate Ferguson (study coordinator), back left Dr Findlay (sub-I), middle Dr Gandhi (sub-I), front right Bernice Wong (back up coordinator), back right Phil Brown (administrator).
Not featured in photo:  Dr Connelly (PI), Taylor Chalmers (clinical trials support worker).

EPAD Update

We currently have 20 sites across Europe enrolling and more than 1,200 research participants screened. There was a total of 90 new research participants enrolled in the EPAD study in October. A special mention goes to Paris La Salpetriere (France) as the team screened 16 research participants in October for their inclusion in the EPAD study. We are pleased that Philip Scheltens’s team in Amsterdam (The Nerthelands) and Pablo Martinez-Lage’s team in San Sebastian (Spain) screened respectively 15 and 13 new participants in October.

What is your current role in EPAD?

I am a brand-new member of the EPAD work package six. Having joined the Alzheimer’s team at Biogen in May 2018, the EPAD work was highlighted as a key coalition to join and support from a communications and advocacy perspective. I bring to the team over six years of experience in working with the pharmaceutical industry across a wide range of corporate affairs competencies, including: patient advocacy, government affairs, communications (internal and external) and stakeholder relations. I hope to support the work package with the next stages of the project including the run up to month 60.  

What did you do prior to joining EPAD?

I am a patient advocacy and corporate affairs professional by trade with over six years’ experience of working in the life sciences sector. Before joining Biogen and the EPAD work package six, I have worked in a range of national, regional and global pharmaceutical roles striving to bring the patient voice closer to company corporate policy. Currently based in Amsterdam with Biogen, I moved to the Netherlands for a Global Patient Advocacy role with Teva Pharmaceuticals, and before that I held a variety of Corporate Affairs roles in Westminster with the Association of the British Pharmaceutical Industry.

Working in the pharmaceutical and life sciences sector has given me an understanding of the industries issues and their contribution to research, health, wellbeing and economic success. It is fundamental for companies and research organizations to have a clear patient advocacy and communications strategy to engage and educate governments, policy makers and the general public. 

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

I am the Senior Manager, EU Patient Advocacy, Alzheimer’s Disease at Biogen. Biogen was founded in 1978 as one of the world’s first global biotechnology companies by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, Biogen has led innovative scientific research with the goal over the last decade to defeat devastating neurological diseases.

Biogen currently works across a wide range of neurological conditions including Multiple Sclerosis, Alzheimer’s Disease, Parkinson’s Disease, and Amyotrophic Lateral Sclerosis (ALS), as well as less common diseases such as Spinal Muscular Atrophy (SMA) and Progressive Supranuclear Palsy (PSP).

Biogen has a collaborative approach to our research, engaging with physicians and scientific leaders around the world with the aim to further medical research, alongside working with advocacy and patient organizations as they serve the communities they represent. It was this strong scientific approach to tackling diseases that really drew me to work for Biogen.

What are your expectations from the EPAD project?

EPAD really embodies the future of research in healthcare. The initiative really is a unique European project aimed at tackling some of the challenges in Alzheimer’s Disease research. My expectations center on the need for Work Package six to communicate the weight of information EPAD is creating. As the largest ever public-private partnership in Alzheimer’s disease research, work package six has a huge role in communicating the combined knowledge and expertise of 38 organisations across multiple sectors. Alongside championing the research milestones and new research advances.

What is your current role in EPAD?

I am the Global Trial Lead for the Proof of Concept Trial working in the Chief Investigator’s office at the University of Edinburgh.  In this role I am responsible for bringing together the EPAD team at the University and IQVIA to work with intervention owners who wish to test their compound using the PoC platform.  I also work very closely with EPAD team members from the EFPIA partners who are integral in the set-up and ongoing work on the PoC platform.

What did you do prior to joining EPAD?

Immediately prior to joining EPAD I worked at Roche for seven years on a global phase 3 program investigating a treatment for Alzheimer’s disease.  In total I have worked for nearly 15 years on clinical trials of potential treatments for Alzheimer’s disease in a variety of roles as a rater and study coordinator on site, a monitor in a CRO and global study leader in the pharmaceutical industry across Australia and the UK.

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

I work for the University of Edinburgh which is the sponsor organisation for the Proof of Concept Trial.  The University of Edinburgh was opened in 1583 and many buildings in the historic Old Town of Edinburgh belong to the university.  I split my work time between Edinburgh and London and when in Edinburgh I work at the Centre for Dementia Prevention at the Royal Edinburgh Infirmary, which is great as I can see how EPAD also works from a TDC perspective.

What are your expectations from the EPAD project?

I hope that the EPAD project can enhance our understanding of Alzheimer’s disease as well as lead the way forward in revolutionising the drug development pathway for clinical trials of potential treatments.  With the expertise and dedication of everyone involved across the different organisations I think we have a great chance of achieving this.

In October 2018, two articles about the EPAD project were published.

On 29 October, the journal Dementia published an article entitled “Research participants as collaborators: Background, experience and policies from the PREVENT Dementia and EPAD programmes”. The article led by Sarah Gregory from the University of Edinburgh (UK) described how the PREVENT Dementia panel forms the basis for participant involvement within EPAD project and highlighted the role of patients and the public as collaborators in dementia research.

On 30 October, the Journal of Alzheimer’s Research & Therapy published online an article entitled “Secondary prevention of Alzheimer’s dementia: neuroimaging contributions”. The article discussed the use of neuroimaging markers in subject selection for inclusion or stratification in secondary prevention trials, their potential to serve as outcome markers in trials, and for monitoring trial safety. The article formulated practical considerations, neuroimaging recommendations for the EPAD Longitudinal Cohort Study. The article also mentioned the EPAD sister project Amyloid imaging to prevent Alzheimer’s disease (AMYPAD) as a large subgroup of the EPAD participants will also undergo amyloid PET, financed through AMYPAD.

On 30 October, NHS Research Scotland organised its seventh NHS Research Scotland Annual Conference in Perth. The event brought together delegates across NHS, academia, industry and third sector under the theme “The impact of research then, now and in the future”.

This year, organisers celebrate 70 years of the NHS. Through a series of plenary and parallel sessions, panel discussions, speed presentations, posters and exhibitor opportunities the NHS Research Scotland Conference celebrated the strength of Scotland’s research environment. 

During the great exhibition and networking time, Sarah Gregory (UEDIN) alongside two participant panel members, presented an EPAD Research Participant Panel poster. The EPAD members are committed to involving actual and potential research participants as much as possible in the development of the project, empowering everyone to play an active role in their progress. Two EPAD research participants attended the NHS Research Scotland Annual Conference and were authors of the EPAD poster as well.

The poster emphasized the panel as a valuable source of information in addressing crucial aspects of participant experience, retention of participants and as an avenue for a meaningful engagement for participants. During the facilitated session the group presented the set up and design of the Edinburgh panel established in March 2017 in Edinburgh. The group also reported its roles, responsibilities and gave some concrete examples of panel involvement in EPAD activities.

On 29-31st October, Alzheimer Europe held the 28th Alzheimer Europe Conference “Making dementia a European priority” in Barcelona (Spain). This year, the event gathered more than 800 participants from 46 countries including 35 people with dementia. The programme included 239 oral presentations and 175 poster presentations.

We were glad to see our epadista Jose Luis Molinuevo (BarcelonaBeta Brain Research Center) giving the keynote presentation “Will we be able to prevent Alzheimer’s disease?”. He gave an overview of the challenges and opportunities regarding the prevention of Alzheimer’s disease. He expressed the rationale behind preventing Alzheimer’s disease and the reason why prevention may be a key way forward to tackle it. He also mentioned EPAD as a European initiative aiming to streamline the testing and development of preventative treatments for Alzheimer’s disease.

The second plenary session on “Dementia as a human rights priority” included the second of four “Meet the researchers of tomorrow” sessions. Our EPAD fellow Stina Saunders from the University of Edinburgh gave an impressive talk on the engagement of the research participants as collaborators within the EPAD project. She highlighted that the EPAD study has set up the EPAD Participant Panel in order to learn from the experience of research participants, provide participants an on-going active voice in the project and incorporate participants’ input.
Isadora Lopes Alves from VU university medical center, another EPAD fellow, gave the fourth and final “Meet the researchers of tomorrow” session within the last plenary session focused on “Dementia as a research priority”. She presented the AMYPAD project, its aims, methods and latest progress.

In addition, Alzheimer Europe launched its new Dementia in Europe magazine during its 28th Alzheimer Europe Conference. This 28th edition of the magazine features an EPAD article underlining the global efforts and cooperation between the participating members and partners. The article reports our significant progress including the launch of the proof-of-concept platform, the EPAD research participant panel, the EPAD Academy as well as our active presence at international conferences.

If you are curious, you can download the presentations below:

• José Luis Molinuevo “The challenge of preventing Alzheimer’s disease: the BBRC experience“
• Stina Saunders “Involving research participants in research: The example of the EPAD project“
• Isadora Lopes Alves “ß-amyloid PET imaging: improving understanding, diagnosis and management of Alzheimer’s disease“

Mark the dates of the next Alzheimer Europe Conference in your calendar. “Making valuable connections” will take place in The Hague (Den Haag) from 23 to 25 October 2019.

On World Alzheimer’s Day, the members of the EPAD initiative have reached a new milestone where the EPAD Longitudinal Cohort Study (LCS) has screened more than 1,000 research participants. Within EPAD, the team at University Of Oxford (UOF) has been recruiting successfully and recruited the 1,000th participant.

Dr Vanessa Raymont, principal investigator of the EPAD project in Oxford was delighted by the success of her team: “’The Oxford site staff are exceptionally proud to have recruited the 1,000th participant – it’s all about the team work!”.

In this newsflash, we get to know the UOF team behind EPAD including their activities already done to recruit, engage and retain research participants. Check out their best practices below:

Do you have any top tips to share for running the LCS efficiently at your site? UOF: Organisation is key! We make sure that the all parts of the visits are booked in as early as possible (sometimes up to 2 months before!) to avoid any issues down the line with the visit windows and limited resource availability. Also, as we work across multiple NHS and University teams, clear communication pathways and processes are vital. With regards to efficient communication with potential participants’, we would highly recommend using the informational videos created by the Alzheimer’s Society (available on YouTube). These videos demonstrate many of the procedures involved in EPAD visits from a participant’s perspective, and lots of our participants have fed back that they found them very useful in helping them make a decision about participation.

How are you able to find suitable subjects for the cohort? UOF: We aim to tap into as many wide-ranging recruitment sources as possible so that we can offer this great opportunity to all those who are interested. By working closely with local memory clinics we ensure that people experiencing mild cognitive impairment are given the chance to get involved, as well as their interested family members, friends and carers. We also use registers such as the national ‘Join Dementia Research’ platform and our own healthy volunteer register ‘OxDARE’, to find suitable participants across Oxfordshire and Buckinghamshire.

Are you organising teleconferences (TC) with other EPAD sites in England? UOF: We have monthly TC’s with the TDC coordinators, where we discuss our progress, successes and struggles. In England, there is quite a lot of overlap in terms of recruitment sources and strategies, as well as contractual arrangements, so it is key to keep in touch, share our experiences and help support each other. As the lead site for the region, Oxford aims to support the CRO and the TDC’s in its region in the setup process, day to day management, as well as in the long term.

Have you organised or attended any events/conferences which have been beneficial for recruitment into EPAD? UOF: Over the summer we have attended multiple different events in and around Oxford to boost recruitment into EPAD and promote dementia research more generally. From providing an informational stall at our hospital’s open day as part of Oxford Open Doors, to giving a talk on current themes in dementia research at a local “Matters of Memory” event, we find that engaging with the public and clinical colleagues about the science of dementia prevention is beneficial for recruitment into EPAD. We are aiming to continue and actually increase these local events in the future. We are currently planning an informational event for carers in partnership with a local care home later in October, as well as an Oxford educational event around dementia prevention.

Pictured: from left to right: Amy Chinner (Research Assistant), Sophie Walker (back, Research Assistant), Jasmine Blane (front, Research Assistant), Laura Eshmene (Research Facilitator, back), Leona Wolters (Research Assistant, front), Sarah Mather (back, Clinical Research Assistant), Jen Lawson (Senior Trials Manager), Emily Broadhurst (Clinical Research Assistant), Dr Vanessa Raymont (Principal Investigator), Prof John Gallacher (National Lead for England and Wales), Juliana Ballaminut (Clinical Research Nurse), Delia Gheorghe (National Lead Coordinator for England and Wales), Dr Sarah Bauermeister (Psychometric Analyst).

EPAD Update:

September was the best month so far in the EPAD LCS for number of participants screened, there was a total of 105 screened across 20 European centres. Special mentions this month go to VUmc (Amsterdam, Netherlands) as the team screened 13 research participants in September for their inclusion in the EPAD study. We are pleased that Bruno Dubois’s team in Paris La Salpetriere (France) and Pablo Martinez-Lage’s team in San Sebastian (Spain) screened both 12 new participants in September.

On 27 October, Professor Craig Ritchie gave a talk at the 11th Clinical Trials on Alzheimer’s Disease (CTAD) conference in Barcelona. The aim of the CTAD conference is to bring together global leaders in the treatment of Alzheimer’s disease to discuss the development of the next generation of Alzheimer’s disease treatments.

For the first time, we presented a summary of EPAD’s First Formal Data Lock (EPAD V500.0) and predictors of amyloid status. The huge efforts on behalf of the participants in the EPAD study as well as the hundreds of research staff working on the study have resulted in a milestone where EPAD has entered the important phase of data analysis and the delivery of new knowledge. We took the opportunity at the CTAD conference to officially release our first wave of data including the baseline data from our first 500 research participants.

Professor Ritchie gave an informative overview characterising the study data and presenting initial analyses of the first EPAD data. He started by introducing the EPAD project and the Longitudinal Cohort Study (LCS), highlighting that LCS recruitment has improved significantly month by month and is in great shape to feed into the Proof of Concept (PoC) platform for drug trials. He explained then the rationale of the EPAD V500.0 Dataset and emphasised the transparency of the data set being used by the researchers. The cohort data will be accessible to the entire research community. The first data release is being worked on and expected by the summer 2019.

In the accompanying slides it was shown that 118 research participants with the Clinical Dementia Rating (CDR) score 0 of the entire sample of 500 research participants were Amyloid Positive while 37 research participants with CDR score 0.5 were Amyloid Positive. Amyloid status is best predicted by ApoE status, increasing age and CDR score 0.5. To finish the talk, Professor Ritchie announced that the PoC interventions will start through 2019/2020.

We were also pleased that five EPAD posters were presented during the 11th edition of Clinical Trials on Alzheimer’s disease:

• Lisa Vermunt “Study enrollment and Alzheimer’s disease pathology in relation to cohort type and participant characteristics in the EPAD Registry”
• Michel Ropacki “Baseline characterization of the European prevention of Alzheimer’s dementia (EPAD) longitudinal cohort study (LCS)”
• Delia Gheorghe “The use of Machine learning algorithms in Clinical Trials on Alzheimer’s disease”
• Lucy Stirland “Association between amyloid status and multiple chronic diseases in European Prevention of Alzheimer’s Dementia (EPAD): network and cluster analyses”
• Sarah Bauermeister ”Psychometric methodologies to increase scale-reliability in dementia-focused epidemiology: Outcomes from the European Prevention of Alzheimer’s Disease Study and UK Biobank”.

Well done and thank you to all EPADistas for your outstanding contributions in working towards a future without dementia.

On 22-23 October, the Innovative Medicines Initiative (IMI) held a scientific symposium in Brussels (Belgium) to celebrate its 10th anniversary. Young researchers from IMI projects were invited to submit abstracts for IMI’s first scientific symposium to showcase the stellar science that IMI projects have been doing.

The symposium featured 72 poster displays and 25 oral presentations that were selected by a Programme Committee comprising top experts, and were clustered around four themes:

• New targets, tools and pathways 
• From concept to trial 
• New clinical and regulatory paradigms 
• Patient engagement along the value chain.

We are glad than three EPAD abstracts were accepted at this year’s IMI Scientific Symposium in Brussels:

• Oral presentation: “Predicting Cognitive Decline through Structural MRI biomarkers: Results from the EMIF-AD Biomarker Discovery Study” – Ingala Silvia, VU Medical Center
• Poster: “Altering disease course before symptom onset: the European Prevention of Alzheimer’s Dementia (EPAD) project (WP4)” – Gheorghe Delia, University of Oxford
• Poster: “European Prevention of Alzheimer’s Dementia (EPAD) Registry for a longitudinal cohort and Alzheimer prevention trials” – Vermunt Lisa, VU University Medical Center.

In addition, Fiona Heeman (VU University Medical Center), Isadora Lopes Alves (VU University Medical Center) and Daniele Altomare (IRCCS – Fatebenefratell), three of our EPAD Academy fellows, presented the AMYPAD project.

More information can be found on the IMI website.