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This month, we get to know the Aeginition Hospital (Athens, Greece) centre behind EPAD. The team of Nikolaos Scarmeas (principal investigator of the EPAD project in Aeginition Hospital) began recruiting in September 2019 and has currently recruited 14 participants in the EPAD Longitudinal Cohort Study (LCS). We caught up with his 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? We invest a lot of time and effort in communicating with possible EPAD candidates, explaining them in detail the procedures of EPAD and the importance of their role in research activities. Furthermore we work closely with our colleagues in other sections of the hospital so that we make sure that we schedule all the appointments included in each visit (e.g. neuropsychological assessment, sample collection, brain imaging) taking into consideration each participant’s daily routine and special needs. In other words, we show a lot of flexibility (i.e. duration, timing and number of visits) towards accommodating participants’ schedules. We believe that this has helped us increase the engagement of our participants, bearing in mind that we also have volunteers coming from regions not of immediate proximity to our centre.

How are you able to find suitable subjects for the cohort? The main source of eligible EPAD participants is the Cognitive Disorders Clinic of Aeginition Hospital. There is only a single Medical School in Athens (that of the National and Kapodistrian University of Athens – NKUA) and Aeginition is the University Hospital for Neurology and Psychiatry of the NKUA. Every year we thoroughly evaluate more than 300 people, some of which are diagnosed with either subjective cognitive complaints or mild cognitive impairment, and are interested in participating in research projects on Alzheimer’s disease (AD). Moreover, we run another observational study, the Aeginition Longitudinal Biomarker Investigation Of Neurodegeneration (ALBION) aiming towards increasing understanding of the preclinical and prodromal stages of AD. Except from the medical and neuropsychological examination, we further collect bio-samples and run laboratory tests for all participants of ALBION. Thus we are able to find participants with ApoE and amyloid brain pathology that match the EPAD eligibility criteria. Furthermore two additional activities have helped us in finding suitable participants: a) close collaboration with the Non Governmental Organization Athens Alzheimer Association which runs Day Care Centers and Memory clinic services all over Athens and b) participation in medical and neurological conferences where we inform health professionals regarding our research activities.

Any past or future events/conference which have been beneficial for recruitment into EPAD? We have announced our research activities in the National Neurological Conferences, as well as in the local and National conferences on dementia themes. We have also been informing the general public in talks and presentations for lay audience.  We intend to continue to do so as the EPAD activities continue to evolve. We are also in the process of groundwork towards strengthening our network with the public primary care centres in our region.

Any activities in terms of participant engagement? Regarding the research participants that have already been enrolled in EPAD, we intend to communicate with them in a frequent basis reminding them of the EPAD goals and asking them about their current condition and needs. We will also continue to inform them about the usefulness of spreading the news to other potential participants they may know.

Pictured (from left to right): Eirini Mamalaki, Eva Danasi, Nikolaos Scarmeas, Faidra Kalligerou and Dora Brikou. 

EPAD update

We currently have 28 sites across Europe enrolling and almost 2,000 research participants screened. Congratulations to the site Sheffield (UK) for screening their first research participants in November. We are pleased that this site became the latest addition to the EPAD family.

We hope that you will share our positive assessment of the continuing progress of this exciting research collaboration. Stay tuned for more news next year. EPAD thanks you all for the hard work within 2019 and wishes you Merry Christmas and a very happy New Year to all of you and your families!

We would like to share the internal release of the baseline data from the first 1500 research participants (V1500.0) for the EPAD Longitudinal Cohort Study. The data set is now available and accessible to all EPAD partners and Trial Delivery Centres for an embargoed period of 6 months. Following which access will be opened to the entire research community globally.

The V1500.0 data release represents the second formal data release from the EPAD project. In our chosen nomenclature (V1500.0): V=version, 1,500 is the number of sequentially recruited research participants and ‘.0’ refers to the data collected at the baseline visit.

The data set is made available via secure online workspaces in order to facilitate collaboration between people and teams with similar research aims.

The previous V500.0 data release recently went into open and external access in November 2019. Academic researchers and institutions from all over the world are invited to access the EPAD Research Access Process and begin the application process by visiting the EPAD website, where you will find a variety of resources to support your research.

If you experience any technical issues or if you want more information please submit your query to epadraadmin@ed.ac.uk.

This month, we get to know the Fundació ACE centre behind EPAD. The team of Dr. Mercè Boada (principal investigator of the EPAD project in Fundació ACE) began recruiting in June 2019 and has currently recruited over 60 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.

“EPAD is an innovative and highly ambitious project because it is based on the belief that we’ll get to preventively treat Alzheimer’s disease. This message aims to change the concept of prediction or prevention to the concept of healing.”, said Dr. Mercè Boada.

Any top tips for running the LCS efficiently at your site? We believe that the success of the recruitment relies on the appropriate coordination between our Memory Unit and the Clinical Trials Unit. Continuous communication between both departments and adaptability as well as the willingness to find new synergies are important factors to take into account. Furthermore, we consciously invest a lot of time in the pre-selection process and in the informative visits for possible candidates to whom we explain purposefully the importance of their role in research. Another highly successful activity in line of efficiently running the LCS is the Open House Initiative (OHI), where we offer free cognitive evaluations for individuals from the community worried about their memory. This initiative allows us to have a better chance of finding people willing to participate in research, as they have proactively asked for the test. We have investigated OHI strategy in another IMI project called Models of Patient Engagement for Alzheimer´s Disease (MOPEAD), finding high rates of engagement using this approach. We recommend its implementation for early detection of mild cognitive impairment and preclinical Alzheimer’s disease.

How are you able to find suitable subjects for the cohort? Considering the current inclusion criteria, our main source of participants is the clinical practice of our institution. Thus, last year we evaluated 794 patients diagnosed with mild cognitive impairment that fulfilled the main inclusion criteria of the current algorithm. In addition, we have an extensive database of patients that has been reviewed for the recruitment process. As mentioned before, the Open House Initiative is another effective strategy to find subjects interested in collaborating in Alzheimer´s disease research.

Any country teleconferences/meetings you are organizing and how frequent? Due to our recent inclusion in the project we haven´t organised any country teleconferences or meetings yet. However, we would be very keen to organise and participate in one, as we think it´s a very good idea for the future.
Any past or future events/conference which have been beneficial for recruitment into EPAD? We will keep conducting the Open House Initiative to increase our recruitment potential, in addition to invite the patients that are evaluated in our Memory Unit.

Any activities in terms of participant engagement? We are planning to participate in the EPAD participant´s platform, because it´s in our interest to enhance the role of the participants and listen to their opinions and necessities in order to adapt our practice using a patient-centred approach.

Pictured: Maitee Rosende-Roca, Montse Alegret, Marta Ibarria, Mercè Boada, Charo Cuevas, Carla Abdelnour, Mar Buendía, Carmen Chaler, Liliana Vargas, Lluís Tárraga, Alba Benaque, Esther Pelejà, Adela Orellana, Isabel Hernández, Ana Mauleón, Laura Montrreal, Anna Calvet, Núria Aguilera, Ángela Sanabria, Asunción Lafuente, Marta Marquié, Laia Cañada, Verónica Ferrer, Silvia Gil, Mariola Moreno, Mercedes González, Ester Esteban, Juan Pablo Tartari, Sara Jofresa, Maribel Ramis, Goretti Brunet, María Jesús Allué, Isabel Rodríguez, Marta Lozano, Silvia Preckler, Susana Diego, Ahmad Safiya, Alba Pérez, Ana Pacho, Pilar Canyabate, Miren Gurruchaga y Salvador Almagro.

EPAD Update:

We currently have 27 sites across Europe enrolling and almost 2,000 research participants screened. Congratulations for the site Santander (Spain) for screening their first research participants in November. We are pleased that this site became the latest addition to the EPAD family. In addition, EPAD is pleased to announce the release of a new publication “The European Prevention of Alzheimer’s Dementia (EPAD) Longitudinal Cohort Study: Baseline Data Release V500.0”. This paper describes the baseline data from the first 500 research participants (V500.0) to assist current and future researchers with their analysis. V500.0 has been collected, quality checked, released and is now available via secure online tools.

EPAD is pleased to announce the release of a new publication entitled “The European Prevention of Alzheimer’s Dementia (EPAD) Longitudinal Cohort Study: Baseline Data Release V500.0” in the Journal of Prevention of Alzheimer’s disease. This paper describes the baseline data from the first 500 research participants (V500.0) to assist current and future researchers with their analysis. V500.0 has been collected, quality checked, released and is now available via secure online tools.

Abstract:

BACKGROUND: The European Prevention of Alzheimer’s Dementia (EPAD) Programme is a pan-European project whose objective is to deliver a platform, adaptive, Phase 2 proof of concept (PoC) trial for the secondary prevention of Alzheimer’s dementia. A component of this platform is the Longitudinal Cohort Study (LCS) which acts as a readiness cohort for the PoC Trial as well as generating data for disease modelling work in the preclinical and prodromal phases of Alzheimer’s dementia.

OBJECTIVES: The first data wave has been collected, quality checked, released and now available for analysis to answer numerous research questions. Here we describe the results from key variables in the EPAD LCS with the objective of using these results to compliment analyses of these data in the future.

DESIGN: EPAD LCS is a cohort study whose primary objective is as a readiness cohort for the EPAD PoC Trial. As such recruitment is not capped at any particular number but will continue to facilitate delivery of the EPAD PoC Trial. Research Participants are seen annually (with an additional 6 month visit in the first year).

SETTING: The EPAD Trial Delivery Network comprises currently 21 centres across Europe.

PARTICIPANTS: Research participants are included if they are over 50 years old and do not have a diagnosis of dementia. Measurements: All research participants undergo multiple assessments to fully characterise the biology of Alzheimer’s disease and relate this to risk factors (both fixed and modifiable) and biomarker expression of disease through brain imaging, fluid samples (CSF, blood, urine and saliva), cognitive performance, functional abilities and neuropsychiatric symptomatology.

RESULTS: V500.0 represents the first 500 research participants baselined into EPAD LCS. The mean age was 66.4 (SD=6.7) and 47.8% were male. The data was split for presentation into 4 groups: [1] CDR=0 and Amyloid + (preclinical AD), [2] CDR=0 and Amyloid –, [3] CDR=0.5 and Amyloid + (prodromal AD) and [4] CDR=0.5 and Amyloid -.

CONCLUSIONS: The EPAD LCS is achieving its primary objective of trial readiness and the structured approach to data release as manifest by this first data release of V500.0 will assist researchers to describe and compare their findings as well as in systematic reviews and meta-analyses. It is anticipated given current recruitment rates that V1500.0 data release will take place in Autumn 2019. V500.1 (when the 1 year follow up is completed on the V500.0 (sub)cohort will be in Autumn 2019 also.

The open access article is available here: https://doi.org/10.14283/jpad.2019.46

The European Prevention of Alzheimer’s Dementia (EPAD), a major Europe-wide initiative aiming to improve the understanding of the early stages of Alzheimer’s disease, has announced the release of its first wave of data as part of its EPAD Longitudinal Cohort Study. The project is one of the world leading dementia prevention studies involving 39 organisations. It offers a unique platform for testing and developing preventative treatments for Alzheimer’s dementia.

“Great to see that with the release of the first EPAD data set another great resource has become available for the Alzheimer’s disease research community worldwide”, said Serge Van der Geyten, EPAD Coordinator.

The members of the EPAD project today announced the availability of the baseline data from the first 500 research participants (V500.0). It represents the first formal public data release from the EPAD project for use by academic researchers and institutions worldwide. In the chosen nomenclature (V500.0): V=version, ‘500’ is the number of sequentially recruited research participants in each dataset and ‘.0’ refers to the study visit the dataset includes (visit 0 refers to the baseline data). Each data set will have a DOI to reference the source of the data in subsequent publication (V500.0: doi:10.34688/epadlcs_v500.0_19.05.10).

Data collected in the EPAD Longitudinal Cohort Study are provided via secure online tools in order to facilitate collaboration between people and teams with similar research aims. Academic researchers and institutions from all over the world are invited to access the EPAD Research Access Process and begin the application process.

About EPAD

EPAD is set up to recruit from existing cohort studies, patient registers and clinics across Europe. EPAD has established the first pan-European register including more than 30,000 research participants aged 50 or over across the dementia risk spectrum. From this register, individuals who do not have dementia are invited to join the EPAD Longitudinal Cohort Study. All research participants undergo multiple assessments including regular health checks, standardised tests and brain scans. The Longitudinal Cohort Study to date has enrolled over 1,900 research participants from 27 active sites in eight European countries. Recruitment rate is expected to increase as recently new sites have been activated. Many participants in the EPAD Cohort Study may be invited to take part in the streamlined EPAD proof-of-concept trial of drugs designed to prevent Alzheimer’s dementia. All data collected from the cohort and trial will become publically available.

The EPAD website itself is a useful resource to find out more about the EPAD initiative and to follow the current status of the study where updates are continuously posted as new research participants, recruiting sites and countries join the project.

Acknowledgment

We would like to thank all members of the EPAD Consortium, local study teams, parent cohort teams and research participants for their contributions to the development, setting up and running of the study.

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.

About IMI

The Innovative Medicines Initiative (IMI) is a 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.

What is your current role in EPAD?

I am a project manager for the overall EPAD project. My main role, as member of the EPAD Project Management office (WP5), is to provide overall management to the project including supporting the coordinator in liaising with the Innovative Medicines Initiative (IMI), follow up and management of the project plan, assurance of timely submission of deliverables, financial management, stakeholder management, procurement, reporting as well as supporting the Executive Committee, Clinical Development Executive and WP leaders in day-to-day management.

Additionally, I am also an active member of the LCS Recruitment Core Team- where we select new sites, follow up on recruitment and balance and support the sites with any hurdle they face, WP6 (Communications & Dissemination)- both internal and external and WP7 (Sustainability)- a very critical piece of work at this moment. 

What did you do prior to joining EPAD?

I have been working in EPAD for 2.5 years. Before joining EPAD, I worked as a Global Regulatory Affairs Artwork Project Manager, also at Janssen. I am a biomedical scientist and biotechnologist by training with a big interest in neurosciences. My master thesis studied LRRK2 kinase inhibitors as a potential therapy for Parkinson’s disease. 

Tell us a bit about your organisation

I am a consultant Project Manager at Janssen. The company to which I am affiliated to is Modis. Modis has more than 30,000 consultants in 20 countries, which provide Life Science, IT and Engineering services. Within the Life Science group, we provide services related to project and portfolio management, regulatory compliance and quality management, R&D process optimization, medical writing, early access programs and market insights, real-world evidence programs, funding and grant management, multi-stakeholder collaborations, sales and marketing, patient support programs, supply chain, etc.

Within Janssen, I am part of the Project Management Office specifically dedicated to provide support to the external funding portfolio across all therapeutic areas.

Janssen is a pharmaceutical company of Johnson & Johnson and it is committed to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. Janssen develops treatments for patients in six therapeutic areas: cardiovascular and metabolism, immunology, infectious disease and vaccines, neuroscience, oncology and pulmonary hypertension. The main research facilities for Janssen Research & Development in Europe are located in Beerse, Belgium, where most of the EU Janssen EPAD team is based.

What are your expectations from the EPAD project?

EPAD is an incredibly innovative and collaborative project. After almost five years of work, I am delighted to see that soon our first set of LCS data (V500.0) will become available to the broad research community. I think that EPAD will position itself as a key initiative with amazing data that will hopefully improve our knowledge of early Alzheimer’s dementia and how to approach this terrible disease.
While discussions are ongoing with several candidate compounds for the EPAD Proof of Concept (PoC) trial, we are working hard on a sustainability model to be able to maintain EPAD once the IMI funding is exhausted. I hope that we will soon host the first EPAD PoC study and that we will continue to do so as part of EPAD 2.0. I am proud of being an EPADista and of what we have built so far. I hope EPAD continues contributing to both science and to accelerating clinical trials in Alzheimer’s disease.

What is your current role in EPAD?

I was the local EPAD Principal Investigator but my neurology colleague Tobias Langheinrich has recently taken over. Greater Manchester is one of the EPAD sites. The Greater Manchester Dementia Research Centre (GMDRC) is a collaboration between the NIHR, Greater Manchester Mental Health Foundation Trust and the University of Manchester which recruits participants to clinical trials of disease modifying drugs in dementia. Currently, we are recruiting through our national “Join Dementia Research” program and local Memory Assessment Services to EPAD. My role is to coordinate GMDRC and NIHR activity to recruit and maintain awareness of research throughout these organizations and Greater Manchester.

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

Greater Manchester Dementia Research Centre is the crystallization of ten years of local research activity in CTIMPS and observational studies. We are the main site for clinical trial investigations in dementia in the North West of England. We conduct Industry and NIHR-funded trials and observational studies but have also recently been awarded our own grant funding for an MRI-PET study in Alzheimer’s disease and expect to be conducting research in molecular diagnostics soon.

What are your expectations from the EPAD project?

In the UK, we are moving towards a national molecular diagnostic framework and we see EPAD as fundamental to this. I will be speaking at the Alzheimer’s Research UK (ARUK) inaugural clinical meeting on 12th November and much of what I say will feature data gleaned from EPAD V500.0, explaining how Age, CDR score and APOE-4 carrier status can give us insights into risk of Alzheimer spectrum disease, and how to direct the most needed/most expensive molecular diagnostics towards those at highest risk. This information, and the information gleaned from the soon-to-be-released V1500.0 data will help us build human-readable algorithms that can help us risk-stratify those with mild cognitive impairment and classify them onto AT(N) categories, and therefore clarify their risk of cognitive progression.

As part of the Clinical Trials Digital Week, KNect365 Life Sciences organised a global 4-day series of live educational webcasts and downloadable resources providing the latest insights into clinical partnerships, outsourcing, operations and technology from 13-16 May 2019.

Katrin Haeverans (Clinical Scientist and External Affairs Director at Janssen) was invited to deliver a webinar on the European Prevention of Alzheimer’s Dementia Consortium (EPAD) project. She introduced the project, its objectives, design and consortium. Then, she mentioned the EPAD Longitudinal Cohort Study (LCS) where research participants are invited to join a cohort of at-risk subjects and detailed the EPAD Proof of Concept (PoC) platform. The EPAD platform has been developed to speed up the development of effective, safe medicines which slow or prevent the development of Alzheimer’s dementia. By setting up a trial-ready cohort of research participants, creating a pan-European network of trial sites, identifying ineffective medicines earlier in the development process and eliminating failures in more advanced (Phase III) trials, EPAD aims to accelerate the development of effective therapies. Katrin Haeverans closed her talk by reporting some operational challenges and the added value for pharma companies.

If you have missed the event, you can read the blog post “Accelerating Alzheimer’s dementia research with collaborative research design” published on the KNect365 website. You can also watch the full on-demand webinar here.

The European Prevention of Alzheimer’s Dementia (EPAD) project, a highly innovative programme aiming to streamline the testing and development of preventative treatments for Alzheimer’s disease, is very pleased to announce the upcoming release of its first wave of data including the baseline data from the first 500 research participants (V500.0).

Researchers will now have access to the EPAD Research Access Process, designed to give academic researchers and institutions from all over the world a way of accessing the data collected in the EPAD Longitudinal Cohort Study. Study data access will be provided via secure online tools in order to facilitate collaboration between people and teams with similar research aims.

At today’s Alzheimer Europe conference in The Hague (Netherlands), Professor Craig Ritchie, EPAD Project Co-coordinator, explained the rationale of the EPAD V500.0 dataset and emphasised the transparency of the data set being used by the project team. He announced that the first data set (V500.0) will be available from 18^th November and invited academic researchers and institutions from all over the world to begin the application process. This would allow applicants to register on-line and complete their request with all the accompanying information. Data workspaces containing the V500.0 data set will be live from 18^th November.

The V500.0 data release represents the first formal public data release from the EPAD project for use by academic researchers and institutions worldwide. It will assist researchers to describe and compare their findings as well as in systematic reviews and meta-analyses. In the chosen nomenclature (V500.0): V=version, “500” is the number of sequentially recruited research participants in each dataset and ‘.0’ refers to the study visit the dataset includes up (visit 0 refers to the baseline data).

Neuronet, a coordination and support action funded by the Innovative Medicines Initiative (IMI), brings together 15 IMI consortium projects working on neurodegenerative disease (such as Alzheimer’s), encompassing over EUR 290 million in research funding.

The Neuronet programme held four parallel sessions as part of the Alzheimer Europe conference on 24 and 25 October. This involved showcasing projects that are working to improve our understanding, diagnosis and treatment of neurodegenerative disease.

The first parallel session was chaired by Lennert Steukers from Janssen. It was entitled “European research collaboration in Alzheimer’s disease and beyond”. The three speakers in this session introduced the work of the IMI on neurodegenerative disease (Elisabetta Vaudano, IMI), presented an overview of the Neuronet project (Carlos Diaz, Synapse Research Partners) and highlighted the importance of meaningful patient and public involvement in IMI research projects (Ana Diaz, Alzheimer Europe).

The second parallel session was chaired by Craig Ritchie, Director of the Centre for Dementia Prevention at Edinburgh University, and was entitled “From risk to dementia: Understanding disease progression and its causes”. In this session, leaders of the ADAPTED (María Eugenia Sáez), PHAGO (Angela Hodges) and AETIONOMY (Martin Hofmann-Apitius) projects presented their work on characterising some of the key molecular drivers of Alzheimer’s disease (AD), such as the ApoE genetic risk factor and the innate immune receptors CD33 and TREM2.

The third parallel session was chaired by Jacoline Bouvy of NICE and was entitled “Improving data access and the development of predictive models”. Four IMI projects were presented in this session: EQIPD (Malcolm Macleod), EMIF (Pieter Jelle Visser), ROADMAP (John Gallacher) and IM2PACT (Dominique Lesuisse.) The EQIPD project is developing a framework for improving research quality, aiming to improve the drug development pipeline, while the EMIF and ROADMAP projects showcased the new platforms and tools they have developed to help researchers visualise and access clinical research data and real-world evidence. This session finished with a presentation on the IM2PACT project, which is working to understand the blood-brain-barrier in health and disease.

The fourth Neuronet session was chaired by José Luis Molinuevo, Neuronet Scientific Coordination Board member, and was entitled “Diagnosis, patient engagement and trials”. AMYPAD (José Luis Molinuevo) and EPAD (Craig Ritchie), two sister projects of the IMI neurodegeneration portfolio, highlighted their achievements in using amyloid-PET scans to diagnose AD (AMYPAD), and in creating clinical trial registries and cohorts of people at risk of developing Alzheimer’s dementia (EPAD). The leader of the MOPEAD (Mercè Boada) project then presented the four patient engagement models that they are currently testing, aiming to improve early patient engagement in clinical trials.  The final Neuronet session was brought to a close with a presentation on the RADAR-AD (Dag Aarsland) project, which is exploring how digital technologies can be used non-invasively to measure the progression of disability associated with AD.

This article was originally posted on: https://www.alzheimer-europe.org/News/EU-projects/Friday-25-October-2019-Neuronet-convenes-annual-event-on-European-research-collaboration-in-Alzheimer-s-disease-and-beyond