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2019 started with great intensity! On 5 February, EPAD held its PoC (Proof of Concept) Kick Off meeting in Berlin, Germany. The event brought together more than 100 delegates including site staff (principal investigators, sub-investigators, study coordinators, national leads), vendors and the wider EPAD PoC coordination team (the University of Edinburgh, Janssen, IQVIA) to showcase the PoC trial platform. For the first time, we gathered 30 sites (active and in set up) working on the project to share experiences, discuss PoC preparations and build core strategies.

Prof Craig Ritchie, EPAD Co-coordinator (the University of Edinburgh), opened the meeting, thanking IQVIA for the organisation of the event and extending a special welcome to the site staff and study team attending the event. He then introduced the EPAD project, its consortium, flow, structure and the PoC platform, which has been developed to run Phase II clinical trials with research participants with preclinical and prodromal Alzheimer’s disease, with biomarker evidence of Alzheimer’s disease pathology using a consistent set of outcomes.

We currently have 21 European sites enrolling and more than 1.450 research participants screened. Over the next months we will open additional sites. Trial Delivery Centres (TDCs) from 11 European countries are identified for participation in EPAD. There are a total of 35 TDCs currently selected for participation, with additional sites pending confirmation on participation.

Prof Ritchie reported then that the recruitment into the PoC is exclusively from the EPAD cohort of at-risk subjects, the Longitudinal Cohort Study, known as the LCS.

“The LCS has to be ‘ready’ to feed the right research participants into the right research sites for the right trial”, Prof Craig Ritchie.

Following Prof Ritchie, Dr Kristy Draper, the EPAD Global Trial Lead (the University of Edinburgh), emphasised the importance of the master protocol. She highlighted its design and the progress towards the first PoC trial. The negotiations with the first intervention owner are progressing well and we are hopeful that we will be able to begin start-up activities for the first PoC appendix in the spring. There was also an exciting announcement that the inclusion of the first participant in will likely happen in Q1 2020. In addition, the clinical candidate selection committee has two more interventions lined up with a scheduled start in 2020.

“We are expecting 2019 to be a busy and exciting year as the EPAD team work with the first intervention owner to action all the plans made to begin the first trial within the EPAD PoC platform”, Kristy Draper.

This meeting marked an important stage in the preparations for the PoC with almost all of the study sites coming together to plan and discuss readiness for the first appendix. Two workshop sessions were organised where each site had the opportunity to discuss and work on the PoC readiness. Firstly, each site reflected on the barriers they might have in term of recruitment as these will likely affect the capacity to also run the PoC and identified ways to increase the number of trial-ready participants in the LCS. Secondly, they gave their thoughts on how to prepare the participants for joining the PoC trial. These sessions were hugely valuable and the outputs from these have been collated. Our study sites were firmly at the heart of the meeting.  Prof Craig Ritchie and Clare Dolan (the University of Edinburgh) took the floor for a scenario between a study staff member and a research participant. This particular practical discussion was displayed to draw together some of the issues the sites could encounter as well as the participants’ concerns during the initial conversation about the PoC. It was an amusing moment that reflected some of the content site staff may see in their own sites.

After an energetic workshop session discussing issues across sites and the generation of creative plans, John Tracey from IQVIA presented an overview of 3^rd Party Vendors. To close the day, a few words were said by Craig Ritchie, “I hope to see you all in May for the EPAD General Assembly Meeting to be held in Geneva”.

With the PoC platform now kicked-off and attracting a great deal of interest from the pharmaceutical sector, it was encouraging to see how the sites are working together to support drug development. We are very pleased about the many conversations had and the enthusiasm for our innovative PoC platform. All our huge efforts are at a point of coming to fruition with compounds about to be tested in a streamlined and efficient way, delivering more effective, targeted interventions to prevent dementia. 

On 4 February, over 90 representatives of the EPAD project met in Berlin. Participants included 15 dedicated teams from UK, Spain, Germany, Italy, Belgium and Greece together with representatives from the University of Edinburgh, Clinical Research Organisations, IQVIA and Janssen. The objective of the meeting was to prepare the new trial delivery centres (TDCs) to put the EPAD Longitudinal Cohort Study (LCS) into action.

This Investigator meeting allowed participants to discuss all materials and procedures for implementing the LCS protocol. It also gave the opportunity to the new study sites that will join the LCS in the coming months to ask questions and share their expectations.

Prof Craig Ritchie (the University of Edinburgh) welcomed the attendees and explained how the LCS works conceptually, the purpose of the protocol and how the LCS is different from other cohort studies. 

Ellie McMaster and Neil Mitchell (the University of Edinburgh) also spoke about their roles and responsibilities within the Sponsor’s office known as ACCORD (The Academic and Clinical Central Office for Research and Development – a partnership between the University of Edinburgh and NHS Lothian Health Board) in the LCS. This was quickly followed by the role of IQVIA by Joe Milne.

After an energetic coffee session, the afternoon was focused on the operational aspects of the project and included presentations on MRI Imaging Processing (IXICO), EPAD cognitive evaluation (Medavante) and biological sample handling (EPAD Biobank).  Craig Ritchie closed then the day by thanking all attendees.

Bernard Hanseeuw, based at the Cliniques universitaires Saint-Luc (Belgium), will be involved in running the trial in Brussels. “EPAD is one of the first experiment of adaptive clinical trial design and one of the first data-sharing experience in Europe in the field of Alzheimer’s disease. I am very much excited about the opportunity to share data and to have a very large cohort”, he said.

Nikolaos Scarmeas, based at the Aeginition Hospital Athens (Greece), enthused the added value of the EPAD project after attending the Berlin meeting “The benefit of EPAD is first of all the collaboration of many people from different countries in Europe who collectively put efforts together. The advantage is that EPAD combines two different methodologies (observational and interventional parts) with a careful design”.

In a video interview during the meeting, Craig Ritchie, José Luis Molinuevo, Katrin Haeverans and Frank Jessen explained the goals of the EPAD project for 2019. Watch the video below.

What is your current role in EPAD?

I joined EPAD in October 2018 and am assigned as a lead EFPIA partner responsible for oversight of the Longitudinal Cohort Study (LCS), working alongside the Chief Investigator office at UEDIN.  I am a member of Work Package 4, currently leading the LCS Recruitment Core Team and am also involved in Work Package 7 activities.

What did you do prior to joining EPAD?

I am a medical doctor specialising in pharmaceutical medicine. I have been working for Janssen since 2006 in a number of different roles with increasing responsibilities. My current role is Global Trial Leader, Associate Director, and since 2010 I have been leading multiple international phase 2 and phase 3 interventional trials in the neuroscience therapeutic area, including Alzheimer’s disease.

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

Janssen is a pharmaceutical company of Johnson & Johnson, a multinational medical devices, pharmaceutical and consumer packaged goods manufacturing company. Simply put, we’re people working hard with a mission to treat, cure, stop and prevent some of the most devastating and complex diseases of our time — from heart disease, diabetes, and psoriasis to Alzheimer’s disease, HIV, and cancer.

What are your expectations from the EPAD project?

I find it fascinating that so many academic and industry partners came together to work on such an important area of unmet medical need for new and more effective treatments for Alzheimer’s disease. The approach of working together, rather than in parallel, is what provides a tremendous motivation to make the EPAD project a success. I expect that the final result will be to help people around the world to live longer, healthier and happier lives. 

This month, we get to know the Grampian centre behind EPAD. The Grampian (that is in North East Scotland!) EPAD trial delivery centre enrolled its first research participant in May 2018. The small but efficient team of six led by Dr. Alasdair Lawrie (principal investigator of EPAD in Grampian) had recruited 22 participants in the EPAD Longitudinal Cohort Study (LCS) by the end of 2018. We caught up with the Grampian centre and asked them a few questions about their best practices and recruitment strategies.

Any top tips for running the LCS efficiently at your site? Being a small team, efficiency is the name of the game. We therefore have to wear many hats. For example, Kirsten McClelland-Brooks coordinates EPAD and is also a rater, phlebotomist and lab processor. To maximise our resources we split our appointments into three visits: for their first visit, participants come for their consent and cognitive assessments, the second visit is for the bloods and MRI scan and this approach enables us to schedule two participant appointments on the same day so that we can process both sets of bloods together followed by a third visit for the lumbar puncture which is carried out by Advanced Nurse Practitioners which although they are not working directly for EPAD gives them an opportunity to work in research as an extension to their normal role in Acute Medicine.

How are you able to find suitable subjects for the cohort? We have been fortunate to have access to participants from Generation Scotland which is a cohort of volunteers who have given their “broad” consent for their data to be used for medical research, but of course suitable participants from this source are limited and we are always looking for new ways to source participants. For example, we encourage spreading the positive message of EPAD through the “word of mouth” approach and this positive participant experience has also resulted in a number of additional participants. The Join Dementia Research is another voluntary register that we have sourced participants interested in taking part in dementia research.

Any country TCs you are organising and how frequent? We have a monthly teleconference with the other three sites in Scotland where there is a platform to share ideas, troubleshoot and motivate each other.

Any past or future events/conference which have been beneficial for recruitment into EPAD? In August 2018 EPAD Scotland held their inaugural conference, a great way to meet the bigger EPAD Scotland family of staff and participants and share information and ideas through breakout sessions. We are all looking forward to a bigger and better 2019 conference!

Any activities in terms of participant engagement? We have recently had two EPAD participants sharing their experience for NHS Grampian videos targeting Patient and Public Involvement (PPI) in research.

‘It’s really exciting to be part of the EPAD study which will hopefully change the course of dementia research and treatment”, said Kirsten McClelland-Brooks, the EPAD study coordinator in Grampian.

Pictured: From left to right: Kirsten McClelland-Brooks (coordinator), Julie Scott (Clinical Studies Officer), Edward Slack (Specialty Trainee), Alison McBain (Blinded rater) and Miriam Lloyd (Clinical Studies Support Worker Part time). Dr Alasdair Lawrie (principal investigator) and Dr Jen Adams (Consultant Psychiatrist) are missing in the photo.

EPAD Update

There was a total of 69 new research participants enrolled in the EPAD study in December 2018 and we are pleased that Pablo Martinez-Lage’s team in San Sebastian (Spain) screened 16 new participants in December 2018.

With the beginning of the New Year, the EPAD project is celebrating its fourth birthday. We currently have more than 1,370 research participants screened and we are delighted to share good news since the EPAD family of trial delivery centres grew to 21 sites in January 2019 with Cambridge (UK) enrolling its first research participant.

 

Alejandro Laquidain is one of the more than 200 Spanish research participants of the EPAD project recruited within the research center of the Pasqual Maragall Foundation (Barcelona, Spain), the Barcelonaβeta Brain Research Center (BBRC).

What motivates you to be a research participant in a research project like EPAD? The volunteering proposal presented by the Pasqual Maragall Foundation, together with the disease of my mother, deeply resonated and encouraged my brothers and myself to immediately get involved. From this time, everything has flowed easily due to the power, humanity and honesty of the project, the involvement and professionalism of the entire team led by Dr. Molinuevo and the personal and collective commitment that I believe we owe to people living with Alzheimer’s disease.

You have joined the EPAD project on February 2017 and have already made several visits. Could you tell us about your experience? It has been incredible, positive and enriching. It is also an honour to collaborate in this project with a group that offers an exquisite treatment and affection. I appreciate their constant interest to improve and evolve in every single way, always with the same purpose: to better understand the disease in order to be able to prevent it. The personal satisfaction of being part of the study is enormous.

What is it like to have a lumbar puncture? Personally, it has not caused me any concerns, neither during the procedure nor after it. It is easy to appreciate that the medical team knows exactly what they are dealing with. On the other hand, it is a few hours of tranquility and silence that I take advantage of to make introspection and reaffirmation in the project.

You are now a member of the EPAD Participant Panel in Barcelona, which is composed of 8 research participants. Can you tell more about your discussions with the participant panel group? It is a diverse and great group! Ideas raise incessantly. Overall, our main intention is to contribute with something different to the project and look for what can concern such a diverse and heterogeneous group. Regarding this last point, we are currently proposing the use of some specific communication tools between research participants and the BBRC where these concerns can be addressed. Another issue we are working on is the preparation of a document on a “Living will”. We believe it is important to reflect in a document the personal positions that should be respected by people living with Alzheimer’s disease.

What message would you like to send to the researchers and partners of the project? I want to congratulate them for the intensity and excellence in every tasks they are doing. We take for granted that they perceive the support, affection and gratitude of all the research participants, but just in case, we will never stop showing our gratitude to them! With regards to the sponsors, I can get a grasp of their feeling and implication in the project, but I encourage them to continue being there and try to attract other companies and entities with the aim to better understand the early stages of Alzheimer’s disease and finally to prevent the disease.

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Spanish:

Alejandro Laquidain es uno de los más de 200 participantes del proyecto European Prevention of Alzheimer’s Dementia (EPAD) en el centro de investigación de la Fundación Pasqual Maragall, el BarcelonaBeta Brain Research Center (BBRC).

Alejandro, ¿qué te mueve a ser voluntario de la investigación en prevención de la enfermedad de Alzheimer? 

La propuesta de voluntariado presentada en su día por la  Fundación Pascual Maragall, unida al largo padecimiento de mi madre debido a la enfermedad, nos hizo saltar como un resorte a mis hermanos y a mí para ofrecernos como voluntarios. A partir de ese momento, todo ha fluido con facilidad debido a la potencia, la humanidad y la honestidad del proyecto, a la implicación y la profesionalidad de todo el equipo que dirige el Dr. Molinuevo, y al compromiso personal y colectivo que  creo debemos a las personas que sufren Alzheimer.

Te sumaste a EPAD en febrero del 2017 y ya has realizado diversas visitas del estudio. ¿Cómo ha sido tu experiencia? 

Increíble, positiva, enriquecedora. Es, además, un orgullo poder colaborar en este proyecto con un grupo humano que ofrece un trato exquisito, que raya en el mimo y del que aprecio el constante interés por mejorar y evolucionar en todos los sentidos, aunque siempre con un mismo fin: intentar conocer mejor la enfermedad para así poder combatirla. La satisfacción personal de formar parte del estudio es enorme.

¿Y con la punción lumbar?

Personalmente, no me ha causado ningún problema, ni durante ni después de la misma. Es fácil apreciar que el equipo médico especialista sabe perfectamente lo que se lleva entre manos y lo demuestra en todo momento. Son, por otro lado, unas horas de total tranquilidad y silencio que aprovecho para hacer introspección y reafirmación en el proyecto.

Ahora eres miembro del EPAD Panel en Barcelona y periódicamente os reunís para debatir diferentes aspectos relacionados con el proyecto o que os preocupan. ¿Cuáles son los puntos que tenéis actualmente sobre la mesa? 

¡Es un grupo variopinto y genial! En líneas generales, nuestra principal intención es aportar algo distinto al proyecto e imaginar lo que puede preocupar a un grupo tan diverso y heterogéneo como es el de los Voluntarios. Respecto a este último punto, actualmente estamos proponiendo la utilización de algún tipo de herramienta de comunicación entre los Voluntarios y la Fundación donde se puedan volcar estas inquietudes. 
Otro de los temas en el que estamos trabajando es en la confección de un documento sobre un Testamento Vital. Creemos que es importante dejar plasmado en un documento cuáles son las posturas personales que se deben respetar en caso de sufrir Alzheimer.

Por último, ¿qué mensaje lanzarías a los investigadores y partners del proyecto?

A los primeros, felicitarlos por la intensidad volcada en todo lo que están haciendo. Suponemos que perciben el apoyo, el cariño y el agradecimiento de todos los Voluntarios, pero nunca nos cansaremos de transmitirlo. De los patrocinadores y partners, intuyo la implicación que sienten por el proyecto, pero los animo a que continúen estando allí y que traten de atraer a otras empresas y entidades con la idea de conseguir, entre todos, poder entender y finalmente luchar contra la enfermedad del Alzheimer.

Another EPAD year has passed and we are proud to look back at a lot of successful deliveries and established relationships. To celebrate turning four, we look back at some of our key achievements of the past 12 months.

January

On 16th January, the EPAD Academy officially started its first activity by proposing online webinars by world-class senior researchers on current topics in Alzheimer’s disease (AD) research for EPAD Fellows.

February

On 27th February, our partner Alzheimer Europe held a successful lunch debate entitled “Will we be able to prevent Alzheimer’s dementia” at the European Parliament in Brussels (Belgium). The lunch debate focused on the prevention of Alzheimer’s disease and dementia through three key presentations. The panel included a presentation by Craig Ritchie (UEDIN) who looked at what the EPAD project can offer in terms of research into prevention.

May

The EPAD General Assembly took place in Amsterdam. The meeting, hosted by VUmc and kindly sponsored by VUmc, Amgen, Novartis and Janssen, was held under the banner “How to assure sustainability”.

June

EPAD was on the news in Australia. Craig Ritchie gave a plenary lecture “Preventing Dementia: False Promise or True Progress” at the International Dementia Conference in Sydney on the 7th June and mentioned EPAD. The Australian national news service Nine News echoed the importance of our project (broadcast available here).

On 27th June, over 400 people attended the IMI event “Celebrating 10 Years of Medical Innovation” at the European Parliament in Brussels. Serge van der Geyten (Janssen) presented the EPAD project.

July

Various activities were undertaken in July to generate awareness on the importance of Alzheimer’s disease prevention and the EPAD project:

• 18th World Congress of Basic and Clinical Pharmacology (Kyoto, Japan). José Luis Molinuevo (BBRC) presented the EPAD project, in two conferences about European research initiatives on Alzheimer’s disease Prevention.
• 3rd UK Dementia MRI conference (Cambridge, UK). Craig Ritchie presented the EPAD project, the progress done so far and highlighted the national and international collaborations.
• AAIC (Chicago, US). For the first time, we exhibited the EPAD study via a large EPAD booth in the exhibition area as well as hosted a satellite symposium dedicated to the EPAD PoC trial. We also took this opportunity to launch the new EPAD website and to release a new EPAD brochure.

August

On 29th August, the EPAD’s Scottish team were lucky to visit the stunning University of Aberdeen campus for the inaugural EPAD Scotland conference. The event gathered almost 80 delegates including participants, site staff and the wider Scottish EPAD team.

Moreover, in August, we reached another milestone as the EPAD family of trial delivery centres grew to 20 sites with Brescia (Italy) enrolling its first research participant.

September

September 21st marks World Alzheimer’s Day. September was a busy month for our EPAD partners and TDCs, with a number of meetings and events taking place to join the World Alzheimer’s Month campaign.

September 21st, a date we will not easily forget, as the 1,000th EPAD Research Participant has joined the EPAD family by volunteering to participate in the EPAD Longitudinal Cohort Study (LCS).

We are also pleased that the first EPAD Academy exchange has officially started in September. Gemma Salvadó from Fundació Pasqual Maragall stayed for three months at Amsterdam UMC – Locatie VUmc supervised by Prof Frederik Barkhof.

October

In October, the EPAD project was presented at various events:

• IMI scientific symposium (Brussels, Belgium). We are glad than three EPAD abstracts were accepted at this year’s IMI Scientific Symposium.
• CTAD (Barcelona, Spain). Craig Ritchie gave an oral overview characterising the study data and presenting initial analyses of the first EPAD data. We took the opportunity to officially release our first wave of data including the baseline data from our first 500 research participants. In addition, five EPAD posters were presented.
• Alzheimer Europe Conference (Barcelona, Spain). Stina Saunders (UEDIN) gave an oral talk on the engagement of the research participants as collaborators within the EPAD project.
• NHS Research Scotland Annual Conference (Perth, Scotland). Sarah Gregory (UEDIN) alongside two participant panel members, presented an EPAD Research Participant Panel poster.

Also in October, our sister project AMYPAD enrolled its first EPAD research participant into its Prognostic and Natural History Study (PNHS) and this at VUmc. This PNHS study has the challenge of being integrated into the EPAD LCS.

November

We are pleased that EPAD LCS marked its best month to date for recruitment of research participants in November 2018 with 118 new research participants enrolled.

We also welcomed the 39th EPAD partner to the project MSD (Merck Sharp and Dohme).

 

In addition, we are glad that several EPAD papers were published through 2018:

• “Perspectives on Communicating Biomarker-Based Assessments of Alzheimer’s Disease to Cognitively Healthy participants”, Ethics Reviews
• “European Prevention of Alzheimer’s Dementia Registry: Recruitment and prescreening approach for a longitudinal cohort and prevention trials”, Alzheimer’s & Dementia
• “The Rationale Behind the New Alzheimer’s Disease Conceptualization: Lessons Learned During the Last Decades”, Journal of Alzheimer’s Disease
• “At, with and beyond risk: expectations of living with the possibility of future dementia”, Sociology of Health & Illness
• “On the personal utility of Alzheimer’s disease-related biomarker testing in the research context”, Journal of Medical Ethics
• “Research participants as collaborators: Background, experience and policies from the PREVENT Dementia and EPAD programmes”, Dementia
• “Secondary prevention of Alzheimer’s dementia: neuroimaging contributions”, Alzheimer’s Research & Therapy

 

We would like to thank you all for a fruitful EPAD year. EPAD combines knowledge and expertise from 39 European organisations from academia and industry. This public-private partnership in Alzheimer’s disease research is a unique collaborative effort that draws on the talents of experts from across the Alzheimer’s disease research and drug development community. EPAD emphasises the importance of collaboration between the different European sites and partners to assure the sustainability of its project.  Looking forward to continuous good collaboration in 2019.

To successfully start the New Year – the pivotal year of EPAD – we are pleased that Cambridge has recruited its first research participant in January 2019 in the LCS. EPAD has now 21 sites enrolling research participants across 7 European countries (i.e. France, Italy, the Netherlands, Spain, Switzerland, Sweden and UK) and more sites to join in 2019. Stay tuned!

Wishing you all an exciting and happy New Year,

The EPADistas

 

 

The EPAD project aims to develop an environment for and then test multiple different interventions targeting the secondary prevention of Alzheimer’s disease dementia. EPAD is conducting a Longitudinal Cohort Study (LCS) in alignment with a Bayesian adaptive designed EPAD Proof-of-Concept (PoC) trial. On 27 December 2018, an article presenting the EPAD LCS study protocol has been published online in BMJ Open.

 

European Prevention of Alzheimer’s Dementia Longitudinal Cohort Study (EPAD LCS): study protocol

Abstract
Introduction: The European Prevention of Alzheimer’s Dementia (EPAD) project is funded initially by the Innovative Medicines Initiative and has been established to overcome the major hurdles hampering drug development for secondary prevention of Alzheimer’s dementia, by conducting the EPAD Longitudinal Cohort Study (LCS) in alignment with the Bayesian adaptive designed EPAD Proof-of-Concept (PoC) trial.
Methods and analysis: EPAD LCS is an ongoing prospective, multicentre, pan-European longitudinal cohort study. Participants are recruited mainly from existing parent cohorts across Europe to form a ‘probability-spectrum’ population covering the entire continuum of anticipated probability for Alzheimer’s dementia development. The primary objective of the EPAD LCS is to be a readiness cohort for the EPAD PoC trial though a second major objective is to generate a comprehensive and large data set for disease modelling of preclinical and prodromal Alzheimer’s disease. This characterisation of cognitive, biomarker and risk factor (genetic and environmental) status of research participants over time will provide the necessary well-phenotyped population for developing accurate longitudinal models for Alzheimer’s disease covering the entire disease course and concurrently create a pool of highly characterised individuals for the EPAD PoC trial.
Ethics and dissemination: The study has received the relevant approvals from numerous Institutional Review Boards across Europe. Findings will be disseminated to several target audiences, including the scientific community, research participants, patient community, general public, industry, regulatory authorities and policy-makers. Regular and coordinated releases of EPAD LCS data will be made available for analysis to help researchers improve their understanding of early Alzheimer’s disease stages and facilitate collaborations.
Trial registration number: NCT02804789.

 

http://dx.doi.org/10.1136/bmjopen-2017-021017

 

We are pleased to announce the arrival of a new project partner, MSD (Merck Sharp and Dohme). We say a warm welcome to MSD and look forward to our collaboration.

EPAD combines knowledge and expertise from 39 European organisations across multiple sectors, bringing a wealth of experience to our activities. The list of our partners can be found here.

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

 

The EPAD family of trial delivery centres grew to 20 sites in August 2018 with Brescia (Italy) enrolling its first research participant. The team of Dr. Samantha Galluzzi (principal investigator of the EPAD project in Brescia) has currently recruited 15 participants in the EPAD Longitudinal Cohort Study (LCS). We caught up with the Brescia team 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 LCS efficiently at your site? We think that where possible, having a large group of people working on the LCS is the key! In our site we have four cognitive raters, the principal investigator, a study-dedicated sub-investigator, a research nurse and a neurologist in charge to perform the lumbar puncture. This structure gives us the possibility to schedule, in one day, two screening visits (a lot of our eligible subjects who are willing to participate in the study present as a pair e.g. partners, friends or siblings). When we propose that they undergo their visits together, they are really happy and if one of the two is hesitant about his/her participation, usually thanks to this proposal he/she decides to participate. There’s strength in numbers!
At the moment we are the only Italian site joining the EPAD project and thus we have participants coming from all over Italy. One of the last subjects screened, for example, came from a town which is located about 800 km from our hospital. In this case, we unify as far as possible the procedures foreseen by the protocol and we offer to the participants free accommodation to stay in our city. We find that engaging with our participants greatly helps to promote their participation in the study.

How are you able to find suitable subjects for the cohort? We share the main information about the study with other neurologists and geriatricians who work in our hospital or outside. When they visit a patient accompanied by relatives who are apprehensive about developing the same disease, these practitioners talk about the prevention studies and provide them with our contact details. In the waiting room of the outpatient clinics, people can also find materials about the studies on the prevention of the Alzheimer’s disease and people who are interested in joining can also fill out a form to authorise us to contact them in order to provide detailed information about the LCS. Moreover, word of mouth is an effective way for EPAD! The majority of the subjects we screen suggest to their friends or relatives to join themselves. Our team is also involved in other clinical trials and we speak about the EPAD project with the caregivers of the participants who have been joining in one of them.

Any past or future events/conferences which have been beneficial for recruitment into EPAD? We organise quarterly meetings where our principal investigator speaks about Alzheimer’s disease and what we know about the biomarkers. Usually, during these meetings, we show the animated video illustrating the aim of the EPAD project and we explain in more details the procedures required by the protocol. In this way we want to encourage the audience to ask as many questions as they want and express any concerns they may have in regards to the study (usually related to the lumbar puncture). At the end of the meetings, we collect subscriptions to participate. At the meeting organised on 28 November, 30 of the 50 attendees confirmed their interest to take part in the study! Furthermore, before the screening visit we call each participant in order to check the main inclusion/exclusion criteria and, if all the main criteria are respected, we will proceed to schedule the first visit.

“At the moment there are no other Italian site involved in LCS. We hope that soon there would be other TDC recruiting which might contribute to increase the number of Italian subjects in the cohort”, said Michela Rampini, the EPAD study coordinator in Brescia.

Pictured: From left to right: Mihaela Munteanu (research nurse), Ilaria Passeggia (CDR rater), Valentina Saletti (study coordinator), Anna Mega (recruiter), Dr. Samantha Galluzzi (PI), Dr. Alberto Tagliapietra (sub-I), Michela Rampini (study coordinator), Dr. Davide Vito Moretti (sub-I), back left Nicola Lopizzo and Monica Mazzelli (lab technicians), front left Stefania Provasi (lab technicians) and Sara Gipponi (CDR rater). 

EPAD Update

We currently have 20 sites across Europe enrolling and more than 1,300 research participants screened. We are pleased to announce that 118 new research participants were screened in the EPAD LCS in November. This made November our most successful month to date. A special mention goes to CITA (San Sebastian, Spain) and VUmc (Amsterdam, Netherlands) as these teams screened respectively 23 and 19 new research participants in November. 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 2018 and wishes you Merry Christmas and a very happy New Year to all of you and your families!