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On 17 November 2020, a coalition of partners including the US Alzheimer’s Association, Gates Ventures and the Wellcome Trust launched the Alzheimer’s Disease Data Initiative (AD Data Initiative) and its Alzheimer’s Disease (AD) Workbench. Designed as a platform for federated data sharing, the AD Workbench aims to facilitate interoperability across existing data platform, by enabling researchers to import, pool and analyse datasets in a secure, cloud-based environment.

One year ago, the AD Data Initiative took its first steps on the path to being a trusted partner in the global data sharing movement. In their fall newsletter, the AD Data Initiative marked its one-year anniversary by sharing achievements, lessons learned along the way, and the work they still have left to do.

In just one year, the AD Data Initiative’s success can be reflected in numbers! Over 2,000 users from 80 countries, including users from 40 low- and middle-income countries, have engaged with the AD Workbench and have created more than 200 workspaces. These data contributing partners have made it possible for these researchers to access more than 35 datasets, with more than 50 new datasets in the development pipeline.

EPAD was the first project to place its entire dataset onto the Alzheimer’s Disease Workbench. From January 2015 until February 2020, the EPAD Longitudinal Cohort Study (LCS) screened over 2,000 participants across nine European countries to collect a wide range of cognitive, clinical, neuroimaging and biomarker data. A total of 2,096 participants were screened. From these 2,096 participants, EPAD followed up with 1,225 after one year, 421 after two years and 121 after three years. The latest and final EPAD dataset called Version.IMI. (V.IMI) is available in the AD Workbench to provide even greater value to the global neuroscience research community. To access the data, you will need to make an online request via the AD Workbench here.

https://www.alzheimersdata.org/news/addi-at-one-year

The EPAD BioRepository team has recently successfully sent 3,000 samples for RNA analyses in Germany. These samples were collected annually from research participants throughout their participation in the EPAD Longitudinal Cohort Study. Once analyses are complete, the data will be integrated into the main EPAD database, accessible via the Alzheimer’s Disease Workbench of the Alzheimer’s Disease Data Initiative (AD Data Initiative).

The samples will be analysed by Hummingbird Diagnostics, a German Biotech who have recently secured support from the Alzheimer’s Drug Discovery Foundation (ADDF). Dr. Bruno Steinkraus, Ph.D. and colleagues at Hummingbird Diagnostics are developing a blood test that detects bloodborne microRNAs, molecules that help maintain the integrity of neurons in the brain and are surrogate markers of the immune system. Levels of microRNAs in the blood appear to be a reliable biomarker showing progression of Alzheimer’s disease.

We would like to thank the EPAD BioRepository team who made this collaboration possible, and the Alzheimer’s Association and the AD Data Initiative who supported the ongoing work on EPAD data and samples following the IMI period.

About Hummingbird Diagnostics:
Hummingbird’s Mission is to harness the power of blood borne miRNAs to “read” the immune system’s response to disease, enhancing the potential for innovative disease screening, symptom-based diagnostics, disease-specific prognostics as well as monitoring of patient-centric therapies. The privately held company is based in Heidelberg, Germany.

How to access the EPAD data and samples?
EPAD offers a way of accessing the data, samples and image data collected during the EPAD Longitudinal Cohort Study to academic researchers, institutions and companies from all over the world. This is shared through secure online Workspaces and you will need to make an online request via the Alzheimer’s Disease Workbench. For more information, click here.

The EFSPI 6th Regulatory Statistics Workshop was held online from 13-15 September. This workshop discussed opportunities and challenges of statistical topics between regulators, academics, and industry.

Philip Hougaard from Lundbeck presented the EPAD project, with an oral presentation entitled “Designing the EPAD trial platform: key issues”. In his talk, he gave an overview of the trends and issues in the Alzheimer’s disease field. He then briefly presented the EPAD project including its Longitudinal Cohort Study and its platform trial.

If you missed the event, you can download the slides and watch the recording on the EFSPI website here.

On 1 July, the Alzheimer’s Disease Data Initiative (AD Data Initiative) released its first ever newsletter, in which EPAD is featured as a key partner and the first project to place its entire dataset onto the Alzheimer’s Disease Workbench.

From January 2015 until February 2020, the EPAD Longitudinal Cohort Study (LCS) screened over 2,000 participants across nine European countries to collect a wide range of cognitive, clinical, neuroimaging and biomarker data. A total of 2,096 participants were screened. From these 2,096 participants, EPAD followed up with 1,225 after one year, 421 after two years and 121 after three years. As the project progressed, four datasets have freely been made available ensuring the use of the data for the Alzheimer’s disease research community worldwide.

“As a participant in the EPAD LCS it is very satisfying to know that my data is being made widely available to researchers. To know that this quality assured data will be used internationally reassures me that my involvement in this project will assist in the unravelling of the mystery that is Alzheimer’s disease,” said Malcolm Smith, Chair of the EPAD Scotland participants panel.

The latest and final EPAD dataset called Version.IMI. (V.IMI) is now available in the AD Workbench and will provide even greater value to the global neuroscience research community. All the data collected and processed during the IMI period of EPAD have been included in this V.IMI release.

“Prospective collection of information and samples in EPAD has been a major scientific effort to expand the frontiers of our knowledge on the natural history of Alzheimer’s in its predementia stages. But now in the AD Workbench, this dataset will be findable, accessible, interoperable and reusable (according to the FAIR principles) to other bona fide researchers for it to exert its full, intended impact to fight Alzheimer’s disease,” said Juan Domingo Gispert, principal investigator of the EPAD study in Barcelona and head of the Neuroimaging group of the Barcelonaβeta Brain Research Center (BBRC).

EPAD members are pleased that this incredibly rich data source, including data that have been collected annually from research participants throughout their participation in the LCS, has been incorporated into the AD Workbench. It is an important step in continuing to share the LCS data in the long-term and ensuring that this valuable resource is used by the research community to generate as much knowledge as possible. The AD Data Initiative platform will provide a crucial acceleration in scientific breakthroughs on the causes, diagnosis, and prevention of Alzheimer’s disease.

“At the heart of the EPAD Programme was an explicit commitment, responsibility and obligation to ensure that the time and effort of research participants and researchers yielded the highest quality outputs of knowledge. The global visibility and ease of access and research which the AD Data Initiative provides helps us to achieve our objective. Moreover, having been involved for the last few years in the design of the AD Workbench it stands to reason that this platform is absolutely perfect for our needs and we are honoured and delighted to be the first project to place our entire dataset onto the work bench. We expect that in the years ahead, new data being collected from EPAD and other programmes from across Europe and the World will utilise the AD Data Initiative workbench making ‘interoperability’ a real success,” said Craig Ritchie, Project Coordinator of the EPAD project.

You can read the AD Data Initiative newsletter here.

On 17 June, an online EPAD–AMYPAD imaging workshop was organised, aiming to engage researchers across the scientific community in the ongoing analyses currently performed in these two large European consortia, funded by the Innovative Medicines Initiative (IMI).

Through these two projects, an abundance of longitudinal MR and amyloid PET imaging data in a pre-dementia Alzheimer’s disease population has been and is still being collected.

Craig Ritchie and Frederik Barkhof kicked off the workshop by giving a brief overview of both EPAD and AMYPAD. During the workshop, information was provided on the imaging processing approaches and decisions made to ensure optimal data quality, especially considering the availability of the data. In addition, seven ongoing projects were presented, showcasing the unique opportunities of cross-project integration of (imaging) data to the field. The presentations illustrated the value of cross-modality analyses, e.g. amyloid-PET, (advanced) MR, cognition, CSF, and genetics.

The objectives of the workshop were therefore to identify and establish possible collaborations between imaging researchers across consortia and develop research questions aimed a cross-modality analyses to further our understanding of the natural history of Alzheimer’s disease.

As previously announced, the latest and final EPAD dataset called Version.IMI (V.IMI) is now available in the Alzheimer’s Disease Workbench to provide even greater value to the global neuroscience research community. All the data collected and processed annually during the IMI period of EPAD from research participants throughout their participation in the Longitudinal Cohort Study (LCS) have been included in this V.IMI release. It is an important step in continuing to share the LCS data in the long-term and ensuring that this valuable resource is used by the research community to generate as much knowledge as possible.

Visit the Alzheimer’s Disease Data Initiative (AD Data Initiative) Portal here to sign in with your existing account or sign up if you don’t have an account yet. You need to be a registered user to be able to access the Alzheimer’s Disease Workbench. If you do not have an account, follow the instructions on registering for a Workspaces account page. After creating an account and logging in, you can request a workspace to access the EPAD data.

The European Prevention of Alzheimer’s Dementia (EPAD) consortium, in their partnership with Aridhia, are proud to announce that the EPAD V.IMI dataset has been incorporated into the Alzheimer’s Disease Workbench to provide even greater value to the global neuroscience research community.

The latest and final EPAD dataset went into open access to all researchers from over the world in November 2020 through the EPAD Research Access Process website. The final dataset is called Version.IMI (V.IMI) as it represents all the data collected and processed during the IMI period of EPAD. This contains the final longitudinal data including cognitive, clinical, biomarker and neuroimaging data sets from over 2,000 participants of the EPAD Longitudinal Cohort Study (LCS). Screening for the first participant in the LCS occurred in May 2016 and finished in early 2020. All 2,096 participants who consented and were included into the dataset are entered in this final V.IMI release.

We are proud to partner with the Alzheimer’s Disease Data Initiative (AD Data Initiative) to help further our understanding of the early stages of Alzheimer’s disease (AD) and accelerate scientific progress. The V.IMI dataset has been incorporated into the Alzheimer’s Disease Workbench and is now available to the AD Data Initiative researchers. This cloud-based platform has recently been launched to accelerate discoveries and innovations for AD and related dementias. The AD Workbench is guided by three main principles: increasing data sharing, easing data access, and developing new tools and analytics for researchers to use and share. It is open, inclusive, global and easy to use.

You can find out more about the AD Workbench by visiting the AD Data Initiative website.

A key achievement of the EPAD project was the establishment of a Longitudinal Cohort Study (LCS) that has screened over 2,000 participants and collected a wide range of cognitive, clinical, neuroimaging and biomarker data to help further our understanding of the early stages of Alzheimer’s disease. EPAD has made this database open access and publicly available to the research community through the EPAD LCS Research Access Process (ERAP).

On 10 March 2021, EPAD has released a report presenting an analysis of applications made to access the EPAD data and samples. The data access application process is described here. This first bulletin covers applications made between May 2019 and January 2021.

A total of 125 applications was processed between the reporting period. 93% of applications was approved, while 5% was withdrawn and 2% was denied. Reasons for an application being denied include the identity of an applicant cannot be established or the applicant is named as a co-applicant on an already approved application.

There are three types of requests:
• Data Only – With “Data Only type of application”, only the quantitative data is made available to the researchers.
• Data + Images – “Data + Images application type” means the quantitative data as well as MRI imaging scans are made available to the researchers.
• Data + Samples – Similarly, the “Data + Samples application” would involve making the quantitative as well as the biological samples available to the researchers once application is approved.

Data Only accounts for about 56% of the total applications received. About 31% of the researchers requested for the MRI scans whereas 13% of the researchers were interested in biological samples.

It is also interesting to note that about 65% of applications received came from researchers within EPAD partner organisations while 35% of the applications were from researchers outside of the EPAD partner organisations.

You can download the full report here.

Alzheimer Europe has published a new edition of its “Dementia in Europe” policy magazine, in an electronic format.

The first section of the magazine includes a closing article on the EPAD project in which Alzheimer Europe has been involved. Our co-leads Craig Ritchie and Serge Van der Geyten have been interviewed and reflect on the achievements of the project.

You can download the PDF, here: http://bit.ly/DementiaInEurope35

“EPAD aimed first to recruit and deeply phenotype potential clinical trial participants across Europe. This was clearly achieved by the establishment of the Longitudinal Cohort Study and by collecting what is an incredible dataset, open access and publicly available to the research community. This dataset is going to be continually enriched with genomic, proteomic and imaging data among others. There is an incredible excitement about what is going to come out of the high quality and large dataset that we developed through the EPAD Longitudinal Cohort Study. EPAD secured some funds to maintain this dataset and make sure that we could continue to allow free access to it. Secondly, EPAD planned to study new drugs in a well-designed Phase II proof of concept trial. The EPAD platform was developed to speed up the development of effective, safe medicines which slow or prevent the development of Alzheimer’s dementia. It is a pity we never had a drug to be able to start the EPAD proof of concept study. However, pharmaceutical companies have learned a lot from stepping into this collaboration. We still think that a platform trial such as the one we tried to set up is the future if we want to accelerate drug development.”, said Craig and Serge

At an online European Parliament workshop hosted by Deirdre Clune MEP (Ireland), Alzheimer Europe launched a new report “Data Sharing in Dementia Research”, which reviews recent changes in EU research policy and sets out recommendations to improve data sharing in dementia research.

In this report, Alzheimer Europe evaluates the legal and policy landscapes that dementia researchers have had to navigate since the launch of Horizon 2020 in 2013. The report identifies key barriers and enablers for data sharing. It maps the Horizon 2020 dementia research portfolio, assessing the scale of EU investment in dementia research and the use of clinical research data. Finally, it reviews recent surveys of researchers, research participants and patients, collating their perceptions and concerns regarding data sharing.

This report includes case studies from three projects: the US-based Alzheimer’s Disease Neuroimaging Initiative (ADNI), the European Medical Information Framework (EMIF) and the European Prevention of Alzheimer’s Dementia (EPAD) project. It also includes insights from participants and researchers including Craig Ritchie.

“Our philosophy in EPAD was to view the Longitudinal Cohort Study (LCS) data and samples as gifts from the people who participated in the LCS. The LCS research participants got involved in EPAD because they wanted to advance the knowledge of Alzheimer’s disease. As custodians of their data, it is therefore our responsibility to ensure this data generates as much knowledge as possible. This means making the data openly accessible, at scale, and in the long-term. During the four years of the LCS, data on a wide range of cognitive, biomarker and neuroimaging outcomes was gathered. We also collected over 100,000 biosamples, which are securely stored in the EPAD biorepository. Together, these assets will continue to generate new knowledge on the causes, diagnosis and prevention of Alzheimer’s disease.

The EPAD cohort recruited over 2,000 individuals across the risk spectrum of Alzheimer’s disease in Europe. However, there is often a disconnect between research cohorts and the general population. By their nature, cohorts tend to be more homogeneous, and do not always capture the diversity present in society. Conversely, data collected in real-world clinical practice can lack measures of value for dementia research – particularly in mid-life age groups, a key target group for dementia prevention. To look beyond the treatment of established disease, and towards the maintenance of brain health, we now need better mechanisms to collect, analyse and share real-world data across the lifecourse. This underpins the establishment of Brain Health Services as is the case through Brain Health Scotland, a Scottish Government backed initiative which commenced in 2020. This will pave the way for early detection, risk profiling and personalised dementia prevention, empowering people to reduce their risk of dementia through positive preventive measures.”, said Craig Ritchie.

Alzheimer Europe gratefully acknowledges the support of GatesVentures for this report.

You can download the report (PDF) here: http://bit.ly/DataSharing_AE