Category: News

With the beginning of this new year, the EPAD project is celebrating it’s 2nd birthday.

2016 was truly exceptional, with the start of the EPAD LCS (longitudinal cohort study) being the highlight of the year. we are looking forward to doing even better this year!

Wishing you all an exciting and happy New Year,

The EPADistas

Our sister project, Amyloid imaging to prevent Alzheimer’s disease (AMYPAD), which began its activities on 1 October 2016, has recently been invited to two international conferences. Members of the project consortium gave two poster presentations, at the following events:

• The Lancet Neurology Conference “Preclinical neurodegenerative disease: towards prevention and early diagnosis”, London 19-21 October 2016.
• The Human Amyloid Imaging (HAI) 2017 conference, Miami Beach, Florida, US, 11-13 Jan 2017.

The focus of the Lancet Neurology Conference in London was prevention and early diagnosis of neurodegenerative diseases. The objectives and design of both AMYPAD and of our project EPAD were introduced to the scientific community, who welcomed with great interest and enthusiasm the efforts of identifying a trial-readiness cohort for secondary prevention of Alzheimer’s disease (AD). The need to find new and more effective ways to identify subjects at high risk of developing Alzheimer’s dementia before they actually experience the clinical symptoms was underlined throughout the talks, and the level of commitment from both projects to those objectives was demonstrated to participants at the congress.

The AMYPAD project aims to improve the diagnostic workup and management of patients suspected to have AD. The partners aim to improve knowledge of the natural history of AD in a pre-symptomatic stage, in order to better select patients for trials. In addition, they will monitor changes in beta amyloid deposition in the brain, in order to quantify the impact of novel therapies.

For more information about the project visit: www.amypad.eu

Pictured: Silvia Ingala from VUmc with the poster presentation at The Lancet Neurology Conference.

The AMYPAD project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115952. The Joint Undertaking receives support from the European Union’s Horizon2020 research and innovation programme and EFPIA.

On 9 and 10 January, members of the work packages for the EPAD (European Prevention of Alzheimer’s Dementia) and AMYPAD (AMYloid imaging to Prevent Alzheimer’s Disease) projects met in Cambridge, UK to discuss ongoing work to provide ethics guidance for the two projects.

Richard Milne presented the preliminary findings from a related study, which explored attitudes towards the communication of various kinds of risk status linked to Alzheimer’s dementia.

Members of the group discussed plans for work related to the two projects and emphasised the need to progress with the setting up of the participant panel to ensure that research participants have the opportunity to contribute towards improving the experience of research participants involved in these studies.

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 AMYPAD project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115952. The Joint Undertaking receives support from the European Union’s Horizon2020 research and innovation programme and EFPIA.

On 13 December 2016, the Financial Times (FT) published a letter to the Editor, from EPAD Executive Committee member Dr Jose Luis Molinuevo of the BarcelonaBeta Brain Research Center. The letter was titled “Early intervention is key to tackling Alzheimer’s”.

Making reference to the FT editorial “The case for prioritising Alzheimer’s research” of 26 November 2016 – which talks of the growing consensus in the scientific community that the genesis of Alzheimer’s disease (AD) precedes the onset of dementia by over 20 years and the therefore urgent need to increase focus on research into an effective treatment – Dr Molinuevo highlights the importance of focusing on research into prevention also. Researchers are increasingly focusing their efforts on prevention and early intervention before symptoms appear, as a more effective way to tackle the disease, he points out.

The letter lists some examples of prevention research programmes in Europe, research initiatives funded by governments in the US and Europe, public private partnerships, international clinical trials aimed at preventing Alzheimer’s dementia, as well as the creation of registries linked to these trials. Aside from the US registries, Dr Molinuevo describes the EPAD project and its goal of creating a Europe-wide register of 24,000 people.

https://www.ft.com/content/b31999e6-c09b-11e6-9bca-2b93a6856354

On 29 November, the Slovak Presidency of the European Union organised a conference on “Alzheimer’s disease – epidemic of the third millennium: Are we ready to face it?” in Bratislava, focussing on four key themes discussed by four panels. One of the panels was on “Prevention and Intervention strategies in Alzheimer’s disease” and included a presentation by the European Prevention of Alzheimer’s dementia (EPAD) initiative.

EPAD Coordinator Serge Van Der Geyten (pictured, second from left), Director for Neuroscience external Affairs at Janssen, Belgium presented the pioneering work being done by our project partners to deliver a novel, more flexible approach to clinical trials for drugs designed to prevent Alzheimer’s dementia.

The prevention panel also included local speakers Simona Adamovičová from the Memory Centre, Slovakia and Petr Novák from the Slovak Institute of Neuroimmunology.

Other panels at the conference were on: “Dementia as a global health priority and scientific challenge” with presenters from the European Commission, the Karolinska Institute, Sweden and the World Health Organisation (WHO); “Alzheimer’s disease trip through the EU Presidency” with presenters from the Scottish Government, the State Secretary for Health, Welfare and Sports of the Netherlands and the Memory Centre, Slovakia; and “National programmes and Action plans on dementia” with presenters from Alzheimer Europe, the Slovak Academy of Science and the 2017 Maltese EU Presidency. In closing this final panel, Justyne Caruana, Malta’s Parliamentary Secretary for Rights of Persons with Disability and Active Ageing together with Charles Scerri, Focal Point for Dementia from Malta highlighted their country’s vision for dementia and Malta’s plans for its EU Presidency during the first half of 2017.

EPAD was delighted and honoured to have been involved in this high-level international conference, which brought together over 100 experts from different EU Member States and provided an opportunity to highlight policy and research initiatives at global, European and national level.

Current Alzheimer’s disease (AD) research initiatives focus on cognitively healthy individuals with biomarkers that are associated with the development of AD. It is unclear whether biomarker results should be returned to research participants and what the psychological, behavioural and social effects of disclosure are. A systematic review by the European Prevention of Alzheimer’s Dementia (EPAD) initiative has examined the effects of disclosing genetic and nongenetic AD-related biomarkers to cognitively healthy research participants.

A systematic literature search in eight scientific databases was performed. Fourteen studies met the inclusion criteria and were included in the data synthesis. Results extracted from the included articles were aggregated and presented per effect group. None of the identified studies examined the effects of disclosing nongenetic biomarkers. All studies but one concerned the disclosure of APOE genotype and were conducted in the US.

Study populations consisted largely of cognitively healthy first-degree relatives of people with AD.

The EPAD reviewers concluded that in cognitively healthy research participants with a first-degree relative with AD, disclosure of genetic biomarkers does not lead to elevated anxiety and depression levels, but does increase test-related distress and results in behaviour changes concerning insurance and health.

They did not find studies reporting the effects of disclosing nongenetic biomarkers and only one study included people without a family history of AD.

“Empirical studies on the effects of disclosing nongenetic biomarkers and of disclosure to persons without a family history of AD are urgently needed” they concluded.

https://alzres.biomedcentral.com/articles/10.1186/s13195-016-0212-z

On 10 November 2016, the European Prevention of Alzheimer’s Dementia (EPAD) initiative held a public conference in Geneva, Switzerland, in collaboration with Hôpitaux universitaires de Genève (HUG). Approximately 100 delegates attended the French and English-language conference, “Prévenir la maladie d’Alzheimer en Suisse – Un but atteignable“ (Preventing Alzheimer’s disease in Switzerland – A realistic goal).

The six eminent speakers included Prof. Frederick Barkhof, Professor of Neuroradiology, Department of Brain repair & Rehabiliation, Institutes of Neurology and Biomedical Engineering, UCL, London and Department of Radiology & Nuclear Medicine, VU University Medical Centre, Amsterdam. Prof. Barkhof’s presentation was on “EPAD and AMYPAD: the future of Alzheimer’s care is today”.

Organisers were Neurologist Prof. Giovanni B. Frisoni, Professor of Clinical Neuroscience and Head of Memory Clinic, HUG and University of Geneva, Switzerland and Dr Idris Guessous, Head of Epidemiology, HUG and University of Geneva. Dr Guessous chaired the conference.

Acknowledgement: This work has received support from the EU/EFPIA Innovative Medicines Initiative Joint Undertaking EPAD grant agreement nº 115736.

What is your current role in EPAD?

I am co-chair with Michael Ropacki of the Clinical and Cognitive Outcomes Scientific Advisory Group (CCO-SAG), which is part of WP1. I am also a member of the Epidemiology Advisory Group. The CCO-SAG includes leading neuropsychologists and neurologists from Europe and the USA, and our work has principally centered on the challenging task of recommending measures of cognitive dysfunction in a pre-clinical phase previously considered to be cognitively silent. This has involved extensive analysis of previous research which has associated cognitive measures with neuroimaging and other biomarkers, and also liaison with cognitive scientists working on the function of very specific brain regions.
What did you do prior to joining EPAD?

Yes, I did have a life before EPAD. For over 20 years I have directed a research centre of around 50 researchers in Neuropsychiatry within the French National Institute of Medical Research (INSERM) based in Montpellier in the South of France. I am also attached to the University of Montpellier Medical Faculty. For two years I held an Honorary Professorship at Imperial College London and will soon be joining the Centre for Dementia Prevention at the University of Edinburgh part-time as Visiting Professor. At a European level I am currently a member of the board of the European Institute of Women’s Health, and undertake consultancy work for WHO, notably in relation to revision of the disease classification systems. My own research as an epidemiologist has focused on the development of etiological models of AD from population and clinical research in order to identify potential windows for intervention. As a neuropsychologist I have been principally concerned with the development of novel cognitive assessment procedures to capture both neurodevelopmental and neurodegnerative processes.
Tell us a bit about your organisation.

INSERM was created in 1964 centralizing all public research in human health under the direction of both the Ministers of Health and Education. As a government research institute specializing in medical research and health promotion, it covers all fields from molecule and nanotechnologies through to population research and public health prevention programmes. INSERM serves a similar function to the MRC in the UK and the NIH in the USA. Within this institute I founded one of the few research units in France in clinical psychiatry. The unit is entitled Neuropsychiatry to distinguish its theoretical approach (genes, biomarkers and their interaction with clinical and environmental factors) from the psychoanalytic approach which predominates in clinical practice in France. Our centre is composed of five research teams specializing in neurodegenerative diseases, affective disorder, trauma, suicidal behaviour, sleep pathologies and biostatistical modelling.  We also undertake research in psychiatric service delivery and participate in numerous clinical trials. The unit is linked to the Institute of Psychiatry, London by a research agreement (European Associated Laboratory).
What are your expectations from the EPAD project?
As an epidemiologist I am delighted to be part of the constitution of a large pre-clinical cohort which will be an important vehicle in coming years for research into early disease etiology. In terms of clinical research EPAD provides an opportunity for the development of better clinical and cognitive outcome measures in the pre-clinical stage of AD within a context which will permit on-going validation and refinement of these measures. This will be a tremendous contribution to AD research as well as drug development. Additionally EPAD, through its extensive clinical and academic networks will certainly play an important role in drawing research and therapeutic investment towards the pre-clinical phase of AD, thus changing the public image of this disease from a problem of the very old, to include younger adults.

What is your current role in EPAD?

I am the industry co-lead for Work Package 6, together with Jean Georges from Alzheimer Europe. Work Package 6 is the communication and information dissemination engine of EPAD. Our primary purpose is to let the world know what EPAD is doing. Our audience is very broad, ranging from healthcare professionals and other healthcare interest groups, to people with dementia and anyone who has an interest in this field. We utilize a number of communication platforms and channels. Medical congresses and journal publications allow us to communicate scientific data. Digital platforms such as our website and social media (e.g. Twitter, Facebook) allow us communicate the progress of the project, the meaning of the data that we are generating, as well as creating a general awareness of Alzheimer’s disease. Whenever we have an important announcement (e.g. first patient in the cohort) we issue a press release and closely monitor how this information is picked up by the outside world.

What did you do prior to joining EPAD?

I am a medical affairs director within the global neuroscience franchise at Novartis Pharmaceuticals. Global medical affairs is mainly responsible for generating and communicating evidence about diseases and medicines. We often serve as the interface between clinical practice and industry as many of us who work in medical affairs are medical doctors by background. I personally find this extremely important and always try to look at everything we do through the eyes of a doctor and patient.

I studied medicine in South Africa and started my career as a medical doctor working in psychiatry in the UK. I have been working in medical affairs for the past ten years in a number of pharmaceutical companies including GlaxoSmithKline, Eisai and Astellas. When I’m not working, I play the cello and piano, and have a passion for chamber music. I continue to be fascinated by the effect that music has on the brain, including its benefits for people with dementia. This is a growing field – just type “music” and “brain” into pubmed and I’m sure you’ll be pleasantly surprised by the results!

Tell us a bit about your organisation.

Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. Novartis operates businesses with global scale and strong customer ties, focusing on innovative patented medicines, generics and eye care devices. Our Innovative Medicines Division has two business units which both commercialize innovative, patented primary care and specialty medicines to enhance health outcomes for patients and health-care providers: Novartis Pharmaceuticals and Novartis Oncology. Our global product portfolio includes many medicines that are innovative leaders in their therapeutic areas, including neuroscience, cardio metabolic, retina, respiratory, oncology, immunology and dermatology. Novartis has built a strong heritage in neuroscience over the past 60 years with marketed products for Alzheimer’s Disease, Multiple Sclerosis, Parkinson’s Disease, Epilepsy, Attention Deficit Hyperactivity Disorder, Migraine/Headache, Depression and Schizophrenia. Novartis is consistently rated as having one of the industry’s most respected development pipelines, with more than 200 projects in clinical development. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide. Novartis remains committed to the field of dementia research with two development projects in Alzheimer’s disease.

What are your expectations from this EPAD project?

This is a particularly exciting collaboration and one I am very proud to be part of. Dementia research is extremely difficult and has not yielded any approved new drug for over a decade. By combining forces across industry and academia my hope is that EPAD will markedly improve our understanding of Alzheimer’s disease and bring us closer to delaying or preventing the onset of dementia. This will ultimately have an important impact on those living with Alzheimer’s disease, their caregivers and society in general. This project is particularly close to my heart as my grandmother had Alzheimer’s disease. I was with her from the early stages until she passed away when she was at a very advanced stage of dementia. The emotional toll it takes on caregivers and loved ones is immense and nothing can prepare anyone for the course of this disease. My expectation of the EPAD project is that we will be able to accelerate the progress in this field so that other families in the not too distant future will not have to endure what my family and millions of others continue to endure right now.

We are thrilled to report on recent progress on the European Prevention of Alzheimer’s Dementia (EPAD) study – just as we are nearing the time point when the first follow-up visits are due there have been two key papers that the EPAD consortium have published. The papers published this week summarise current assessment measures that are used for detecting cognitive decline – and highlight the lack of evidence-based guidelines for measuring cognitive change in a preclinical population where the cognitive decline is “silent” and occurring years before memory problems arise.

As EPAD will undertake large-scale proof-of-concept trials in predementia Alzheimer’s disease, the monitoring of cognitive trajectories in the preclinical period will constitute a central outcome measure. However, there are currently no clear guidelines as to how this should be achieved as most measures have been developed for the period around dementia diagnosis. The EPAD Scientific Advisory Group for Clinical and Cognitive Outcomes identified appropriate cognitive measures for use on preclinical population based on a literature search covering both cognitive correlates of preclinical brain changes from imaging studies and cognitive changes observed over time in nondementia population cohorts developing incident dementia.

The resulting consensus statement provides recommendations for both future drug trials and research into preclinical Alzheimer’s disease. More background to the EPAD publications is available at the University of Edinburgh Centre for Dementia Prevention website.

Pictured: Lead author of both papers Prof. Karen Ritchie, Chair of the EPAD Neuropsychology and Clinical Scientific Advisory Group.

Mortamais, M., Ashc, J.A., Harrison, J., Kaye, J., Kramer, J., Randolph, J., Pose, C., Albala, B., Ropacki, M., Ritchie C.W., Ritchie, K., (2016). Detecting cognitive changes in preclinical Alzheimer’s disease: A review of its feasibility. Alzheimer’s & Dementia, 1-25

Ritchie, K., Ropacki, M., Albala, B., Harrison, J., Kaye, J., Kramer, J., Randolph, C., Ritchie, C.W. (2016). Recommended cognitive outcomes in preclinical Alzheimer’s disease: Consensus statement from the European Prevention of Alzheimer’s Dementia project. Alzheimer’s & Dementia, 1-10