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Special Supplement Clinical Trials on Alzheimer’S Disease in Europe Contents Issue 31 October 2019 Special Supplement Clinical trials on Alzheimer’s disease in Europe Contents 3 Foreword 4 Understanding clinical trials Contact Alzheimer Europe 6 Clinical Trials Watch 14, rue Dicks L-1417 Luxembourg 13 Recent failed disease-modifying treatment trials +352 29 79 70 16 The academic perspective on recent clinical trials and on +352 29 79 72 www.alzheimer-europe.org the future of AD research [email protected] @AlzheimerEurope 19 Acknowledgements alzheimer.europe 19 Further information and references Alzheimer Europe gratefully acknowledges the grant provided Board by Janssen, which led to the production of this report. Chairperson: Iva Holmerová (Czech Republic) Vice-Chairperson: Charles Scerri (Malta) Honorary Secretary: Jim Pearson (UK – Scotland) Honorary Treasurer: Maria do Rosário Zincke dos Reis (Portugal) th Members Want to fi nd out more about clinical trials at the 29 Helen Rochford-Brennan, Chairperson of the European Working Group of People with Alzheimer Europe Conference #29AEC in The Hague? Dementia (Ireland) Stefanie Becker (Switzerland) Join our special symposium SS3 “Clinical trials Marco Blom (Netherlands) in Alzheimer’s disease” on Thursday 24 October Sabine Jansen (Germany) Pat McLoughlin (Ireland) 2019, from 12.45–13.45 in room Princess Ariane. Sirpa Pietikäinen (Finland) Jesús Rodrigo (Spain) Karin Westerlund (Sweden) Staff Jean Georges, Executive Director Christophe Bintener, Project Offi cer Cindy Birck, Project Offi cer Kate Boor Ellis, Communications Offi cer Angela Bradshaw, Project Offi cer Ana Diaz, Project Offi cer Dianne Gove, Director for Projects Gwladys Guillory, Event and Conference Coordinator Owen Miller, Policy Offi cer Aideen O’Brien, Administrative Assistant Stefanie Peulen, Finance Offi cer Grazia Tomasini, Administrative Assistant Photo Credit Innovative Medicines Initiative (IMI) Layout: The Publishing Bureau 2 Dementia in Europe SPECIAL SUPPLEMENT Foreword Alzheimer Europe has started to cover this subject in 2014 with the aim to build an accessible, user-friendly, web-based resource that can help people with dementia and their carers to gain and share better information about clinical trials for the “prevention and treatment of Alzheimer’s dementia and other types of dementia.” I am very pleased to welcome our readers of prevention of Alzheimer’s disease and other scientists are confronted with, there is a com- our Dementia In Europe magazine to this spe- dementias in an accessible format. At that monality in learning from these failed clinical cial supplement about clinical trials. time, only Phase III clinical trials recruiting trials. It is encouraging to see that new direc- participants in at least two European coun- tions in Alzheimer’s disease research are Clinical trials represent an essential step tries were included. In 2018, thanks to the being considered and that a major emphasis toward the development of new ways to pre- funding from the EU health programme, the is placed on early intervention and prevention. vent, diagnose and treat dementia. A range resource was further expanded to include of clinical trials is being conducted at a Euro- Phase II and III studies that are being con- We hope you will find this special supple- pean level. People with dementia or those ducted in all European countries. ment helpful in outlining the Phase II and who are at risk of developing it and healthy III clinical trials that are currently investi- volunteers are needed today to help advance The special supplement will give you a com- gating drugs for Alzheimer’s disease and/ Alzheimer’s disease research. However, the prehensive insight into our Clinical Trials or dementia in Europe, whilst also providing pathways to access to these clinical trials Watch and we hope that you will share our a useful reference for our member organi- are complex. It is apparent that information interest and commitment to this important sations wishing to promote clinical trials about clinical trials is not easily accessible. research topic. The supplement begins with participation in their countries. People cannot find information on the clini- an introduction on and explanation of clinical cal trials related to their own diseases. trials. We have also included a section on the I want to acknowledge the contribution of rationale behind the Clinical Trials Watch and the people involved in this work. My thanks For that reason, Alzheimer Europe has how it was conceived. Next, Phase II and III go to Cindy Birck, Project Officer at Alzheimer started to cover this subject in 2014 with clinical trials that are currently investigating Europe, who coordinates the Clinical Trials the aim to build an accessible, user-friendly, drugs for Alzheimer’s disease and/or demen- Watch and wrote this report. I would like to web-based resource that can help peo- tia in Europe are listed. thank the European Group of People with ple with dementia and their carers to gain Dementia (EWGPWD) and the pharmaceuti- and share better information about clini- This is followed by an overview of the recent cal companies who are providing insightful cal trials for the prevention and treatment Phase III clinical trials that failed to show feedback on the Clinical Trials Watch. of Alzheimer’s dementia and other types of significant results supporting their clinical dementia. Alzheimer Europe reached out to outcomes. Although pharmaceutical compa- Lastly, if you are reading this during our 29th both researchers and people with dementia nies have invested heavily in various potential Alzheimer Europe conference (#29AEC) in and involved them in the provision of infor- disease-modifying drugs for Alzheimer’s The Hague, I would like to invite you to join mation on clinical trials in a language that is disease, the past years have brought some the special symposium on “Clinical trials in both understandable and accessible for peo- disappointing results. Alzheimer’s disease” on Thursday 24 October ple with dementia and scientifically accurate from 12.45 to 13.45 pm. A special thanks goes and checked by the researchers involved. This We also feature an interview with Craig to Janssen who provided a special grant for this resulted in the launch in 2016 of our Clinical Ritchie in this special supplement. We are supplement and the conference symposium. Trials Watch, a new service bringing together very grateful for his willingness to share his up-to-date information on clinical trials thoughts and experiences so far. It is evi- Jean Georges investigating drugs for the treatment and dent that despite the many challenges that Executive Director, Alzheimer Europe Dementia in Europe 3 biotechnology companies, hospitals, aca- Understanding clinical trials demic institutions, other organisations or individuals. They are usually conducted at hospitals or clinics. Relevance in the What is a clinical trial? Alzheimer’s disease field A clinical trial (also called interventional What are the types To date there is no preventative or curative study) is a biomedical/health-related research of clinical trials? treatment for Alzheimer’s disease. Some study conducted to evaluate the effects on drugs exist for Alzheimer’s disease that humans of a new medical treatment. In most There are two main types of clinical studies: can, for some people, temporarily alleviate cases, clinical trials refer to a research study interventional and observational. some of their symptoms, such as mem- conducted in people to determine whether ory loss and confusion. There are currently treatments are safe and effective. The word y Interventional clinical studies are clini- four drugs approved and currently used in “treatment” most often refers to new drugs cal trials conducted to determine whether symptomatic treatment: donepezil (Aricept, but may also refer to new technology, device, a candidate drug, a new combination of 1996), rivastigmine (Exelon, 2000), galan- vaccine, surgical procedures, therapy or meth- drugs, experimental treatment or therapy tamine (Razadyne, 2001) and memantime ods of prevention, screening and diagnosis is safe and effective. (Namenda, 2003). Three of the four available of a disease. y Observational clinical studies investigate drugs – donepezil, rivastigmine and galan- health issues and outcomes in large groups tamine – are known as acetylcholinesterase Clinical research is key of people. The participants do not receive inhibitors and are prescribed to treat symp- any investigational treatment or drug. toms related to memory, thinking, language, for advancing medicine, Instead, researchers observe participants judgment and other thought processes in leading to new interventions by monitoring their health over a period people with mild to moderate Alzheimer’s and improving medications – of time to collect data about the disease. dementia. The fourth drug, memantine, notably in the field of Alzheimer’s regulates the activity of a different neuro- “ Different types of interventional clinical trials transmitter in the brain known as glutamate. disease research at a time when can be categorised according to their objec- Memantine is prescribed to improve memory, the disease is becoming more tives and the way they are organised. Below attention, reason, language and the ability to are descriptions of some different types of perform simple tasks in people with moder- prevalent with the ageing of the clinical trials that exist in addition to treat- ate to severe Alzheimer’s dementia. world’s population.” ment trials: Every product
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