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Symposium S3: Facing dementia together - Doctors and researchers & people with dementia and their carers

Detailed Programme and abstracts

Saturday, 2 October 2010: 09.00-10.30 (Red Room)

S3.1. Bringing new treatments and diagnostic procedures to patients – Understanding the drug development process

Maria Isaac, European Medicines Agency, United Kingdom

A number of medicines have been authorised in Europe for the treatment of Alzheimer’s disease or other forms of dementia. Since the review of the pharmaceutical legislation in 2004, it has become mandatory for all future drugs in the field of neurodegenerative diseases to be authorised through the centralised procedure by the European Medicines Agency (EMA).

In her presentation, Francesca Cerreta will give an overview of the lengthy development process of new medicines with particular attention to the European system for the approval of new medicines. She will present some of the highlights of the current EMA guideline on medicinal products for the treatment of Alzheimer’s disease and other dementias and identify some of the challenges identified by the Agency with regard to the diagnostic criteria to be used and the assessment of therapeutic efficacy.

S3.2. European collaboration on dementia research: the Joint Programming Initiative

Philippe Amouyel, France, MD, PhD, CEO French National Foundation on Alzheimer's disease and related disorders, France;

Today in Europe, only about 5% of the total public funding of research is common to European countries through the 7th Framework Programme for Research and Technological Development, and about 10% to support intergovernmental schemes or organisations. Conversely, 85% of research budgets are spent on national programmes exclusively. European research is perceived to be especially fragmented and less efficient than other major countries. One research field, which is amongst the most affected this high degree of fragmentation and lack of coordination, is dementia and Alzheimer’s disease.

How could we, as European States, build a new way of efficient collaboration to tackle such a major medical, societal and economic challenge? What resources could we mobilise despite the deep financial and economic crisis currently affecting public budgets of all European countries?

To provide a method allowing this calculated sharing to be organised, a communication to the European Parliament, the Council, the European Economic and Social Committee and the Committee of Regions was published in July 2008 by the Commission introducing a new concept of collaboration among owners of national research programmes: this is joint programming. It can be defined as "a process in which Member States define a common vision and a strategic research agenda, in order to address a major societal challenge for which the scale and the scope of their national programmes alone may not reach adequate proportions". Participation of Member States and Framework Programme Associated Countries in such a process is carried out "on a voluntary basis and according to the principles of variable geometry and open access".

Joint programming is neither another programme, nor any new tool to add to the extensive tool box of the existing national, intergovernmental or Framework Programmes. The focus of Joint Programming is not on spending the money, but about assigning the money. In a programming cycle, implementation follows and results from strategic steps which include horizon scanning, scenarios and impact assessments, budget arbitrations, prioritisation, evaluations, criteria and indicator setting. Joint Programming intends to cover those steps but in a specific configuration of countries willing to go together for the same ambitious objective. Joint programming addresses the accountability of governments to stakeholders in pooling research efforts to address common societal issues in Europe in the most efficient way.

Today 23 countries (Albania, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxemburg, the Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom) have joined the JPND initiative. Beside the management board of the initiative, a scientific advisory board has been identified that will prepare the SRA. The SAB has identified priorities that may be launched as soon as possible, already. All aspects of research are covered: basic, clinic and care and health service researches.

/The ultimate goal of all this work is to lead to new initiatives around research excellence in neurodegenerative diseases and Alzheimer’s in particular, intended to offer a competitive and attractive image of European research for the greatest benefit of the patients and their families.

S3.3. New treatments for people with dementia – Current research approaches

Bengt Winblad, Karolinska Institutet Alzheimer Disease Research Center, Huddinge, Sweden

Alzheimer’s disease (AD) is the most common cause of dementia in advanced age. Currently available medications improve AD symptoms, and development of disease-modifying drugs is a very active area of research, which includes cholinergic, antiamyloid compounds, drugs targeting tau-protein or mitochondria, neurotrophins and other therapeutic approaches. The amyloid cascade hypothesis dominates current drug development strategies, but whether Aβ is more pathognomonic than pathogenetic is not yet clear, and so is the therapeutic role of Aβ removal.

Identification of effective disease-modifying drugs will benefit from understanding the interplay between mechanisms causing neurodegeneration in AD. Combined therapy could be a more effective strategy to halt AD progression. Solving methodological problems in clinical trials on AD - including use of standardized diagnostic criteria able to identify homogeneous group of patients, appropriate treatment duration and measures of disease-modifying effects - will help finding a cure for AD.

The lecture will summarize the main findings for new, and less new drugs with novel therapeutic use in AD, focusing mainly on compounds in the human testing phase.

S3.4. Addressing ethical questions in dementia research

François Blanchard, MD, PhD1 2 3 ,Stéphane Sanchez 1 2, Interne

1 Service de Médecine Interne et Gériatrie – CHU de Reims – Hôpital Maison Blanche – 45 rue Cognacq Jay – F 51092 REIMS Cedex – -

2 EA 3797 “Santé Publique, Vieillissement, Qualité de Vie et Réadaptation des Sujets Fragiles” – Faculté de Médecine, Université de Reims Champagne-Ardenne – 51 rue Cognacq Jay – F 51095 REIMS Cedex

3 Association Francophone des Droits de l’Homme Agé (A.F.D.H.A.)

Researchers in the field of dementia have to cover several areas. The four main areas are the onset of the disease and it’s limits, the consequences of the disease, treatment and prevention. Neuroscience, epidemiology, clinical research, psychology, sociology and public health are all relevant. Each of the sciences has its own way of dealing with dementia but all researchers must follow the ethical requirements and usual rules of good conduct for research.

  • Research must be prepared and carried out in the framework of clearly defined programmes in which all partners are included from the beginning.
  • Benefit to patients must be the first aim for the research programme.
  • Transparency at every step of the process for all partners is required (financial aspects, the executive part including data collection and analysis, publication of the results including negative results).
  • Informed consent of the patient and/or of his/her representatives must be obtained.
  • Good and appropriate methods must be adopted in order to assure the quality of results.

All research programmes, whatever their nature, must have received approval from an ethics committee and this committee must be knowledgeable about Alzheimer’s disease. However, cognitive impairment and decline of the capacity of judgement make specific ethical reflection about research necessary.

The diagnosis must have been disclosed before the person is invited to take part in the study. Clear and simple information about the research programme must be provided. Informed consent can be obtained at a more severe stage of the illness than is usually believed. The patient should be the main person consulted. This takes time and it may be necessary to repeat information several times and also to check the person’s level of understanding. Decision making tools would be useful.

For practical and ethical reasons, the same information must be given to family carers and their consent is also needed. Advance directives for research can be helpful. This can be proposed to the person at the time of disclosure of the diagnosis when s/he still has sufficient capacity to consent.

A very strict application of the principle of autonomy, as being something linked to full consciousness, could block the possibility of research on patients with severe dementia who cannot give clear informed consent. But this condemns the development of research for those patients. On other hand, the principal of solidarity encourages the development of research for the benefit of this population. We need progress in knowledge and in the care of these very disadvantaged and penalised patients.

Very often patients and their families want to participate in research. Their participation is a way to provide a kind of service for others. Recognition of their contribution to future advances in knowledge and in the care of people with their own condition may help them to maintain a link with other people in the community.



Last Updated: Wednesday 03 November 2010