Background

This position paper sets out the position of Alzheimer Europe and its member organisations in relation to the involvement of people with dementia in clinical trials in Europe. This paper was developed in response to the European Commission's work around a Clinical Trial Directive.

Executive Summary

Alzheimer Europe would like to recall some general principles which guide this present response:

  • A diagnosis of dementia does not in itself constitute a lack of legal capacity.
  • An early and accurate diagnosis of dementia is essential and people with dementia have a right to be informed about their diagnosis.
  • People with dementia should be encouraged to write advance directives regarding important decisions in case they become incapacitated.
  • National governments should put into place legislation recognising the legally binding character of advance directives.
  • Informed written consent has to be given by the person with dementia or his/her legal representative for important treatment decisions.

On the basis of these principles, Alzheimer Europe has developed the following position with regard to the participation of people with dementia in clinical trials:

  • In the early stages of their disease, people with dementia can themselves consent to clinical trials or declare their willingness to participate in clinical trials in an advance directive.
  • Legal representatives should be able to consent on behalf of people with dementia to participate in clinical trials, if the following main conditions are met:
    • the potential direct benefit for the person's health is clearly greater than the possible risks;
    • the risk of causing discomfort or distress is minimal;
    • the research has been approved by an independent ethics committee;
    • the same results could not be obtained with other subjects.

Alzheimer Europe called for further information to be provided on the participation of people with dementia in Phase I drug trials and the use of the concept of "direct benefit" in placebo trials. In addition, Alzheimer Europe encouraged ongoing dialogue between political decision makers, patients' and carers' organisations, the pharmaceutical industry and researchers on this subject.

Based on current information, Alzheimer Europe does not endorse the participation of people with dementia in clinical trials without a potential direct benefit for the participants. Nevertheless it reserves the right to re-consider its current position after receiving further information from the scientific community and the pharmaceutical industry with regard to the kinds of research that would be covered by this definition.