The Problem of Informed Consent of Persons with Neurocognitive Disorders in Clinical Investigations

From the beginning of the millennium showed that the prevalence of Alzheimer's disease was at 24.3 million of patients globally, but also anticipated a significant increase of the number of new cases of dementia, which are currently at 4.6 million. Currently, based on estimates from the ADI (Alzheimer Disease International), a head association that aggregates data 80 national Alzheimer organizations, it is apparent that there are more than 47 million persons with dementia in the world today. However, what is concerning is the statement that this number will continue to grow progressively. Biomedical investigations are an invaluable (and the only) source of new knowledge, thanks to which significant progress has been achieved in medicine during previous century and continues to be achieved today. In the field of clinical investigations, persons with dementia represent a vulnerable group. The legal representative of the person with dementia cannot give consent for participation in clinical investigation, which represents a potentially limiting factor for clinical investigations that include persons with dementia. In psychiatry, the evaluation of patient competence for giving informed consent is necessary. Given the specificity of mental disorders, this evaluation is necessary in order to protect the patient and their choice of medical procedure as well as to avoid misuse in everyday clinical practice.