 Any relevant changes to physical health will be noted during these investigations including whether the PWD is still in charge of their own medication and whether the same individual is still the informal carer of PWD. In case of an adverse event AE or serious adverse event SAE, medical or psychosocial, the investigator and his or her team are responsible for detecting, recording, reporting and taking appropriate actions in according to the requirements of the local institutional review board IRB and the appropriate regulatory body with health- and social care in respective country of the study. Reporting of any AE and SAE must be done within 24 hours by an SAE Report Form sent to the clinical lead of this study. 