Prospective
Pilot Study

The prospective clinical pilot study will be performed in two stages. In Stage 1, a small-scale feasibility test run will be performed in the three clinics, with limited participation (at two samples from 10 patients per clinical centre) to identify constraints (e.g., which time of the day should the measurement take place), limitations (e.g., how easy it is to use it, if the end-users accept and trust the result, etc.), and improvements. Following, in Stage 2, the clinical validation will take place over up to 300 subjects (app. 100 subjects per clinical centre) diagnosed from subjective complaints, to MCI, to AD or other dementia (following also other specific inclusion and exclusion criteria), following a real-life pilot design with a harmonised examination protocol in terms of diagnosis, biological fluids handling, etc., following the results from the retrospective study and the prospective stage 1 (i.e., feasibility). The observation of these subjects will start early in the 3rd year of the project, to allow a 1-year follow up in case the diagnosis is not conclusive during the first examination.