Retrospective
Pilot Study
The Retrospective Pilot Study aims to support the Technical Validation of the 2D-BioPAD system.
The combined samples from the consortium clinical centres, extending to around 60 samples (app. 20 per clinical centres), will be leveraged to (i) establish a reference/baseline by using existing lab equipment for different sets of five biomarkers and (ii) evaluate and validate the prototypes developed, covering the necessary range from MCI to AD, through several diverse (i.e., progression stage, gender, age, comorbidities, etc.) use cases. These samples will be made available early in the project to support benchmarking, development, testing, evaluation, and technical validation of the 2D-BioPad device.
Primary
Objectives
The Primary Objectives of this clinical pilot study are to (i) identify and analyse the set of five biomarkers that can effectively support accurate diagnosis of MCI to AD (in regards also with other parameters such as demographics, comorbidities, etc.); and (ii) evaluate and validate the performance of the developed device under specific use cases over the available samples.
Secondary
Objectives
The Secondary objectives are focused mainly on (i) retrieving preliminary feedback from both technical and clinical experts; (ii) improve the device design and offered functionalities; and (iii) preliminary assessment of projected benefits, such as cost reduction, examination time reduction, hospitalisation reduction, etc.
