WP1 Clinical Study Design. Clinical Verification of Models and Platforms

Objective tools for early diagnosis and follow-up of progression in different diseases that affect memory and cognition are of high importance. The focus of this work package is to design appropriate study protocols, acquire prospective data and evaluate the clinical usefulness of the developed research and clinical tools. In addition to accuracy, the tools should be easy to use and fit to clinical work-flows. This work package also ensures that ethical and legal issues pertinent to the involvement of patients and their data are taken into account.

The overarching aim of this WP is to ensure that a clinically-driven, hypothesis-focused approach guides the VPH-DARE@IT knowledge discovery and methodological developments carried out in all subsequent WPs, particularly WP2 to WP6, so that the platforms developed in WP7 and WP8 are truly aligned with clinical needs and are aware of the main hypothesis that requires testing in the context of dementia. In particular, the specific objectives are:

  • To drive the overall study design & project steering through clinical hypothesis definition & testing
  • To acquire prospective data of selected small cohorts including lifestyle & environmental factors
  • To oversee the data analysis tasks in WP3 and define the quality criteria of the analysis
  • To evaluate and test clinical and research platforms and models from WP7 and WP8.
  • To evaluate and test usability of clinical platforms from WP8
  • To oversee compliance with ethical and legal issues (in conjunction with WP10)
  • Overall study design & hypotheses definition
  • Prospective data acquisition of selected small cohorts
  • Early differential diagnosis of the dementias focus on molecular level
  • Early differential diagnosis of the dementias focus on MRI sequences
  • Pervasive and quantitative sensing of physical performance, and physiological and gait data
  • Toward early screening program for dementias by engaging population at large
  • Metabolomics analysis Small molecules and lipids
  • IT enabled information management of retrospective and prospective data
  • Verification of research and clinical platforms and models
  • Evaluation and usability testing of clinical platform and models
  • Compliance with ethical and legal regulations