MAIN STUDY: Clinical assessment and follow-up of a naturalistic population of patients enrolled in an amyloid imaging program in memory clinics in Brescia, Italy" COMPANION STUDY: Evaluation of florbetapir (18F) PET in subjects participating in the IRCCS-FBF protocol"

Detection of brain amyloidosis with PET has become increasingly relevant since the NIA-AA diagnostic criteria for AD (McKhann et al., 2011) and MCI (Albert et al., 2011) have been published. 11C-Pittsburgh compound B (11C-PIB) is to date the most widely utilized amyloid binding PET tracer (Herholz et al., 2011). Previous studies with the novel fluorine radiotracer 18F-florbetapir demonstrated that it may label amyloid aggregates in a manner similar to 11C-PIB, exhibiting high-affinity and specific binding to amyloid plaques (Clark et al., 2011; Clark et al., 2012). 18F-florbetapir is the first FDA-approved imaging marker for in vivo brain amyloid burden. “Clinical assessment and follow-up of a naturalistic population of patients enrolled in an amyloid imaging program in memory clinics in Brescia, Italy” and “Evaluation of florbetapir (18F) PET in subjects participating in the IRCCS-FBF protocol” are two companion multicentre studies to be carried on a sample of 250 AD, MCI, non-AD patients, coming to observation of the Evaluation Units in Brescia and province, and 30 healthy elderly controls. These studies are expected to last approximately 28 months. The aims are:

1. to estimate the diagnostic accuracy of PET imaging with 18F-florbetapir for the differentiation of clinical AD from healthy elderly controls (HC), and non-AD dementia;
2. to assess the predictive value of PET imaging with 18F-florbetapir of progression of cognitive impairment and conversion to dementia in patients with MCI;
3. to expand the database of 18F-florbetapir safety, amyloid binding as measured by PET imaging in patients coming to observation of the Evaluation Units complaining with cognitive disturbances, and in cognitively normal volunteers;
4.  to provide standardized conditions for 18F-florbetapir use, data collection and analysis.