Incremental diagnostic value of Florbetaben Imaging vs other core biomarkers for Alzheimer Disease in patients with Mild Cognitive Impairment.

An Investigator-Initiated Sponsored Study

(18)F-florbetaben is a novel (18)F-labeled tracer for PET imaging of β-amyloid deposits in the human brain. It has potential value as an imaging biomarker for amyloid deposits in subjects with cognitive impairment. The aim of this study is to evaluate the incremental diagnostic value for Mild Cognitive Impairment (MCI) due to Alzheimer’s Dementia (AD) of Florbetaben Imaging versus Cerebrospinal Fluid (CSF) markers (Aβ42, τ, and ph-τ) in patients with MCI. 100 amnestic MCI patients will be studied at 11 European academic memory clinics. Patients will be followed for 2 years to evaluate cognitive deterioration and development of dementia. The study capitalizes on patients enrolled and data collected in funded ADNI-compatible studies, on top of which FBB Imaging will be taken. Patients will be included in the study if they will have MR, neuropsychological testing, CSF biomarker results, and clinical and neuropsychological follow-up at 1 and 2 years. Patients will undergo FBB imaging once. The study will provide information on the incremental value of FBB Imaging on the diagnostic confidence that MCI is due to AD in patients with MCI. The data will be used to position FBB Imaging in diagnostic flowcharts and guidelines with other core biomarkers for the diagnosis of MCI due to AD.

The study is under submission to the Regulatory Authorities.