Florbetapir (18F) Solution for Injection is an 18F-labeled positron emission tomography (PET) imaging agent that binds with high affinity to the amyloid-β (Aβ) peptide fibrils that constitute amyloid plaques, and thus, has potential value as an imaging biomarker for amyloid deposits in subjects with cognitive impairment. It is the first FDA-approved imaging marker for amyloid.
The principal aim of this study is to provide data on the clinical utility of florbetapir (18F) when introduced into local standard of care for patients with symptoms of cognitive decline. The study prospectively will measure the impact of a florbetapir (18F) scan on diagnostic thinking and patients’ management during the 3 months post florbetapir (18F) PET scan. It will also measure resource utilization, patient outcomes, and caregiver burden over 12 months of study follow-up. The prognostic value of beta amyloid imaging will be assessed over 12 months by comparing the rate of cognitive decline in scan positive patients with mild impairment who do not meet criteria for dementia as compared with scan negative patients.
This study is an international multicentre trial. In total, about 600 patients will be enrolled at approximately 60 sites in the United States and Europe. This study will be randomly divided in two arms:
1) approximately 300 patients will be enrolled in the Interventional Arm where they will receive the PET scan results immediately;
2) approximately 300 patients will be enrolled in the Control Arm where they will be blinded to the PET scan results for 12 months.
The participation of the patients in this study could last up to 14 months.