drugset / Trial / NCT02681172

Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD

NCT02681172

Phase 4 Completed 218 enrolled Piramal Imaging Limited
NaSingle-groupOpen-labelHealth-services research

Summary

This phase 4 study will explore, in the context of the present French clinical practice, the impact of florbetaben 18F (FBB) in patients evaluated for AD who require a biomarker for etiologic determination of the cognitive and functional impairment, but in whom: 1. lumbar puncture was not feasible for medical conditions 2. results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating physicians 3. lumbar puncture (LP) was refused by the patient

Timeline

Start
2015-10
Primary completion
2016-09
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-Florbetaben Diagnostic / imaging agent 300 mbq Intravenous

Indications