Phase 4CompletedAge-related condition
Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD
Multicenter Study to Explore the Impact of Florbetaben (FBB) in Change of Diagnosis in Patients Who Are Evaluated for AD and in Whom Lumbar Puncture is Contraindicated or CSF Results Are Ambiguous
- Sponsor
- Lantheus Biosciences Ltd. (Industry)
- Enrolment
- 218 enrolled
- Conditions
- Alzheimer's Disease (AD)
- Interventions
- Neuraceq (florbetaben 18F); PET
- Ages
- adults, older adults
- Registry
- NCT02681172, EUCTR2015-002606-37
Full record on ClinicalTrials.gov
From the registry
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
Primary outcomes
- Number of Participants With a Change of Diagnosis Comparing Pre- and Post-scan Outcomes
History
Last registry update
Results first posted
Study completion
Primary completion
Registered
Started