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Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD
Sponsor: Lantheus Biosciences Ltd.
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
218
Start Date
2015-10
Completion Date
2016-11
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Neuraceq (florbetaben 18F)
Florbetaben 18F is given as an i.v. injection followed by a flush of sodium chloride solution to ensure full delivery of the dose.
PET
A brain PET scan is usually taken 90 minutes after the i.v. injection of florbetaben 18F.
Locations (1)
Coordinating center (Hôpital de La Timone) and 18 associated centers in France
Marseille, France