NCT02681172

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Piramal Imaging Limited · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Detailed description

It will be conducted in an outpatient setting at the tertiary memory clinics (CMRR) in France in patients with a preliminary diagnosis based on the completion of a prior, full diagnostic workup, not more than 12 months previously - which could include, but will not be limited to brain imaging if needed (magnetic resonance imaging (MRI) or computed tomography (CT)), neuropsychological evaluation including a Mini-Mental Status Examination (MMSE), CSF examination and other examinations according to "Haute Autorité de santé" (HAS, National Authority of Health, France) Recommendations - and 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 For all subjects the study will comprise 3 outpatient clinic visits to record information on previous work ups and to perform the FBB Positron Emission Tomography (PET) scan (Visit 1: screening/ baseline, Visit 2: PET scan, Visit 3: subject informed on the FBB PET scan result). At Visit 1, the initial diagnosis based on previous work up will be collected and rated on a five-point Likert confidence scale by the Physician. At Visit 2, the FBB PET scan will be performed. Adverse events will be reported during the exam and up to 7 days after the PET procedure. At Visit 3, based on the amyloid PET scan results, change of diagnosis will be collected, in addition to physician confidence.

Conditions

• Alzheimer's Disease (AD)

Interventions

Type	Name	Description
DRUG	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.
PROCEDURE	PET	A brain PET scan is usually taken 90 minutes after the i.v. injection of florbetaben 18F.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-09-01
• Completion: 2016-11-01
• First posted: 2016-02-12
• Last updated: 2018-11-02
• Results posted: 2018-11-02

Locations

1 site across 1 country: France