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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
218
Florbetaben 18F is given as an i.v. injection followed by a flush of sodium chloride solution to ensure full delivery of the dose.
A brain PET scan is usually taken 90 minutes after the i.v. injection of florbetaben 18F.
Coordinating center (Hôpital de La Timone) and 18 associated centers in France
Marseille, France
Number of Participants With a Change of Diagnosis Comparing Pre- and Post-scan Outcomes
The Physician's diagnosis was assessed before and after FBB PET scan. The initial Physician's diagnosis was collected before the PET scan, at Visit 1, based on key diagnostic results of current or previous workup. After the PET scan, the final Physician's diagnosis was collected at Visit 3, based on the amyloid PET scan results.
Time frame: Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)
Number of Subjects With Improved Level of Physician Confidence in Diagnosis at Visit 3
The Physician's diagnostic confidence was rated on a five-point Likert scale before and after FBB PET scan. Likert scales consisted of the categories: "very weak", "weak", "moderate", "high", and "very high".
Time frame: Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)
Number of Participants With a Change of Management Plan Comparing Pre- and Post-scan Outcomes
For all subjects, concomitant medications were reported and any change of the management plan (e.g. new medications initiated, medications withdrawn, additional diagnostic tests ordered, referred to another specialist) was noted.
Time frame: Visit 1 (baseline evaluation) and Visit 3 (up to 3 months later)
Number of Subjects With Positive FBB PET Scan
PET image interpretation was performed locally in each centre by readers who had undergone training for appropriate interpretation of scans. Scans were interpreted as either "positive" or "negative" according to the approved visual assessment method.
Time frame: Visit 3 (up to 6 months after baseline evaluation)
Number of Subjects With Negative FBB PET Scans
PET image interpretation was performed locally in each centre by readers who had undergone training for appropriate interpretation of scans. Scans were interpreted as either "positive" or "negative" according to the approved visual assessment method.
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Time frame: Visit 3 (up to 6 months after baseline evaluation)
Number of Subjects With Contraindicated or Failed Lumbar Puncture
Number of subjects with contraindicated or failed LP (anticoagulant therapy, thrombocytopenia, lumbar puncture failed, spinal problems)
Time frame: Visit 1 (baseline evaluation)
Number of Subjects With Available CSF Analysis But Results Considered as Non-contributory by the Clinician
Non-contributory CSF results (ambiguous CSF result, CSF result inconsistent with clinical information, uninterpretable CSF result for technical reasons)
Time frame: Visit 1 (baseline evaluation)
Number of Subjects Who Refused Lumbar Puncture.
Time frame: Visit 1 (baseline evaluation)