Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002606-37 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuraceq (florbetaben 18F) PET scan | Experimental | A single dose of 300 Megabecquerels (8.1 millicuries) Neuraceq will be administered per subject. The applied florbetaben radioactive dose will be ± 20%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuraceq (florbetaben 18F) | Drug | Florbetaben 18F is given as an i.v. injection followed by a flush of sodium chloride solution to ensure full delivery of the dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later) |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mathieu Ceccaldi, Prof. MD. | Hôpital de La Timone, Marseille, France | Principal Investigator |
| Eric Guedj, Prof. | Hôpital de la Timone, Marseille, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coordinating center (Hôpital de La Timone) and 18 associated centers in France | Marseille | 13385 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29107051 | Derived | Ceccaldi M, Jonveaux T, Verger A, Krolak-Salmon P, Houzard C, Godefroy O, Shields T, Perrotin A, Gismondi R, Bullich S, Jovalekic A, Raffa N, Pasquier F, Semah F, Dubois B, Habert MO, Wallon D, Chastan M, Payoux P; NEUUS in AD study group; Stephens A, Guedj E. Added value of 18F-florbetaben amyloid PET in the diagnostic workup of most complex patients with dementia in France: A naturalistic study. Alzheimers Dement. 2018 Mar;14(3):293-305. doi: 10.1016/j.jalz.2017.09.009. Epub 2017 Nov 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This was a Phase IV, multi-center study which was conducted in an outpatient setting documenting routine clinical care in the Centres Mémoire Ressources et Recherches (CMRR). Subjects were recruited in 18 active centers in France.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Neuraceq (Florbetaben 18F) PET Scan | A single dose of 300 Megabecquerels (8.1 millicuries) Neuraceq was administered per subject. The applied florbetaben radioactive dose was ± 20%. Neuraceq (florbetaben 18F): Florbetaben 18F was 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 was taken 90 minutes after the i.v. injection of florbetaben 18F. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects who received any amount of florbetaben were included in the safety analysis set.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Neuraceq (Florbetaben 18F) PET Scan | A single dose of 300 Megabecquerels (8.1 millicuries) Neuraceq was administered per subject. The applied florbetaben radioactive dose was ± 20%. Neuraceq (florbetaben 18F): Florbetaben 18F was 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 was taken 90 minutes after the i.v. injection of florbetaben 18F. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All subjects who received any amount of florbetaben were included in the Safety analysis set | Posted | Count of Participants | Participants | Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later) |
|
Adverse events were captured for up to 7 days after the PET scan procedure.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Analysis Set | All subjects who received any amount of florbetaben were included. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebellar infarct | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glaucoma | Eye disorders | MedDRA (18.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Juergen Hirschfeld, Head of GRA & PV | Piramal Imaging | +49 30461124615 | Juergen.Hirschfeld@piramal.com |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C527756 | 4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| PET | Procedure | A brain PET scan is usually taken 90 minutes after the i.v. injection of florbetaben 18F. |
|
|
| 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. | 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. | 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. | 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) | 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) | Visit 1 (baseline evaluation) |
| Number of Subjects Who Refused Lumbar Puncture. | Visit 1 (baseline evaluation) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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". | Posted | Count of Participants | Participants | Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later) |
|
|
|
| Secondary | 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. | All subjects who received any amount of florbetaben were included in the Safety analysis set. | Posted | Count of Participants | Participants | Visit 1 (baseline evaluation) and Visit 3 (up to 3 months later) |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Visit 3 (up to 6 months after baseline evaluation) |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Visit 3 (up to 6 months after baseline evaluation) |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | Visit 1 (baseline evaluation) |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | Visit 1 (baseline evaluation) |
|
|
|
| Secondary | Number of Subjects Who Refused Lumbar Puncture. | Posted | Count of Participants | Participants | Visit 1 (baseline evaluation) |
|
|
|
| 0 |
| 205 |
| 1 |
| 205 |
| 21 |
| 205 |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Injection Site Haematoma | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Injection Site Paraesthesia | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
|
| Polymyalgia Rheumatica | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Confusional State | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
|
| Acute Kidney injury | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
Not provided
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |