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Trial record 12 of 15 for:    Florbetaben | "Amyloidosis"

Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02681172
Recruitment Status : Completed
First Posted : February 12, 2016
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging Limited

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Alzheimer's Disease (AD)
Interventions Drug: Neuraceq (florbetaben 18F)
Procedure: PET
Enrollment 218
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Neuraceq (Florbetaben 18F) PET Scan
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 218
Safety Analysis Set 205
Full Analysis Set 205
Per Protocol Set 205
Completed 205
Not Completed 13
Arm/Group Title Neuraceq (Florbetaben 18F) PET Scan
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 205
Hide Baseline Analysis Population Description
All subjects who received any amount of florbetaben were included in the safety analysis set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 205 participants
70.9  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 205 participants
Female
102
  49.8%
Male
103
  50.2%
1.Primary Outcome
Title Number of Participants With a Change of Diagnosis Comparing Pre- and Post-scan Outcomes
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received any amount of florbetaben were included in the Safety analysis set
Arm/Group Title Safety Analysis Set
Hide Arm/Group Description:
All subjects who received any amount of florbetaben were included.
Overall Number of Participants Analyzed 205
Measure Type: Count of Participants
Unit of Measure: Participants
137
  66.8%
2.Secondary Outcome
Title Number of Subjects With Improved Level of Physician Confidence in Diagnosis at Visit 3
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Safety Analysis Set
Hide Arm/Group Description:
All subjects who received any amount of florbetaben were included.
Overall Number of Participants Analyzed 205
Measure Type: Count of Participants
Unit of Measure: Participants
167
  81.5%
3.Secondary Outcome
Title Number of Participants With a Change of Management Plan Comparing Pre- and Post-scan Outcomes
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received any amount of florbetaben were included in the Safety analysis set.
Arm/Group Title Safety Analysis Set
Hide Arm/Group Description:
All subjects who received any amount of florbetaben were included.
Overall Number of Participants Analyzed 205
Measure Type: Count of Participants
Unit of Measure: Participants
164
  80.0%
4.Secondary Outcome
Title Number of Subjects With Positive FBB PET Scan
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Safety Analysis Set
Hide Arm/Group Description:
All subjects who received any amount of florbetaben were included.
Overall Number of Participants Analyzed 205
Measure Type: Count of Participants
Unit of Measure: Participants
132
  64.4%
5.Secondary Outcome
Title Number of Subjects With Negative FBB PET Scans
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Safety Analysis Set
Hide Arm/Group Description:
All subjects who received any amount of florbetaben were included.
Overall Number of Participants Analyzed 205
Measure Type: Count of Participants
Unit of Measure: Participants
73
  35.6%
6.Secondary Outcome
Title Number of Subjects With Contraindicated or Failed Lumbar Puncture
Hide Description Number of subjects with contraindicated or failed LP (anticoagulant therapy, thrombocytopenia, lumbar puncture failed, spinal problems)
Time Frame Visit 1 (baseline evaluation)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Safety Analysis Set
Hide Arm/Group Description:
All subjects who received any amount of florbetaben were included.
Overall Number of Participants Analyzed 205
Measure Type: Count of Participants
Unit of Measure: Participants
45
  22.0%
7.Secondary Outcome
Title Number of Subjects With Available CSF Analysis But Results Considered as Non-contributory by the Clinician
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Safety Analysis Set
Hide Arm/Group Description:
All subjects who received any amount of florbetaben were included.
Overall Number of Participants Analyzed 205
Measure Type: Count of Participants
Unit of Measure: Participants
87
  42.4%
8.Secondary Outcome
Title Number of Subjects Who Refused Lumbar Puncture.
Hide Description [Not Specified]
Time Frame Visit 1 (baseline evaluation)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Safety Analysis Set
Hide Arm/Group Description:
All subjects who received any amount of florbetaben were included.
Overall Number of Participants Analyzed 205
Measure Type: Count of Participants
Unit of Measure: Participants
75
  36.6%
Time Frame Adverse events were captured for up to 7 days after the PET scan procedure.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Safety Analysis Set
Hide Arm/Group Description All subjects who received any amount of florbetaben were included.
All-Cause Mortality
Safety Analysis Set
Affected / at Risk (%)
Total   0/205 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Safety Analysis Set
Affected / at Risk (%) # Events
Total   1/205 (0.49%)    
Nervous system disorders   
Cerebellar infarct  1  1/205 (0.49%)  1
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Safety Analysis Set
Affected / at Risk (%) # Events
Total   21/205 (10.24%)    
Eye disorders   
Glaucoma  1  1/205 (0.49%)  1
Gastrointestinal disorders   
Nausea  1  1/205 (0.49%)  1
General disorders   
Fatigue  1  1/205 (0.49%)  1
Inflammation  1  1/205 (0.49%)  1
Injection Site Haematoma  1  2/205 (0.98%)  2
Injection Site Pain  1  4/205 (1.95%)  4
Injection Site Paraesthesia  1  5/205 (2.44%)  5
Metabolism and nutrition disorders   
Dehydration  1  1/205 (0.49%)  1
Musculoskeletal and connective tissue disorders   
Polymyalgia Rheumatica  1  1/205 (0.49%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm malignant  1  1/205 (0.49%)  1
Nervous system disorders   
Cerebellar infarction  1  1/205 (0.49%)  1
Headache  1  1/205 (0.49%)  1
Psychiatric disorders   
Confusional State  1  1/205 (0.49%)  1
Renal and urinary disorders   
Acute Kidney injury  1  1/205 (0.49%)  1
Skin and subcutaneous tissue disorders   
Erythema  1  1/205 (0.49%)  1
Pruritus  1  1/205 (0.49%)  1
Skin Ulcer  1  1/205 (0.49%)  1
Surgical and medical procedures   
Cataract operation  1  1/205 (0.49%)  2
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Juergen Hirschfeld, Head of GRA & PV
Organization: Piramal Imaging
Phone: +49 30461124615
Responsible Party: Piramal Imaging Limited
ClinicalTrials.gov Identifier: NCT02681172     History of Changes
Other Study ID Numbers: FBB_01_02_2015
2015-002606-37 ( EudraCT Number )
First Submitted: February 4, 2016
First Posted: February 12, 2016
Results First Submitted: August 16, 2017
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018