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    Clinical Trial Results:
    Multicenter study to explore the impact of florbetaben (FBB) in change of diagnosis in patients who are evaluated for AD at the CMRR, and are eligible for analysis of CSF according to HAS recommendations, and in whom lumbar puncture is contraindicated or CSF results are ambiguous.

    Summary
    EudraCT number
    		 2015-002606-37
    Trial protocol
    		 FR  
    Global end of trial date
    29 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Sep 2017
    First version publication date
    24 Sep 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FBB-01-02-15
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02681172
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Piramal Imaging Limited
    Sponsor organisation address
    Langstone Technology Park, Langstone Road, Havant, United Kingdom, P09 1SA
    Public contact
    South West Europe Medical Affairs , Piramal Imaging Ltd, 49 30461124615, rossella.gismondi@piramal.com
    Scientific contact
    South West Europe Medical Affairs , Piramal Imaging Ltd, 49 30461124615, rossella.gismondi@piramal.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To estimate the change in diagnosis comparing pre- and post-scan outcomes in the study population
    Protection of trial subjects
    The trial was conducted in accordance with GCP Guidelines, the Declaration of Helsinki and according to national law. The trial started only after regulatory and ethical approval. Recruitment only started after the protocol was signed by the investigator. Only patients with informed consent were included in the study. All necessary insurances to guarantee compensation of patients in the case of adverse reactions were in place.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Nov 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 218
    Worldwide total number of subjects
    218
    EEA total number of subjects
    218
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    66
    From 65 to 84 years
    136
    85 years and over
    16

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible patients were evaluated for AD in tertiary memory centers and had a preliminary uncertain diagnosis after a prior comprehensive workup, according to recommendations from the French Health Authority.

    Pre-assignment
    Screening details
    		 At total of 218 patients were enrolled in the study. 13 patients did not receive a florbetaben injection or did not have at least one PET/CT image available (e.g. consent withdrawn), therefore, 205 patients were included in the full analysis set and were evaluated.

    Pre-assignment period milestones
    Number of subjects started
    		 218
    Number of subjects completed
    		 205

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No FBB scan available: 13
    Period 1
    Period 1 title
    Full Analysis Set (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Full Analysis Set
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Florbetaben
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    A single dose of 300 Megabecquerel (8.1 millicurie) Neuraceq was administered per subject. The applied FBB radioactive dose was ± 20%.

    Number of subjects in period 1 [1]
    		Full Analysis Set
    Started
    205
    Completed
    205
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: At total of 218 patients were enrolled in the study. For 13 patients no amyloid PET scans were available, therefore, 205 patients were evaluated in the full analysis set.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Full Analysis Set
    Reporting group description
    		 -

    Reporting group values
    		 Full Analysis Set Total
    Number of subjects
    		 205 205
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 62 62
        From 65-84 years
    		 129 129
        85 years and over
    		 14 14
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 70.9 ± 9.7 -
    Gender categorical
    Units: Subjects
        Female
    		 102 102
        Male
    		 103 103
    MMSE score
    Units: MMSE
        arithmetic mean (standard deviation)
    		 22.1 ± 5.1 -

    End points

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    End points reporting groups
    Reporting group title
    Full Analysis Set
    Reporting group description
    		 -

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    To determine the impact of FBB Positron Emission Tomography (PET) imaging on clinical utility parameters in the study population.

    Primary: Change of Diagnosis Comparing Pre- and Post-scan Outcomes

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    End point title
    		 Change of Diagnosis Comparing Pre- and Post-scan Outcomes [1]
    End point description
    End point type
    Primary
    End point timeframe
    Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: For the full analysis set (n=205), 137 of the patients had a change in diagnosis post-FBB scan. Only frequency results are reported that correspond to a change of 66.8% (137/205) with a 95% confidence interval of 59.9% - 73.2%.
    End point values
    		 Full Analysis Set
    Number of subjects analysed
    205
    Units: Number of subjects
    137
    No statistical analyses for this end point

    Secondary: Improved Level of Physician Confidence in Diagnosis at Visit 3

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    End point title
    		 Improved Level of Physician Confidence in Diagnosis at Visit 3
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)
    End point values
    		 Full Analysis Set
    Number of subjects analysed
    205
    Units: Number of subjects
    167
    No statistical analyses for this end point

    Secondary: Change of Management Plan

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    End point title
    		 Change of Management Plan
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 1 (baseline evaluation) and Visit 3 (up to 3 months later)
    End point values
    		 Full Analysis Set
    Number of subjects analysed
    205
    Units: Number of subjects
    164
    No statistical analyses for this end point

    Secondary: Number of Subjects With Positive FBB PET Scan

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    End point title
    		 Number of Subjects With Positive FBB PET Scan
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 3 (up to 6 months after baseline evaluation)
    End point values
    		 Full Analysis Set
    Number of subjects analysed
    205
    Units: Number of subjects
    132
    No statistical analyses for this end point

    Secondary: Number of Subjects With Negative FBB PET Scans

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    End point title
    		 Number of Subjects With Negative FBB PET Scans
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 3 (up to 6 months after baseline evaluation)
    End point values
    		 Full Analysis Set
    Number of subjects analysed
    205
    Units: Number of subjects
    73
    No statistical analyses for this end point

    Secondary: Subjects With Contraindicated or Failed Lumbar Puncture

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    End point title
    		 Subjects With Contraindicated or Failed Lumbar Puncture
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 1 (baseline evaluation)
    End point values
    		 Full Analysis Set
    Number of subjects analysed
    205
    Units: Number of subjects
    45
    No statistical analyses for this end point

    Secondary: Subjects With Available CSF Analysis But Results Considered as Non-contributory by the Clinician

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    End point title
    		 Subjects With Available CSF Analysis But Results Considered as Non-contributory by the Clinician
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 1 (baseline evaluation)
    End point values
    		 Full Analysis Set
    Number of subjects analysed
    205
    Units: Number of subjects
    87
    No statistical analyses for this end point

    Secondary: Lumbar Punctures Refused by the Patient

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    End point title
    		 Lumbar Punctures Refused by the Patient
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 1 (baseline evaluation)
    End point values
    		 Full Analysis Set
    Number of subjects analysed
    205
    Units: Number of subjects
    75
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were captured for up to 7 days after the PET scan procedure.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Safety Analysis Set
    Reporting group description
    		 -

    Serious adverse events
    		 Safety Analysis Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 205 (0.49%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Cerebellar infarction
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Safety Analysis Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 205 (10.24%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm malignant
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    Surgical and medical procedures
    Cataract operation
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    2
    Nervous system disorders
    Cerebellar infarction
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    Inflammation
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    Injection site haematoma
         subjects affected / exposed
    2 / 205 (0.98%)
         occurrences all number
    2
    Injection site pain
         subjects affected / exposed
    4 / 205 (1.95%)
         occurrences all number
    4
    Injection site paraesthesia
         subjects affected / exposed
    5 / 205 (2.44%)
         occurrences all number
    5
    Eye disorders
    Glaucoma
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    Skin ulcer
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Polymyalgia rheumatica
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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