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    Clinical Trial Results:
    A study evaluating the imaging characteristics of 18F-AV-45 in patients with frontotemporal dementia compared to patients with Alzheimer's disease and normal controls

    Summary
    EudraCT number
    		 2008-003597-18
    Trial protocol
    		 GB  
    Global end of trial date
    12 Jan 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2016
    First version publication date
    26 Sep 2014
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    18F-AV-45-010
    Additional study identifiers
    ISRCTN number
    		 ISRCTN58435532
    US NCT number
    		 NCT01890343
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Avid Radiopharmaceuticals
    Sponsor organisation address
    3711 Market St., Philadelphia, United States, 19104
    Public contact
    Clinical Operations, Avid Radiopharmaceuticals, 215 2980700,
    Scientific contact
    Chief Medical Officer, Avid Radiopharmaceuticals, 215 2980700,
    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
    18 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Dec 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To compare amyloid pathology as determined by 18F-AV-45 positron emission tomography (PET) in patients with frontal temporal dementia (FTD) vs. Alzheimer's disease (AD); 2. To expand the database of 18-F-AV-45 PET imaging in cognitively normal volunteers; 3. To expand the database of 18F-AV-45 PET imaging in AD and FTD patients to determine if 18F-AV-45 PET imaging yields the expected prevalence of AB positivity in clinically defined AD and FTD patients, based on historical autopsy data: 4. To determine the relationship between 18F-AV-45 in-vivo kinetics, cortical atrophy and metabolic impairment in FTD.
    Protection of trial subjects
    Subjects who received florbetapir 18F were closely followed by means of adverse event reporting and vital signs. In the event of a study related adverse event, subjects would not have been discharged until the event had resolved or stabilized. Subjects were made aware of the planned procedures and their comfort in the scanner was mazimized to minimize the risk of any discomfort while in the PET scanner.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jul 2009
    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
    United Kingdom: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    34
    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)
    21
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were enrolled as either cognitively normal subjects, subjects with AD or subjects with FTD.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Frontotemporal Disorder
    Arm description
    		 Subjects with frontotemporal disorder (FTD). florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. 18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.
    Arm type
    		 Experimental

    Investigational medicinal product name
    florbetapir (18F)
    Investigational medicinal product code
    18F-AV-45
    Other name
    Amyvid, florbetapir F 18
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir (18F).

    Investigational medicinal product name
    18F-FDG
    Investigational medicinal product code
    Other name
    FDG, fluorodeoxyglucose (18F), fludeoxyglucose (18F)
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.

    Arm title
    		 Cognitively Normal
    Arm description
    		 Cognitively normal (CN) subjects.
    Arm type
    		 Experimental

    Investigational medicinal product name
    florbetapir (18F)
    Investigational medicinal product code
    18F-AV-45
    Other name
    Amyvid, florbetapir F 18
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.

    Arm title
    		 Alzheimer's Disease
    Arm description
    		 Subjects with Alzheimer's disease (AD).
    Arm type
    		 Experimental

    Investigational medicinal product name
    florbetapir (18F)
    Investigational medicinal product code
    18F-AV-45
    Other name
    Amyvid, florbetpair F 18
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.

    Number of subjects in period 1 [1]
    		Frontotemporal Disorder Cognitively Normal Alzheimer's Disease
    Started
    8
    10
    10
    Completed
    8
    10
    10
    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: The worldwide total represents the number of subjects enrolled in the study. Six subjects dropped out of the study prior to receiving a florbetapir injection. The baseline period represents the number of subjects who received a florbetapir (18F) scan.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Frontotemporal Disorder
    Reporting group description
    		 Subjects with frontotemporal disorder (FTD). florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. 18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.

    Reporting group title
    Cognitively Normal
    Reporting group description
    		 Cognitively normal (CN) subjects.

    Reporting group title
    Alzheimer's Disease
    Reporting group description
    		 Subjects with Alzheimer's disease (AD).

    Reporting group values
    		 Frontotemporal Disorder Cognitively Normal Alzheimer's Disease Total
    Number of subjects
    		 8 10 10 28
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.4 ± 9.62 62.4 ± 4.99 62.6 ± 4.35 -
    Gender categorical
    Units: Subjects
        Female
    		 0 5 3 8
        Male
    		 8 5 7 20

    End points

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    End points reporting groups
    Reporting group title
    Frontotemporal Disorder
    Reporting group description
    		 Subjects with frontotemporal disorder (FTD). florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. 18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.

    Reporting group title
    Cognitively Normal
    Reporting group description
    		 Cognitively normal (CN) subjects.

    Reporting group title
    Alzheimer's Disease
    Reporting group description
    		 Subjects with Alzheimer's disease (AD).

    Primary: Qualitative Amyloid Image Assessment

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    End point title
    		 Qualitative Amyloid Image Assessment [1]
    End point description
    Four readers blinded to all clinical information classified florbetapir Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read classification is presented as either positive, negative or tied.
    End point type
    Primary
    End point timeframe
    50-60 minutes after injection
    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: No statistical analysis was performed on this outcome measure.
    End point values
    		 Frontotemporal Disorder Cognitively Normal Alzheimer's Disease
    Number of subjects analysed
    8
    10
    10
    Units: Participants
        Positive
    2
    1
    8
        Negative
    4
    8
    2
        Tie
    2
    1
    0
    No statistical analyses for this end point

    Primary: Quantitative Amyloid Image Assessment

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    End point title
    		 Quantitative Amyloid Image Assessment
    End point description
    The effect of diagnostic group on mean total cortical grey matter florbetapir binding relative to cerbellar cortex is presented as standard uptake value ratios (SUVRs).
    End point type
    Primary
    End point timeframe
    50-60 minutes after injection
    End point values
    		 Frontotemporal Disorder Cognitively Normal Alzheimer's Disease
    Number of subjects analysed
    8
    10
    10
    Units: SUVr
    arithmetic mean (standard deviation)
        Mean cortical SUVR
    1.25 ± 0.36
    1.29 ± 0.11
    1.77 ± 0.38
    Statistical analysis title
    		 Effect of diagnostic group on SUVr
    Statistical analysis description
    The effect of diagnostic group on mean cortical florbetapir binding relative to cerebellar cortex was determined.
    Comparison groups
    Frontotemporal Disorder v Alzheimer's Disease v Cognitively Normal
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.002
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [2] - Null hypothesis is no difference between the group means.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    7 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Frontotemporal Disorder
    Reporting group description
    		 Subjects with frontotemporal disorder (FTD). florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. 18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.

    Reporting group title
    Cognitively Normal
    Reporting group description
    		 Cognitively normal (CN) subjects.

    Reporting group title
    Alzheimer's Disease
    Reporting group description
    		 Subjects with Alzheimer's disease (AD).

    Serious adverse events
    		 Frontotemporal Disorder Cognitively Normal Alzheimer's Disease
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Frontotemporal Disorder Cognitively Normal Alzheimer's Disease
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    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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