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    Clinical Trial Results:
    Florbetapir F 18 (18F-AV-45) Amyloid PET Imaging in Focal Dementia Syndromes

    Summary
    EudraCT number
    		 2010-023852-10
    Trial protocol
    		 GB  
    Global end of trial date
    19 Jul 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2016
    First version publication date
    02 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    18F-AV-45-020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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 Radiopharmaceutcals, 1 2152980700,
    Scientific contact
    Chief Medical Officer, Avid Radiopharmaceutcals, 1 2152980700,
    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
    19 Jul 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jul 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To use florbetapir (18F) to investigate the pathological underpinning of the neuropsychologically distinct variants of primary progressive aphasia (PPA); and to compare patterns of florbetapir (18F) uptake between these patients and those with posterior cortical Alzheimer’s disease (PCA-AD) and age-matched controls. 2.To use 18F-fluoro-2-deoxy-D-glucose (FDG) PET imaging to assess the patterns of focal hypometabolism occurring in these disorders.
    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 maximized to minimize the risk of any discomfort while in the PET scanner.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Mar 2012
    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: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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)
    13
    From 65 to 84 years
    10
    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 PPA

    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
    		 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
    		 Posterior Cortical Alzheimer's Disease
    Arm description
    		 Subjects with posterior cortical Alzheimer'es disease (PCA-AD).
    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
    		 Primary Progressive Aphasia
    Arm description
    		 Subjects with primary progressive aphasia (PPA). Efficacy endpoints for this arm will be reported as subgroup analyses by syndromic group.
    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).

    Number of subjects in period 1 [1]
    		Cognitively Normal Posterior Cortical Alzheimer's Disease Primary Progressive Aphasia
    Started
    5
    5
    12
    Completed
    5
    5
    12
    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. One subject elected to leave the study prior to receiving florbetapir (18F). 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
    Cognitively Normal
    Reporting group description
    		 Cognitively normal (CN) subjects.

    Reporting group title
    Posterior Cortical Alzheimer's Disease
    Reporting group description
    		 Subjects with posterior cortical Alzheimer'es disease (PCA-AD).

    Reporting group title
    Primary Progressive Aphasia
    Reporting group description
    		 Subjects with primary progressive aphasia (PPA). Efficacy endpoints for this arm will be reported as subgroup analyses by syndromic group.

    Reporting group values
    		 Cognitively Normal Posterior Cortical Alzheimer's Disease Primary Progressive Aphasia Total
    Number of subjects
    		 5 5 12 22
    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)
    		 63.2 ± 6.34 58.8 ± 2.17 66.5 ± 6.84 -
    Gender categorical
    Units: Subjects
        Female
    		 3 2 6 11
        Male
    		 2 3 6 11

    End points

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    End points reporting groups
    Reporting group title
    Cognitively Normal
    Reporting group description
    		 Cognitively normal (CN) subjects.

    Reporting group title
    Posterior Cortical Alzheimer's Disease
    Reporting group description
    		 Subjects with posterior cortical Alzheimer'es disease (PCA-AD).

    Reporting group title
    Primary Progressive Aphasia
    Reporting group description
    		 Subjects with primary progressive aphasia (PPA). Efficacy endpoints for this arm will be reported as subgroup analyses by syndromic group.

    Subject analysis set title
    Logopenic Progressive Aphasia
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PPA syndromic group Logopenic Progressive Aphasia (LPA).

    Subject analysis set title
    Progressive Nonfluent Aphasia
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PPA syndromic group Progressive Nonfluent Aphasia (PNFA).

    Subject analysis set title
    Semantic Dementia
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PPA syndromic group Semantic Dementia (SD).

    Primary: Qualitative Image Assessment

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    End point title
    		 Qualitative Image Assessment [1] [2]
    End point description
    A blinded visual assessment was performed by three independent, experienced nuclear medicine clinicians for both florbetapir (18F) images (AB+/AB-) and FDG images (FDG abnormal/FDG normal).
    End point type
    Primary
    End point timeframe
    Florbetapir (18F) PET imaging 50-60 minutes after injection. FDG PET Imaging 30-60 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.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The PPA arm is composed of 3 subgroups: LPA, PNFA, and SD. The efficacy data for the PPA arm is presented in the subgroup analysis for this end point.
    End point values
    		 Cognitively Normal Posterior Cortical Alzheimer's Disease Logopenic Progressive Aphasia Progressive Nonfluent Aphasia Semantic Dementia
    Number of subjects analysed
    5
    5
    3
    4
    5
    Units: Participants
        AB+
    0
    5
    3
    1
    0
        AB-
    5
    0
    0
    3
    5
        FDG abnormal
    0
    5
    3
    3
    5
        FDG normal
    5
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Quantitative Image Assessment

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    End point title
    		 Quantitative Image Assessment [3] [4]
    End point description
    SUVr was calculated using a whole cerebellum reference region with no partial volume correction.
    End point type
    Primary
    End point timeframe
    Florbetapir (18F) PET imaging 50-60 minutes after injection. FDG PET Imaging 30-60 minutes after injection.
    Notes
    [3] - 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.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The PPA arm is composed of 3 subgroups: LPA, PNFA, and SD. The efficacy data for the PPA arm is presented in the subgroup analysis for this end point.
    End point values
    		 Cognitively Normal Posterior Cortical Alzheimer's Disease Logopenic Progressive Aphasia Progressive Nonfluent Aphasia Semantic Dementia
    Number of subjects analysed
    5
    5
    3
    4
    5
    Units: SUVr
    arithmetic mean (standard deviation)
        Florbetapir (18F)
    1.02 ± 0.05
    1.48 ± 0.11
    1.47 ± 0.1
    1.12 ± 0.1
    0.98 ± 0.04
        FDG
    1.19 ± 0.08
    0.95 ± 0.02
    0.98 ± 0.06
    1.07 ± 0.13
    1.09 ± 0.07
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    48 hours
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Cognitively Normal
    Reporting group description
    		 Cognitively normal (CN) subjects.

    Reporting group title
    Posterior Cortical Alzheimer's Disease
    Reporting group description
    		 Subjects with posterior cortical Alzheimer'es disease (PCA-AD).

    Reporting group title
    Primary Progressive Aphasia
    Reporting group description
    		 Subjects with primary progressive aphasia (PPA).

    Serious adverse events
    		 Cognitively Normal Posterior Cortical Alzheimer's Disease Primary Progressive Aphasia
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cognitively Normal Posterior Cortical Alzheimer's Disease Primary Progressive Aphasia
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
    General disorders and administration site conditions
    Injection site irritation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         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.
    This study is limited by a small sample size at a single recruiting center.
    For support, Contact us.
    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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