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    Clinical Trial Results:
    Evaluation of 18F-AV-1451 kinetic modeling in patients in Alzheimer's disease and healthy controls

    Summary
    EudraCT number
    		 2014-003047-35
    Trial protocol
    		 NL  
    Global end of trial date
    28 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 May 2018
    First version publication date
    12 May 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    18F-AV-1451-A10
    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., 7th Floor, Philadelphia, United States, 19104
    Public contact
    Stephen Truocchio, Avid Radiopharmaceuticals, Inc., 1 2152980700,
    Scientific contact
    Michael Pontecorvo, Avid Radiopharmaceuticals, Inc., 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
    28 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate tracer kinetic models for the purpose of quantifying specific binding of 18F-AV-1451 in cross sectional and longitudinal applications and to evaluate simplified methods for quantitation of 18F-AV-1451 uptake.
    Protection of trial subjects
    Subjects who received flortaucipir F 18 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
    05 Jan 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
    Netherlands: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    7
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 One subject was enrolled in the study but withdrew consent prior to receiving flortaucipir.

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

    Arms
    Arm title
    		 All Subjects
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    flortaucipir 18F
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    240 Mbq IV Injection. Dynamic Scan 0-60 and 80-130 min post injection. Arterial blood withdrawn continuously 0-60 min post injection. Manual blood camples taken at 5, 10, 15, 20, 40, 60, 80, 105, and 130 min post injection. No more than 500cc of blood was withdrawn during the PET session.

    Number of subjects in period 1 [1]
    		All Subjects
    Started
    21
    Completed
    17
    Not completed
    4
         Physician decision
    3
         Consent withdrawn by subject
    1
    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: One subject was enrolled in the study but withdrew consent prior to receiving flortaucipir.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    		 -

    Reporting group values
    		 All Subjects Total
    Number of subjects
    		 21 21
    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)
    		 67.7 ( 6.52 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 13 13
    Race
    Units: Subjects
        Asian
    		 0 0
        Black or African American
    		 1 1
        Caucasian
    		 19 19
        Native American/Alaskan Native
    		 0 0
        Native Hawaiian or Pacific Islander
    		 0 0
        Other
    		 1 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0
        Not Hispanic or Latino
    		 21 21
    Highest Level of Education
    Units: Subjects
        Elementary School
    		 0 0
        Middle School
    		 0 0
        High School
    		 7 7
        College/University
    		 11 11
        Post Graduate School
    		 3 3
        Other
    		 0 0
    Alcohol History
    Units: Subjects
        Never
    		 3 3
        Not Current User
    		 2 2
        Occasional
    		 6 6
        Moderate
    		 10 10
        Frequent
    		 0 0
    Smoking History
    Units: Subjects
        Never
    		 7 7
        Not Current User
    		 11 11
        Occasional
    		 0 0
        Moderate
    		 2 2
        Frequent
    		 1 1
    MMSE
    Mini-Mental State Examination
    Units: Points
        arithmetic mean (standard deviation)
    		 26.2 ( 3.79 ) -

    End points

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    End points reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    		 -

    Primary: Kinetic Modeling

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    End point title
    		 Kinetic Modeling [1]
    End point description
    BPND (2TC DVR-1) values, and SUVr-1 values from 3 timepoints using multiple target areas with both PERSI and cere-crus as reference region were compared by a regression analysis. SUVr from scans acquired 80-100 min post dose, using the PERSI reference region provided the best approximation (r2, goodness of fit) to the BPND (2TC DVR-1) values. For this timepoint/reference region the slope of the regression line approached 1 and the intercept approached zero and the SUVr-1 value explained more than 90% of variance in BPND values. In contrast SUVr values from later timepoints or SUVr values using cere-crus reference region tended to explain less variance and tended to slightly overestimate BPND. SUVR = Standard Uptake Value Ratio BPND = Binding Potential 2TC = Two Tissue Compartment Model DVR = Distribution Volume Ration PERSI = Parametric Estimate of Reference Signal Intensity cere-crus = Cerebellum-crus, a gray matter region of cerebellum
    End point type
    Primary
    End point timeframe
    40-60, 80-100, and 110-130 minutes postinjection
    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: There was no formal hypothesis to be tested in this study.
    End point values
    		 All Subjects
    Number of subjects analysed
    20 [2]
    Units: Goodness of Fit (r2)
    number (not applicable)
        40-60 min (PERSI)
    0.8022
        80-100 min (PERSI)
    0.9064
        110-130 min (PERSI)
    0.8509
        40-60 min (cere-crus)
    0.7575
        80-100 min (cere-crus)
    0.8969
        110-130 min (cere-crus)
    0.8218
    Notes
    [2] - One subject did not complete the PET scan due to excessive and repeated movement.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Within 48 hours of flortaucipir injection.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Safety Population
    Reporting group description
    		 All subjects who received flortaucipir F 18.

    Serious adverse events
    		 Safety Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Safety Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 21 (14.29%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Gastrointestinal disorders
    Change of bowel habit
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Feb 2016
    Arterial blood draw is now required for all study subjects. In a previous amendment, there was the possibility that the arterial blood draw could be dropped for cohort 2 (baseline scan only) subjects after analyzing the data from cohort 1 subjects (baseline and 1 year scan). Additionally, If brain MRI has been performed more than 6 months (AD) or 12 months (HV) before baseline imaging, brain MRI will be repeated.

    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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