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    Clinical Trial Results:
    Validating in vivo quantification of tau with [18F]AV-1451 PET

    Summary
    EudraCT number
    		 2015-004230-10
    Trial protocol
    		 NL  
    Global end of trial date
    08 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions
    Summary report(s)
    		 Published paper

    Trial information

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    Trial identification
    Sponsor protocol code
    15-14
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VU University Medical Center
    Sponsor organisation address
    De Boellelaan 1117, Amsterdam, Netherlands, 1081 HV
    Public contact
    Dept of Radiology Nuclear Medicine, VU University Medical Center, 0031 204441948, t.timmers@vumc.nl
    Scientific contact
    Dept of Radiology Nuclear Medicine, VU University Medical Center, 0031 204441948, t.timmers@vumc.nl
    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
    30 Sep 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To validate the previously defined simplified tracer kinetic model to quantify specific binding of [18F]AV-1451
    Protection of trial subjects
    No trial specific measures were put in place. Regular procedures regarding scanning and puncture procedures were in place.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 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: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    6
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All AD patients will be recruited from the memory clinic of the VUmc Alzheimer Center Amsterdam. Annually, the Alzheimer Center receives 600 new patients. Control subjects will be recruited through advertisements in newspapers and by means of flyers.

    Pre-assignment
    Screening details
    		 Inclusion criteria included: Amyloid positive MCI or AD patients over the age of 50, with a MMSE above 17, able to tolerate scanning procedures. Or 50+ CN subjects able to tolerate scanning procedures

    Period 1
    Period 1 title
    test
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall study
    Arm description
    		 NA
    Arm type
    		 18F-AV1451 scan

    Investigational medicinal product name
    [18F]AV1451
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    240 MBq via intravenous injection

    Number of subjects in period 1
    		Overall study
    Started
    14
    Completed
    14
    Period 2
    Period 2 title
    retest
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall study
    Arm description
    		 -
    Arm type
    		 overall study

    Investigational medicinal product name
    [18F]AV1451
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    240 MBq via intravenous injection

    Number of subjects in period 2
    		Overall study
    Started
    14
    Completed
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    test
    Reporting group description
    		 8 MCI/AD subjects and 6 CN controls were reqruited and scanned with [18F]AV1451

    Reporting group values
    		 test Total
    Number of subjects
    		 14 14
    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
    66,5 (51-81)
    Units: years
        median (full range (min-max))
    		 66.5 (51 to 81) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 7 7

    End points

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    End points reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 NA
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Primary: test-retest variability of the previously defined simplified tracer kinetic model to quantify specific binding of [18F]AV-1451

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    End point title
    		 test-retest variability of the previously defined simplified tracer kinetic model to quantify specific binding of [18F]AV-1451
    End point description
    For all methods and across ROIs, TRT repeatability ranged from (median (IQR)) 0.84% (0.68–2.15) to 6.84% (2.99–11.50). TRT repeatability was good for all reference methods used, although semi-quantitative models (i.e. SUVr) performed marginally worse than quantitative models, for instance TRT repeatability of RPM: 1.98% (0.78–3.58) vs. SUVr80–100: 3.05% (1.28–5.52), p<0.001. The count for RPM method is provided, given that that is the most used method.
    End point type
    Primary
    End point timeframe
    Test-retest repeatability
    End point values
    		 Overall study Overall study
    Number of subjects analysed
    14
    14
    Units: percentages
    2
    2
    Statistical analysis title
    		 Main statistics
    Statistical analysis description
    TRT repeatability (%) was defined as jretest–testj/ (average (testþretest))100. For RPM and STRM2, TRT repeatability was assessed using BPNDþ1, corresponding to DVR, in order to directly compare values to RLogan and SUVr methods. To compare TRT repeatability per reference region method (RLogan, RPM, SRTM2, SUVr for 3 time intervals) and to compare TRT repeatability per tau-specific region (MTL, LTL and global ROI), we used Kruskal–Wallis tests and post-hoc Mann–Whitney U testing with B
    Comparison groups
    Overall study v Overall study
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05 [1]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [1] - With Bonferroni correction

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All adverse events, which occur 48 hours after administration of the radioactive tracer, and are reported spontaneously by the subject or observed by the investigator or his staff will be recorded.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 VUmc/CRB
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No no-serious adverse events were reported during the study

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2018
    Wijzigingen in het studieprotocol: tijdens de screening wordt geen ECG en geen lab verricht, er wordt geen arterieel bloed meer afgenomen, ook patiënten met MCI op basis van de ziekte van Alzheimer worden geïncludeerd. Wijzigingen in de informatiebrief en het IC: aanpassingen voor de proefpersoon zoals boven beschreven, en vrouwen mogen tot 24u na de PET scan niet zwanger worden. Voor mannen gelden geen restricties.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31575335
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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
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