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    Clinical Trial Results:
    Pilot study to assess P-glycoprotein function at the blood-brain barrier of patients with mild to moderate Alzheimer's disease

    Summary
    EudraCT number
    		 2013-001724-19
    Trial protocol
    		 AT  
    Global end of trial date
    13 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2013/2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria,
    Public contact
    Klinische Pharmakologie, Medizinische Universität Wien, 0043 1404002981, klin-pharmakologie@meduniwien.ac.at
    Scientific contact
    Klinische Pharmakologie, Medizinische Universität Wien, 0043 1404002981, klin-pharmakologie@meduniwien.ac.at
    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 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    13 May 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of this study is to examine differences in Pgp function at the BBB between AD patients and age-matched control subjects by performing (R)-11C-verapamil PET scans before, during and after Pgp modulation with tariquidar. Tariquidar will be administered at a dose of 3 mg/kg which corresponds to the half-maximum effect dose for inhibition of Pgp at the BBB. We hypothesize that AD patients will show higher increases in (R)-11C-verapamil brain distribution following tariquidar administration than control subjects due to reduced cerebral Pgp function in AD patients. Furthermore the influence of ABCB1 single nucleotide polymorphisms (SNPs, 3435C>T, 2677G>T, 1236C>T) on (R)-11C-verapamil distribution to the brain before, during and after tariquidar infusion will be assessed.  To compare rate constants of (R)-11C-verapamil transport across the BBB before, during and after tariquidar infusion between AD patients and age-matched control subjects. Secondary objectives:
    Protection of trial subjects
    Subjects were during the trial under the supervision of an physician or an experienced Nurse.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Dec 2013
    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
    Austria: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited using the data base of the Dep. of Clinical Pharmacology, Medical University of Vienna.

    Pre-assignment
    Screening details
    		 Check of the in- and exclusion criteria, physical examination, vital signs, laboratory assessment and ECG recording

    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
    		 Group B: Age-matched controls
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tariquidar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg BW given once as an i.v. infusion over 30 min (R)-11C-verapamil at a tracer dose of <100 μg corresponding to an activity of approximately 5.5 MBq/kg BW, maximum 400 MBq as an i.v. bolus twice per study day

    Arm title
    		 Group C: Young controls
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tariquidar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg BW given once as an i.v. infusion over 30 min (R)-11C-verapamil at a tracer dose of <100 μg corresponding to an activity of approximately 5.5 MBq/kg BW, maximum 400 MBq as an i.v. bolus twice per study day

    Number of subjects in period 1
    		Group B: Age-matched controls Group C: Young controls
    Started
    5
    11
    Completed
    5
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 16 16
    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)
    		 13 13
        From 65-84 years
    		 3 3
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    Group B: Age-matched controls
    Reporting group description
    		 -

    Reporting group title
    Group C: Young controls
    Reporting group description
    		 -

    Primary: Rate constants of (R)-11C-verapamil transport across the BBB before, during and after tariquidar infusion obtained from kinetic modeling of the blood and PET data

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    End point title
    		 Rate constants of (R)-11C-verapamil transport across the BBB before, during and after tariquidar infusion obtained from kinetic modeling of the blood and PET data
    End point description
    End point type
    Primary
    End point timeframe
    scan 1: 120 min, scan 2: 40 min, for 5 healthy subjects scan 3: 60 min,
    End point values
    		 Group B: Age-matched controls Group C: Young controls
    Number of subjects analysed
    5
    11
    Units: kBq/ml
    5
    11
    Statistical analysis title
    		 End point statistic
    Comparison groups
    Group B: Age-matched controls v Group C: Young controls
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    10.09.2014-13.05.2016
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Adverse events overall trail
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse events overall trail
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adverse events overall trail
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 16 (43.75%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Phlebitis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Gastrointestinal disorders
    Dysgeusia
         subjects affected / exposed
    4 / 16 (25.00%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    1 / 16 (6.25%)
         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
    21 Nov 2013
    Amendment to study protocol
    30 May 2014
    Amendment to study protocol

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    13 May 2016
    Unsuccessful recruitment
    -

    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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