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    Clinical Trial Results:
    In-vivo assessment of nicotinic acetylcholine receptor binding in neurodegenerative diseases using the radioligand 2-[18F]FA-85380 and positron emission tomography (PET)

    Summary
    EudraCT number
    		 2007-004979-19
    Trial protocol
    		 DE  
    Global end of trial date
    01 Nov 2016

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 May 2021
    First version publication date
    04 Oct 2020
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of a mistake in the primary endpoint description (missing word).
    Summary report(s)
    		 Trial Results

    Trial information

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    Trial identification
    Sponsor protocol code
    EK Reg.-Nr. 040-2007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universität Leipzig
    Sponsor organisation address
    Ritterstraße 26, Leipzig, Germany,
    Public contact
    Prof. Dr. med. Osama Sabri, Universität Leipzig Klinik und Poliklinik für Nuklearmedizin, 0049 3419718000, mbnuksekr@medizin.uni-leipzig.de
    Scientific contact
    Prof. Dr. med. Osama Sabri, Universität Leipzig Klinik und Poliklinik für Nuklearmedizin, 0049 3419718000, mbnuksekr@medizin.uni-leipzig.de
    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
    27 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    (1) In-vivo quantification of nicotinic acetylcholine receptor availability in neurodegenerative diseases (2) To find diagnostic patterns of altered in-vivo nicotinic acetylcholine receptor binding in neurodegenerative disease
    Protection of trial subjects
    Patients were closely monitored by the treating staff for safety during the course of the trial. This included documentation of (S)AEs as well as trial specific safety parameters.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Feb 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
    Germany: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    36
    From 65 to 84 years
    43
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 80 patients were recruited between February 2009 and November 2016.

    Pre-assignment
    Screening details
    		 Patients were pre-screened for neurodegenerative diseases.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Patients with neurodegenerative diseases
    Arm description
    		 Patients with neurodegenerative diseases
    Arm type
    		 Experimental

    Investigational medicinal product name
    2-[18F]F-A-85380
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    One time bolus injection. The mean dose administered to trial subjects by intravenous injection was 367,1 MBq in 10 mL saline.

    Arm title
    		 Healthy Controls
    Arm description
    		 -
    Arm type
    		 Control

    Investigational medicinal product name
    2-[18F]F-A-85380
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    One time bolus injection. The mean dose administered to trial subjects by intravenous injection was 367,1 MBq in 10 mL saline.

    Number of subjects in period 1
    		Patients with neurodegenerative diseases Healthy Controls
    Started
    42
    38
    Completed
    42
    38

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Patients with neurodegenerative diseases
    Reporting group description
    		 Patients with neurodegenerative diseases

    Reporting group title
    Healthy Controls
    Reporting group description
    		 -

    Reporting group values
    		 Patients with neurodegenerative diseases Healthy Controls Total
    Number of subjects
    		 42 38 80
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 14 22 36
        From 65-84 years
    		 28 15 43
        85 years and over
    		 0 1 1
    Gender categorical
    Units: Subjects
        Female
    		 17 20 37
        Male
    		 25 18 43

    End points

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    End points reporting groups
    Reporting group title
    Patients with neurodegenerative diseases
    Reporting group description
    		 Patients with neurodegenerative diseases

    Reporting group title
    Healthy Controls
    Reporting group description
    		 -

    Primary: Imaging of nicotinic acetylcholine receptor availability in neurodegenerative diseases

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    End point title
    		 Imaging of nicotinic acetylcholine receptor availability in neurodegenerative diseases [1]
    End point description
    End point type
    Primary
    End point timeframe
    After PET Imaging.
    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: See attached PDF.
    End point values
    		 Patients with neurodegenerative diseases Healthy Controls
    Number of subjects analysed
    42
    38
    Units: Whole
    42
    38
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From FPI to LPO.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: See attached PDF.

    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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