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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Clinical Trial Results:
    Die antidementive Therapie mit Acetylcholinesteraseinhibitoren: Untersuchung von Plasmakonzentrationen, Arzneimittelinteraktionen und Therapieeffekt in Abhängigkeit von genetischen Polymorphismen

    Summary
    EudraCT number
    		 2008-005472-27
    Trial protocol
    		 AT  
    Global end of trial date
    30 Nov 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Oct 2022
    First version publication date
    20 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    70639
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52, Innsbruck, Austria, 6020
    Public contact
    Ao. Univ.Prof. Eberhard Deisenhammer, Medical University Innsbruck, University Hospital for Psychiatry I Anichstrasse 35, 6020 IBK, +43 (0)50504-23669, eberhard.deisenhammer@tirol-kliniken.at
    Scientific contact
    Ao. Univ.Prof. Eberhard Deisenhammer, Medical University Innsbruck, University Hospital for Psychiatry I Anichstrasse 35, 6020 IBK, +43 (0)50504-23669, eberhard.deisenhammer@tirol-kliniken.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
    30 Nov 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Nov 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Das primäre Ziel der Studie ist, den Einfluss genetischer Polymorphismen im CYP2D6-Gen auf die Wirkstoffkonzentration im Plasma der Acetylcholinesterase-inhibitoren Donezepil und Rivastigmin zu untersuchen.
    Protection of trial subjects
    Es ist einmalig ein Mundhöhlenabstrich für die genetische Untersuchung notwendig.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Mar 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
    Austria: 126
    Worldwide total number of subjects
    126
    EEA total number of subjects
    126
    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)
    5
    From 65 to 84 years
    90
    85 years and over
    31

    Subject disposition

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    Recruitment
    Recruitment details
    		 Die Rekrutierung der Demenzpatienten erfolgt über die Universitätsklinik für Psychiatrie Innsbruck, (zum Hauptanteil über die Gedächtnissprechstunde), die bereits über ein großes und gut untersuchtes Patientenkollektiv verfügt.

    Pre-assignment
    Screening details
    		 Inkludiert werden geschäftsfähige Patienten mit der Diagnose einer Demenz vom Alzheimer Typ oder gemischt vaskulärem Typ. Vor Studieneinschluss erfolgt ein ausführliches Informationsgespräch bzw. eine genetische Aufklärung.

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

    Arms
    Arm title
    		 Behandlung
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aricept 5mg-Filmtabletten
    Investigational medicinal product code
    Other name
    Donepezil Hydrochloride
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Nach einer klinischen Beurteilung der Behandlung mit 5 mg/Tag nach einem Monat kann die Aricept-Dosis bei Bedarf auf 10 mg/Tag (einmal tägliche Gabe) erhöht werden. Die empfohlene Maximaldosis beträgt 10 mg/Tag.

    Investigational medicinal product name
    Aricept 10mg-Filmtabletten
    Investigational medicinal product code
    Other name
    Donepezil Hydrochloride
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Nach einer klinischen Beurteilung der Behandlung mit 5 mg/Tag nach einem Monat kann die Aricept-Dosis bei Bedarf auf 10 mg/Tag (einmal tägliche Gabe) erhöht werden. Die empfohlene Maximaldosis beträgt 10 mg/Tag.

    Investigational medicinal product name
    Reminyl 4mg-Filmtabletten
    Investigational medicinal product code
    Other name
    Galantamine Hydrobromide
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Initialdosis: 4 mg 2mal / Tag, über 4 Wochen anfängliche Erhaltungsdosis : 8 mg 2mal / Tag; über mind. 4 Wochen gesteigerte Erhaltungsdosis: 12 mg 2mal / Tag; individuell nach sorgfältiger Beurteilung der Behandlung im Hinblick auf therapeutischen Nutzen und Verträglichkeit reduzierte Erhaltungsdosis: 16 mg / Tag; bei einzelnen Patienten, die bei Gabe von 24 mg / Tag keine erhöhte Ansprechrate zeigen oder die diese Dosis nicht vertragen

    Investigational medicinal product name
    Reminyl 8 mg-Filmtabletten
    Investigational medicinal product code
    Other name
    Galantamine Hydrobromide
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Die Behandlung wird mit der 8-mg-Hartkapsel, die einmal täglich eingenommen wird, begonnen. Nach 4 Behandlungswochen wird die Dosis erhöht. Dann wird die 16-mg-Hartkapsel einmal täglich eingnommen. Frühestens nach weiteren 4 Behandlungswochen kann die Dosis auf 24-mg einmal täglich erhöht werden.

    Investigational medicinal product name
    Exelon 4,6 mg/24 Stunden transdermales Pflaster
    Investigational medicinal product code
    Other name
    Rivastigmine
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Normalerweise beginnt die Behandlung mit Exelon 4,6 mg/24 Stunden. Die empfohlene übliche Tagesdosis ist Exelon 9,5 mg/24 Stunden. Wird sie gut vertragen, kann der behandelnde Arzt eine Erhöhung der Dosis auf 13,3 mg/24 Stunden in Betracht ziehen. Ein Pflaster wird pro Tag angewendet.

    Investigational medicinal product name
    Exelon 9,5 mg/24 Stunden transdermales Pflaster
    Investigational medicinal product code
    Other name
    Rivastigmine
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Normalerweise beginnt die Behandlung mit Exelon 4,6 mg/24 Stunden. Die empfohlene übliche Tagesdosis ist Exelon 9,5 mg/24 Stunden. Wird sie gut vertragen, kann der behandelnde Arzt eine Erhöhung der Dosis auf 13,3 mg/24 Stunden in Betracht ziehen. Ein Pflaster wird pro Tag angewendet.

    Number of subjects in period 1
    		Behandlung
    Started
    126
    Completed
    126

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Behandlung
    Reporting group description
    		 -

    Reporting group values
    		 Behandlung Total
    Number of subjects
    		 126 126
    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)
    		 5 5
        From 65-84 years
    		 90 90
        85 years and over
    		 31 31
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 78.4 (58 to 93) -
    Gender categorical
    Units: Subjects
        Female
    		 86 86
        Male
    		 40 40

    End points

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    End points reporting groups
    Reporting group title
    Behandlung
    Reporting group description
    		 -

    Primary: CYP2D6

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    End point title
    		 CYP2D6 [1]
    End point description
    End point type
    Primary
    End point timeframe
    Tag 0
    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: Für eine statistische Auswertung hätten 300 Patienten eingeschlossen werden müssen (100 Patienten je Medikament)
    End point values
    		 Behandlung
    Number of subjects analysed
    126
    Units: Polymorphismen
        number (not applicable)
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    31.03.2009-2011-11-30
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 126 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 126 (0.00%)
    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: Es wurde nur ein einmaliger Mundhöhlenabstrich durchgeführt.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Mar 2009
    Zusatz Studienprotokoll (Version 4): Relevante Gene für die Wirkung von Antidementiva Relevante Gene für die Pathogenese der Alzheimer Demenz

    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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