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    Summary
    EudraCT Number:2011-006011-62
    Sponsor's Protocol Code Number:NL38747.048.11
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-01-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-006011-62
    A.3Full title of the trial
    The ACER-study - the effects of galantamine on the variability and stability of walking among patients with Alzheimer's disease.
    De ACER-studie - effecten van galantamine op de variabiliteit en stabiliteit van het looppatroon bij patienten met de ziekte van Alzheimer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The ACER-study - examining the effects of galantamine on gait.
    De ACER-studie - onderzoek naar de effecten van galantamine op het looppatroon.
    A.3.2Name or abbreviated title of the trial where available
    The ACER-study
    De ACER-studie
    A.4.1Sponsor's protocol code numberNL38747.048.11
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSlotervaart Hospital
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportStichting Klinisch Wetenschappelijk Onderzoek Slotervaartziekenhuis (SKWOSZ)
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSlotervaart Hospital
    B.5.2Functional name of contact pointMaartje de Groot
    B.5.3 Address:
    B.5.3.1Street AddressLouwesweg 6
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066EC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31205124612
    B.5.5Fax number+31205125209
    B.5.6E-mailMaartje.deGroot@slz.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Reminyl Tablets 4mg, Reminyl Tablets 8mg, Reminyl Tablets 12mg
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag B.V., Tilburg, the Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namegalantamine
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGALANTAMINE
    D.3.9.1CAS number 357-70-0
    D.3.9.2Current sponsor codeGalantamine
    D.3.9.4EV Substance CodeSUB07870MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4 to 12
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dementia of the Alzheimer type
    Dementie van het type Alzheimer
    E.1.1.1Medical condition in easily understood language
    Dementia
    Dementie
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the present study is to examine the effects of treatment with galantamine among patients with AD on the variability and stability of walking (with and without dual-task), functional mobility, standing balance, and cognitive functions (e.g. attention and executive functions).
    Het doel van het onderzoek is om te onderzoeken wat bij patienten met de ziekte van Alzheimer de effecten zijn van de ACER galantamine op de variabiliteit en stabiliteit van het looppatroon (met en zonder dubbeltaken), functionele mobiliteit, stabalans, en cognitieve functies (m.n. aandacht en executieve functies).
    E.2.2Secondary objectives of the trial
    Furthermore, the relation between variability and stability of walking with and without dual-tasking, and cognitive functions (e.g. attention and executive functions), and activities of daily living, will be examined.
    Tevens wordt de relatie tussen de verschillende loopparameters (zie methodesectie van het onderzoeksprotocol), cognitie, activiteiten van het dagelijks leven en vallen, onderzocht.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be included for the present study when they are (a) aged 65 years or older; (b) diagnosed with mild to moderate Alzheimer's disease (according to the criteria of the DSM-IV and the NINCDS-ADRDA); and (c) able to walk for at least 160 meter without using any assistive device.
    Patienten worden geincludeerd voor de studie als zij (a) 65 jaar of ouder zijn; (b) gediagnosticeerd zijn met milde tot matige ziekte van Alzheimer (volgens de criteria van de DSM-IV en de NINCDS-ADRDA); en (c) ten minste 160 meter kunnen lopen zonder hulpmiddelen te gebruiken.
    E.4Principal exclusion criteria
    Patients will be excluded from the present study when they (a) have had any treatment with acetylcholine esterase inhibitors during the three months before inclusion; (b) have any mobility problems due to (lateral) neurological or orthopedic disorders with function limitations of one or both legs; (c) have severe visual impairments; or (d) are unable to understand and follow simple verbal instructions.
    Patienten worden geëxcludeerd voor de studie als zij (a) een behandeling met een acetylcholinesteraseremmer hebben gehad in de drie maanden voorafgaand aan inclusie; (b) mobiliteitsproblemen hebben door (laterale) neurologische of orthopedische aandoeningen aan een of beide benen; (c) ernstige visuele beperkingen hebben; of (d) niet in staat zijn simpele verbale instucties te begrijpen en op te volgen.
    E.5 End points
    E.5.1Primary end point(s)
    Statistically significant difference in outcome parameters between intervention and control group after 6 months of galantamine use.
    Statistisch significant verschil in uitkomstmaten tussen de interventie en controlegroep na 6 maanden galantamine-gebruik.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 12 months, a half-time evaluation will be done.
    Na 12 maanden, wordt een tussentijdse evaluatie gedaan.
    E.5.2Secondary end point(s)
    None
    Geen
    E.5.2.1Timepoint(s) of evaluation of this end point
    None
    Geen
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    geen behandeling
    no treatment
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Laatste bezoek van de laatste patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with mild to moderate Alzheimer's disease.
    Patienten met milde tot matige dementie van het type Alzheimer.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None, after the trial is ended, the patient will receive the usual care as given during the trial.
    Geen, wanneer de studie is afgelopen, ontvangt de patient verder de gewone zorg, zoals ook al tijdens de studie het geval was.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-08
    P. End of Trial
    P.End of Trial StatusOngoing
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