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    Summary
    EudraCT Number:2017-002707-10
    Sponsor's Protocol Code Number:SJ-596
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-03
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-002707-10
    A.3Full title of the trial
    Serum-monitoring of anti-dementia drugs, and the relevance to side-effects, clinical efficacy and compliance
    MONitorering af ANTI-demens lægemidler ved bestemmelse af serumkoncentrationer, betydning af monitorering for bivirkningsforekomst, klinisk effekt og kompliance.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Measurements of drug concentration in the blood for anti-dementia drugs, in order to improve efficacy and reduce side-effects
    Måling af medicinmængde i blodet for lægemidler mod demens med henblik på forbedring af virkning og mindskning af bivirkninger
    A.3.2Name or abbreviated title of the trial where available
    MONANTI
    A.4.1Sponsor's protocol code numberSJ-596
    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 SponsorRegional Dementia Research Centre, Dept of Neurology
    B.1.3.4CountryDenmark
    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 supportRegional Dementia Research Centre, Dept of Neurology
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegional Dementia Research Centre, Dept of Neurology
    B.5.2Functional name of contact pointRVD
    B.5.3 Address:
    B.5.3.1Street AddressVestermarksvej 11
    B.5.3.2Town/ cityRoskilde
    B.5.3.3Post code4000
    B.5.3.4CountryDenmark
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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 Memantin Orion
    D.2.1.1.2Name of the Marketing Authorisation holderOrion
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical 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 INNMEMANTINE
    D.3.9.1CAS number 19982-08-2
    D.3.9.2Current sponsor codePR1
    D.3.9.4EV Substance CodeSUB08731MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 20
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    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.2.1.1.2Name of the Marketing Authorisation holderSandoz
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameDonepezil Sandoz
    D.3.2Product code 25330
    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 INNDONEPEZIL
    D.3.9.1CAS number 120014-06-4
    D.3.9.2Current sponsor codePR2
    D.3.9.4EV Substance CodeSUB06362MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 10
    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 in Alzheimers Disease, Parkinsons Disease and Dementia with Lewy Bodies
    Demens ved Alzheimers sygdom, Parkinsons sygdom og Lewy Body Demens
    E.1.1.1Medical condition in easily understood language
    Dementia in Alzheimers Disease, Parkinsons Disease and Dementia with Lewy Bodies
    Demens ved Alzheimers sygdom, Parkinsons sygdom og Lewy Body Demens
    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 20.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012284
    E.1.2Term Dementia due to Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067889
    E.1.2Term Dementia with Lewy bodies
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10075174
    E.1.2Term Mixed dementia
    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
    To investigate whether serum-monitoring of anti-dementia drugs may reduce side-effects and improve clinical efficacy and patient compliance.
    At undersøge hvorvidt serum-monitorering af anti-demenslægemidler, kan mindske grad og styrke af bivirkninger samt øge den kliniske effekt og forbedre patient compliance.
    E.2.2Secondary objectives of the trial
    To investigate eatiology of diverse serum-concentrations, including genetics
    At undersøge årsagerne til stor variation i serum-koncentration på standard-dosis, herunder genetiske.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Focused group-interview with relatives to dementia patients, describing patient-compliance and what influences compliance
    Strukturerede fokusgruppe-interview med pårørende til demente, mhp. afdækning af patient-compliance og hvad der har indflydelse herpå
    E.3Principal inclusion criteria
    Dementia in Alzheimers Disease, Parkinsons Disease and Dementia with Lewy Bodies in treatment with either donepezil or memantin
    Demens ved Alzheimers sygdom, Parkinsons sygdom og Lewy Body Demens og i behandling med donepezil eller memantin.
    E.4Principal exclusion criteria
    Patients without relatives, or living alone. Patients with no ablility to cooperrate. Patients not able to give consent. Patients with primary psychiatric condition. Patients with other medical or neurological conditions which may by themselves explain dementia symptoms. Patients treated with anti-psychotics during past 3 months. Patients with alcohol or drug abuse. Patients receiving ECT within past 3 months. Anaestesia within past 3 months.
    • Manglende ledsagelse af pårørende eller anden nærtstående.
    • Patienter, der bor alene og ikke har hjælp til medicineringen
    • Manglende evne til at samarbejde, herunder svært nedsat syn eller hørelse, amputation eller andre svære handicaps.
    • Manglende evne til at på meningsfuld måde at give informeret samtykke grundet kognitiv svækkelse.
    • Patienter med kendte psykiatriske grundsygdomme (skizofreni, bipolar affektiv sindslidelse m.fl.), dog tillades depression, såfremt patienten har været i fast medicinsk behandling mindst 3 måneder inden inklusion.
    • Patienter med kendte neurologiske sygdomme (DS, epilepsi, hjernetumorer e.lign.), som i sig selv kunne være bidragende til deres kognitive symptomer.
    • Patienter med medicinske sygdomme (nyre, lever, metaboliske m.fl.) som i sig selv kunne være bidragende til deres kognitive symptomer.
    • Patienter, som aktuelt eller de seneste 3 måneder inden inklusion, har været i behandling med anti-psykotika, eller neuroleptika. Minimale doser af benzodiazepiner eller hypnotika accepteres.
    • Patienter med tidligere stort misbrug af alkohol eller medicin, eller ethvert misbrug inden for de seneste 3 måneder inden inklusion.
    • Patienter med tidligere svære hovedtraumer eller neuroinfektioner, som i sig selv kunne være bidragende til deres kognitive symptomer.
    • Patienter, som inden for de seneste 3 måneder har fået ECT-behandling.
    • Anæstesi indenfor de sidste 3 mdr.
    E.5 End points
    E.5.1Primary end point(s)
    Last patient in cohorte (app.-110 patients) finishes 1-year follow-up
    Når sidste patient har været til 1-års opfølgning
    E.5.1.1Timepoint(s) of evaluation of this end point
    look above
    se ovenfor
    E.5.2Secondary end point(s)
    not applicable
    ikke relevant
    E.5.2.1Timepoint(s) of evaluation of this end point
    na
    na
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Yes
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To monitor drug concentrations i order to avoid side-effects and improve efficacy, improve compliance, investigate causes of diverse serum-concentrations on standard dose, including genetic causes.
    Monitorere serum-koncentrationer af anti-demens lægemidler mhp. at undgå bivirkninger, øge effektiviteten og øge patient-compliance, og afdække årsager til variabel serum-koncentration trods standard-dosering, herunder genetiske årsager
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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
    Sammenligner effekt og forekomst af bivirkninger i gruppe som serúm-monitoreres vs gruppe som ikke
    Comparing efficacy and side-effects in groups with serum-monitoring vs group with "business as usual
    E.8.2.4Number of treatment arms in the trial2
    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. Expected total trial peiod of no more than 2 years.
    LVLS. Forventes at inklusion afsluttes efter højst 1 år og sidste opfølgningsbesøg efter højst 2 år.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with dementia
    F.4 Planned number of subjects to be included
    F.4.1In the member state110
    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 Decision2017-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-16
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