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    Summary
    EudraCT Number:2016-001436-35
    Sponsor's Protocol Code Number:COFITAGE2016
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-06-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-001436-35
    A.3Full title of the trial
    How sleep and circadian rhythmicity promote cognitive fitness and protect against cognitive decline in the elderly population
    Comment le sommeil et les rythmes circadiens favorisent une bonne cognition et protègent contre le déclin cognitif au cours du vieillissement
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    How sleep and circadian rhythmicity promote cognitive fitness and protect against cognitive decline in the elderly population
    Comment le sommeil et les rythmes circadiens favorisent une bonne cognition et protègent contre le déclin cognitif au cours du vieillissement
    A.3.2Name or abbreviated title of the trial where available
    COFITAGE
    COFITAGE
    A.4.1Sponsor's protocol code numberCOFITAGE2016
    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 SponsorService of Neurology, CHU Liege
    B.1.3.4CountryBelgium
    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 supportGIGA -CRC, University of Liège
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationULG, GIGA-CRC
    B.5.2Functional name of contact pointProf. Eric Salmon
    B.5.3 Address:
    B.5.3.1Street AddressB30 Sart Tilman
    B.5.3.2Town/ cityLiège
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3243662316
    B.5.5Fax number3243662946
    B.5.6E-maileric.salmon@ulg.ac.be
    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 No
    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 name[18F]THK-5351
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot yet available
    D.3.9.1CAS number 1707148-68-2
    D.3.9.2Current sponsor codeTHK5351
    D.3.9.3Other descriptive name(S)-1-[18F]fluoro-3-((2-(6-(methylamino)pyridin-3-yl)quinolin-6yl)oxy)propan-2-ol
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number50
    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 Yes
    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 No
    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 name[18F]flutemetamol
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 765922-62-1
    D.3.9.3Other descriptive nameFLUTEMETAMOL (18F)
    D.3.9.4EV Substance CodeSUB33652
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number50
    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 Yes
    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: 3
    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 VIZAMYL
    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 name[18F]flutemetamol
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 765922-62-1
    D.3.9.3Other descriptive nameFLUTEMETAMOL (18F)
    D.3.9.4EV Substance CodeSUB33652
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number50
    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 Yes
    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
    Healthy middle aged (50 - 70 y.o.) individual with and without preclinical Alzheimer's disease defined by biomarkers
    Individu d'âge moyen (50 à 70 ans) en bonne santé, avec ou sans biomarqueurs de maladie d'Alzheimer (MA) préclinique
    E.1.1.1Medical condition in easily understood language
    Healthy middle aged (50 - 70 y.o.) individual with and without preclinical Alzheimer's disease defined by biomarkers
    Individu d'âge moyen (50 à 70 ans) en bonne santé, avec ou sans biomarqueurs de maladie d'Alzheimer (MA) préclinique
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To quantify the disruption of sleep and circadian rhythmicity, its impact on cognition and brain structure, and its relationships with biomarkers for preclinical AD (amyloid and tau brain deposition).

    2. To develop novel quantitative neurophysiological biomarkers of cortical neurodynamics associated with cognitive fitness and preclinical AD biomarkers. We will use beyond state-of-the-art methods based on advanced analysis of electroencephalographic (EEG) responses evoked by transcranial magnetic stimulation (TMS) during sleep deprivation.

    3. To develop novel quantitative MR imaging biomarkers of cognitive fitness related to preclinical AD stages.
    1. Quantifier les troubles du sommeil et du rythme circadien, leur impact sur la cognition, la structure cérébrale et leur relations avec les biomarqueurs de MA préclinique (dépôts cérébraux d'amyloide et de protéine tau)
    2. Développer de nouveaux biomarqueurs neurophysiologiques associés au bon fonctionnement cognitif et aux biomarqueurs de MA préclinique.
    3. Développer de nouveaux biomarqueurs de MA préclinique en imagerie par résonance magnétique
    E.2.2Secondary objectives of the trial
    In the same population, we want to build-up a detailed longitudinal database of healthy middle-aged participants focusing on health, cognitive and brain statuses
    Avec la même population, nous allons créer une base de données de participants d'âge moyen focalisée sur leur état de santé, et leur état cognitif et cérébral
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Relatively healthy late middle aged individuals (50-70 y.o.; 50% females)
    Individus d'âge moyen (50 à 70 ans), en relativement bonne santé, 50% de femmes
    E.4Principal exclusion criteria
    Body mass index (BMI) > 29; depression, anxiety, history of epilepsy, addiction and other psychiatric disorders, diabetes, and use of psychoactive drug; early signs of dementia; excessive caffeine/alcohol consumption (> 5 cups/day and > 14 units/week respectively); shift-work in the last 6 months; transmeridian travel in the past 2 months.
    Indice de masse corporelle>29, dépression, anxiété, épilepsie, addiction ou autre pathologie psychiatrique, diabète, utilisation de drogues psychotropes, signes de démence, consommation excessive de caféine ou d'alcool, travail à horaire décalé dans les 6 derniers mois, voyage trans-méridien dans les 2 derniers mois
    E.5 End points
    E.5.1Primary end point(s)
    No uniquely defined end points
    Neuropsysiological parameters;
    Structural brain pameters;
    cognitive function
    Pas de critère d'évaluation unique:
    Paramètres neurophysiologiques
    Paramètres de structure cérébrale
    Fonction cognitive
    E.5.1.1Timepoint(s) of evaluation of this end point
    non applicable
    non applicable
    E.5.2Secondary end point(s)
    Parametric brain tau protein deposit
    Evaluation paramétrique des dépôts cérébraux de protéine tau
    E.5.2.1Timepoint(s) of evaluation of this end point
    Analyses to be performed at the end of the acquisitions
    Les analyses seront réalisées à la fin des acquisitions
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 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
    Sélection de groupe par biomarqueur
    Group selection by biomarker
    E.8.2.4Number of treatment arms in the trial4
    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
    24h after the last visit of the last subject
    24h après la dernière visite du dernier sujet
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 Yes
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    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)
    If a preclinical AD is identified, participant will be offered clinical follow up in our memory clinic
    Si une MA préclinique est identifiée, une prise en charge sera proposée au sein de notre clinique de la mémoire
    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 Decision2017-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-29
    P. End of Trial
    P.End of Trial StatusOngoing
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