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    Summary
    EudraCT Number:2016-002223-28
    Sponsor's Protocol Code Number:PHAO14-CH/TEPTAU
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-11-30
    Trial results View 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 ConcernedFrance - ANSM
    A.2EudraCT number2016-002223-28
    A.3Full title of the trial
    Tau brain imaging in typical and atypical Alzheimer’s Disease (AD)
    Imagerie de la protéine Tau dans les formes typiques et atypiques de la maladie d’Alzheimer (MA).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tau brain imaging in typical and atypical Alzheimer’s Disease (AD)
    Imagerie de la protéine Tau dans les formes typiques et atypiques de la maladie d’Alzheimer (MA).
    A.3.2Name or abbreviated title of the trial where available
    TEPTAU
    TEPTAU
    A.4.1Sponsor's protocol code numberPHAO14-CH/TEPTAU
    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 SponsorCHRU DE TOURS
    B.1.3.4CountryFrance
    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 supportREGION CENTRE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU DE TOURS
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address2 Boulevard Tonnellé
    B.5.3.2Town/ cityTours
    B.5.3.3Post code37044
    B.5.3.4CountryFrance
    B.5.4Telephone number0033218370803
    B.5.5Fax number0033247473876
    B.5.6E-mailk.chene@chu-tours.fr
    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 name7-(6-[F-18]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole
    D.3.2Product code [18F]-T807
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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
    Alzheimer's diseases
    Maladie d'Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer's diseases
    Maladie d'Alzheimer
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    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
    L'objectif principal est d’évaluer le profil de fixation (densité et distribution) des agrégats tau à l’aide d’une imagerie TEP au [18F]-T807, un nouveau traceur spécifique de ces protéines tau, dans la forme visuo-perceptive/visuospatiale de MA et de le comparer à celui des formes typiques de MA.
    E.2.2Secondary objectives of the trial
    1/ Comparer le profil de l’imagerie TEP avec le traceur tau [18F]T807 (Δ SUV) dans chaque groupe de malades, comparativement au groupe de sujets sains. Les sujets sains permettent d’obtenir une valeur de référence par région d’intérêt.
    2/ Évaluer la relation entre les biomarqueurs du LCR et l’imagerie TEP avec le traceur tau [18F]T807 (densité et distribution) dans chaque groupe patient.
    3/ Évaluer la relation entre l’imagerie TEP avec le traceur tau [18F]T807 (densité et distribution) et le profil cognitif à l’inclusion entre chaque groupe patient.
    4/ Évaluer la relation entre la fixation cérébrale du radiotraceur tau [18F]T807 et la neuro-dégénérescence mesurée avec le FDG et à l’IRM à l’inclusion pour les patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 50 years
    - Native language: French
    - Studies level ≥ 7 years (considering as a starting point in the first year of primary education)
    - Correct sensory capabilities (hearing aids accepted) to perform the tests
    - Affiliation to the social security system,
    - Informed Consent
    Critères communs à toutes les personnes participantes :
    - Âge ≥ 50 ans
    - Langue maternelle : français
    - Niveau d’étude ≥ 7 ans (considérant comme point de départ la première année des études primaires)
    - Capacités sensorielles correctes (appareillage auditif accepté) pour réaliser les tests
    - Affiliation à régime de sécurité sociale,
    - Consentement éclairé

    1- Pour le groupe de patients atteints de MA :
    MA forme amnésique, débutante définie selon les critères NINCDS-ADRDA (2) (5) : MA au stade léger à modéré défini par un score au MMS compris entre 15 et 25 (test récent, maximum 2 mois avant).

    2- Pour le groupe de patients atteints d’un trouble visuo-spatial/visuo-perceptif progressif (syndrome de Benson) :
    - Critères de Mendez et al. (2002) et Tang Wai et al. (2004)
    Début insidieux et évolution progressive
    Plainte visuelle en l’absence de cause ophtalmologique
    Mémoire épisodique, fluence verbale et personnalité relativement préservés
    Signes visuels pouvant inclure une agnosie visuelle, une simultagnosie, une ataxie optique, une apraxie du regard, des troubles praxiques
    Exclusion par l’imagerie d’une atteinte spécifique (accident vasculaire cérébral, tumeur)
    Signes possiblement associés : alexie, apraxie idéo-motrice, agraphie, acalculie ; atrophie ou hypoperfusion des régions postérieures en imagerie

    3- Pour le groupe de sujets volontaires sains :
    - score MMS normal, établi en fonction du niveau socioéducatif (MMS >26 si niveau baccalauréat en terme de diplôme)
    E.4Principal exclusion criteria
    Critères communs à toutes les personnes participantes
    - Antécédent de pathologie pouvant avoir des conséquences sur le fonctionnement cognitif : tumeur, AVC constitué, traumatisme crânien (avec séquelles cliniques ou parenchymateuses objectivées sur l’imagerie cérébrale), chirurgie au niveau de l’encéphale
    - Prise chronique d’alcool ou de drogues
    - Anomalies à l'examen neurologique (déficit focal) ne figurant pas dans les symptômes classiques
    - Contre-indication à la réalisation d’une IRM cérébrale : pace maker, défibrillateur cardiaque, neurostimulateur, clips homéostatiques des anévrismes intracérébraux ou des artères carotides, implants cochléaires, corps étrangers métalliques intra oculaire
    - Contre indication à la réalisation d’une TEP : Personne présentant un allongement de l’intervalle QT ou prise de médicament pouvant entraîner des torsades de pointe.
    - Claustrophobie
    - Majeur protégé
    - Période d’exclusion d’une autre RBM (notamment période d'exclusion de tout examen irradiant du fait d’une participation à une étude précédente) et participation en cours à une autre RBM
    - Femme enceinte ou en période d’allaitement ou en capacité de procréer sans méthode contraceptive efficace
    E.5 End points
    E.5.1Primary end point(s)
    - Imagerie TEP : l'évaluation de la fixation du [18F]-T807 sera faite à l'aide des SUVR en prenant comme référence la fixation cérébelleuse.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Inclusion - Visite 1
    E.5.2Secondary end point(s)
    - Biomarqueurs du LCR : dosage des protéines Tau et des βamyloïdes (Aß42 et Aß40).
    - Profils cognitifs des patients : résultats aux tests neuropsychologiques (échelle de dépression de Hamilton (MADRS), Inventaire Neuro-Psychiatrique, score MMSE.
    - Neuro-dégénerescence mesurée avec le FDG et à l’IRM
    E.5.2.1Timepoint(s) of evaluation of this end point
    Inclusion - Visite 1
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    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
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3Specific vulnerable populations No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    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
    Aucun
    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 Decision2016-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
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