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    Summary
    EudraCT Number:2015-002606-37
    Sponsor's Protocol Code Number:FBB-01-02-15
    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:2015-08-06
    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 number2015-002606-37
    A.3Full title of the trial
    Multicenter study to explore the impact of florbetaben (FBB) in change of diagnosis in patients who are evaluated for AD at the CMRR, and are eligible for analysis of CSF according to HAS recommendations, and in whom lumbar puncture is contraindicated or CSF results are ambiguous.
    Etude multicentrique explorant l’impact du florbetaben (FBB) sur le changement de diagnostic chez des patients évalués pour une maladie d’Alzheimer dans les CMRR, étant éligibles pour l’analyse du LCR selon les recommandations de l’HAS, et pour qui la ponction lombaire est contre-indiquée ou les résultats du LCR sont ambigus.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of florbetaben, an imaging marker of Alzheimer's disease, in change of diagnosis in patients who attend a memory clinic (CMRR) for memory decline, in whom the analysis of the biomarkers of the disease in the cerebro-spinal fluid is recommended to support the diagnosis, but in whom these biomarkers cannot be collected or evaluated
    Impact du florbetaben, un marqueur d'imagerie de la maladie d'Alzheimer, sur le changement de diagnostic de patients consultant un centre mémoire (CMRR) pour un déclin mnésique, pour qui l'analyse des marqueurs de la maladie dans le liquide céphalo-rachidien est recommandée pour étayer le diagnostic, mais pour qui ces marqueurs ne peuvent être collectés ou évalués
    A.4.1Sponsor's protocol code numberFBB-01-02-15
    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 SponsorPiramal Imaging Ltd
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPiramal Imaging Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPiramal Imaging Ltd
    B.5.2Functional name of contact pointSouth West Europe Medical Affairs
    B.5.3 Address:
    B.5.3.1Street AddressTegeler Straße 6-7
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.4Telephone number4930461124615
    B.5.5Fax number4930461124609
    B.5.6E-mailrossella.gismondi@piramal.com
    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 Neuraceq
    D.2.1.1.2Name of the Marketing Authorisation holderPiramal Imaging Ltd
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 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 Disease
    Maladie d´Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer's disease is a disease that affects brain. Main symptoms are memory loss, difficulties with thinking and language.
    La maladie d'Alzheimer est une maladie qui affecte le cerveau. Les principaux symptômes sont une perte de la mémoire, des difficultés de raisonnement et de langage.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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
    To estimate the change in diagnosis comparing pre- and post-scan outcomes in the study population
    Estimer le changement de diagnostic en comparant les données pré- et post-scan dans la population d’étude
    E.2.2Secondary objectives of the trial
    Physician confidence: Confidence Assessment scale - change in confidence
    Number of positive and negative scans: Percentage of negative scans
    Percentage of positive scans
    Description of the study population: Gender, Age, Education, LP refused, LP not feasible, CSF ambiguous, Clinical Profile
    - Changement du degré de confiance du médecin dans le diagnostic (Confidence Assessment Scale)
    - Nombre de scanners positifs et négatifs: Pourcentage de scanners négatifs, Pourcentage de scanners positifs
    - Description des caractéristiques de la population d'étude: sexe, âge, niveau d’éducation, ponction lombaire refusée ou ponction lombaire non réalisable, résultats du LCR ambigus, profil clinique
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects < 90 years of age
    2. Patients being evaluated for Alzheimer disease and related dementias according to HAS recommendations (atypical dementia, early onset and rapid progressive dementia)
    3. Patients who have previously been evaluated for AD and related dementias to whom a CSF examination was recommended in the last 12 months, but lumbar puncture was contraindicated or refused or CSF results were ambiguous, or
    4. Patients currently being evaluated for AD and related dementias to whom a CSF examination is recommended but lumbar puncture is contraindicated or refused
    5. Patients have a proxy informant who is willing and able to accompany him/her to all clinic visits for the duration of the protocol
    6. Patients able to complete all clinical visits according to the protocol
    7. Patients able to tolerate a 20-minute FBB PET scan
    8. Patient and legal representative to provide informed consent for study participation, visits and data source verification.
    1. Homme ou femme < 90 ans
    2. Patients étant évalués pour une maladie d’Alzheimer ou un syndrome apparenté selon les recommandations de l’HAS (démence atypique, démence à début précoce et démence progressive à évolution rapide),
    3. Patients précédemment évalués pour une maladie d’Alzheimer ou un syndrome apparenté pour qui un examen du LCR a été recommandé au cours des 12 derniers mois, mais la ponction lombaire était contre-indiquée ou refusée ou les résultats de l’examen du LCR étaient ambigus, ou
    4. Patients actuellement évalués pour une maladie d’Alzheimer ou un syndrome apparenté pour qui un examen du LCR est recommandé, mais la ponction lombaire est contre-indiquée ou refusée,
    5. Patients ayant un proche (« accompagnant ») qui est disposé et capable de les accompagner sur l’ensemble des visites cliniques toute la durée du protocole,
    6. Patients capables de réaliser l’ensemble des visites cliniques du protocole,
    7. Patients capables de tolérer un scanner TEP-FBB de 20 minutes,
    8. Le patient et son représentant légal fournissent un consentement libre et éclairé de participation à l’étude.
    E.4Principal exclusion criteria
    1. The subject had a previous beta amyloid imaging scan
    2. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
    3. Is currently receiving any investigational pharmaceutical product or has participated in a clinical trial with an investigational pharmaceutical product within 30 days prior to screening and/or was administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study.
    1. Le sujet a déjà bénéficié d’un examen d’imagerie bêta-amyloïde,
    2. Toute maladie systémique ou condition médicale instable qui pourraient entraîner des difficultés à se conformer au protocole,
    3. Le patient reçoit actuellement tout produit pharmaceutique expérimental ou a participé à un essai clinique avec un produit pharmaceutique expérimental dans les 30 jours avant la sélection et/ou a reçu un radiopharmaceutique dans les 10 demi-vies radioactives avant l’administration du produit de cette étude.
    E.5 End points
    E.5.1Primary end point(s)
    to explore the impact of florbetaben PET imaging in change of diagnosis in patients with dementia for whom collection of biomarkers is required
    Explorer l'impact de l'imagerie TEP au florbetaben dans le changement de diagnostic chez des patients avec une démence pour qui la collection de biomarqueurs est nécessaire.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after florbetaben PET imaging results disclosure
    Après la divulgation des résultats de l'imagerie TEP au florbetaben.
    E.5.2Secondary end point(s)
    change in level physician confidence pre and post florbetaben PET imaging, number of subjects with a positive scan and number of subjects with a negative scan, description of reason for inclusion in the trial (LP refused or not performed, CSF results ambiguous)
    - Changement du degré de confiance du médecin dans le diagnostic avant et après l'imagerie TEP au florbetaben.
    - Nombre de sujets avec un scanner positif, nombre de sujets avec un scanner négatif.
    - Description des raisons de l'inclusion dans l'étude (ponction lombaire refusée ou non réalisable, résultats du LCR ambigus)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening visit and final visit
    Visite de sélection et visite finale
    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 Yes
    E.6.5Efficacy Yes
    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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    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
    Last visit last subject
    Dernière visite du dernier sujet
    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) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 197
    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
    Many of the subjects will suffer from dementia
    Beaucoup de sujets souffriront d'une démence.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state207
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 207
    F.4.2.2In the whole clinical trial 207
    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 Decision2015-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-29
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