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    The EU Clinical Trials Register currently displays   41470   clinical trials with a EudraCT protocol, of which   6815   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2018-002277-22
    Sponsor's Protocol Code Number:AMYPAD-02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-11-23
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-002277-22
    A.3Full title of the trial
    AMYPAD Prognostic and Natural History Study (PNHS), an open label, prospective, multicentre, cohort study linked to the European Prevention of Alzheimer's Dementia (EPAD) Longitudinal Cohort Study (LCS) in individuals without dementia to evaluate the additional value of quantitative amyloid imaging in determining Alzheimer's Disease (AD) dementia risk
    Estudio de pronóstico e historia natural (PNHS) del AMYPAD, abierto, prospectivo, multicéntrico, cohorte vinculada al Estudio de Cohorte Longitudinal (ECL) del European Prevention of Alzheimer’s Dementia (EPAD) en personas sin demencia para evaluar el valor añadido de la imagen cuantitativa de amiloide en la determinación del riesgo de demencia por enfermedad de Alzheimer (EA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prognostic and Natural History Study
    Estudio de Pronóstico e Historia Natural
    A.3.2Name or abbreviated title of the trial where available
    AMYPAD PNHS
    AMYPAD PNHS
    A.4.1Sponsor's protocol code numberAMYPAD-02
    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 SponsorStichting VUmc
    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 supportInnovative Medicines Initiative 2 Joint Undertaking
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportEFPIA (from Janssen Pharmaceutical)
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportEFPIA (from Piramal Imaging)
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportEFPIA (from GE Healthcare)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStichting VUmc
    B.5.2Functional name of contact pointVUmc
    B.5.3 Address:
    B.5.3.1Street AddressBoelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.6E-mailf.barkhof@vumc.nl
    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 Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNeuraceq
    D.3.2Product code PRD1617296
    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 INNFLORBETABEN (18F)
    D.3.9.1CAS number 902143-01-5
    D.3.9.2Current sponsor codeAMYPAD-02
    D.3.9.4EV Substance CodeSUB119774
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Yes
    D.2.1.1.1Trade name Vizamyl
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameVizamyl
    D.3.2Product code V09AX04
    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 INNFlutemetamol (18F)
    D.3.9.1CAS number 765922-62-1
    D.3.9.2Current sponsor codeAMYPAD-02
    D.3.9.3Other descriptive nameFLUTEMETAMOL (18F)
    D.3.9.4EV Substance CodeSUB33652
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number185
    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 Disease
    Enfermedad de Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer's Disease (AD) is a neurodegenerative condition that represents the most common cause of cognitive impairment and dementia worldwide.
    La Enfermedad de Alzheimer (EA) es una condición neurodegenerativa que representa la causa más común de deterioro cognitivo y demencia en el mundo
    E.1.1.2Therapeutic area Health Care [N] - Population Characteristics [N01]
    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 evaluate the value of quantitative PET amyloid imaging measures for predicting progression within an AD risk probability spectrum (derived from four different dimensions: cognition, other biomarkers, traditional genetic and environmental risk factors and temporal changes in these dimensions) based on quantitative PET amyloid imaging measures, with or without other biomarkers.
    Evaluar el valor de las medidas cuantitativas de las imágenes obtenidas mediante PET de amiloide para predecir la evolución del rango de probabilidad de riesgo de presentar EA (derivado de cuatro dimensiones diferentes: cognición, otros biomarcadores, factores de riesgo genéticos y medioambientales tradicionales y cambios temporales de estas dimensiones) basada en las medidas de imagen cuantitativa obtenida mediante PET de amiloide, con o sin otros biomarcadores.
    E.2.2Secondary objectives of the trial
    1. To evaluate the value of quantitative PET amyloid imaging, with or without other biomarkers, to predict a) cognitive decline, b) brain atrophy, and c) functional decline.
    2. To compare regional quantitative PET amyloid imaging measures and global quantitative PET and CSF amyloid measures for their ability to identify participants most likely to experience subsequent cognitive decline.
    3. To assess the relationship between (a) continuous measures of baseline amyloid and cognitive decline; and (b) these continuous measures and clinical outcomes.
    4. To determine the agreement between the classifications of brain amyloid status based on (a) quantitative PET imaging and (b) visual amyloid PET image interpretation, and compare their ability to predict subsequent cognitive decline.
    5. To determine the optimal methodology for the quantification of amyloid load by amyloid PET imaging, through analysis of biological and technical factors affecting quantitative PET amyloid imaging.
    1. Evaluar el valor de la imagen cuantitativa obtenida de PET de amiloide, con o sin otros biomarcadores, para predecir a) deterioro cognitivo, b) atrofia cerebral, y c) deterioro funcional
    2. Comparar medidas de amiloide de imágenes cuantitativas regionales y globales obtenidas mediante PET y CSF para determinar su capacidad de identificar participantes con más probabilidad de experimentar un deterioro cognitivo
    3. Evaluar la relación entre (a) medidas continuas de amiloide basales; y (b) estas medidas continuas y las evaluaciones de los resultados clínicos
    4. Determinar el acuerdo entre clasificaciones del estado de amiloide cerebral basado en (a) imágenes obtenidas de PET y (b) interpretaciones visuales, y comparar su habilidad para predecir deterioro cognitivo
    5. Determinar la metodología óptima para la cuantificación de la carga de las imágenes obtenidas de PET de amiloide, a través del análisis de factores técnicos y biológicos que pueden afectar la imagen amiloide PET
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Baseline Eligibility Criteria
    1. Participants who are currently active in the EPAD LCS and older than 50 years of age will be eligible if they provide separate written informed consent to participate in the AMYPAD PNHS
    2. Participants with a suitable baseline biomarker, cognitive and risk factor profile, as determined by the Selection and Feasibility Committee, based on an adaptive selection algorithm that aims to provide optimal representation of the probability spectrum for AD risk; OR participants that have been randomly selected to maintain the mandated
    nondisclosure EPAD LCS.
    3. Participants who are assessed by the recruiting investigator to be physically fit to undergo PET scanning and able to tolerate the PET scanning procedure for at least the duration of a static scan (20 minutes).

    Follow-up Eligibility Criteria
    1. Participants who underwent dynamic PET scanning at baseline:
    a. Participants who are willing and available to undergo a follow-up
    scan. All participants with a dynamic scan at baseline will be invited for
    follow-up scans.
    2. Participants who underwent static PET scanning at baseline:
    a. Participants who are willing and available to undergo a follow-up
    scan, and
    b. Are selected based on the Selection and Feasibility Committee's
    algorithm for follow-up, which in addition to the previous algorithm also
    considers baseline composite SUVR values.
    Criterios de elegibilidad basales
    1. Participantes que son actualmente activos en el ECL del EPAD y mayores de 50 años de edad serán elegibles si proporcionan otro consentimiento informado para participar en el PNHS del AMYPAD.
    2. Participantes con un adecuado perfil basal de biomarcadores, cognición y factores de riesgo, determinado por el Comité de Selección y Viabilidad, basado en un algoritmo de selección adaptativo que tiene como objetivo proporcionar la representación óptima del rango de probabilidad del riesgo de EA; O participantes que han sido seleccionados de forma aleatoria para mantener la confidencialidad estipulada en el ECL del EPAD.
    3. Participantes que el investigador encargado del reclutamiento determine que presentan las condiciones físicas adecuadas para someterse a la PET y que sean capaces de tolerar el procedimiento de la PET al menos durante el tiempo necesario para la obtención de una imagen estática (20 minutos).

    Criterios de elegibilidad de seguimiento
    1. Aquellos participantes que se hayan sometido a una PET dinámica en la basal:
    a. Aquellos participantes que estén dispuestos y disponibles para someterse a una imagen de seguimiento. Se invitará a todos los participantes con una imagen dinámica en la basal a someterse a imágenes de seguimiento.
    2. Aquellos participantes que se hayan sometido a una PET estática en la basal:
    a. Aquellos participantes que estén dispuestos y disponibles para someterse a una imagen de seguimiento y
    b. Sean seleccionados de acuerdo con el algoritmo de seguimiento del Comité de Selección y Viabilidad, que además del algoritmo previo también contempla los valores de SUVR integrados en la basal.
    E.4Principal exclusion criteria
    1. Participants who are not currently active in the EPAD LCS.
    2. Participants in whom PET scanning or magnetic resonance imaging (MRI) are contraindicated.
    3. Participants who are not able to complete the study procedures as judged by the investigator.
    4. Participants who have known hypersensitivities to the active ingredients of [18F]flutemetamol and [18F]florbetaben, or the excipients for both products (listed in section 6.1 of the respective Summary of Product Characteristics [SPC]).
    5. Women who are pregnant, planning to become pregnant, or lactating.
    1. Participantes que en la actualidad no sean activos en el ECL del EPAD.
    2. Participantes para los que la PET o la resonancia magnética (RM) estén contraindicadas.
    3. Participantes que sean incapaces de completar los procedimientos del estudio a criterio del investigador.
    4. Aquellos participantes que hayan experimentado hipersensibilidad a los principios activos de [18F]flutemetamol y [18F]florbetaben o a los excipientes de los dos productos (se encuentran en el apartado 6.1 de la ficha técnica [FT] correspondiente).
    5. Aquellas mujeres que estén embarazadas, que planeen quedarse embarazadas o que se encuentren en el periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Variables:
    1. Composite Centiloid, SUVR and/or BPND values measured from [18F]flutemetamol or [18F]florbetaben PET images
    2. Change from baseline in measures of cognitive status and daily functioning, modifiable risk factors, and MRI measures of brain atrophy
    1. Valores compuestos de Centiloid, SUVR o de BPND medidos a partir de las imágenes PET con [18F]flutemetamol o [18F]florbetaben.
    2. Cambio respecto a la visita basal en una puntuación compuesta de medidas del estado cognitivo y actividades cotidianas, factores de riesgo modificables y medidas de atrofia cerebral obtenidas mediante RM.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cross-sectionally at baseline visit of all subjects;
    Longitudinally at the end of the trial.
    Corte transversal en la visita basal de todos los sujetos;
    Longitudinalmente al final del ensayo.
    E.5.2Secondary end point(s)
    Secondary Variables:
    1. Change from baseline in measures of cognitive status (e.g. RBANS Total Scale Index Score)
    2. Change from baseline in MRI measures of brain atrophy
    3. Change from baseline in measures of daily functioning
    4. Change from baseline in measures of modifiable risk factors
    5. Regional SUVR and/or BPND values at baseline
    6. Change from baseline in Centiloid, SUVR and BPND values (global
    and/or regional)
    7. Baseline R1 values from dynamic scans
    8. Change from baseline in R1 values from dynamic scans
    9. Threshold values of Centiloid, SUVR and/or BPND for negative/positive amyloid status that produce the greatest agreement with visual interpretation by a trained nuclear physician or radiologist
    10. Threshold values of Centiloid, SUVR and/or BPND for negative/positive/grey-zone amyloid status that produce the highest accuracy with respect to predicting cognitive decline (and/or brain atrophy as measured by MRI)
    1. Cambio respecto la visita basal en medidas del estado cognitivo (p. ej., la puntuación total de la escala de RBANS).
    2. Cambio respecto a la visita basal en medidas de atrofia cerebral por RM.
    3. Cambio respecto a la visita basal en medidas de las actividades cotidianas.
    4. Cambio respecto a la visita basal en medidas de los factores de riesgo modificables
    5. Valores regionales de SUVR o BPND en la visita basal.
    6. Cambio respecto a la visita basal en los valores de Centiloid, SUVR y BPND (globales o regionales).
    7. Valores basales de R1 de imágenes dinámicas.
    8. Cambio respecto a la basal en los valores de R1 de imágenes dinámicas.
    9. Valores límite de Centiloid, SUVR o BPND para un estado de amiloide negativo/positivo que produzcan la mayor coincidencia con la interpretación visual por parte de un médico nuclear o radiólogo con formación.
    10. Valores límite de Centiloid, SUVR o BPND para un estado de amiloide negativo/positivo/zona gris que produzcan la máxima precisión para predecir el deterioro cognitivo (o atrofia cerebral medida mediante RM).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cross-sectionally at baseline visit of all subjects;
    Longitudinally at the end of the trial.
    Corte transversal en la visita basal de todos los sujetos;
    Longitudinalmente al final del ensayo.
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Germany
    Italy
    Netherlands
    Spain
    Sweden
    Switzerland
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1200
    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 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 dementia due to Alzheimer's Disease
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1800
    F.4.2.2In the whole clinical trial 2000
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Stichting VUmc
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation University of Edinburgh
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Barcelonabeta Brain Research Center
    G.4.3.4Network Country Spain
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Karolinska Institutet
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Centre Hospitalier Universitaire de Toulouse
    G.4.3.4Network Country France
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation University Hospital of Cologne
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation Université de Genève
    G.4.3.4Network Country Switzerland
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-18
    P. End of Trial
    P.End of Trial StatusOngoing
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