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    Summary
    EudraCT Number:2015-004474-15
    Sponsor's Protocol Code Number:PETFLUTEMETAMOL-FDG/BBRC2015
    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:2016-02-03
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-004474-15
    A.3Full title of the trial
    Characterization of cerebral amyloid deposition with 18F-Flutemetamol PET and of glucose metabolism with 18F-FDG PET in individuals enrolled in the ALFA project
    Caracterización de los participantes del proyecto ALFA a través de la deposición de amiloide cerebral mediante PET con 18F-Flutemetamol y del metabolismo de la glucosa mediante PET con 18F-FDG
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Brain characterization of amyloid protein and glucose metabolism of ALFA project participants
    Caracterización cerebral de la proteína amiloide y del metabolismo de glucosa en los participantes del proyecto ALFA
    A.4.1Sponsor's protocol code numberPETFLUTEMETAMOL-FDG/BBRC2015
    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 SponsorBarcelonaBeta Brain Research Center
    B.1.3.4CountrySpain
    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 supportBarcelonaBeta Brain Research Center
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportGeneral Electric Healthcare
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportObra social "La Caixa"
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBarcelonaBeta Brain Research Center
    B.5.2Functional name of contact pointBBRC
    B.5.3 Address:
    B.5.3.1Street AddressAiguader 88
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08003
    B.5.3.4CountrySpain
    B.5.4Telephone number0034933160988
    B.5.5Fax number0034933160996
    B.5.6E-mailsrabanaque@fpmaragall.org
    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 nameFlutemetamol (18F) Injection
    D.3.2Product code AH110690 (18F) Injection
    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 INN[18F]flutemetamol
    D.3.9.1CAS number 765922-62-1
    D.3.9.2Current sponsor code[18F]AH110690
    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.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 BARNASCAN 3000 MBq/ml
    D.2.1.1.2Name of the Marketing Authorisation holderBARNATRON S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameFludeoxyglucose (18F) Injection
    D.3.2Product code 18F-FDG
    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 INNFLUORINE (18F) FLUDEOXYGLUCOSE
    D.3.9.1CAS number 86783-82-6
    D.3.9.2Current sponsor code18F-FDG
    D.3.9.3Other descriptive name2-deoxy-2-((18)F)fluoro-alpha-D-glucopyranose
    D.3.9.4EV Substance CodeSUB07680MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3000
    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
    Study to understand factors related with the preclinical stages of Alzheimer's Disease and investigate markers that predict its progression.
    Estudio para estudiar factores relacionados con los estadios preclínicos de la enfermedad de Alzheimer e investigar marcadores que puedan predecir su progresión.
    E.1.1.1Medical condition in easily understood language
    Study to investigate Alzheimer's Disease before first clinical symptoms have appeared.
    Estudio para investigar la enfermedad de Alzheimer en una fase previa a la aparición de los primeros síntomas clínicos.
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10036654
    E.1.2Term Prevention
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the prevalence of a positive 18F-Flutemetamol scan in the individuals recruited in the ALFA project according to age, APOE4 and familiar history of AD.
    Estudiar la prevalencia PET amiloide positivo en los participantes del proyecto ALFA de acuerdo a su edad, APOE4 y su historia familiar de enfermedad de Alzheimer.
    E.2.2Secondary objectives of the trial
    To study the prevalence of the different stages of preclinical AD in the individuals recruited in the ALFA project according to age, APOE4 and familiar history of AD.
    Estudiar la prevalencia de los diferentes estadios preclínicos de la enfermedad de Alzheimer en los participantes del proyecto ALFA de acuerdo a su edad, APOE4 y su historia familiar de enfermedad de Alzheimer.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Sign the study informed consent document approved by the corresponding authorities.
    2. Men and women enrolled in the ALFA project (STUDY 45-65 FPM/2012).
    3. No previous evidence of radiological incidental findings constituting an exclusion criterion as determined by magnetic resonance imaging (MRI).
    4. Cognition within psychometrics normal range: MMSE (Mini Mental State Examination) ?26 and Semantic Fluency (animals) ?12.
    5. Score of 0 in the CDR scale (Clinical Dementia Rating).
    6. Good knowledge of the language and being literate.
    7. Female subjects should be post-menopausal or present a negative pregnancy test at the moment of PET scans.
    1. Firma del formulario de consentimiento informado aprobado por la autoridades competentes.
    2. Hombres y mujeres reclutadas en el proyecto ALFA (Estudio 45-65 FPM/2012).
    3. No evidencia previa de hallazgos radiológicos inesperados que constituyan un criterio de exclusión para la realización de una Resonancia Nuclear Magnética.
    4. Estado cognitivo dentro de los valores de normalidad psicométricos: MMSE (Mini Mental State Examination) ?26 and Fluencia semántica (animales) ?12.
    5. Puntuación igual a 0 en la escala CDR (Clinical Dementia Rating).
    6. Buen conocimiento del idioma local y saber leer y escribir.
    7. Las participantes femeninas deben ser post-menopáusicas o presentar un resultado negativo en un test de embarazo en el momento de realización de los PET.
    E.4Principal exclusion criteria
    1. Present any cognitive impairment for age and educational level.
    2. Presence of clinically relevant psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV-TR) criteria: major depressive disorder, generalized anxiety disorder, schizophrenia or bipolar disorder.
    3. Individual with visual and/or hearing impairment.
    4. History of encephalitis, ictus or seizures excluding feverish convulsions during childhood.
    5. Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by magnetic resonance imaging (MRI).
    6. Any contraindication to MRI examination, (i.e., metal implants) or phobia to performing the scan as determined by the onsite physician.
    7. Previous participation in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or administration of a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study.
    8. Clinically relevant renal or hepatic insufficiency.
    9. Any other condition clinically important condition that may jeopardize the study or is dangerous for the subject.
    10. Active drug or alcohol abuse.
    11. Presence of pacemaker, aneurysm graft, artificial heart valves, auditory implants, cerebral shunts, metal fragments or strange objects in the eyes, skin or body that may be contraindicate magnetic resonance imaging.
    12. Previous intolerance to PET studies or known hypersensitivity to 18F-Flutemetamol or 18F-FDG.
    13. Being pregnant or breast feeding.
    1. Presentar deterioro cognitivo según edad y nivel educativo.
    2. Presencia de trastornos psiquiátricos clínicamente relevantes de acuerdo con el Diagnostic and Statistical Manual of Mental Disorders, cuarta edición (DSM-IV-TR) Criterios: trastorno depresivo mayor, trastorno de ansiedad generalizada, esquizofrenia o trastorno bipolar.
    3. Persona con discapacidad visual y/o auditiva.
    4. Historia de encefalitis, ictus o convulsiones, excluyendo convulsiones febriles en la infancia.
    5. Enfermedad cerebrovascular severa (es decir, multi-infarto) o tumor cerebral (metástasis / cáncer cerebral) verificada por resonancia nuclear magnética (MRI).
    6. Cualquier contraindicación para la realización de una resonancia nuclear (es decir, implantes metálicos) o fobia a la realización de la exploración según lo determine el médico del centro.
    7. Participación previa en un estudio clínico que implica la administración de un producto farmacéutico en investigación en los 30 días anteriores a la selección y/o la administración de un radiofármaco dentro de las 10 vidas medias radiactivas antes de estudiar la administración del fármaco en este estudio.
    8. Insuficiencia renal o hepática clínicamente relevante.
    9. Cualquier otra condición clínicamente importante que pueda poner en peligro el estudio o sea peligrosa para el sujeto.
    10. Abuso activo de drogas o alcohol.
    11. Presencia de marcapasos, injertos de vaso sanguíneo por aneurisma, válvulas cardíacas artificiales, implantes auditivos, derivaciones cerebrales, fragmentos de metal u objetos extraños en los ojos, la piel o el cuerpo que puedan suponer una contraindicación para la realización de una resonancia magnética.
    12. Intolerancia previa a la obtención de imágenes PET o hipersensibilidad conocida a la 18F-Flutemetamol o 18F-FDG.
    E.5 End points
    E.5.1Primary end point(s)
    A? protein deposition detected by in vivo PET imaging using 18F-Flutemetamol as radiotracer. 18F-Flutemetamol scans will be categorized as either positive or negative according to the standardized uptake value ratio.
    Deposición de proteína ?-amiloide detectada a través de imágenes PET en vivo con el radiotrazador 18F-Flutemetamol. Las imágenes obtenidas con 18F-Flutemetamol serán categorizadas como positivas o negativas en base a un ratio estandarizado de valoración de la captación.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As a cross-sectional study, the primary endpoint will only evaluated once.
    Se trata de un estudio transversal, por lo que la variable principal sólo será evaluada una vez.
    E.5.2Secondary end point(s)
    Retention of 18F-Flutemetamol and 18F-FDG in brain regions and voxel-based analysis of 18F-Flutemetamol and 18F-FDG will be measured by in vivo PET imaging using 18F-Flutemetamol and 18F-FDG as radiotracer.

    Brain Morphology performing structural MRI:
    - High resolution 3D T1-weighted images: determination of cortical thickness maps and the calculation of regional grey matter volume maps. Volumetric measurements of key cerebral brain regions will be calculated and expressed as a percentage of total intracranial volume.
    - Clinical sequences images (T2 and FLAIR): number and extension of white matter hyperintensities.
    - Diffusion Weighted Imaging (DWI) data: mapping of fractal anisotropy, apparent diffusion coefficient and mean diffusivity.

    Brain function performing functional MRI. Resting State (RS) analysis for the study of functional connectivity mapping, including (but not limited to) default mode network.
    Captaciones de 18F-Flutemetamol and 18F-FDG en regiones cerebrales y análisis basados en voxels de 18F-Flutemetamol and 18F-FDG serán medidos a través de imagénes PET obtenidas mediante la utilización de los radiotrazadores 18F-Flutemetamol and 18F-FDG.

    Morfología cerebral mediante la realización de una resonancia nuclear magnética estructural:
    - Imágenes de alta resolución 3D T1: determinación de mapas de espesor cortical y cálculo de mapas regionales de volumen de materia gris. Se calcularán medidas volumétricas de regiones cerebrales clave expresándose como porcentaje del volumen intracraneal total.
    - Imágenes de secuencias clínicas (T2 y FLAIR): número y extensión de las hiperintensidades en materia blanca.
    - Datos de Difusión Weighted Imaging (DWI): mapeo de anisotropía fraccional, coeficiente de difusión aparente y
    difusividad media.

    Función cerebral a través de la realización de una resonancia nuclear magnética funcional. Análisis del Resting State (RS) para el estudio del mapeo de la conectividad funcional, incluyendo (pero no limitado a) Red Neuronal por Defecto (Default Mode Network).
    E.5.2.1Timepoint(s) of evaluation of this end point
    As a cross-sectional study, the secondary endpoints will only evaluated once.
    Se trata de un estudio transversal, por lo que las variables secundarias sólo serán evaluadas una vez.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Factors related with the preclinical stages of Alzheimer's Disease and markers that predict its progression.
    Factores relacionados con los estadios preclínicos de la enfermedad de Alzheimer y marcadores que pueden predecir su progresión.
    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 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
    The trial will be performed until the end of the recruitment, or will be stopped if a SUSAR occurs.
    El estudio será llevado a cabo hasta la finalización del periodo de inclusión o se detendrá si aparece una RAGI.
    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
    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: 390
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 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 state440
    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
    Ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-12
    P. End of Trial
    P.End of Trial StatusOngoing
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