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    Summary
    EudraCT Number:2019-004290-84
    Sponsor's Protocol Code Number:tau-PET/BBRC2019
    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:2020-05-10
    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 number2019-004290-84
    A.3Full title of the trial
    Characterization of cerebral tau aggregates with 18F-RO6958948 PET in the ALFA population.
    Caracterización en la población ALFA de agregados cerebrales tau con PET 18F-RO6958948
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Characterization of cerebral tau aggregates with 18F-RO6958948 PET in the ALFA population.
    Caracterización en la población ALFA de agregados cerebrales tau con PET 18F-RO6958948
    A.4.1Sponsor's protocol code numbertau-PET/BBRC2019
    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 supportF. HOFFMANN-LA ROCHE LTD
    B.4.2CountrySwitzerland
    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 pointClinical Operations Manager
    B.5.3 Address:
    B.5.3.1Street AddressC\ Wellington 30
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08005
    B.5.3.4CountrySpain
    B.5.6E-mailcherrero@barcelonabeta.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.3.2Product code [18F]RO6958948
    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.3.9.2Current sponsor code[18F]RO6958948
    D.3.9.3Other descriptive name[18F]RO948
    D.3.9.4EV Substance CodeSUB205278
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.1 to 35
    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 del 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
    The overall objective of the present study is to characterize tau tracer retention as a function of amyloid levels transversally and longitudinally.
    1 Cross sectional objectives
     To measure 18F-RO6958948 retention in selected participants of BBRC ALFA-related studies as a function of amyloid levels.
     To study the relation between 18F-RO6958948 retention and amyloid levels.
    2 Longitudinal objectives
     To measure tau accumulation and spreading in participants of the ALFA-related studies of BBRC as a function of baseline amyloid levels.
     To study the dynamic relation between tau spreading and amyloid levels longitudinally.
    El objetivo general de este estudio es caracterizar la retención del trazador tau en función de los niveles de amiloide transversalmente y longitudinalmente.
    1. Objetivos Transversales:
    Medir la retención de 18F-RO6958948 en participantes seleccionados de estudios relacionados con ALFA en función de los niveles de amiloide.
    2. Objetivos longitudinales:
    Medir la acumulación y diseminación de tau en los participantes de los estudios de BBRC relacionados con ALFA en función de los niveles basales de amiloide.
    Estudiar la relación dinámica entre la expansión de tau y los niveles de amiloide longitudinalmente.
    E.2.2Secondary objectives of the trial
    1 Cross sectional objectives
     To characterize imaging correlates as a function of tau and amyloid levels.
     To study the role of tau retention on cognitive performance.
     To define predictors of tau retention.
    2 Longitudinal objectives
     To define predictors of tau spreading.
    1. Objetivos Transversales:
    Estudiar la relación entre la retención de 18F-RO6958948 y los niveles de amiloide.
    Caracterizar las imágenes relacionadas en función de los niveles de tau y amiloide.
    Estudiar el papel de la retención de tau en el rendimiento cognitivo.
    Definir predictores de retención de tau.
    2. Objetivos longitudinales:
    Definir predictores de propagación de tau.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signature of the study informed consent form approved by the corresponding authorities.
    2. Men and women that have participated in a BBRC-sponsored study, including the ALFA project (STUDY 45-65 FPM/2012), the ALFA+ cohort study (ALFA – FPM – 0311), the ALFAcognition study (ALFAcognition/BBRC2017) or the Barcelonaeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018).
    3. Participants with an available cerebral MRI (magnetic resonance imaging) in the last 12 months not suggestive of radiological incidental findings constituting an exclusion criterion.
    4. Known cognitive status based on the cognitive workup of the BBRC-sponsored studies specified above. Cognitive status should have been determined within the last 12 months.
    5. Known A and tau status.
    6. Good knowledge of the language and being literate.
    7. Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET acquisition.
    1. Firma del consentimiento informado del estudio aprobado por las autoridades correspondientes.
    2. Hombres y mujeres que han participado en un estudio patrocinado por BBRC, incluido el proyecto ALFA (ESTUDIO 45-65 FPM / 2012), el estudio de cohorte ALFA + (ALFA - FPM - 0311), el estudio ALFAcognition (ALFAcognition / BBRC2017) o el Barcelonaβeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018).
    3. Participantes con una resonancia magnética cerebral disponible en los últimos 12 meses que no sugiera hallazgos incidentales radiológicos que constituyan un criterio de exclusión.
    4. Estado cognitivo conocido basado en el trabajo cognitivo de los estudios patrocinados por BBRC especificados anteriormente. El estado cognitivo debería haberse determinado en los últimos 12 meses.
    5. Niveles conocidos de proteína amiloide y tau.
    6. Buen conocimiento del idioma y saber leer y escribir.
    7. Las participantes femeninas deben ser posmenopáusicas o presentar una prueba de embarazo negativa en el momento de la adquisición de PET.
    E.4Principal exclusion criteria
    1. Presence of clinically relevant psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria: major depressive disorder, generalized anxiety disorder, schizophrenia and bipolar disorder, as assessed in the BBRC-sponsored studies specified above.
    2. Individuals with visual and/or hearing impairment.
    3. History of encephalitis, ictus or seizures excluding feverish convulsions during childhood, as assessed in the BBRC-sponsored studies specified above.
    4. Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by MRI.
    5. 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.
    6. Clinically relevant renal or hepatic insufficiency.
    7. Any other clinically important condition that may jeopardize the study or be dangerous for the participant.
    8. Active drug or alcohol abuse, as assessed in the BBRC-sponsored studies specified above.
    9. Previous intolerance to PET studies or known hypersensitivity to 18F-RO6958948.
    10. Being pregnant or breast-feeding.
    1. Presencia de trastorno psiquiátrico clínicamente relevante de acuerdo con los criterios del Manual diagnóstico y estadístico de trastornos mentales, 5a edición (DSM-V): trastorno depresivo mayor, trastorno de ansiedad generalizada, esquizofrenia y trastorno bipolar, según lo evaluado en los estudios específicos patrocinados por BBRC especificados anteriormente.
    2. Individuos con discapacidad visual y / o auditiva.
    3. Antecedentes de encefalitis, ictus o convulsiones, excluidas las convulsiones febriles durante la infancia, según lo evaluado en los estudios patrocinados por BBRC especificados anteriormente.
    4. Enfermedad macrovascular cerebral grave (es decir, accidente cerebrovascular múltiple) o tumor cerebral (metástasis / cáncer cerebral) según lo verificado por la resonancia magnética.
    5. Participación previa en un estudio clínico que involucre un producto farmacéutico en investigación dentro de los 30 días previos a la detección y / o administración de un radiofármaco dentro de las 10 vidas medias radiactivas antes de la administración del medicamento en este estudio.
    6. Insuficiencia renal o hepática clínicamente relevante.
    7. Cualquier otra condición clínicamente importante que pueda poner en peligro el estudio o ser peligrosa para el participante.
    8. Abuso activo de drogas o alcohol, según lo evaluado en los estudios patrocinados por BBRC especificados anteriormente.
    9. Intolerancia previa a los estudios de PET o hipersensibilidad conocida a 18F-RO6958948.
    10. Estar embarazada o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Global and regional retention rate of 18F-RO6958948.
    Tasa de retención global y regional de 18F-RO6958948.
    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.
    Transversalmente en la visita basal de todos los sujetos;
    Longitudinalmente al final del ensayo.
    E.5.2Secondary end point(s)
    1 Cross sectional variables
     Brain MRI acquisition:
    a. MRI-based volumetry of different brain regions
    b. Voxel-based study of brain volumetry
    c. Resting-state functional connectivity of the default mode network
     Neuropsychological Tests
    1. Variables Transversales
    Adquisición de resonancia magnética cerebral:
    a. Volumetría basada en resonancia magnética de diferentes regiones del cerebro
    b. Estudio basado en voxel de volumetría cerebral
    c. Conectividad funcional en estado de reposo de la red en modo predeterminado
    Pruebas neuropsicológicas
    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.
    Transversalmente 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 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) 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
    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 months9
    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: 50
    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 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 state100
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-13
    P. End of Trial
    P.End of Trial StatusOngoing
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