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    Summary
    EudraCT Number:2016-003451-30
    Sponsor's Protocol Code Number:Euro-SCD-FBB2
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-12-09
    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 number2016-003451-30
    A.3Full title of the trial
    Subjects with subjective cognitive decline: 18F-Florbetaben Positrón Emission Tomography Study.
    Estudio de sujetos con deterioro cognitivo subjetivo: estudio con Tomografía por Emisión de Positrones con 18-Florbetaben.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Subjects with subjective cognitive decline: 18F-Florbetaben Positrón Emission Tomography Study.
    Sujetos con disminución cognitiva subjetiva: Estudio de Tomografía por Emisión de Positrones con 18F-Florbetaben
    A.3.2Name or abbreviated title of the trial where available
    Euro-SCD-FBB2
    Euro-SCD-FBB2
    A.4.1Sponsor's protocol code numberEuro-SCD-FBB2
    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 SponsorInstitut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)
    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 supportPiramal Imaging GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportBECA Instituto de Salud Carlos III (RESULTADO EXPEDIENTE - AC14/00014)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU CLINIC (Clinical Trial Unit)
    B.5.2Functional name of contact pointFarmacologia clinica
    B.5.3 Address:
    B.5.3.1Street AddressRosello 138
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+ 349322754009838
    B.5.5Fax number+ 34932279877
    B.5.6E-mailacruceta@clinic.ub.es
    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 solution for injection Florbetaben (18F) 300 Mbq/ml
    D.2.1.1.2Name of the Marketing Authorisation holderPiramal Imaging Limited
    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 nameNeuraceq 300 MBq/ml solución inyectable
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 codeNeuraceq
    D.3.9.4EV Substance CodeSUB119774
    D.3.10 Strength
    D.3.10.1Concentration unit Bq/ml becquerel(s)/millilitre
    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.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
    Subjects with subjective cognitive decline.
    sujetos con deterioro cognitivo subjetivo.
    E.1.1.1Medical condition in easily understood language
    Subjects with subjective cognitive decline.
    sujetos con deterioro cognitivo subjetivo.
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10032831
    E.1.2Term Other specified non-arthropod-borne viral diseases of central nervous system
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess safety of a single dose of FBB followed by PET scan in individuals with subjective cognitive decline (SCD).
    2. To determine the number of SCD subjects with positive visual FBB-PET scan.
    1. Evaluar la seguridad de una dosis única de FBB tras la realización de un PET-scan en sujetos con deterioro cognitivo subjetivo (DCS).
    2. Determinar el número de sujetos con DCS con FBB-PET scan positivo visualmente.
    E.2.2Secondary objectives of the trial
    1. To determine the number of SCD subjects with positive standardized uptake value ratios (SUVRs) of FBB-PET scan.
    2. To explore the cortical pattern of amyloid deposition in SCD subjects.
    1. Determinar el número de sujetos con DCS con FBB-PET scan positivo según ratios de valor de captación estándar (SUVRs).
    2. Explorar el patrón cortical de depósito de amiloide en sujetos con DCS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. According to the principal investigator, participants must be committed to participate and complete all study procedures.
    2. The patient must report a memory problem (in isolation or in combination with complaints in other domains) with concern.
    3. Age >/= 60*.
    4. MMSE cutoff for inclusion will be ≥ 26.
    5. CDR<0.5.
    6. Has signed the Informed Consent Form voluntarily to participate in the study.

    * Women of childbearing potential must agree to sexual abstinence, barrier or hormonal contraceptive methods during the study.
    1. Según el investigador principal, los participantes deben comprometerse a participar y completar todos los procedimientos del estudio.
    2. El paciente debe informar de un problema de memoria (de forma aislada o en combinación con las quejas de otras esferas) con preocupación.
    3. Edad > / = 60*.
    4. MMSE cuyo punto de corte para la inclusión será ≥ 26.
    5. CDR<0.5.
    6. Haya firmado el formulario de consentimiento informado para participar voluntariamente en el estudio.

    * Las mujeres en edad fértil deben estar de acuerdo con la abstinencia sexual, barrera o métodos anticonceptivos hormonales durante el estudio.
    E.4Principal exclusion criteria
    1. Subjects those are not able to complete the study.
    2. Any major disease or history of a major disease, especially hepatobilliar disease (AST /ALT ≥ 5 x ULN) or advanced renal insufficiency (creatinine ≥ 2 x ULN).
    3. Current or previous history of alcohol abuse or epilepsy.
    4. Allergic to Florbetaben or any of its constituents.
    5. Multiple drug allergies and/or previous history of contrast allergy.
    6. Any disease or history of disease which, in the opinion of the investigator, can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function).
    7. Evidence for any other neurological or psychiatric disease, eg. parkinsonism, history of stroke or seizure.
    8. Pregnancy or breast feeding or planned pregnancy during the study period.
    1. Los sujetos que no son capaces de completar el estudio.
    2. Cualquier enfermedad importante o antecedentes de una enfermedad importante, especialmente enfermedad hepatobilliar (AST / ALT ≥ 5 x LSN) o insuficiencia renal avanzada (creatinina ≥ 2 x LSN).
    3. Historia actual o anterior de abuso de alcohol o la epilepsia.
    4. Alergia a Florbetaben o cualquiera de sus componentes.
    5. Alergia a múltiples medicamentos y / o antecedentes de alergia al contraste.
    6. Cualquier enfermedad o historia de enfermedad que, en opinión del investigador, puede causar trastornos de la función cerebral (por ejemplo, el déficit de vitamina B12 o ácido fólico, función tiroidea alterada).
    7. Evidencia de cualquier otra enfermedad neurológica o psiquiátrica, por ejemplo: parkinsonismo, antecedentes de accidente cerebrovascular o convulsión.
    8. Embarazo o lactancia o embarazo planificado durante el período de estudio.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals with SCD.
    2. Proportion of SCD subjects that present positive uptake after FBB-PET through visual examination.
    1. Incidencia de eventos adversos tras una dosis única de FBB en la realización del PET scan en sujetos con deterioro cognitivo subjetivo (DCS).
    2. Proporción de sujetos con DCS que presentan un FBB-PET positiva tras la valoración visual.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. SUSARs, SAEs, death.
    2. Proportion of FBB-PET with positive result through visual examination.
    1. SUSARs, SAEs, muerte.
    2. Porporción de FBB-PET con resultado positivo tras la valoración visual.
    E.5.2Secondary end point(s)
    1. Proportion of SCD subjects presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.
    2. The cortical pattern of amyloid deposition in SCD subjects at visual and semi-quantitative examination.
    1. Porporción de sujetos con DCS que presentan un SUVRs en el FBB-PET superior a 1,4.
    2. El patrón cortical de depósito de amiloide en sujetos con DCS en la valoración visual y semi-cuantitativa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Proportion of SCD subjects presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.
    2. The cortical pattern of amyloid deposition in SCD subjects at visual and semi-quantitative examination.
    1. Porporción de sujetos con DCS que presentan un SUVRs en el FBB-PET superior a 1,4.
    2. El patrón cortical de depósito de amiloide en sujetos con DCS en la valoración visual y semi-cuantitativa.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.2.3.1Comparator description
    No comparador
    No comparator
    E.8.2.4Number of treatment arms in the trial1
    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 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 years0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 state30
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-02-28
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