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    Summary
    EudraCT Number:2014-000763-41
    Sponsor's Protocol Code Number:FBB-FAD-2014
    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:2014-07-22
    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 number2014-000763-41
    A.3Full title of the trial
    Study of genetic Alzheimer?s disease mutation carriers in preclinical stages of the disease: 18F-Florbetaben Positron Emission Tomography study.
    Estudio de sujetos con riesgo de enfermedad de Alzheimer genético en estadios preclínicos: estudio con tomografía por emisión de positrones con 18F-Florbetaben
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the uptake pattern of 18F-Florbetaben in Positron Emission Tomography in healthy volunteers carrying genetic mutations in Alzheimer´s disease-related genes.
    Estudio del patrón de captación de 18F-Florbetaben con Tomografía de Emisión de Positrones en voluntarios sanos con riesgo de enfermedad de Alzheimer.
    A.4.1Sponsor's protocol code numberFBB-FAD-2014
    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 SponsorFUNDACIÓ CLÍNIC PER A LA RECERCA BIOMÈDICA
    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 SA
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACIÓ CLÍNIC PER A LA RECERCA BIOMÈDICA
    B.5.2Functional name of contact pointRaquel Sánchez-Valle
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel, 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number93342275785
    B.5.5Fax number93342278783
    B.5.6E-mailrsanchez@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
    D.2.1.1.2Name of the Marketing Authorisation holderPiramal Imaging GmbH
    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
    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.3.9.4EV Substance CodeSUB119774
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(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
    Healthy voulnteers carrying a mutation in at least one of the following genes: PSEN1, PSEN2 or APP.
    Voluntarios sanos portadores de mutación en al menos uno de los siguientes genes: PSEN1, PSEN2 o APP.
    Voluntarios sanos no portadores de mutación.
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers with familial Alzheimer disease.
    Voluntarios sanos con enermedad de Alzheimer familiar genético
    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 17.0
    E.1.2Level HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    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
    1. To assess safety of a single dose of FBB followed by PET scan
    in individuals at risk of genetic Alzheimer?s disease.
    2. To determine the number of Familiar Alzheimer´s disease
    (FAD) mutation carriers with positive FBB-PET at visual
    assessment.
    1.-Evaluar el perfil de seguridad de FBB-PET en individuos con riesgo genético de enfermedad de Alzheimer.

    2.-Determinar el número de portadores de mutaciones asociadas a enfermedad de Alzheimer familiar (FAD) que presentan captación positiva en el análisis visual y semicuantitativo de FBB-PET
    E.2.2Secondary objectives of the trial
    1. To determine the number of FAD mutation carriers with
    abnormally high standardized uptake value ratios (SUVRs) of
    FBB-PET scan.
    2. To compare global SUVR scores of FBB-PET scan between
    mutation carriers and non-carriers.
    3. To study the earliest age of FAD mutations carriers with
    positive FBB-PET scan at visual assessment.
    4.-To explore the cortical pattern of amyloid deposition in FAD
    mutations carriers
    1.- Determinar el número de portadores de mutaciones asociadas a Alzheimer familiar (FAD) que presentan valores estandarizados de captación anormalmente altos en el FBB-PET.

    2.- Comparar los valores estandarizados de captación globales del FBB-PET entre los portadores y no portadores de mutación.

    3.- Describir la edad más temprana en la que los portadores de mutación FAD presentan captación positiva en el FBB-PET en el análisis visual.

    4.- Explorar el patrón cortical de deposición amiloide en individuos portadores de mutaciones FAD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult children (> 18 yo) of genetic Alzheimer?s disease
    patients with a known mutation in PSEN1, APP o PSEN2
    genes and who are either cognitively normal (CDR=0) or
    have mild symptoms of cognitive decline (CDR 0.5 or 1)
    2. According to the principal investigator, participants must
    be committed to participate and complete all study
    procedures.
    3. Has signed the Informed Consent Form voluntarily to
    participate in the study
    1. Hijos adultos (> 18 años) de pacientes con enfermedad de Alzheimer genético con una mutación conocida en los genes PSEN1, PSEN2 o APP, cognitivamente normales (CDR=0) o con signos leves de deterioro cognitivo (CDR 0.5 o 1).
    2. A criterio del investigador principal, los participantes deben comprometerse a cumplir todos los procedimientos del estudio.
    3. Firma voluntaria de consentimiento informado.
    E.4Principal exclusion criteria
    1. Subjects that 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. Pregnancy or breast feeding or planned pregnancy during
    the study period
    7. 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)
    8. Evidence for any other neurological or psychiatric disease
    1. Sujetos que no puedan completar el estudio
    2. Cualquier enfermedad grave previa o actual especialmente, enfermedad hepatobiliar (GOT/GPT ? 5 LSN) o insuficiencia renal avanzada (creatinina ? 2 LSN)
    3. Historia de consumo abusivo de alcohol previo o actual o epilepsia
    4. Alergia a florbetaben o alguno de sus componentes.
    5. Múltiples alergias a fármacos o antecedentes previos de alergia a contraste
    6. Mujeres embarazadas o en periodo de lactancia o que hayan planeado quedarse embarazadas durante el periodo del estudio.
    7. Cualquier enfermedad o antecedente previo que en opinión del investigador pueda alterar la función cerebral (deficiencia de vitamina B-12 o ácido fólico, alteración de la función tiroidea)
    8. Evidencia de cualquier otra enfermedad neurológica o psiquiátrica.
    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 at risk of genetic Alzheimer?s disease.
    2. Proportion of FAD mutation carriers that present positive
    uptake after FBB-PET through visual examination
    1.- Incidencia de acontecimientos adversos tras la administración de una única dosis de FBB durante el PET en individuos con riesgo de enfermedad de Alzheimer genético.
    2.- Proporción de portadores de mutación FAD que presentan captación positiva de FBB en el PET medida por exámen visual.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline, when FBB-PET is performed.
    En el momento basal, cuando se realiza el FBB-PET.
    E.5.2Secondary end point(s)
    1. Proportion of FAD mutation carriers presenting standardized
    uptake value ratios (SUVRs) of FBB-PET higher than 1,4.
    2. Areas of significant difference (p<0,05) in regional SUVR
    between FAD mutation carriers and non-carriers.
    3. Earliest age of positive FBB-PET in FAD mutation carriers.
    4. Individual cortical areas with positive amyloid deposition at
    visual or semi-quantitative assessment
    1.- Proporción de portadores de mutación FAD que presentan valores estandarizados de captación (SUV) en el FBB-PET superiores a 1.4.

    2.- Áreas con un valor estandarizado de captación regional significativamente diferente (p<0,05) en los portadores y no portadores de mutación.

    3.- Edad más temprana en la que los portadores de mutación FAD presentan captación positiva en el FBB-PET.

    4.- Áreas individuales corticales con deposición positiva de amiloide en el examen visual o semi-cauntitativo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at baseline
    en el momento basal
    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 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 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) Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    controlado con no portadores
    controlled with non-carriers
    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 portadores
    non-carriers
    E.8.2.4Number of treatment arms in the trial2
    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 end of the trial will be defined by the last visit of the last patient.
    El final del estudio se corresponderá con la última visita del último paciente.
    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 months
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) No
    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 state40
    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 Decision2014-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-01-15
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