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    Summary
    EudraCT Number:2010-022598-32
    Sponsor's Protocol Code Number:ABE4955g
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-18
    Trial results View 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 number2010-022598-32
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND,
    PLACEBO-CONTROLLED, PARALLEL-GROUP,
    MULTICENTER, PHASE II STUDY TO EVALUATE
    THE IMPACT OF MABT5102A ON BRAIN
    AMYLOID LOAD AND RELATED BIOMARKERS
    IN PATIENTS WITH MILD TO MODERATE
    ALZHEIMER?S DISEASE
    ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE GRUPOS PARALELOS Y MULTICÉNTRICO EN
    FASE II PARA EVALUAR LOS EFECTOS DE MABT5102A SOBRE LA CARGA AMILOIDE CEREBRAL Y OTROS BIOMARCADORES RELACIONADOS EN PACIENTES CON ENFERMEDAD DE ALZHEIMER LEVE O MODERADA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial of MABT5102A for the treatment of Alzheimer's Disease
    Un ensayo clínico de MABT5102A para el tratamiento de la Enfermedad de Alzheimer
    A.4.1Sponsor's protocol code numberABE4955g
    A.5.4Other Identifiers
    Name:BlazeNumber:ABE4955g
    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 SponsorGenentech Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGenentech Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles
    B.5.2Functional name of contact pointDermot Curtin
    B.5.3 Address:
    B.5.3.1Street AddressEastpoint Business Park
    B.5.3.2Town/ cityDublin
    B.5.3.3Post code3
    B.5.3.4CountryIreland
    B.5.4Telephone number35318217596
    B.5.5Fax number35318099511
    B.5.6E-maildermot.curtin@quintiles.com
    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 nameMABT5102A
    D.3.2Product code MABT5102A
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.1CAS number 1095207-05-8
    D.3.9.2Current sponsor codeMABT5102A
    D.3.9.3Other descriptive nameMABT5102A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 No
    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 Yes
    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 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 nameMABT5102A
    D.3.2Product code MABT5102A
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot applicable
    D.3.9.1CAS number 1095207-05-8
    D.3.9.2Current sponsor codeMABT5102A
    D.3.9.3Other descriptive nameMABT5102A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 No
    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 Yes
    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: 3
    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 nameFlorbetapir
    D.3.2Product code AV-45
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFlorbetapir
    D.3.9.2Current sponsor codeAV-45
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number370
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous drip use (Noncurrent)
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's Disease
    Enfermdad de Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer' disease (AD) is a slowly developing neurologic disease of the brain. AD is the most common of all forms of dementia.
    La enfermedad de Alzheimer (EA) es una enfermedad de desarrollo neurológico lento del cerebro. EA es la más común de todas las formas de demencia
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess amyloid burden via 18F-florbetapir (18F-AV-45) positron emission tomography
    (florbetapir-PET) in patients with mild to moderate AD and to evaluate whether treatment with MABT5102A (a monoclonal antibody to ?-amyloid [Abeta]) over 68 weeks results in a change in amyloid burden after dosing
    Evaluar la carga amiloide mediante tomografía por emisión de positrones con 18F-florbetapir
    (18F-AV-45) (TEP-florbetapir) en pacientes con EA leve o moderada y determinar si el tratamiento
    con MABT5102A (un anticuerpo monoclonal frente al -amiloide [Abeta]) durante 68 semanas
    modifica la carga amiloide después de la administración.
    E.2.2Secondary objectives of the trial
    ? To evaluate other potential biomarkers (e.g., CSF Abeta, CSF total tau, CSF phospho-tau-181) of safety, efficacy, and risk of disease progression in response to MABT5102A treatment
    ? To assess brain metabolism via 18F-fluorodeoxyglucose (FDG)?PET in patients with mild to moderate AD and to evaluate whether treatment with MABT5102A over 68 weeks results in a change in FDG-PET uptake compared with placebo
    ? See protocol for more
    Evaluar otros posible biomarcadores (p. ej., Abeta en LCR, tau total en LCR, fosfo tau-181 en LCR)
    de seguridad, eficacia y riesgo de progresión de la enfermedad en respuesta al tratamiento con
    MABT5102A.
    Evaluar el metabolismo cerebral por medio de TEP con 18F fluorodesoxiglucosa
    (FDG) en pacientes con EA leve o moderada y determinar si el tratamiento con MABT5102A durante
    68 semanas modifica la captación en TEP-FDG en comparación con el placebo.
    VER MÁS EN EL PROTOCOLO
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    DNA REPOSITORY SUBSTUDY IN ASSOCIATION WITH MABT5102A STUDY ABE4955g
    Dated 10 Dec 2010
    The primary objective of this study is to perform exploratory analyses to generate hypotheses identifying genes associated with treatment response, toxicity, or disease risk. If such genetic hypotheses are identified, they may be tested in future clinical studies within this therapeutic area.
    SUBESTUDIO DE BANCO DE ADN EN ASOCIACIÓN CON EL ESTUDIO ABE4955g DE MABT5102A
    Fecha 10 Dic 2010
    El objetivo principal de este estudio es realizar análisis exploratorios para generar
    hipótesis que identifiquen genes asociados a la respuesta al tratamiento, a la toxicidad o al riesgo de
    enfermedad. En caso de identificar dichas hipótesis genéticas, éstas podrán analizarse en futuros
    estudios clínicos dentro de este área terapéutica.
    E.3Principal inclusion criteria
    General
    ? Ability to provide written informed consent by the patient
    ? Ability and willingness of patient to comply with the protocol?s requirements
    ? Age 50?80 years
    ? Body weight ? 45 kg and ? 120 kg
    ? Adequate visual and auditory acuity in the investigator's judgment to allow for
    neuropsychological testing
    ? Fluent in the language of the test assessments
    ? For female patients, a negative serum ??human chorionic gonadotropin
    (?-hCG) pregnancy test at screening
    ? Normal thyroid-stimulating hormone (TSH) level and vitamin B12 level
    of ? 200 pg/mL at screening
    ? For male patients with partners with reproductive potential, agreement to use
    a reliable means of contraception (e.g., condoms) during the study
    ? Availability of a person ("caregiver") who can provide information on activities of
    daily living and behavior in order to complete the study-specific assessments
    This caregiver must have sufficient cognitive capacity, in the judgment of
    the investigator, to accurately report upon the patient's function and
    behavior. In addition, the caregiver must spend sufficient time with the
    patient to be familiar with the overall function and behavior of the patient.
    As guidance, a caregiver would ordinarily need to spend an average of at
    least 8 hours per week with the patient in order for the caregiver to meet
    the requirements for this study.
    Related to Neurology/Cognition
    ? Diagnosis of probable AD according to the NINCDS-ADRDA criteria
    (McKhann et al. 1984)
    ? MMSE score of 18?26 points at screening (Folstein et al. 1975)
    ? ADAS-Cog Delayed Word Recall score of ? 5 (i.e., ? 5 errors)
    ? GDS-15 score of < 6
    ? CDR score of ? 0.5
    ? Completion of 6 years of education (or good work history consistent with
    exclusion of mental retardation or other pervasive developmental disorders)
    Related to Medication
    ? For patients currently receiving treatment with approved AD treatments
    (AChE inhibitors or memantine): Treatment initiated and continued for at
    least the last 3 months prior to randomization, at a stable dose for at least the
    last 2 months prior to randomization
    ? For patients currently receiving other prescription medications that might
    affect cognitive function (e.g., antidepressants, antipsychotics): Treatment at
    a stable dose for ? 1 month prior to randomization
    Related to Brain Amyloid Load
    ? Brain amyloid load in the range expected for AD patients as assessed by an
    expert, blinded visual reading of the screening florbetapir-PET scan
    Generales Capacidad para prestar el consentimiento informado por escrito. Capacidad y voluntad para
    cumplir con los requisitos del protocolo. Edad comprendida entre 50 y 80 años. Peso corporal 45 kg y
    120 kg. Agudeza visual y auditiva adecuada a criterio del investigador para poder realizar las pruebas
    neuropsicológicas. Fluidez en el idioma de las evaluaciones. En el caso de mujeres, prueba de embarazo
    de gonadotropina coriónica humana (-hCG) en suero negativa en la selección. Nivel normal de hormona
    estimulante de tiroides (TSH) y nivel de vitamina B12 200 pg/ml en la selección. En el caso de varones
    con pareja en edad fértil, aceptación del uso de métodos anticonceptivos fiables (p. ej., preservativos)
    durante el estudio. Disponibilidad de una persona («cuidador») que pueda facilitar información sobre las
    actividades cotidianas y el comportamiento con miras a la realización de las evaluaciones específicas
    del estudio. Este cuidador debe tener una capacidad cognitiva suficiente, a juicio del investigador, para
    informar de forma precisa sobre la función y el comportamiento del paciente. Además, debe pasar
    tiempo suficiente con el paciente para familiarizarse con su función global y comportamiento. Como
    orientación, sería necesario que pasara normalmente una media de al menos 8 horas a la semana con el
    paciente para cumplir los requisitos de este estudio. Relacionados con las funciones
    neurológicas/cognitivas Diagnóstico de EA probable según los criterios NINCDS-ADRDA (McKhann y
    cols. 1984) Puntuación MMSE de 1826 puntos en la selección (Folstein y cols. 1975) Puntuación en el
    recuerdo diferido de palabras de ADAS-Cog 5 (es decir, 5 errores). Puntuación GDS-15 6. Puntuación
    CDR 0,5. Tener 6 años de educación (o buenos antecedentes laborables indicativos de exclusión de
    retraso mental u otros trastornos generalizados del desarrollo). Relacionados con la medicación En el
    caso de pacientes que reciban tratamientos aprobados para la EA (inhibidores de ACE o memantina):
    tratamiento iniciado y mantenido durante al menos los 3 meses previos a la asignación aleatoria con una
    dosis fija durante al menos los 2 meses previos a la asignación aleatoria. En el caso de pacientes que
    actualmente reciban otros medicamentos de prescripción que puedan afectar a la función cognitiva (p.
    ej., antidepresivos o antipsicóticos): tratamiento con una dosis fija durante 1 mes antes de la asignación
    aleatoria. Relacionados con la carga amiloide cerebral Carga amiloide cerebral en el intervalo
    establecido para los pacientes con EA, evaluada según la interpretación visual realizada por un experto,
    en condiciones ciegas, de la exploración mediante TEP-florbetapir de la selección.
    E.4Principal exclusion criteria
    General
    ? Lack of peripheral venous access
    ? Inability to tolerate MRI or lumbar puncture procedures or contraindication to
    MRI, including but not limited to pacemakers; implantable cardioverter
    defibrillators; cochlear implants; cerebral aneurysm clips; implanted infusion
    pumps; implanted nerve stimulators; metallic splinters in the eye;
    other magnetic, electronic, or mechanical implants; or any other clinical
    history or examination finding that, in the judgment of the investigator,
    would pose a potential hazard in combination with MRI
    ? Female patient with reproductive potential
    Female patients must either have undergone documented surgical
    sterilization or have not experienced menstruation for at least
    12 consecutive months.
    ? Severe or unstable medical condition that, in the opinion of the investigator or
    Sponsor, would interfere with the patient's ability to complete the study
    assessments or would require the equivalent of institutional or hospital care
    Related to PET Imaging
    ? Inability to tolerate PET procedure
    ? Abnormal findings that, in the opinion of the investigator, may affect his or
    her response to the radiopharmaceutical and related testing procedures
    Related to Medical History/Conditions
    ? History or presence of clinically evident vascular disease potentially affecting
    the brain (e.g., stroke, clinically significant carotid or vertebral stenosis or
    plaque, aortic aneurysm, intracranial aneurysm, cerebral hemorrhage,
    arteriovenous malformation)
    ? History of severe, clinically significant (persistent neurologic deficit or structural
    brain damage) central nervous system trauma (e.g., cerebral contusion)
    ? History or presence of intracranial tumor (e.g., meningioma, glioma)
    ? Presence of infections that affect the brain function or history of infections
    that resulted in neurologic sequelae (e.g., syphilis, neuroborreliosis, viral or
    bacterial meningitis/encephalitis, HIV encephalopathy)
    ? History or presence of systemic autoimmune disorders potentially causing
    progressive neurologic disease (e.g., multiple sclerosis, lupus
    erythematosus, anti-phospholipid antibody syndrome, Behçet disease)
    ? History or presence of psychiatric disease other than AD that may affect
    cognition, including but not limited to clinically significant major psychiatric
    disorder according to the criteria of the Diagnostic and Statistical Manual of
    Mental Disorders IV (DSM-IV) (e.g. major depression, schizophrenia,
    bipolar disorder)
    A history of major depression is acceptable if no episode has been
    reported within the previous 5 years.
    ? History or presence of a neurologic disease other than AD that may affect
    cognition, including but not limited to Parkinson?s disease, corticobasal
    degeneration, dementia with Lewy bodies, Creutzfeldt?Jakob disease,
    progressive supranuclear palsy, frontotemporal degeneration, Huntington?s
    disease, normal pressure hydrocephalus, and hypoxia
    ? History of seizures with the exception of childhood febrile seizures
    ? History of severe allergic, anaphylactic, or other hypersensitivity reactions to
    chimeric, human, or humanized antibodies or fusion proteins
    ? Positive urine test for drugs of abuse at screening or known or suspected
    history of alcohol or drug abuse within the previous 5 years (DSM-IV criteria)
    Medical marijuana is not allowed and must be discontinued 3 months prior
    to randomization. The intermittent use of benzodiazepines is allowed,
    except within 2 days prior to any neurocognitive assessment.
    ? Evidence of malignancies, acute infections, renal failure that requires
    dialysis, or other unstable medical disease not related to AD that in the
    investigator?s opinion would preclude patient participation
    ? Hospitalization within 4 weeks prior to screening
    ? History or presence of atrial fibrillation that poses a risk for future stroke in
    the investigator?s judgment
    ? Clinically significant laboratory or ECG abnormalities (e.g., abnormally
    prolonged or shortened QTc interval) in the investigator?s judgment
    ? Chronic kidney disease of Stage ? 4
    ? Impaired hepatic function, as indicated by transaminases > 2 times the upper
    limit of normal (ULN) or abnormalities in synthetic function tests judged by
    the investigator to be clinically significant
    ? Impaired coagulation (aPTT > 1.2 × ULN)
    Generales Ausencia de acceso venoso periférico. Incapacidad para tolerar los procedimientos de RM o
    de punción lumbar, o contraindicación para la RM, incluidos, entre otros, marcapasos, desfibriladores
    cardioversores implantables, implantes cocleares, pinza para aneurisma cerebral, bombas de perfusión
    implantadas, neuroestimuladores implantados, esquirlas metálicas en el ojo, otros implantes magnéticos,
    electrónicos o mecánicos o cualquier antecedente clínico o signo de exploración que, a criterio del
    investigador, suponga un posible riesgo en combinación con la RM. Mujeres en edad fértil. Las mujeres
    deben haberse sometido a una esterilización quirúrgica documentada o no haber tenido la menstruación
    durante al menos 12 meses consecutivos. Enfermedad grave o inestable que, a criterio del investigador o
    el promotor, afecte a la capacidad del paciente para realizar las evaluaciones del estudio o requiera el
    equivalente a cuidados institucionales u hospitalarios Relacionados con la TEP Incapacidad para tolerar
    la TEP. Signos anómalos que, en opinión del investigador, puedan afectar a su respuesta a los
    procedimientos radiofarmacéuticos y a las pruebas relacionadas. Relacionados con los antecedentes
    patológicos/enfermedades Antecedentes o presencia de vasculopatía clínicamente manifiesta que pueda
    afectar al cerebro (p. ej., ictus, estenosis o placa carotídea o vertebral clínicamente significativa,
    aneurisma aórtico, aneurisma intracraneal, hemorragia cerebral o malformación arteriovenosa).
    Antecedentes de traumatismo grave del sistema nervioso central clínicamente significativo (deficiencia
    neurológica persistente o daño cerebral estructural) (p. ej., contusión cerebral). Antecedentes o
    presencia de tumor intracraneal (p. ej., meningioma, glioma). Presencia de infecciones que afecten a la
    función cerebral o antecedentes de infecciones que den lugar a secuelas neurológicas (p. ej., sífilis,
    neuroborreliosis, meningitis/encefalitis vírica o bacteriana o encefalopatía por VIH). Antecedentes o
    presencia de trastornos autoinmunes sistémicos que puedan causar enfermedad neurológica progresiva
    (p. ej., esclerosis múltiple, lupus eritematoso, síndrome de anticuerpos antifosfolípidos o enfermedad de
    Behçet). Antecedentes o presencia de enfermedad psiquiátrica distinta de EA que pueda afectar a la
    cognición, incluidos, entre otros, trastorno psiquiátrico importante clínicamente significativo según los
    criterios del Manual diagnóstico y estadístico de trastornos mentales IV (DSM-IV) (p. ej., depresión
    mayor, esquizofrenia o trastorno bipolar). Son aceptables los antecedentes de depresión mayor si no se
    han notificado episodios durante los 5 años previos. Antecedentes o presencia de enfermedad
    neurológica distinta de EA que pueda afectar a la cognición, incluidos entre otros, enfermedad de
    Parkinson, degeneración corticobasal, demencia con cuerpos de Lewy, enfermedad de
    Creutzfeldt-Jakob, parálisis supranuclear progresiva, degeneración frontotemporal, enfermedad de
    Huntington, hidrocefalia de presión normal e hipoxia. Antecedentes de convulsiones, excepto
    convulsiones febriles infantiles. Antecedentes de alergia, reacciones anafilácticas u otras reacciones de
    hipersensibilidad graves a anticuerpos quiméricos, humanos o humanizados o a proteínas de fusión.
    Resultado positivo de la prueba de drogas en orina en la selección o conocimiento o sospecha de
    antecedentes de alcoholismo o consumo de drogas durante los 5 años previos (criterios DSM-IV). No
    está permitido el consumo médico de marihuana y debe interrumpirse 3 meses antes de la asignación
    aleatoria. Se permite el uso intermitente de benzodiacepinas, excepto en los 2 días previos a cualquier
    evaluación neurocognitiva. Indicios de neoplasia maligna, infecciones agudas, insuficiencia renal que
    requiera diálisis u otra enfermedad inestable no relacionada con la EA que, en opinión del investigador,
    pudiera impedir la participación del paciente. Hospitalización en las 4 semanas previas a la selección.
    Antecedentes o presencia de fibrilación auricular que suponga un riesgo de un futuro ictus a juicio del
    investigador. Anomalías analíticas o en el ECG clínicamente significativas (p. ej., prolongación o
    acortamiento anómalo del intervalo QTc) a juicio del investigador. Nefropatía crónica en estadio 4.
    Insuficiencia hepática, indicada mediante niveles de transaminasas 2 veces el límite superior normal
    (LSN) o anomalías en las pruebas de función sintética clínicamente significativas a criterio del
    investigador. Trastornos de la coagulación (TTPa > 1,2 × LSN) Recuento plaquetario 100.000/l. Signos
    de diabetes mal controlada (hemoglobina glucosilada [HbA1c] 8,0%). Relacionados con la RM
    Presencia de siderosis superficial o más de cuatro microhemorragias cerebrales o signos de una
    macrohemorragia cerebral previa según la evaluación mediante RM con GRE ponderada en T2*. VER
    PROTOCOLO PARA LISTA COMPLETA
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome measure is the change in brain amyloid load from
    baseline to Week 69 as assessed by florbetapir-PET imaging.
    El criterio de valoración de la eficacia es el cambio en la carga amiloide cerebral
    desde el inicio del estudio hasta la semana 69, evaluado mediante TEPflorbetapir.
    E.5.1.1Timepoint(s) of evaluation of this end point
    69 weeks
    69 semanas
    E.5.2Secondary end point(s)
    The secondary efficacy outcome measures are as follows:
    ? Changes in CSF biomarkers relevant to AD from baseline to Week 69
    ? Change in brain metabolism from baseline to Week 69 as assessed by
    FDG-PET imaging
    ? Change in CDR-SOB score from baseline to Week 73
    ? Change in ADAS-Cog (12-item) score from baseline to Week 73
    Los criterios secundarios de valoración de la eficacia son los siguientes:
    ? Cambios en los biomarcadores del LCR relevantes para la EA desde el inicio del estudio hasta la semana 69.
    ? Cambio en el metabolismo cerebral desde el inicio del estudio hasta la
    semana 69, evaluado mediante TEP-FDG.
    ? Cambio en la puntuación CDR-SOB desde el inicio del estudio hasta la semana 73.
    ? Cambio en la puntuación ADAS-Cog (12 ítems) desde el inicio del estudio hasta la semana 73.
    E.5.2.1Timepoint(s) of evaluation of this end point
    73 weeks
    73 semanas
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    France
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    As per protocol
    Según protocolo
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-11-18. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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
    Alzheimers Patients
    Pacientes de Alzheimer
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state68
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 142
    F.4.2.2In the whole clinical trial 360
    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)
    In protocol
    En el protocolo
    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 Decision2011-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-17
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