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    Summary
    EudraCT Number:2010-021926-37
    Sponsor's Protocol Code Number:ABE4869g
    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 number2010-021926-37
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER, PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MABT5102A 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 LA EFICACIA Y LA SEGURIDAD DE MABT5102A 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 numberABE4869g
    A.5.4Other Identifiers
    Name:AbbyNumber:ABE4869g
    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 number+3531 8217596
    B.5.5Fax number+3531 8099511
    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.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 evaluate the efficacy of MABT5102A compared with placebo, when administered over 68 weeks to patients with mild to moderate AD, in inhibiting disease progression using the Alzheimer?s Disease Assessment Scale Cognitive Subscale (ADAS-Cog [12-item])
    ?To evaluate the safety and tolerability of MABT5102A compared with placebo when administered over 68 weeks to patients with mild to moderate AD
    -Evaluar la eficacia de MABT5102A en comparación con placebo cuando se administra durante 68
    semanas a pacientes con EA leve o moderada, en la inhibición de la progresión de la enfermedad
    usando la Subescala cognitiva de la Escala de evaluación de la enfermedad de Alzheimer (ADASCog
    [12 ítems]) -Evaluar la seguridad y tolerabilidad de MABT5102A en comparación con placebo cuando
    se administra durante 68 semanas a pacientes con EA leve o moderada.
    E.2.2Secondary objectives of the trial
    ?To evaluate the efficacy of MABT5102A compared with placebo, when administered over 68 weeks to patients with mild to moderate AD, in inhibiting disease progression using a global assessment measure, the Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score
    Evaluar la eficacia de MABT5102A en comparación con el placebo, cuando se administra durante 68 semanas a pacientes con EA leve o moderada, en la inhibición de la progresión de la enfermedad usando una medida de evaluación global, la puntuación de la suma de las casillas de la Clasificación clínica de demencia (CDRSOB)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    SUBSTUDY IN ASSOCIATION WITH MABT5102A STUDY ABE4869g
    Dated 10 Dec 2010
    The objectives of this research substudy are to characterize the effects of MABT5102A on multiple putative neurodegenerative and pharmacodynamic measures in the CSF of AD patients and to determine whether posttreatment changes are associated with or predict clinical response to MABT5102A.

    DNA REPOSITORY SUBSTUDY IN ASSOCIATION WITH MABT5102A STUDY ABE4869g
    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 EN ASOCIACIÓN CON EL ESTUDIO ABE4869g DE MABT5102AEfectos de
    MABT5102A sobre posibles determinaciones neurodegenerativas y farmacodinámicas en el LCR de
    pacientes con EA y determinar si los cambios postratamiento están asociados a MAB5102A o
    predicen respuesta clínica al mismo.SUBESTUDIO DE BANCO DE ADN EN ASOCIACIÓN CON
    EL ESTUDIO ABE4869g DE MABT5102ARealizar análisis exploratorios que identifiquen genes
    asociados a la respuesta al tratamiento,a la toxicidad o riesgo de enfermedad.
    E.3Principal inclusion criteria
    General
    ?Ability to provide written informed consent by the patient and a legally authorized health care representative for the patient
    ?Ability and willingness of patient and a legally authorized health care representative 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
    ?Negative urine test for drugs of abuse (including medical marijuana) at screening
    ?For female patients, a negative serum ??human chorionic gonadotropin (?-hCG) pregnancy test at screening
    ?Normal thyroid-stimulating hormone (TSH) and vitamin B12 levels 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 who can provide information on activities of daily living and behavior to complete the related assessments
    This person must live with the patient at least 4 days per week and be familiar with the overall function and behavior of the patient.
    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)
    ?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 screening, at a stable dose for at least the last 2 months prior to screening
    ?For patients currently receiving other prescription medications: Treatment at a stable dose for ? 1 month prior to screening
    Generales Capacidad para prestar el consentimiento informado por escrito y un cuidador legalmente
    autorizado para el paciente Capacidad y voluntad del paciente y de un cuidador legalmente autorizado
    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. -Prueba de orina negativa para las
    drogas de abuso (incluyendo la marihuana medicinal) en selección 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 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 que pueda facilitar información sobre
    las actividades cotidianas y el comportamiento para completar las evaluaciones relacionadas Esta
    persona debe vivir con el paciente al menos 4 días por semana y estar familiarizado con la función
    global y comportamiento del paciente. 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 GDS-15 6. Puntuación en el
    recuerdo diferido de palabras de ADAS-Cog 5 (es decir, 5 errores). 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
    actualmente reciban otros medicamentos de prescripción:tratamiento con una dosis fija durante 1 mes
    antes de la asignación aleatoria. 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.
    E.4Principal exclusion criteria
    General
    ?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 investigator's or Sponsor's opinion, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care
    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)
    ?Presence of more than two micro- or macrohemorrhages as assessed by T2* weighted GRE MRI
    ?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 potential metabolic cause of dementia or encephalopathy (e.g., vitamin B12 deficiency, thyroid abnormalities)
    ?History or presence of infections that affect the brain (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)
    ?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
    ?Presence of visual hallucinations, parkinsonism, chorea, eye movement abnormalities, dystonia, or gait disturbance suggestive of a non-AD diagnosis
    ?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
    ?Known or suspected history of alcohol or drug abuse within the previous 5 years (DSM-IV criteria) Medical marijuana is allowed if stopped 3 months prior to screening.
    ?Evidence of malignancies, acute infections, renal failure that requires dialysis, or other unstable medical disease
    ?Hospitalization within 4 weeks prior to screening
    ?History of atrial fibrillation
    ?Thyroid disease unless euthyroid on treatment
    ?Clinically significant laboratory or ECG abnormalities in the investigator?s judgement
    ?Prolonged QTc interval (> 450 msec in males, > 470 msec in females)
    ?Impaired renal function (creatinine > 2 times the upper limit of normal [ULN])
    ?Impaired hepatic function (as indicated by transaminases > 1.2 x ULN or abnormalities in synthetic function tests judged by the investigator to be clinically significant)
    ?Impaired coagulation (PT or PTT > 1.5 x ULN)
    ?Platelet count < 100,000/uL
    ?Evidence of poorly controlled diabetes (glycosylated hemoglobin [HbA1c] >8.0%)
    ?Presence of significant cerebral vascular pathology as assessed by MRI imaging
    Related to Medication
    ?Previous treatment with MABT5102A or any other therapeutic that targets Abeta
    ?Treatment with any investigational agent within 4.5 half-lives or 4 weeks prior to screening, whichever is longer
    ?Chemotherapy-induced cognitive dysfunction
    ?Chronic treatment with systemic steroids
    ?Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, with the exception of routinely recommended vaccinations, which are allowed

    See Protocol for full list
    Generales -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 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 al cerebral (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). 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. Nefropatía crónica en estadio 4. Indicios de neoplasia
    maligna, infecciones agudas, insuficiencia renal que requiera diálisis u otra enfermedad inestable
    Hospitalización en las 4 semanas previas a la selección. Histirial de fibrilación auricular La enfermedad de tiroides a menos que en tratamiento Anomalías analíticas o en el ECG clínicamente significativas (p.
    ej., prolongación o acortamiento anómalo del intervalo QTc) a juicio del investigador. -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. 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 ³ 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/&#956;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 indicios de una macrohemorragia cerebral previa según la evaluación mediante RM con GRE
    ponderada en T2*. Presencia de patología cerebrovascular significativa evaluada mediante RM.
    Relacionados con la medicación Tratamiento previo con MABT5102A o cualquier otro agente
    terapéutico dirigido a Abeta. Tratamiento con cualquier fármaco en investigación en las 5 semividas o
    las 4 semanas previas a la selección, lo que sea más largo. Disfunción cognitiva que pueda ser debida a
    la medicación actual o pasada (p. ej., quimioterapia o esteroides). Cualquier tratamiento biológico en las
    5 semividas o los 3 meses previos a la selección, lo que sea más largo, a excepción de las vacunas
    periódicas recomendadas, que están permitidas. VER PROTOCOLO PARA LISTA COMPLETA
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome measure is change in ADAS-Cog (12-item) score between baseline and Week 73. This will be used to estimate the difference in mean change from baseline in ADAS-Cog (12-item) score at Week 73 between MABT5102A- and placebo-treated patients. Analysis of covariance (ANCOVA) adjusting for ApoE4 status and MMSE score will be used to estimate the primary endpoint.
    El principal criterio de valoración de la eficacia es el cambio en la puntuación ADAS-Cog (12 ítems)
    desde el inicio del estudio hasta la semana 73.Esto se utilizará para estimar la diferencia media en el
    cambio desde el inicio en la puntiación ADAS-Cog (12 ítems) hasta la Semana 73 entre los pacientes
    tratados con MABT5102A y los tratados con placebo. Un análisis de covarianza (ANCOVA) para
    ajustar el estado ApoE4 y la puntuación MMSE se utilizarán para estimar la variable principal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    73 weeks
    73 semanas
    E.5.2Secondary end point(s)
    Change in ADCS-ADL score from baseline to Week 73
    Cambio en la puntuación ADCS-ADL 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Canada
    France
    Germany
    Spain
    United Kingdom
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state80
    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 Opinion2011-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-18
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