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    Summary
    EudraCT Number:2015-000966-72
    Sponsor's Protocol Code Number:221AD301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2015-07-10
    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 number2015-000966-72
    A.3Full title of the trial
    A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects with Early Alzheimer's Disease
    Estudio de fase 3, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y la seguridad de aducanumab (BIIB037) en pacientes con enfermedad de Alzheimer temprana
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    221AD301 Phase 3 Study of Aducanumab in Early Alzheimer's Disease
    Estudio fase 3 de Aducanumab en pacientes con enfermedad de Alzheimer temprana
    A.4.1Sponsor's protocol code number221AD301
    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 SponsorBiogen Idec Research Limited
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointN/A
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number900838917
    B.5.6E-mailclinicaltrials@biogen.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 nameAducanumab
    D.3.2Product code BIIB037
    D.3.4Pharmaceutical form Concentrate for solution for 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 INNAducanumab
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeBIIB037
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.13.1Other medicinal product typerecombinant monoclonal antibody
    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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Early Alzheimer's Disease
    Enfermedad de Alzheimer Temprana
    E.1.1.1Medical condition in easily understood language
    Early Alzheimer's Disease
    Enfermedad de Alzheimer Temprana
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    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
    Placebo-controlled period:
    To evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the CDR-SB score as compared with placebo in subjects with early AD.

    Long-term Extension:
    To evaluate the long-term safety and tolerability profile of aducanumab in subjects with early AD.
    ?
    To evaluate the long-term efficacy of aducanumab treatment as measured by clinical, radiological, and additional assessments reported by the subject and informant/care partner.
    El objetivo principal de este estudio consiste en evaluar la eficacia de
    dosis mensuales de aducanumab en la ralentización del deterioro
    cognitivo y funcional, a través de las mediciones de los cambios en la
    puntuación de la CDR-SB en comparación con placebo en sujetos con EA
    temprana.
    Extensión a largo plazo:
    Evaluar el perfil de seguridad y la tolerabilidad a largo plazo de
    aducanumab en sujetos con EA temprana.
    ? Evaluar la eficacia a largo plazo del tratamiento con aducanumab, a
    través de los análisis clínicos y radiológicos, y las evaluaciones
    complementarias que comunique el sujeto o la persona
    informante/cuidadora.
    E.2.2Secondary objectives of the trial
    To assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by the MMSE.

    To assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by ADAS-Cog 13.

    To assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by ADCS-ADL-MCI.
    Analizar el efecto sobre la progresión clínica de dosis mensuales de aducanumab en comparación con placebo, según lo determinado por el MMSE.
    Analizar el efecto sobre la progresión clínica de dosis mensuales de aducanumab en comparación con placebo, según lo determinado por el ADAS-Cog 13.
    Analizar el efecto sobre la progresión clínica de dosis mensuales de aducanumab en comparación con placebo, según lo determinado por el ADCS-ADL-MCI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    - Must meet all of the following clinical criteria for MCI due to AD or mild
    AD and must have:
    - A Clinical Dementia Rating (CDR)-Global Score of 0.5.
    - A Repeatable Battery for Assessment of Neuropsychological Status (RBANS) score of 85 or lower indicative of objective cognitive impairment
    - An MMSE score between 24 and 30 (inclusive)
    - Must have a positive amyloid Positron Emission Tomography (PET)
    scan
    - Must consent to apolipoprotein E (ApoE) genotyping
    - Must have stable symptomatic AD medications
    - Must have a reliable informant or caregiver

    LTE specific Criteria at week 78:
    - Must have completed the placebo-controlled period of the study.
    - MMSE score > 15 at the Week 78 Visit.
    - Must (or the subject?s legally authorized representative) understand the purpose and risks of the study and provide signed consent (or assent)
    - Apart from a clinical diagnosis of AD, subject must be in good health as determined by the Investigator, based on medical history.
    - Must have the ability to comply with procedures for protocol-related tests.
    - Must have reliable informant or caregiver

    NOTE: Other protocol defined Inclusion criteria may apply
    Criterios de inclusion:
    -Debe cumplir todos los criterios clínicos siguientes de MCI debido a EA o
    EA leve y debe presentar:
    - Una puntuación CDR-Global de 0,5.
    - Una puntuación RBANS de 85 o inferior, indicativa de deterioro cognitivo objetivo.
    - Una puntuación MMSE entre 24 y 30 (ambas inclusive).
    -Debe presentar un estudio de la carga amiloide por PET con resultado positivo
    -Debe dar su consentimiento para la genotipificación de la
    apolipoproteína E (ApoE).
    -Debe tener medicamentos sintomáticos estables para la EA
    -Debe contar con un informante/cuidador

    Para ser idóneos para participar en la ELP, los sujetos deben cumplir los
    siguientes criterios de idoneidad en la semana 78:
    -El sujeto debe haber terminado el período controlado con placebo del estudio
    - Puntuación MMSE >15 en la visita de la semana 78.
    -El sujeto (o el representante legal autorizado del sujeto) tiene la capacidad de comprender el objetivo y los riesgos del estudio y de dar el consentimiento (o asentimiento) informado firmado y fechado
    -Aparte del diagnóstico clínico de EA, el sujeto debe tener buena salud según lo determinado por el investigador a partir de los antecedentes médicos.
    - Debe tener la capacidad para cumplir con los procedimientos de las pruebas relacionadas con el protocolo.
    - Debe contar con un informante/cuidador que a juicio del
    investigador tenga un contacto frecuente y suficiente con el sujeto, de manera que pueda proporcionar información exacta sobre la capacidadcognitiva y funcional del sujeto

    NOTA: Se pueden aplicar otros criterios de inclusión del protocolo
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    - Any medical or neurological condition (other than Alzheimer's Disease)
    that might be a contributing cause of the subject's cognitive impairment
    - Have had a stroke or Transient Ischemic Attack (TIA) or unexplained
    loss of consciousness in the past 1 year
    - Clinically significant psychiatric illness in past 6 months
    - History of unstable angina, myocardial infarction, chronic heart failure,
    or clinical significant conduction abnormalities within 1 year prior to Screening
    - Indication of impaired renal or liver function
    - Have human immunodeficiency virus (HIV) infection
    - Have a significant systematic illness or infection in past 30 days
    - Relevant brain haemorrhage, bleeding disorder and cardiovascular abnormalities
    - Any contraindications to brain magnetic resonance imaging (MRI) or PET scans
    - Alcohol or substance abuse in past 1 year
    - Taking blood thinners (except for aspirin at a prophylactic dose or less)
    - Use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening Visit 1

    Subjects will be excluded from entering the LTE if at Week 78 they have:
    - any medical or psychiatric contraindication or clinically significant abnormality that, in the opinion of the Investigator, will substantially increase the risk associated with the subject's participation in the study.

    NOTE: Other protocol defined Exclusion criteria may apply
    Criterios de exclusión:
    - Cualquier trastorno médico no controlado o
    neurológico/neurodegenerativo (distinto de la EA), que en opinión del investigador pudiera ser una causa que contribuye al deterioro cognitivo del sujeto
    - Accidente isquémico transitorio, ictus o desmayo no filiado en el año anterior a la selección
    - Enfermedad psiquiátrica clínicamente significativa (p. ej., depresión mayor no controlada, esquizofrenia o trastorno afectivo bipolar) en los 6 meses anteriores a la selección.
    - Antecedentes de angina inestable, infarto de miocardio, insuficiencia cardíaca crónica o anomalías de la conducción clínicamente significativas en el año anterior a la selección.
    - Indicios de daño renal o de función hepática
    - Resultados positivos en la prueba del virus de la inmunodeficiencia humana
    - Enfermedad sistémica clínicamente significativa o infección grave en los 30 días anteriores a la selección o durante esta.
    - Hemorragia cerebral aguda, trastornos de sangrado y anormalidades cardiovasculares
    - Cualquier contraindicación para realizar Resonancia Magnética (RM) o PET (Tomografía por emisión de positrones )
    - Abuso de sustancias alcoholicas en el último año
    - Consumo de medicamentos con propiedades antiagregantes
    plaquetarias o anticoagulantes (se permite el uso de aspirina con dosis profiláctica )
    - Consumo de medicamentos) con dosis inestables durante 8 semanas como mínimo antes de la visita 1 de selección.
    Los sujetos quedarán excluidos de la entrada en la ELP si en la semana 78 presentan cualquier contraindicación médica o psiquiátrica, o anomalía clínicamente significativa, que a criterio del investigador incremente el riesgo relacionado con la participación y la finalización del estudio por parte del sujeto.
    NOTA: Se pueden aplicar otros criterios de inclusión del protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    Change from baseline in CDR-SB score at Week 78.

    LTE period endpoints:
    The incidence of AEs and/SAEs; brain MRI findings (including the incidence of ARIA-E and ARIA-H); and the incidence of anti-aducanumab antibodies in serum over the placebo-controlled and LTE periods of the study.
    Change in the following measures over the placebo-controlled and LTE periods of the study:
    CDR-SB score.
    MMSE score.
    ADAS-Cog 13 score.
    ADCS-ADL-MCI score.
    Amyloid PET signal (in a subset of subjects).
    Whole brain volume, hippocampal volume, ventricular volume, and cortical gray matter volume measured by MRI.
    Functional connectivity as measured by tf-fMRI (where available).
    Cerebral blood flow as measured by ASL-MRI (where available).
    Disease-related biomarker levels in CSF which will include, but are not limited to, amyloid and tau proteins (in a subset of subjects).
    Disease-related biomarker levels in blood which may include, but are not limited to, amyloid and tau proteins.
    NPI-10 total score.
    Informant-rated EQ-5D index score.
    Informant/care partner?s own self-reported EQ-5D index score.
    Caregiver burden measures.
    Objetivo principal:
    Variación de la puntuación en CDR-SB en la semana 78.

    Objetivo ELP:
    Incidencias de los AA y los AAG, observaciones de las RM cerebrales (incluida la incidencia de ARIA-E y ARIA-H) e incidencia de anticuerpos antiaducanumab en suero durante el período controlado con placebo y el período de ELP del estudio.
    ? Variaciones en los parámetros siguientes durante el período
    controlado con placebo y el período de ELP del estudio:
    ? Puntuación de la CDR-SB.
    ? Puntuación del MMSE.
    ? Puntuación de la ADAS-Cog 13.
    ? Puntuación del ADCS-ADL-MCI.
    ? Señal de carga amiloide mediante PET (en un subgrupo de sujetos).
    ? Volumen cerebral total, volumen del hipocampo, volumen ventricular y volumen de sustancia gris cortical según lo determinado en las RM.
    ? Conectividad funcional según lo determinado en las RMf-ER (dondeestén disponibles).
    ? Flujo sanguíneo cerebral según lo determinado en las ASL-MRI (dondeestén disponibles).
    ? Nivel de biomarcadores relacionados con la enfermedad presentes en el LCR, que incluirán, entre otros, las proteínas amiloide y ? (en un subgrupo de sujetos).
    ? Nivel de biomarcadores relacionados con la enfermedad presentes en la sangre, que podrán incluir, entre otros, las proteínas amiloide y ?.
    ? Puntuación total del NPI-10.
    ? Puntuación del índice EQ-5D evaluado por el informante.
    ? Puntuación del índice EQ-5D autoevaluado del informante/cuidador.
    ? Mediciones de la carga del cuidador.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint:
    Week 78

    LTE endpoints:
    On-going over the course of the study
    Objetivo principal:
    Semana 78

    Objetivo ELP:
    La marcha en el transcurso del estudio
    E.5.2Secondary end point(s)
    Change from baseline in MMSE score at Week 78.
    Change from baseline in ADAS-Cog 13 score at Week 78.
    Change from baseline in ADCS-ADL-MCI score at Week 78.
    Variación en la puntuación inicial del MME en la semana 78
    Variación en la puntuación inicial del ADAS-Cog 13 en la semana 78
    Variación en la puntuación inicial del ADCS-ADL-MCI en la semana 78
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 78
    Semana 78
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    evaluation of biomarkers for AD
    evaluación de biomarcadores para EA
    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) No
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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
    Australia
    Austria
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Portugal
    Spain
    Taiwan
    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
    LVLS
    Ultima Visita Ultimo Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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.1.1.1In 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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 750
    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 No
    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
    At the start of the study, subjects must be capable of giving consent personally, however, in the LTE, subjects whose MMSE score is still >15 will be eligible and these subjects will need legal representative to provide consent
    Al inicio del estudio, los sujetos deben ser capaces de consentir
    personalmente, sin embargo, en el ELP, sujetos cuya puntuación MMSE sigue siendo> 15 serán elegibles y estos pacientes necesitarán representante legal para dar su consentimiento
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state63
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 521
    F.4.2.2In the whole clinical trial 1350
    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)
    No further provisions are made for access to the study treatment. Patients will revert to most appropriate standard of care. If aducanumab is proven to be beneficial, all regulatory requirements regarding poststudy access will be met
    No hay disposiciones adicionales para el acceso al tratamiento del
    estudio. Los pacientes volverán a nivel más apropiado de cuidado. Si
    aducanumab ha demostrado ser beneficioso, se cumplirán todos los
    requisitos regulatorios para el acceso después del estudio
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation TrialNetworks
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-15
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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