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    The EU Clinical Trials Register currently displays   41200   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2018-002102-31
    Sponsor's Protocol Code Number:221AD205
    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:2018-11-23
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-002102-31
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Parallel-Group, Double-Blind,
    Controlled Study of Aducanumab (BIIB037) in Subjects With Mild Cognitive Impairment
    due to Alzheimer’s Disease or With Mild Alzheimer’s Disease Dementia to Evaluate the
    Safety of Continued Dosing in Subjects with Asymptomatic Amyloid-Related Imaging
    Estudio en fase II, multicéntrico, aleatorizado, doble ciego, controlado y de grupos paralelos de Aducanumab (BIIB037) en sujetos con deterioro cognitivo leve debido a la enfermedad de Alzheimer o con demencia de la enfermedad de Alzheimer leve para evaluar la seguridad de la administración de dosis continuada en sujetos asintomáticos con anomalías en las imágenes relacionadas con el amiloide.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Aducanumab in Participants With Mild
    Cognitive Impairment due to Alzheimer’s Disease or
    With Mild Alzheimer’s Disease Dementia to Evaluate the
    Safety of Continued Dosing in Participants With
    Asymptomatic Amyloid-Related Imaging Abnormalities
    Estudio de Aducanumab (BIIB037) en sujetos con deterioro cognitivo leve debido a la enfermedad de Alzheimer o con demencia de la enfermedad de Alzheimer leve para evaluar la seguridad de la administración de dosis continuada en sujetos asintomáticos con anomalías en las imágenes relacionadas con el amiloide.
    A.4.1Sponsor's protocol code number221AD205
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02477800
    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 pointBiogen España
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 41
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.4Telephone number0034913107110
    B.5.5Fax number0034913107181
    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 number100
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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. 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
    Mild Cognitive Impairment due to Alzheimer's Disease and Mild Alzheimer's Dementia
    Deterioro cognitivo leve debido a la enfermedad de Alzheimer o con demencia de la enfermedad de Alzheimer leve.
    E.1.1.1Medical condition in easily understood language
    Mild Cognitive Impairment due to Alzheimer's Disease and Mild Alzheimer's Dementia
    Deterioro cognitivo leve debido a la enfermedad de Alzheimer o con demencia de la enfermedad de Alzheimer leve.
    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 20.0
    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

    The primary objective of the study is to assess the safety impact of continuing aducanumab dosing in
    asymptomatic Amyloid-related Imaging Abnormalities
    (ARIA) in participants with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or with mild AD dementia.
    El objetivo principal del estudio es evaluar el impacto en la seguridad de continuar la administración de la dosis de aducanumab en las ARIA asintomáticas en sujetos con DCL debido a EA o con demencia de la EA leve.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to characterize ARIA, from both the imaging and the clinical perspective and to characterize the safety, tolerability, pharmacokinetics (PK), and immunogenicity of aducanumab.
    Caracterizar las ARIA, tanto desde la perspectiva de las imágenes diagnósticas como de la perspectiva clínica y caracterizar la seguridad, tolerabilidad, farmacocinética (FC) y la inmunogenia de aducanumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    • Ability of the participant or his/her legally authorized representative to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential
    health information in accordance with national and local
    participant privacy regulations.
    • Must have at least 6 years of education or work
    experience to exclude mental deficits other than MCI
    due to AD or mild AD dementia.
    • Must have evidence of cerebral Aβ accumulation, based on a positive PET scan of the brain. Previously obtained positron emission tomography (PET) scan
    (within 12 months of screening) is permissible. Previous PET scan images must be submitted to the central imaging vendor to confirm that study inclusion criteria
    are met.
    • Must consent to apolipoprotein E (ApoE) genotyping.
    • Must meet all of the following clinical criteria for MCI due to AD or mild AD dementia according to NIAAA criteria [Albert 2011; McKhann 2011], and must have
    the following: MCI due to AD (a CDR global score of 0.5, and an MMSE score between 24 and 30
    (inclusive)), and Mild AD dementia (a CDR global score of 0.5 or 1, and as MMSE score between 20 and 26 (inclusive)).
    Criterios de Inclusión Principales:
    - Capacidad del sujeto o su representante legal para comprender el objetivo y los riesgos del estudio, así como facilitar el consentimiento informado firmado y fechado, y la autorización para usar información sanitaria confidencial de acuerdo con las normativas nacionales y locales sobre la privacidad de los sujetos.
    - Debe tener al menos 6 años de experiencia en el sistema educativo o laboral con el fin de excluir deficiencias mentales distintas al DCL debido a EA o demencia de la EA leve.
    - Debe presentar indicios de acumulación de Aβ cerebral, en base a un resultado positivo en la exploración por TEP del cerebro. Una TEP obtenida anteriormente (en los 12 meses anteriores a la selección) es aceptable. Las imágenes de las TEP anteriores deben enviarse al proveedor central de diagnóstico por la imagen para confirmar que se cumplen los criterios de inclusión del estudio.
    - Debe dar consentimiento para la genotipificación de la ApoE.
    - Debe cumplir todos los criterios clínicos siguientes de DCL debido a EA o demencia de la EA leve de acuerdo con los criterios del Instituto Nacional sobre el Envejecimiento y la Asociación de Alzheimer (National Institute on Aging-Alzheimer's Association, NIA-AA) [Albert 2011; McKhann 2011] y deben presentar lo que sigue: DCL debido a EA (Una puntuación global de la CDR de 0,5, y una puntuación del MMSE de entre 24 y 30 (ambas inclusive)), y Demencia de la EA leve (Una puntuación global de la CDR de 0,5 o 1 y Una puntuación del MMSE de entre 20 y 26 (ambas inclusive)).
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    • Any uncontrolled medical or
    neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause of the participant’s cognitive
    impairment (e.g., substance abuse, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, Lewy body dementia,
    frontotemporal dementia, head trauma).
    • Clinically significant unstable psychiatric illness
    (e.g., uncontrolled major depression, uncontrolled
    schizophrenia, uncontrolled bipolar affective disorder)
    within 6 months prior to Screening.
    • Transient ischemic attack or stroke or any
    unexplained loss of consciousness within 1 year prior to Screening.
    • Vaccinations within 10 days prior to randomization (Day 1).
    • Female participants who are pregnant or currently breastfeeding.
    Criterios de Exclusión Principales:
    - Cualquier afección médica o neurológica/neurodegenerativa no controlada (distinta de la EA) que, en opinión del investigador, pudiera ser una causa que contribuye al deterioro cognitivo del sujeto (p. ej., abuso de sustancias, déficit de vitamina B12, función tiroidea anómala, accidente cerebrovascular u otro trastorno cerebrovascular, demencia con cuerpos de Lewy, demencia frontotemporal, traumatismo craneal).
    - Enfermedad psiquiátrica inestable clínicamente significativa (p. ej., depresión mayor no controlada, esquizofrenia no controlada, trastorno afectivo bipolar no controlado) en los 6 meses anteriores a la selección.
    - Accidente isquémico transitorio, accidente cerebrovascular o pérdida de conciencia sin explicación en el plazo de 1 año antes de la selección.
    - Vacunas en el plazo de 10 días antes de la aleatorización (día 1).
    - Sujetos de sexo femenino que estén embarazadas o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    Number of Clinically Impactful
    Amyloid-related Imaging
    Abnormalities (ARIA)

    Clinically impactful ARIA is
    defined as symptoms and/or
    signs associated with ARIA
    that are life threatening,
    require hospitalization, and/or
    result in persistent or
    significant disability as
    assessed by the independent
    Adjudication Committee.
    Criterios de Valoración principal:
    El criterio de valoración principal relacionado con este objetivo es la incidencia de las ARIA clínicamente significativas, definidas como síntomas y/o signos asociados con ARIA que son potencialmente mortales, que requieran hospitalización y/o provocan discapacidad persistente o significativa, según lo evaluado por el Comité de adjudicación independiente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint:
    Baseline up to Week 54
    Valoración principal:
    Desde la visita Basal hasta la semana 54
    E.5.2Secondary end point(s)
    1. Number of Participants With
    ARIA by Severity as Obtained
    on Magnetic Resonance
    Imaging (MRI)
    2. Time to Onset of ARIA as
    Obtained on MRI
    3. Time to Resolution of ARIA as
    Obtained on MRI
    4. Number of Participants With
    Symptomatic ARIA by Severity
    5. Time to Onset of Symptomatic
    6. Time to Resolution of
    Symptomatic ARIA
    7. Number of Participants With
    Adverse Events (AEs) and Serious Adverse Events (SAEs)
    8.Change From Baseline in the
    Montreal Cognitive
    Assessment (MoCA) at Week
    9.Aducanumab Concentration in
    10. Number of Participants With
    Antiaducanumab Antibodies in
    Incidencia, intensidad, tiempo hasta la aparición y tiempo hasta la resolución de las ARIA obtenidas en las RM
    Incidencia, intensidad, tiempo hasta la aparición y tiempo hasta la resolución de las ARIA sintomáticas
    Incidencia de acontecimientos adversos (AA) y acontecimientos adversos graves (AAG)
    Cambio desde el inicio hasta la semana 54 en la evaluación cognitiva de Montreal (Montreal Cognitive Assessment, MoCA)
    Concentración de aducanumab en suero
    Incidencia de anticuerpos antiaducanumab en suero
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints ;
    1-7 will be Baseline up to week 54.

    Secondary endpoint 8 ; baseline, week 54
    Secondary endpoint 9 and 10; Pre-dose on Day 1 of
    Weeks 1, 16, 24, 32, 44,
    54, 56, 70, 80, 104
    Del 1-7 desde la visita basal hasta la semana 54

    El 8: visita basal, semana 54
    El 9 y 10: Pre dosis Día 1 de la Semana 1, 16, 24, 32, 44, 54, 56, 70, 80, 104.
    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 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. 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 No
    E.8.2.3Other Yes
    E. description
    Por favor mirar el Protocolo Sección 11.1.2 (0.9% cloruro sódico)
    Please refer to Protocol Section 11.1.2 (0.9% sodium chloride)
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Korea, Republic of
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months11
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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. of subjects incapable of giving consent
    There maybe some patients who are incapable of giving consent personally.
    Podría haber pacientes que no puedan otorgar su consentimiento personalmente.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 500
    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. If aducanumab is proven to be
    beneficial, all regulatory requirements regarding poststudy access will be met.
    No se preve acceso al tratamiento del estudio. Si se demotrase que aducanumab es beneficioso, se seguirían los requisitos post estudio regulatorios.
    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 Decision2018-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-07-30
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