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    Summary
    EudraCT Number:2018-002102-31
    Sponsor's Protocol Code Number:221AD205
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 ConcernedItaly - Italian Medicines Agency
    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
    Abnormalities
    Studio di fase 2, multicentrico, randomizzato, a gruppi paralleli, in doppio cieco, controllato su aducanumab (BIIB037) in soggetti affetti da deterioramento cognitivo lieve dovuto a malattia di Alzheimer o affetti da demenza lieve da malattia di Alzheimer per valutare la sicurezza della somministrazione continua in soggetti con anomalie asintomatiche all’imaging correlate all’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
    Uno studio su Aducanumab in Partecipanti affetti da deterioramento cognitivo lieve dovuto a malattia di Alzheimer o affetti da demenza lieve da malattia di Alzheimer per valutare la sicurezza della somministrazione continua in soggetti con anomalie asintomatiche all’imaging correlate all’amiloide
    A.3.2Name or abbreviated title of the trial where available
    nd
    nd
    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 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.5.6E-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.3.9.2Current 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.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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
    deterioramento cognitivo lieve dovuto a malattia di Alzheimer e demenza lieve da malattia di Alzheimer
    E.1.1.1Medical condition in easily understood language
    Mild Cognitive Impairment due to Alzheimer's Disease and Mild Alzheimer's Dementia
    deterioramento cognitivo lieve dovuto a malattia di Alzheimer e demenza lieve da malattia di Alzheimer
    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.
    L’obiettivo primario dello studio è quello di valutare l’impatto di sicurezza della somministrazione continua di aducanumab in caso di anomalie asintomatiche di imaging correlate all’amiloide (ARIA) in soggetti affetti da deterioramento cognitivo lieve (MCI) dovuto a malattia di Alzheimer (AD) o affetti da demenza lieve da AD.
    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.
    L’obiettivo secondario dello studio è quello di caratterizzare le ARIA dal punto di vista sia dell’imaging sia clinico e di caratterizzare la sicurezza, la tollerabilità, la farmacocinetica (PK) e l’immunogenicità di 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 Aß 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)).

    Principali criteri di inclusione:
    • Capacità del partecipante o del suo rappresentante legalmente autorizzato di comprendere lo scopo e i rischi dello studio, di fornire un consenso informato firmato e datato, e di concedere l’autorizzazione a utilizzare le informazioni sanitarie riservate secondo le normative sia nazionali sia locali che tutelano la privacy del partecipante.
    • Il partecipante deve avere almeno 6 anni di esperienza educativa/formativa o lavorativa, al fine di escludere deficit mentali diversi dal MCI dovuto ad o a demenza lieve da AD.
    • Il partecipante deve presentare evidenza di accumulo di Aß cerebrale sulla base di una scansione PET positiva del cervello. È consentito utilizzare una scansione mediante tomografia a emissione di positroni (PET) eseguita in precedenza (entro 12 mesi dallo screening). Le scansioni PET eseguite in precedenza devono essere inviate al lettore centrale per confermare che i criteri di inclusione nello studio siano soddisfatti.
    • Il partecipante deve acconsentire alla genotipizzazione dell’apolipoproteina E (ApoE).
    • Il partecipante deve soddisfare tutti i seguenti criteri clinici per l’MCI dovuto a malattia di Alzheimer (AD) o demenza lieve da AD, secondo i criteri del NIAAA [Albert 2011; McKhann 2011] e deve presentare: MCI dovuto ad (punteggio CDR globale pari a 0,5, punteggio MMSE compreso fra 24 e 30 inclusi); demenza lieve da AD (punteggio CDR globale pari a 0,5 o 1, punteggio MMSE compreso fra 20 e 26 inclusi).
    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.
    Principali criteri di esclusione:
    • Qualsiasi disturbo medico o neurologico/neurodegenerativo non controllato (diverso dall’AD) che, secondo l’opinione dello sperimentatore, potrebbe essere una causa che contribuisce al deterioramento cognitivo del partecipante (per esempio abuso di sostanze, carenza di vitamina B12, funzionalità tiroidea anormale, ictus o altro disturbo cerebrovascolare, demenza a corpi di Lewy, demenza frontotemporale, trauma cranico).
    • Malattia psichiatrica clinicamente significativa e instabile (per esempio depressione maggiore non controllata, schizofrenia non controllata, disturbo affettivo bipolare non controllato) nei 6 mesi precedenti lo screening.
    • Attacco ischemico transitorio, ictus o qualsiasi perdita di coscienza inspiegata nell’anno precedente lo screening.
    • Vaccinazioni nei 10 giorni precedenti la randomizzazione (giorno 1).
    • Partecipanti di sesso femminile in gravidanza o in allattamento.
    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.
    Endopint primario:
    Numero di anomalie asintomatiche di imaging correlate all’amiloide (ARIA) aventi un impatto clinico

    ARIA aventi un impatto clinico, definite come sintomi e/o segni associati alle ARIA che sono potenzialmente letali, richiedono ricovero e/o sfociano in un’invalidità persistente o significativa, come valutato dal Comitato di valutazione indipendente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint:
    Baseline up to Week 54
    Baseline fino alla settimana 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
    ARIA
    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
    54
    9.Aducanumab Concentration in
    Serum
    10. Number of Participants With
    Antiaducanumab Antibodies in
    Serum
    1. Numero di partecipanti con ARIA, in base alla gravità, secondo quanto rilevato mediante risonanza magnetica (RM)
    2. Tempo all’insorgenza delle ARIA secondo quanto rilevato mediante RM
    3. Tempo alla risoluzione delle ARIA secondo quanto rilevato mediante RM
    4. Numero di partecipanti con ARIA sintomatiche, in base alla gravità
    5. Tempo all’insorgenza delle ARIA sintomatiche
    6. Tempo alla risoluzione delle ARIA sintomatiche
    7. Numero di partecipanti con eventi avversi (AE) ed eventi avversi seri (SAE)
    8. Variazione dal basale sulla scala di valutazione cognitiva di Montreal (MoCA) alla Settimana 54
    9. Concentrazione di aducanumab nel siero
    10. Numero di partecipanti con anticorpi anti-aducanumab nel siero
    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
    End point secondario: 1-7 sarà dal Baseline fino alla settimana 54
    End point secondario8 ; baseline, settimana 54
    End point secondario 9 e 10; Pre-dose al Giorno 1 delle settimane 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.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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Si faccia riferimento al protocollo Sezione 11.1.2 (cloruro di sodio allo 0,9%)
    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 concerned10
    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 Information not present in EudraCT
    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
    Belgium
    Canada
    Denmark
    Finland
    France
    Germany
    Italy
    Korea, Republic of
    Netherlands
    Poland
    Portugal
    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
    LVLS
    LVLS
    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.3.3.6.1Details of subjects incapable of giving consent
    There maybe some patients who are incapable of giving consent personally.
    Potrebbero esserci pazineti non in grado di dare il proprio consenso personalmente
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    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.
    Non sono previste ulteriori disposizioni per l'accesso al trattamento di studio. Se si dimostra che aducanumab è vantaggioso, saranno soddisfatti tutti i requisiti normativi relativi all'accesso a poststudy.
    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 Decision2018-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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