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    Summary
    EudraCT Number:2017-001364-38
    Sponsor's Protocol Code Number:WN29922
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-15
    Trial 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 number2017-001364-38
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, PARALLEL-GROUP, EFFICACY, AND SAFETY STUDY OF GANTENERUMAB IN PATIENTS WITH EARLY (PRODROMAL TO MILD) ALZHEIMER'S DISEASE
    STUDIO DI EFFICACIA E SICUREZZA DI FASE III, MULTICENTRICO, RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO CON PLACEBO E A GRUPPI PARALLELI VOLTO A VALUTARE EFFICACIA E SICUREZZA DI GANTENERUMAB IN PAZIENTI AFFETTI DA MALATTIA DI ALZHEIMER IN FASE INIZIALE (DA PRODROMICA A LIEVE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Efficacy and Safety of Gantenerumab in Patients with Early Alzheimer's Disease
    Uno Studio volto a valutare l'efficacia e la sicurezza di Gantenerumab in pazienti affetti da malattia di Alzheimer in fase iniziale
    A.3.2Name or abbreviated title of the trial where available
    To Evaluate Efficacy and Safety of Gantenerumab in Patients with Early Alzheimer¿s Disease
    Valutare l'efficacia e la sicurezza di Gantenerumab in pazienti affetti da malattia di Alzheimer in
    A.4.1Sponsor's protocol code numberWN29922
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    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 supportF.Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post codeCH-4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041616881111
    B.5.5Fax number0041616919391
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameGantenerumab
    D.3.2Product code [RO4909832]
    D.3.4Pharmaceutical form 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 INNGANTENERUMAB
    D.3.9.2Current sponsor codeRO4909832/F10-02
    D.3.9.3Other descriptive nameGANTENERUMAB RO4909832/F10-02
    D.3.9.4EV Substance CodeSUB177613
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 nameGANTENERUMAB
    D.3.2Product code [RO4909832]
    D.3.4Pharmaceutical form 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 INNGANTENERUMAB
    D.3.9.2Current sponsor codeRO4909832/F10-03
    D.3.9.3Other descriptive nameGANTENERUMAB RO4909832/F10-03
    D.3.9.4EV Substance CodeSUB177613
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGANTENERUMAB
    D.3.2Product code [RO4909832]
    D.3.4Pharmaceutical form 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 INNGANTENERUMAB
    D.3.9.2Current sponsor codeRO4909832/F10-04
    D.3.9.3Other descriptive nameGANTENERUMAB RO4909832/F10-04
    D.3.9.4EV Substance CodeSUB177613
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution 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 Disease (AD)
    Malattia Alzheimer
    E.1.1.1Medical condition in easily understood language
    AD is a progressive disorder that causes problems with memory, thinking and behavior. Symptoms usually develop slowly and get worse over time, becoming severe enough to interfere with daily tasks
    L'AD un disturbo progressivo che causa problemi con la memoria, il pensiero e il comportamento. I sintomi di solito si sviluppano lentamente e peggiorano nel tempo, diventando abbastanza gravi.
    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 HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10074616
    E.1.2Term Prodromal 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 gantenerumab administered by subcutaneous injection compared with placebo, as measured by the Clinical Dementia Rating-Sum of Boxes score
    Valutare l'efficacia di gantenerumab somministrato mediante iniezione sottocutanea rispetto al placebo secondo il punteggio CDR-SOB
    E.2.2Secondary objectives of the trial
    ¿ To evaluate the efficacy of gantenerumab versus placebo on cognition and function
    ¿ To evaluate the safety of gantenerumab compared with placebo
    ¿ To characterize the pharmacokinetic profile of gantenerumab
    ¿ Valutare l'efficacia di gantenerumab rispetto al placebo sulla cognizione e la funzione
    ¿ Valutare la sicurezza di gantenerumab rispetto al placebo
    ¿ Caratterizzare il profilo farmacocinetico di gantenerumab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: LONGITUDINAL AMYLOID PET
    SUBSTUDY v 2 dated 10-Feb-2018
    The objective of the WN29922 longitudinal amyloid positron emission tomography (PET)
    substudy is to assess changes in brain amyloid load over time using the change in florbetaben
    or flutemetamol from baseline to Week 104 in the standardized uptake value ratio (SUVr) in
    patients enrolled in Study WN29922 who are treated with gantenerumab or placebo.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: SOTTOSTUDIO LONGITUDINALE SULLA PET-AMILOIDE v 2 del 10-Feb-2018
    L¿obiettivo del sottostudio longitudinale WN29922 sulla tomografia a emissione di positroni con traccianti per l¿amiloide consiste nel valutare le alterazioni del carico di amiloide cerebrale nel tempo mediante la variazione dei livelli di florbetaben o flutemetamolo nel rapporto del valore di captazione standardizzato (SUVr) dal basale alla Settimana 104 nei pazienti arruolati nello studio WN29922 trattati con gantenerumab o il placebo.
    E.3Principal inclusion criteria
    - Age 50-90 years
    - Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment)
    - Evidence of AD pathological process, as confirmed by cerebrospinal fluid or amyloid positron emission tomography scan
    - Demonstrate abnormal memory function
    - MMSE score between 22-30 (inclusive)
    - Clinical Dementia Rating Global Score of 0.5 or 1.0
    - Availability of a reliable study partner who accepts to participate in study procedure throughout the study duration
    - If receiving symptomatic AD medication the dosing regimen must have been stable for 3 months prior to screening and until randomization
    - Età 50-90 anni
    - Incontra i principali criteri clinici per la probabile demenza da AD o prodromica previsti dall'Istituto Nazionale sull'Anvecchiamento / Associazione Alzheimer (NIAAA)per la probabile demenza da AD o prodromica (in linea con i criteri diagnostici NIAAA e le linee guida per il
    decadimento cognitivo)
    - Evidenza del processo patologico di AD, come confermato da prelievo cerebrospinale o da scansione tomografica a emissione di positroni fluida o amiloide
    - Dimostrare la funzione di memoria anormale
    - Punteggio MMSE tra 22-30 (inclusi)
    - Punteggio globale di demenza clinico di 0,5 o 1,0
    - Disponibilità di un partner di studio affidabile che acconsenta a partecipare alle procedure dello studio per tutta la durata dello studio
    - In caso di somministrazione di farmaci sintomatici con AD, il regime posologico deve essere risultere stabile per 3 mesi prima dello screening e fino alla randomizzazione
    E.4Principal exclusion criteria
    - Any evidence of a condition other than AD that may affect cognition
    - History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function
    - History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
    - Unstable or clinically significant cardiovascular, kidney or liver disease
    - At risk of suicide in the opinion of the investigator
    - Alcohol or substance abuse in past 2 years
    - Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
    - Any contraindications to brain magnetic resonance imaging
    - Uncontrolled hypertension
    - Qualsiasi evidenza di una condizione diversa da AD che possa influire sull’attività cognitiva
    - Storia o presenza di malattia vascolare sistemica clinicamente evidente che secondo il parere dello sperimentatore ha il potenziale di influenzare la funzione cognitiva
    - Storia di schizofrenia, disturbo schizoaffettivo, depressione maggiore o disturbo bipolare
    - Malattia cardiovascolare, renale o epatica instabile o clinicamente significativa
    - A rischio di suicidio secondo il parere dello sperimentatore
    - Abuso di alcol o stupefacenti negli ultimi 2 anni
    - Emorragia cerebrale rilevante, disturbo emorragico e anomalie cerebrovascolari
    - Qualsiasi controindicazione alla risonanza magnetica cerebrale
    - Ipertensione incontrollata
    E.5 End points
    E.5.1Primary end point(s)
    1. The change from baseline (Day 1) to Week 116 in global outcome, as measured by the Clinical Dementia Rating-Sum of Boxes
    1. Variazione dell'outcome globale dal basale (Giorno 1) alla settimana 116 secondo il punteggio CDR-SOB
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline (Day 1) to Week 116
    1. Dal basale (giorno 1) alla settimana 116
    E.5.2Secondary end point(s)
    1. The change from baseline to Week 116 in cognition, as measured by MMSE total score, Alzheimer's Disease Assessment Scale-Cognition, Subscale 11 and 13, Verbal Fluency Task and Coding
    2. The change from baseline to Week 116 in function, as measured by Functional Activities Questionnaire and Alzheimer's Disease Cooperative Study Group-Activities of Daily Living total score and instrumental score
    3. Nature, frequency, severity, and timing of adverse events and serious adverse events
    4. Physical examinations, vital signs, blood tests, ECGs, and Columbia-Suicide Severity Rating Scale
    5. Nature, frequency, severity, and timing of MRI findings: ARIA-E and amyloid-related imaging abnormality-hemosiderin deposition
    6. Nature, frequency, severity, and timing of injection-site reactions
    7. Presence of anti-drug antibody (ADAs) during the study relative to the presence of ADAs at baseline
    8. Plasma concentration of gantenerumab at specified timepoints
    9. Change from baseline in brain amyloid load, as measured by amyloid PET scan in a subset of participants
    10. Change from baseline in brain tau load, as measured by tau PET scan in a subset of participants
    11. Change from baseline in cerebral spinal fluid markers of disease in a subset of participants, including, but not limited to, A beta1-42, total tau, and phosphorylated tau
    12. MRI-derived measurements over time, such as volumetric changes in whole brain, ventricles, hippocampus, or other structures, in all participants
    1. Variazione della funzione cognitiva e/o della funzionalità dal basale alla Settimana 116 secondo quanto segue: Punteggio MMSE totale, ADAS-Cog13 e ADAS-Cog11, Fluenza verbale, Coding
    2. Variazione della funzionalità dal basale alla Settimana 116 secondo il questionario FAQ e secondo il punteggio totale e strumentale ADCS-ADL
    3. Natura, frequenza, gravià e tempistica degli eventi avversi e eventi avversi gravi
    4. Esami fisici, segni vitali, esami del sangue, ECG e scala di valutazione della gravità del Columbia-Suicide
    5. Natura, frequenza, gravità e tempistica dei risultati della risonanza magnetica: ARIA-E e anormalià correlate all'amiloide-deposizione di emosiderina
    6. Natura, frequenza, gravità e tempi delle reazioni al sito di iniezione
    7. Presenza di anticorpi anti-farmaco (ADA) durante lo studio relativo alla presenza di ADA al basale
    8. Concentrazione plasmatica di gantenerumab a determinati orari
    9. Variazione rispetto al basale del carico di amiloide del cervello, misurata mediante scansione PET amiloide in un sottogruppo di partecipanti
    10. Cambiamento rispetto al basale del carico cerebrale, come misurato dalla scansione PET tau in un sottogruppo di partecipanti
    11. Cambiamento rispetto al basale nei marcatori del liquido spinale cerebrale di malattia in un sottogruppo di partecipanti, inclusi, ma non limitati a, A beta1-42, tau totale e tau fosforilato
    12. Misure derivate dalla risonanza magnetica nel tempo, come i cambiamenti volumetrici dell'encefalo, nella sua interezza, dei ventricoli cerebrali, dell' ippocampo o di altre strutture, in tutti i partecipanti
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-2. Baseline to Week 116
    3-7. Baseline up to end of study (week 164 and Week 35 [Open label extension])
    8. Baseline, Week 2, 24, 41, 52, 76, 103, 115, 128, 164, and at early termination and unscheduled visit, Week 1 and Week 24 (Open label extension)
    9-12. Baseline up to week 116
    Note: The continuing impact of the COVID-19 pandemic on study procedures will be closely monitored, and if there are greater than
    anticipated disruptions to study drug administration, the sponsor will
    have the option to further extend the double-blind treatment period by
    another 12 weeks and time points will be adapted accordingly.
    1-2. dal basale fino alla settimana 116
    3-7. dal basale fino alla fine dello studio (settimana 164 e settimana 35 [studio di estensione in aperto])
    8. al basale, alla settimana 2, 24, 41, 52, 76, 103, 115, 128, 164, e alla risoluzione anticipata e visita non programmata, alla settimana 1 e settimana 24 (studio di estensione in aperto)
    9-12. dal basale fino alla settimana 116
    Nota: L'impatto globale della pandemia COVID-19 sulle procedure dello studio sarà attentamente monitorato e, nel caso in cui le interruzione delle somministrazioni di farmaco fossero maggiori di quanto anticipato, lo sponsor avrà la possibilità di prolungare ulteriormente il periodo di trattamento in doppio cieco di altre 12 settimane e i time points verranno adattati di conseguenza
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker
    Biomarcatori
    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 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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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
    Brazil
    Canada
    China
    Colombia
    Denmark
    France
    Germany
    Hungary
    Italy
    Japan
    Lithuania
    Peru
    Poland
    Russian Federation
    Spain
    Taiwan
    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
    The end of the study is defined as the date when the last patient, last visit (LPLV) occurs or the date at which the last data point required for safety analyses or safety follow-up is received for the last patient, whichever occurs later.




    La fine dello studio ¿ definita come la data in cui si verifica l'ultimo paziente, l'ultima visita (LPLV) o la data in cui l'ultimo punto dati richiesto per le analisi di sicurezza o il follow-up di sicurezza ¿ ricevuto per l'ultimo paziente, a seconda di quale evento si verifichi successivamente.
    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 months0
    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 months0
    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: 203
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 813
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 326
    F.4.2.2In the whole clinical trial 1322
    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)
    The Sponsor will offer continued access to Sponsor study drug (gantenerumab) free of
    charge to eligible patients in accordance with the Roche Global Policy on Continued
    Access to Investigational Medicinal Product, as outlined in protocol section 4.3.4.
    The Roche Global Policy on Continued Access to Investigational Medicinal Product is
    available at the following Web site:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    Lo sponsor continuer¿ a fornire gratuitamente il farmaco di studio (gantenerumab) senza addebito ai pazienti idonei in conformit¿ con la Roche Global Policy.
    Accesso al prodotto medicinale sperimentale, come descritto nella sezione 4.3.4 del protocollo.
    La Roche Global Policy sull'accesso continuo al prodotto medicinale sperimentale ¿ disponibile sul seguente sito Web:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf.
    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 Decision2018-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-26
    P. End of Trial
    P.End of Trial StatusOngoing
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