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    Summary
    EudraCT Number:2017-001365-24
    Sponsor's Protocol Code Number:WN39658
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-03-14
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-001365-24
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY, AND SAFETY STUDY OF GANTENERUMAB IN PATIENTS WITH EARLY (PRODROMAL TO MILD) ALZHEIMER’S DISEASE
    ESTUDIO DE FASE III, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y DE GRUPOS PARALELOS PARA EVALUAR LA EFICACIA Y SEGURIDAD DE GANTENERUMAB EN PACIENTES CON ENFERMEDAD DE ALZHEIMER PRECOZ (DE
    PRODRÓMICA A LEVE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To Evaluate Efficacy and Safety of Gantenerumab in Patients with Early Alzheimer’s Disease
    Evaluar la eficacia y seguridad de Gantenerumab en pacientes con Enfermedad de Alzheimer temprana.
    A.4.1Sponsor's protocol code numberWN39658
    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 SponsorRoche Farma S.A.(Soc. Unipersonal) que realiza el ensayo en España y actúa como representante de F.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 number+34913257300
    B.5.5Fax number+34913248195
    B.5.6E-mailspain.start_up_unit@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
    D.3.9.3Other descriptive nameGANTENERUMAB RO4909832
    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 number105
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the 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’s Disease (AD)
    Enfermedad de Alzheimer (EA)
    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
    La EA es un desorden que causa problemas de memoria, pensamiento y comportamiento. Los síntomas se desarrollan despacio y empeoran convirtiéndose en severos e interfiriendo en las tareas diarias
    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 on global outcome
    • Evaluar la eficacia de gantenerumab administrado mediante inyección subcutánea en comparación con placebo en el resultado global
    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
    •Evaluar la eficacia de gantenerumab en comparación con placebo sobre la cognición y la función
    •Evaluar la seguridad de gantenerumab en comparación con placebo
    •Determinar el perfil farmacocinético de 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
    The substudies associated with Study WN39658 will be described in separate protocols, and patients consenting to enroll in these substudies will be asked to sign the associated Informed Consent Forms.
    Los subestudios asociados con el ensayo WN39658 se describirán en protocolos separados, y a los pacientes que consientan a participar en esos subestudios se les pedirá que firmen los consentimientos informados asociados
    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
    -Edad de 50-90 años
    -Demencia por EA probable (compatible con los criterios clínicos del NIA/AA de demencia por EA probable) o EA prodrómica (compatible con los criterios diagnósticos y las directrices sobre deterioro cognitivo leve debido a EA del NIA/AA).
    -Datos del proceso patológico de EA, confirmados en LCR o una PET
    -Función anormal de la memoria demostrada
    -Puntuación MMSE entre 22 y 30 (inclusive)
    -Clinical Dementia Rating Global Score de 0,5 o 1,0.
    -Disponibilidad de una persona de confianza que acceda a participar en los procedimientos del estudio a lo largo de todo el ensayo
    -Si el paciente está recibiendo medicación sintomática para la EA, pauta posológica estable durante al menos tres meses antes del screening
    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
    -Cualquier signo de un trastorno distinto de la EA que pueda afectar a la cognición
    -Antecedentes o presencia de una enfermedad vascular sistémica clínicamente evidente que, en opinión del investigador, pueda afectar a la función cognitiva
    -Antecedentes de esquizofrenia, trastorno esquizoafectivo, depresión mayor o trastorno bipolar.
    -Enfermedad cardiovascular, renal o hepatica clínicamente significativa o inestable
    -Riesgo de suicidio, en opinión del investigador.
    -Abuso o dependencia de alcohol en los últimos 2 años
    -Hemorragia cerebral relevante, desorden hemorragico y anormalidades cerebrovasculares
    -Cualquier contraindicación a las resonancias magneticas cerebrales
    -Hipertension no controlada
    E.5 End points
    E.5.1Primary end point(s)
    1.The change from baseline (Day 1) to Week 104 in global outcome, as measured by the Clinical Dementia Rating-Sum of Boxes
    1. El cambio desde basal (dia 1) a la semana 104 en el resultado global, medido por el Clinical Dementia Rating-Sum of Boxes
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline (Day 1) to Week 104
    1. Basal (dia 1) a semana 104
    E.5.2Secondary end point(s)
    1. The change from baseline to Week 104 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 104 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 patients
    10. Change from baseline in brain tau load, as measured by tau PET scan in a subset of patients
    11. Change from baseline in cerebral spinal fluid markers of disease in a subset of patients, 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 patients
    1. El cambio desde la visita basal hasta la semana 104 en la cognición medido mediante Puntuación total MMSE, ADAS-Cog11, ADAS-Cog13, Prueba de fluidez verbal y Codificación.
    2. Cambio con respecto al valor basal en la semana 104 en función, medido por Escala del Alzheimer Disease Cooperative Study Group-Puntuacion de actividades de vida cotidianas diarias y puntuación instrumental.
    3. Naturaleza, frecuencia, intensidad y cronología de los acontecimientos adversos y acontecimientos adversos graves
    4. Exploraciones físicas, constantes vitales, análisis de sangre, ECG y C-SSRS
    5. Naturaleza, frecuencia, intensidad y cronología de los hallazgos de RM: ARIA-E y ARIA-H
    6. Naturaleza, frecuencia, intensidad y cronología de las reacciones en el lugar de la inyección
    7. Presencia de anticuerpos contra el fármaco (ACF) durante el estudio con respecto a su presencia en la visita basal
    8. Concentración plasmática de gantenerumab en momentos especificados
    9. Cambio con respecto al valor basal en la carga de amiloide cerebral, determinada mediante PET para amiloide en un subgrupo de pacientes
    10. Cambio con respecto al valor basal en la carga de proteína tau cerebral, determinada mediante PET para tau en un subgrupo de pacientes
    11. Cambio con respecto al valor basal de marcadores de enfermedad en líquido cefalorraquídeo en un subgrupo de pacientes, entre otros, Aβ1−42, tau total y tau fosforilada
    12. Mediciones derivadas de la RM a lo largo del tiempo en todos los pacientes, como variaciones volumétricas de todo el cerebro, los ventrículos, el hipocampo u otras estructuras
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-2. Baseline to Week 104
    3-7. Baseline up to end of study (week 152)
    8. Baseline, Week 2, 24, 41, 52, 76, 103, 116, 152 and at early termination and unscheduled visit
    9-12. Baseline up to week 104
    1-2. Basal a semana 104
    3-7. Basal hasta como máximo el fin de ensayo (semana 152)
    8. Basal, semanas 2, 24, 41, 52, 76, 103, 116, 152 y en las visitas de terminación temprana y no programadas
    9-12. Basal hasta como maximo la semana 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 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
    Biomarcadores
    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 concerned18
    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
    Argentina
    Belgium
    Chile
    Croatia
    Denmark
    Finland
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Portugal
    Singapore
    Spain
    Sweden
    Turkey
    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
    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.
    El final del estudio se define como la fecha en la que se produzca la última visita del último paciente (UVUP) o la fecha en la que se reciban los últimos datos necesarios para los análisis de la seguridad o el seguimiento de la seguridad del último paciente, lo que ocurra más tarde
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 480
    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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 265
    F.4.2.2In the whole clinical trial 760
    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
    El promotor ofrecerá acceso continuado al fármaco del ensayo del promotor (gantenerumab) de manera gratuita a los pacientes elegibles de acuerdo con la política global de Roche de acceso continuado a los fármacos en investigación, tal y como se señala en la sección 4.3.4 del protocolo
    La política global de Roche de de acceso continuado a los fármacos en investigación está disponible en la siguiente página web:
    http://www.roche.com/policy_continued_access_to_investigational_medicines
    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 Decision2018-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-29
    P. End of Trial
    P.End of Trial StatusOngoing
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