Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-003398-87
    Sponsor's Protocol Code Number:GN40040
    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:2019-05-31
    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 number2018-003398-87
    A.3Full title of the trial
    A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY, AND SAFETY STUDY OF MTAU9937A IN PATIENTS WITH MODERATE ALZHEIMER’S DISEASE
    ESTUDIO EN FASE II, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO, EN GRUPOS PARALELOS, QUE EVALÚA LA EFICACIA Y SEGURIDAD DE MTAU9937A EN PACIENTES CON ENFERMEDAD DE ALZHEIMER MODERADA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of RO7105705 in Patients with Moderate Alzheimer’s disease
    Estudio para evaluar la eficacia y seguridad de RO7105705 en pacientes con enfermedad de Alzheimer moderada
    A.4.1Sponsor's protocol code numberGN40040
    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 por delegación de Genentech, Inc.
    B.1.3.4CountryUnited States
    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 code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    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 nameMTAU9937A
    D.3.2Product code RO7105705
    D.3.4Pharmaceutical form Solution for injection/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 INNMTAU9937A
    D.3.9.2Current sponsor codeRO7105705
    D.3.9.3Other descriptive nameMTAU9937A
    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 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/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
    Alzheimer’s disease (AD)
    Enfermedad de Alzheimer (EA)
    E.1.1.1Medical condition in easily understood language
    AD is a chronic neurodegenerative disease that destroys memory and other important mental functions
    EA es una enfermedad crónica neurodegenerativa que destruye la memoria y otras funciones mentales importantes
    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
    -To evaluate the effects of RO7105705 compared with placebo on cognition and function on the basis of Alzheimer’s Disease Assessment Scale, Cognitive Subscale, 11-item version (ADAS-Cog11) and Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL)
    -Evaluar los efectos de RO7105705 comparado con placebo sobre la capacidad cognitiva y la función basado en la versión de 11 ítems de Escala de evaluación de la enfermedad de Alzheimer (ADAS-Cog11) y en el cuestionario de actividades cotidianas del estudio cooperativo de la enfermedad de Alzheimer (ADCS-ADL)
    E.2.2Secondary objectives of the trial
    -To evaluate the effect of RO7105705 on global cognition and function compared with placebo on the basis of Clinical Dementia Rating-Sum of Boxes (CDR-SB)
    -To evaluate the effect of RO7105705 on cognition compared with placebo on the basis of Mini-Mental State Examination (MMSE)
    -Evaluar los efectos de RO7105705, comparado con placebo, sobre la capacidad cognitiva global y la función en base a la suma de recuadros de la evaluación de demencia clínica (CDR-SB)
    -Evaluar los efectos de MTAU9937A, comparado con placebo, sobre la capacidad cognitiva en base al Miniexamen cognoscitivo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age between 50 and 85 years
    - National Institute on Aging/Alzheimer’s Association core clinical criteria for probable AD dementia
    - Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid Aβ 1- 42 or amyloid positron emission tomography (PET) scan. Historical amyloid PET scans may be accepted in some cases.
    - AD dementia of moderate severity, as defined by a screening MMSE score of 16-21 points and a Clinical Dementia Rating (CDR)-Global Score of 1 or 2
    - Availability of a person with sufficient contact with the patient to be able to provide accurate information regarding the participant’s cognitive, behavioral, and functional abilities
    -Tener una edad de entre 50 y 85 años
    -Criterios clínicos esenciales de probable demencia de la EA del instituto Nacional estadounidense de envejecimiento y la asociación para el Alzheimer
    -Indicios de un proceso patológico de EA, obtenidos por una evaluación positiva de amiloide bien por Aβ1-42 en el LCR o bien por una imagen de TEP
    -Demencia de la EA de intensidad moderada, definida por una puntuación en MEC de 16-21 puntos, ambos inclusive en la selección y de 1 o 2 en CDR-GS.
    -Disponibilidad de una persona que
    tiene contacto frecuente y suficiente con el paciente para poder proporcionar información precisa sobre las habilidades cognitivas, de conducta y funcionales del paciente; acepta proporcionar información en las visitas clínicas firmar los formularios de consentimiento necesarios; y tiene capacidad cognitiva suficiente para informar detalladamente del comportamiento del paciente y de sus habilidades cognitivas y funcionales
    E.4Principal exclusion criteria
    - Pregnant or breastfeeding
    - Inability to tolerate MRI procedures or contraindication to MRI
    - Contraindication to PET imaging
    - Residence in a skilled nursing facility
    - Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study, or bias the assessment of the clinical or mental status of the participant to a significant degree
    - Any evidence of a condition other than AD that may affect cognition
    - Substance abuse within the past 2 years
    - Use of any experimental therapy within 90 days or 5 half-lives prior to screening, whichever is greater, or any passive immunotherapy against tau
    - Use of any passive immunotherapy (immunoglobulin) against Aβ, unless the last dose was at least 1 year prior to screening or any active immunotherapy (vaccine) that is under evaluation to prevent or postpone cognitive decline
    - Any other biologic therapy or previous treatment with medications specifically intended to treat Parkinsonian symptoms or any other non-AD neurodegenerative disorder within 1 year of screening
    - Systemic immunosuppressive therapy within 12 months of screening through the entire study period
    - Typical antipsychotic or neuroleptic medication within 6 months of screening
    - Daily treatment with any of the following classes of medication (except for intermittent short-term use): opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally-acting antihistamine or anticholinergic activity
    - Stimulant medications, unless the dose has been stable within the 6 months prior to screening and is
    expected to be stable throughout the study
    -Embarazada o en periodo de lactancia
    -Incapacidad para tolerar los procedimientos de RM o contraindicación para realizar RM
    -Contraindicaciones para la prueba diagnóstica de TEP
    -Residencia en un centro especializado en cuidados
    -Cualquier afección médica grave o anomalía en los análisis clínicos que, a opinión del investigador, pueda afectar a una participación segura del paciente y a la finalización del estudio o pueda sesgar la evaluación del estado clínico o mental del participante en un grado significativo
    -Cualquier indicio de una afección distinta a la EA que pueda afectar a la cognición
    -Abuso de sustancias en los dos últimos años
    -Uso de un tratamiento experimental durante 90 días o 5 semividas antes de la selección, lo que tenga una mayor duración o uso de cualquier inmunoterapia pasiva frente a las tau.
    -Uso de inmunoterapia pasiva (inmunoglobulina) contra Aβ, a menos que la última dosis se haya administrado al menos un año antes de la selección o uso de inmunoterapia activa (vacuna) que se evalúa para prevenir o posponer el deterioro cognitivo
    -Cualquier tratamiento anterior con medicación específica para el tratamiento de los síntomas de Parkinson o cualquier otro trastorno neurodegenerativo que no sea EA en el año anterior a la selección
    -Tratamiento inmunosupresor sistémico en el plazo de 12 meses antes de la selección a lo largo de todo el periodo del estudio
    -Medicación antipsicótica o neuroléptica habitual en el plazo de 6 meses antes de la selección
    -Tratamiento diario con cualquiera de las siguientes clases de medicación, excepto si se trata de un uso intermitente de corta duración: Opiáceos u opioides, Benzodiacepinas, barbitúricos o hipnóticos y cualquier medicación con antihistamínico de acción central o actividad anticolinérgica clínicamente significativa
    -Medicamentos estimulantes a menos que se haya mantenido una dosis estable en los 6 meses anteriores a la selección y se espere mantenerla estable a lo largo del estudio
    E.5 End points
    E.5.1Primary end point(s)
    1.Change from baseline to Week 49 in cognitive function as measured by the Alzheimer’s Disease Assessment Scale, Cognitive Subscale, 11-item version (ADAS-Cog11)
    2. Change from baseline to Week 49 in functional capacities as measured by the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL)
    1. Cambio desde basal a la semana 49 en las funciones cognitivas medidas por la versión de 11 ítems de Escala de evaluación de la enfermedad de Alzheimer (ADAS-Cog11)
    2. Cambio desde basal a la semana 49 en las funciones cognitivas medidas por el cuestionario de actividades cotidianas del estudio cooperativo de la enfermedad de Alzheimer (ADCS-ADL)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 49
    Desde basal a la semana 49
    E.5.2Secondary end point(s)
    1.Change from baseline to Week 49 on the Clinical Dementia Rating-Sum of Boxes (CDR-SB)
    2.Change from baseline to Week 49 on the MMSE
    1.Cambio desde Basal a la semana 49 en la suma de recuadros de la evaluación de demencia clínica (CDR-SB)
    2.Cambio desde Basal a la semana 49 en el Miniexamen cognoscitivo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to Week 49
    Desde basal a la semana 49
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    France
    Poland
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Last Patient Last Visit
    Ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 260
    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)
    An optional open-label extension (OLE) period, and a safety follow-up period.
    Un periodo opcional de extensión en abierto (OLE), y un periodo de seguimiento de seguridad
    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 Decision2019-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-22
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 19 06:30:56 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA