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    Summary
    EudraCT Number:2017-001800-31
    Sponsor's Protocol Code Number:GN39763
    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:2018-01-31
    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 number2017-001800-31
    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 PRODROMAL TO MILD 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 DE FASE PRODRÓMICA A LEVE.
    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 RO7105705 in Patients with Prodromal to Mild Alzheimer’s disease
    Estudio para evaluar la eficacia y seguridad de RO7105705 en pacientes con enfermedad de Alzheimer de Prodromal a Leve
    A.4.1Sponsor's protocol code numberGN39763
    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 codeRO710-5705
    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
    E.1.1.1Medical condition in easily understood language
    AD is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually the ability to carry out the simplest tasks
    EA es un desorden irreversible, progresivo del cerebro que lentamente destruye la memoria y las habilidades del pensamiento y eventualmente la capacidad de llevar a cabo las tareas mas sencillas.
    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 efficacy of RO7105705 compared with placebo
    •To evaluate the safety and tolerability of RO7105705 compared with placebo
    •Evaluar la eficacia de RO7105705 en comparación con placebo
    •Evaluar la seguridad y tolerabilidad de RO7105705 en comparación con placebo
    E.2.2Secondary objectives of the trial
    •To evaluate the effect of RO7105705 on cognition compared with placebo
    •To evaluate the effect of RO7105705 on activities of daily living compared with placebo
    •To characterize the pharmacokinetics of RO7105705
    •To evaluate the immune response to RO7105705

    Exploratory objective
    •To evaluate the effect of RO7105705 on pathological burden of tau, using tau PET imaging
    •Evaluar la eficacia de RO7105705 en la función cognitiva en comparación con placebo
    •Evaluar el efecto de RO7105705 en las actividades diarias en comparación con placebo
    •Caracterizar la FC de RO7105705
    •Evaluar la respuesta inmunitaria a RO7105705
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age between 50 and 80 years
    - National Institute on Aging/Alzheimer’s Association core clinical criteria for probable AD dementia or mild cognitive impairment (prodromal AD)
    - Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid Aβ1−42 OR amyloid positron emission tomography (PET) scan. Historical amyloid PET scans may be accepted in some cases
    - Mild AD symptomatology, as defined by a screening Mini-Mental State Examination score of >= 20 points and Clinical Dementia Rating (CDR) −Global Score of 0.5 or 1
    - Abnormal memory function at screening
    - Availability of a person with sufficient contact with the patient to be able to provide accurate information on the patient’s cognitive and functional ability
    -Tener una edad de entre 50 y 80 años
    -Criterio clínico principal según el NIA-AA de probable demencia por EA o EAp
    -Indicios de un proceso patológico de EA, obtenidos por una evaluación positiva para amiloide bien por una concentración de Aβ1−42 en el LCR O BIEN por una imagen de TEP de amiloide. Imagenes de TEP de amiloide históricas podrían ser aceptadas en algunos casos
    -Sintomatología de EAl según una puntuación de >= 20 puntos en el MEC realizado en el momento de la selección y de 0,5 o 1 en la CDR-GS.
    -Funcionamiento anómalo de la memoria en el momento de la selección
    -FVD).
    -Disponibilidad de una persona que tiene contacto frecuente y suficiente con el paciente para proporcionar información precisa sobre las habilidades cognitivas y funcionales del paciente
    E.4Principal exclusion criteria
    - Pregnant or breastfeeding
    - Inability to tolerate magnetic resonance imaging (MRI) procedures or contraindication to MRI
    - Able to undergo either PET imaging or lumbar dural puncture, or both, and patients with contraindications to both procedures are ineligible
    - Residence in a skilled nursing facility
    - Any serious medical condition or abnormality in clinical laboratory tests that remains abnormal on retest and, 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
    - Alcohol or 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 and any passive immunotherapy (immunoglobulin) against tau, except use of RO7105705 in Genentech Study GN39058, as long as the last dose was at least 90 days prior to screening
    - Use of any passive immunotherapy (immunoglobulin) against Aβ, unless the last dose was at least 1 year prior to screening and any active immunotherapy (vaccine) that is under evaluation to prevent or postpone cognitive decline
    - Any previous treatment with medications specifically intended to treat Parkinsonian symptoms or any other 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, which is permitted except within 2 days or 5 half-lives (whichever is longer) prior to any COA such as atypical antipsychotics, Opiates or opioids ,Benzodiazepines, barbiturates, or hyponotics and any medication with 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
    -Mujeres embarazadas o en periodo de lactancia
    -Incapacidad para tolerar los procedimientos de RMN o contraindicación para realizar RMN
    -Los pacientes deben poder someterse bien a las pruebas de diagnóstico de TEP o a la punción lumbar epidural, o a ambas. Los pacientes con contraindicaciones para ambos procedimientos no son aptos para participar en este estudio.
    -Residencia en un centro especializado de enfermería
    -Cualquier afección médica grave o anomalía en los análisis clínicos y cuyo resultado anómalo permanezca al volver a realizar el análisis y 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
    -Dependencia del alcohol o de las drogas en los últimos 2 años.
    -Uso de un tratamiento experimental durante 90 días o 5 semividas antes de la selección, lo que tenga una mayor duración y uso de inmunoterapia pasiva (inmunoglobulina) contra tau, excepto el uso de MTAU9937A en el estudio de Genetech GN39058, siempre y cuando la última dosis se administrara al menos 90 días antes de la selección.
    -Uso de inmunoterapia pasiva (inmunoglobulina) contra Aβ, a menos que la última dosis se administrara al menos un año antes de la selección y uso de inmunoterapia activa (vacuna) que se evalúa para prevenir o posponer el deterioro cognitivo.
    -Cualquier tratamiento previo con medicación específica para el tratamiento de síntomas parkinsonianos o cualquier otro trastorno neurodegenerativo en el plazo de 1 año antes de la selección.
    -Tratamiento inmunosupresor sistémico en el plazo de 12 meses antes de la selección y 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 los siguientes tipos de medicación, excepto si se trata de un uso intermitente de corta duración, que se permite excepto 2 días o 5 semividas (lo que tenga una mayor duración) antes de cualquier ERC tales como antipsicóticos atípicos, Opiáceos u opioides (incluida la medicación opioide de acción prolongada), Benzodiacepinas, barbitúricos o hipnóticos, o cualquier medicación con antihistamínico de acción central o actividad anticolinérgica.
    -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 on the CDR−Sum of Boxes
    2. Nature, frequency, severity, and timing of adverse events and serious adverse events.
    3. Changes from baseline in vital signs, physical findings, neurologic findings, ECG, and clinical laboratory results during and following RO7105705 administration
    4. Nature, frequency, severity, and timing of neuroimaging abnormalities
    5. Changes from baseline in suicidal ideation and behavior during and following RO7105705 administration
    1. Cambio desde basal en el CDR-SB
    2. La naturaleza, frecuencia, intensidad y momento en el que se producen los acontecimientos adversos y acontecimientos adversos graves.
    3. Cambios con respecto al inicio de las constantes vitales, los hallazgos físicos, los hallazgos neurológicos, ECG y los resultados de análisis clínicos durante y después de la administración de RO7105705
    4.Naturaleza, frecuencia, intensidad y momento en el que se producen las anomalías en neuroimágenes
    5. Cambios con respecto al inicio en los pensamientos y comportamiento suicidas durante y después de la administración de RO7105705
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline to Week 73, Baseline to 39 months if participating in the OLE
    2-5. Baseline to Week 81, Baseline to 42 months if participating in the OLE
    1. De basal a la semana 73, de basal al mes 39 si participan en el OLE
    2-5. De basal a la semana 81, de basal al mes 42 si participan en el OLE
    E.5.2Secondary end point(s)
    1. Change from baseline on the RBANS
    2. Change from baseline on the Alzheimer’s disease Assessment Scale−Cognitive
    Subscale 13
    3. Change from baseline on the Amsterdam Instrumental Activity of Daily Living questionnaire
    4. Change from baseline on the Alzheimer’s disease Cooperative Study Group−Activities of Daily Living Inventory
    5. Serum concentrations of RO7105705 at specified timepoints
    6. Presence of anti-drug antibody during the study relative to their presence at baseline

    Exploratory endpoint
    1. Change from baseline in brain tau burden as measured by [18F] GTP1 PET
    1. Cambio desde basal en el RBANS
    2. Cambio desde basal en el ADAS-Cog 13
    3. Cambio desde basal en el cuestionario Amsterdam iADL
    4. Cambio desde basal en el ADCS-ADL
    5. Concentraciones séricas de RO7105705 en puntos temporales determinados
    6. Presencia de anticuerpos antifármaco durante el estudio en relación con la presencia de AAF al inicio
    Objetivo exploratorio
    1. Cambios desde basal en la carga cerebral de la proteína tau según una TEP con [18F]GTP1
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4. Baseline to Week 73, Baseline to 39 months if participating in the OLE
    5-6. Baseline to Week 81, Baseline to 42 months if participating in the OLE

    Exploratory Timepoint
    1. Baseline to Week 73, Baseline to 39 months if participating in the OLE
    1-4. De basal a la semana 73, de basal al mes 39 si participan en el OLE
    5-6. De basal a la semana 81, de basal al mes 42 si participan en el OLE
    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 trial3
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Australia
    Belgium
    Canada
    Denmark
    Finland
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    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 this study is defined as the date when the last patient, last visit occurs or the date at which safety follow-up is received from the last patient, whichever occurs later. The end of the study is expected to occur 43 months after the last patient is enrolled.
    El final de este estudio se define como la fecha en la que el último paciente acude a la última visita o la fecha en la que el último paciente recibe el seguimiento de la seguridad, lo que ocurra más tarde. Se espera que el final del estudio se produzca 43 meses después de inscribir al último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 280
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 176
    F.4.2.2In the whole clinical trial 360
    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 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 Decision2018-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-01-15
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