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    Summary
    EudraCT Number:2013-001119-54
    Sponsor's Protocol Code Number:H8A-MC-LZAX
    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:2013-08-14
    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 number2013-001119-54
    A.3Full title of the trial
    Effect of Passive Immunization on the Progression of Mild Alzheimer?s Disease: Solanezumab (LY2062430) versus Placebo
    Efecto de la inmunización pasiva en la progresión de la enfermedad de Alzheimer leve: solanezumab (LY2062430) frente a placebo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Progress of Mild Alzheimer?s Disease in Patients on Solanezumab versus Placebo
    Progreso de la enfermedad de Alzheimer leve en pacientes con Solanezumab versus Placebo.
    A.3.2Name or abbreviated title of the trial where available
    EXPEDITION 3
    EXPEDITION 3
    A.4.1Sponsor's protocol code numberH8A-MC-LZAX
    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 SponsorEli Lilly and Company
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post codeIN 46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameSolanezumab
    D.3.2Product code LY2062430
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSolanezumab
    D.3.9.2Current sponsor codeLY2062430
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typehumanized IgG1 monoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild Alzheimer's Disease
    Enfermedad de Alhzmeimer leve.
    E.1.1.1Medical condition in easily understood language
    Mild Alzheimer's Disease
    Enfermedad de Alhzmeimer leve.
    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 16.0
    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 test the hypothesis that solanezumabwill slow the cognitive and functional decline of AD as compared with placebo in patients with mild AD.
    Probar la hipótesis de que solanezumab ralentizará el deterioro cognitivo y funcional asociado a la enfermedad de Alzheimer (EA) en comparación con el placebo, en pacientes con EA leve.
    E.2.2Secondary objectives of the trial
    ? To assess the relationship between treatment effect and time.
    ? To test the hypothesis that solanezumab will slow the rate of cognitive and functional decline associated with ADassessed using a slope analysis from a repeated-measures model.
    ? Evaluar la relación entre el efecto del tratamiento y el tiempo.
    ? Probar la hipótesis de que solanezumab ralentizará la tasa de deterioro cognitivo y funcional asociada a la EA, en comparación con el placebo evaluada mediante un análisis de la pendiente del modelo para medidas repetidas.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    H8A-MC-LZAX Addendum ? Lumbar Punctures
    Lumbar punctures will be used to collect cerebrospinal fluid (CSF) for assays of several CSF measures
    H8A-MC-LZAX(1) (punciones lumbares)
    Las punciones lumbares se utilizarán para extraer líquido cerebroespinal para evaluar diversas medidas del líquido crebroespinal.
    E.3Principal inclusion criteria
    [1] Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer?s Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD.
    [2] Has a Modified Hachinski Ischemia Scale score of less than or equal to 4.
    [3] Has an MMSE score of 20 through 26 at Visit 1 (Screening visit).
    [4] Has a Geriatric Depression Scale score of less than or equal to 6 (on the staff-administered short form).
    [5] Has had an MRI or computerized tomography (CT) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of AD.
    [6] Male or female patients ages 55 to 90 years old.
    [7] Has a florbetapir PET scan or CSF result consistent with the presence of amyloid pathology at screening.
    [1] Cumplir los criterios de EA probable del National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer?s Disease and Related Disorders Association (NINCDS/ADRDA) (NINCDS/ADRDA).
    [2] Tener en la escala de isquemia de Hachinski modificada una puntuación menor o igual a 4.
    [3] Tener una puntuación de entre 20 y 26 en el MMSE en la visita 1
    [4] Tener una puntuación menor o igual a 6 en la escala de depresión geriátrica
    [5] Haberse sometido a una RM o tomografía computerizada (TC) en los dos últimos años, en la que se haya confirmado la ausencia de hallazgos incompatibles con un diagnóstico de EA.
    [6] Varones o mujeres de edades comprendidas entre los 55 y los 90 años.
    [7] Tener un resultado en la PET con florbetapir o el análisis de LCR que indique la presencia de patología amiloide en la selección.
    E.4Principal exclusion criteria
    [1] Does not have a reliable caregiver who is in frequent contact with the patient (defined as at least 10 hours per week), will accompany the patient to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications.
    [2] Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l?Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia.
    [3] Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator?s opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of <2 years.
    [4] Has had a history within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in protracted loss of consciousness.
    [5] Has a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen posttreatment.
    [6] Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
    [7] Has received AChEIs, memantine and/or other AD therapy for less than 4 months or has less than 2 months of stable therapy on these treatments
    [8] Has received medications that affect the central nervous system (CNS), except treatments for AD for less than 4 weeks.
    [1] No disponer de un cuidador fiable que esté en contacto frecuente con el paciente (definido como, al menos, 10 horas a la semana), que acompañe al paciente a la consulta y/o esté disponible por teléfono a las horas designadas y que controle la administración de los medicamentos prescritos.
    [3] Cumplir los criterios de demencia vascular establecidos por el National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l?Enseignement en Neurosciences (NINDS/AIREN) (NINDS/AIREN)
    Presentar enfermedades graves o inestables, incluyendo enfermedades cardiovasculares (como cardiopatía isquémica inestable), hepáticas, renales, gastroenterológicas, respiratorias, endocrinas, neurológicas (además de EA), psiquiátricas, inmunológicas o hematológicas y otras afecciones que, en opinión del investigador, podrían interferir en los análisis de la seguridad y eficacia del presente estudio o supongan una esperanza de vida inferior a 2 años.
    [5] Tener un historial en los últimos 5 años de enfermedad maligna primaria o recurrente, con las excepciones de carcinoma de células escamosas cutáneo extirpado in situ, carcinoma basocelular, carcinoma de cuello uterino in situ o cáncer de próstata in situ con unos valores normales de antígeno prostático específico tras el tratamiento.
    [6] Tener un historial conocido de infección por el virus de la inmunodeficiencia humana (VIH), alergias a fármacos múltiples e intensas clínicamente significativas, reacciones de hipersensibilidad intensas postratamiento.
    [7] Haber recibido AChEI, memantina y/u otro tratamiento para la EA durante menos de 4 meses o llevar menos de 2 meses de terapia estable con estos tratamientos antes de la visita 2.
    [8] Haber recibido medicamentos que afectan al sistema nervioso central (SNC), salvo tratamientos para la EA durante menos de 4 semanas; es decir, las dosis de medicaciones crónicas que afectan al SNC deberán haberse mantenido estables al menos durante las 4 semanas anteriores a la visita 2.
    E.5 End points
    E.5.1Primary end point(s)
    ADAS-Cog14 and ADCS-iADL
    ADAS-Cog14 y ADCS-iADL.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 0, 12, 28, 40, 52, 64, 80 and Early Discontinuation Visits
    Semana 0, 12, 28, 40, 52, 64, 80 y Visita de finalización temprana
    E.5.2Secondary end point(s)
    ADAS-Cog11, MMSE, ADCS-ADL, FAQ, CDR-SB, NPI, RUD-Lite, QoL-AD, and EQ-5D Proxy.
    ADAS-Cog11, MMSE, ADCS-ADL, FAQ, CDR-SB, NPI, RUD-Lite, QoL-AD y EQ-5D Proxy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 0, 28, 52, 80 and Early Discontinuation Visits
    Semana 0, 28, 52, 80 y Visita de finalización temprana
    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 Yes
    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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    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
    Germany
    Italy
    Poland
    Spain
    Sweden
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último 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 days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 420
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1680
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 530
    F.4.2.2In the whole clinical trial 2100
    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)
    Patients who complete this study may be eligible to participate in an open-label extension study. During the open-label extension study, all patients will receive solanezumab
    Pacientes que completen este estudio pueden ser elegible para participar en un estudio abierto de extensión.
    Durante este estudio de extensión abierto todos los pacientes recivirán solanezumab.
    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 Decision2013-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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