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    Summary
    EudraCT Number:2007-000414-36
    Sponsor's Protocol Code Number:IG0602
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-04-17
    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 number2007-000414-36
    A.3Full title of the trial
    ESTUDIO FASE II PARA VALORAR LA EFICACIA Y SEGURIDAD DEL RECAMBIO PLASMÁTICO CON ALBÚMINA 5% EN EL ACLARAMIENTO DEL PÉPTIDO BETA-AMILOIDE EN LÍQUIDO CEFALORRAQUÍDEO, Y SUS EFECTOS EN PACIENTES CON ENFERMEDAD DE ALZHEIMER LEVE-MODERADA
    A.4.1Sponsor's protocol code numberIG0602
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstituto Grifols, S.A.
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name Albumina Humana Grifols 5%, solución para persfusión intravenosa
    D.2.1.1.2Name of the Marketing Authorisation holderInstituto Grifols, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameAlbumina humana Grifols 5%, solucion para perfusion intravenosa
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNAlbumina humana
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Enfermedad de Alzheimer, leve a moderada
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar si el recambio plasmático con albumina humana 5% es capaz de modificar la concentración de beta-amiloide en el LCR en el grupo de tratamiento de pacientes con enfermedad de Alzheimer.
    E.2.2Secondary objectives of the trial
    Evaluar variación de otros parámetros (P-tau, ß-secretasa, G-secretasa, nicastrina)
    Evaluar si la plasmaféresis con albumina humana 5% es capaz de modificar la concentración plasmática beta-amiloide
    Evaluar la cantidad de B-amiloide en plasma extraído al paciente en cada plasmaféresis
    Evaluar las variaciones en los dominios cognitivo, funcional, conductual y global mediante las escalas y baterías psicométricas
    Evaluar los cambios estructurales de volumen del hipocampo, área posterior del cíngulo y otras areas de asociación mediante RM (respecto al basal) y variaciones en la hipoperfusión por SPECT
    Evaluar las variaciones cognitivas y conductuales
    Evaluar la seguridad de la plasmaféresis con albumina humana 5% según los factores: 1Tipo, gravedad y frecuencia de las reacciones adversas durante y después del procedimiento. 2Cambios en signos vitales y cambios clínicamente relevantes según los parámetros de laboratorio. 3Control de episodios de accidentes vasculares cerebrales por RM
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    . Hombres o mujeres de edad comprendida entre 55 y 85 años de edad cuando firmen el consentimiento informado.
    2. Que se les haya diagnosticado una enfermedad de Alzheimer probable, de leve a moderada (criterio NINCDS_ADRDA), y un Minimental Status Examination (MMSE) de entre 18 y 26.
    3. Estar en tratamiento estable con inhibidores de acetilcolinesterasa durante los últimos 3 meses
    4. Haber leído (ya sea el propio paciente, un familiar cercano o representante legal) la hoja de información al paciente, estar de acuerdo con participar en el ensayo clínico y haber firmado el consentimiento informado (el propio paciente y un familiar cercano o representante legal).
    5. Ser capaces de seguir los procedimientos del protocolo, recibir el tratamiento en el periodo de tiempo establecido y continuar en el periodo de seguimiento.
    6. Disponer de la RM o TAC craneal realizada dentro de los doce meses previos al reclutamiento con ausencia de patología vascular cerebral.
    7. Presencia de un cuidador estable y que asista a las visitas del paciente en estudio
    E.4Principal exclusion criteria
    1. Cualquier contraindicación para el recambio plasmático debido a trastornos conductuales o parámetros de coagulación anormales, como por ejemplo:
    a- Hipocalcemia (Ca < 8,7 mg/dl).
    b- Trombocitopenia (<100.000/l).
    c- Fibrinógeno <1,5 g/l.
    d- Tiempo de protrombina (Quick) p<60% respecto al control.
    e- Tratamiento betabloqueante y bradicardia <60/min.
    f- Tratamiento con inhibidores del enzima convertidor de angiotensina (aumento del riesgo de reacción alérgica).
    2. Dificil acceso venoso que impida el recambio plasmático.
    3. Antecedentes de reacciones adversas frecuentes (ya sean graves o no) a productos hemoderivados.
    4. Hipersensibilidad a la Albumina o alergias a cualquiera de los componentes de la Albumina Humana Grifols 5%.
    5. Creatinina en plasma > 2 mg/dl.
    6. Hipertension arterial no controlada.
    7. Cirrosis hepática o cualquier alteración hepática con alanina aminotransferasa (GPT) > 2,5xLSN ó bilirrubina > 2 mg/dl.
    8. Enfermedades cardíacas incluyendo antecedentes de enfermedades coronarias e insuficiencia cardíaca.
    9. Haber participado en otros ensayos clínicos o haber recibido cualquier otro fármaco en investigación durante los 3 meses previos al inicio del estudio.
    10. Cualquier condición que dificulte el cumplimiento del protocolo (enfermedades con menos de un año de superviencia, hábitos tóxicos, etc.).
    11. Mujeres embarazadas o en periodo de lactancia o mujeres que no usen un método anticonceptivo adecuado como mínimo hasta 1 mes después del recambio plasmático.
    12. Nivel de estudios inferior a 6 años de escolarización.
    13. Alteraciones de conducta previas que requieran tratamiento farmacológico, incluyendo el insomnio.
    E.5 End points
    E.5.1Primary end point(s)
    Variación de los niveles de AB1-42 en LCR en el periodo comprendido entre la punción lumbar basal (antes del inicio del tratamiento) y la punción lumbar inmediatamente posterior a la finalización del último recambio plasmático, cuando quiera que éste se produzca.
    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 Yes
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Simulación de la Plasmaféresis
    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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pacientes con enfermedad de Alzheimer
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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 Decision2007-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-03-07
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