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    Summary
    EudraCT Number:2007-001975-12
    Sponsor's Protocol Code Number:V00191 PO 202
    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:2008-09-16
    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 number2007-001975-12
    A.3Full title of the trial
    Evaluación del efecto de 6 meses de tratamiento con V0191 sobre la evolución de los síntomas en pacientes con un déficit cognitivo leve. Estudio multicéntrico, de asignación aleatoria, doble ciego, en grupos paralelos controlado con placebo.
    A.4.1Sponsor's protocol code numberV00191 PO 202
    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 SponsorPIERRE FABRE MEDICAMENT - IDPF
    B.1.3.4CountryFrance
    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 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.3.2Product code V0191
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeV0191
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 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 placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Déficit cognitivo leve
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009846
    E.1.2Term Cognitive impairment
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la mejoría cognoscitiva en pacientes con deterioro cognitivo leve tipo Alzheimer tras 6 meses de tratamiento con V0191.
    E.2.2Secondary objectives of the trial
     Evaluar la mejoría de la memoria,
     Evaluar el efecto sobre las actividades de la vida diaria,
     Evaluar la mejoría clínica global percibida por el paciente y calificada por el investigador,
     Evaluar la seguridad y tolerabilidad del producto.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Hombres o mujeres con edad comprendida entre los 55 y los 90 años
    - Deterioro cognitivo progresivo que cumple criterios de déficit cognitivo leve:
    * quejas de memoria, corroboradas por la familia inmediata,
    * síndrome amnésico de tipo Hipocámpico (aislado o asociado a otros déficit cognitivos) que en el test de Grober y Buschke dé los resultados siguientes: evocación libre ≤20, evocación total ≤40,
    * actividades de la vida diaria normales o suficientemente conservadas como para excluir el diagnóstico de demencia,
    * ausencia de demencia(DSM-IV),
    - Puntuación en el mini-examen mental (MMSE) entre 24 y 30,
    - Puntuación global de 0.5 en la escala CDR con: una puntuación en el dominio “memoria” de 0´5 o 1, ninguna puntuación > 1
    - Haber otorgado por escrito su consentimiento informado para participar en el estudio,
    - Si lo estipulan las leyes reguladoras nacionales, pacientes cubiertos por la Seguridad social o algún sistema de seguro de salud.
    E.4Principal exclusion criteria
    CRITERIOS RELACIONADOS CON LA ENFERMEDAD BAJO ESTUDIO
     pacientes con sospecha diagnóstica o diagnóstico firme de demencia,
     presencia de enfermedad grave que pueda amenazar a la vida en plazo breve,
     enfermedad vascular cerebral manifiesta con una puntuación en la escala de Hachisnki >4,
     paciente con un trastorno psiquiátrico progresivo o mal equilibrado según el DSM-IV, especialmente:
    - episodio depresivo mayor en curso o depresión recurrente, o trastorno bipolar según el DSM-IV, y/o una puntuación ≥ 12 en la escala Hamilton de depresión de 17 puntos,
    - paciente con alucinaciones tempranas o fluctuaciones cognitivas,
     paciente con los trastornos neurológicos siguientes: epilepsia, demencia por cualquier causa, enfermedad de Parkinson, presencia de imágenes que sugieran enfermedad vascular
     Paciente con déficit conocido de Vitamina B12 o Folato (a no ser que haya recibido suplementos a dosis estables durante un mínimo de 6 meses antes de la selección) o sífilis conocida.
     paciente con síndrome de apnea del sueño.

    CRITERIOS RELACIONADOS CON LA MEDICACIÓN PREVIA O SIMULTÁNEA
     paciente con alergia conocida al producto en investigación o a alguno de sus ingredientes,
     paciente con hipertensión inestable (PAS > 160 mmHg y/o PAD >95 mmHg) evaluado por el investigador,
     paciente tratado previamente con agentes anti-colinesterasa de acción central o Memantina independientemente de la duración del tratamiento y de la fecha de prescripción,
     paciente que esté actualmente recibiendo tratamiento con un producto indicado para el tratamiento sintomático del deterioro crónico neuro-sensorial o cognitivo del anciano (Gingko biloba, Almitrina, Piracetam, etc),
     pacientes que hayan recibido, durante los dos meses previos a la inclusión, tratamiento con un producto indicado para el tratamiento sintomático del deterioro crónico neuro-sensorial o cognitivo del anciano (Gingko biloba, Almitrina, Piracetam, etc).
     pacientes que reciban durante el estudio tratamiento con medicación prohibida.

    CRITERIOS RELACIONADOS CON LOS PACIENTES
     pacientes con trastornos visuales o auditivos incompatibles con la realización y/o interpretación de los test neuro-psicológicos,
     pacientes que vivan en un asilo,
     pacientes que carezcan de un círculo fiable,
     pacientes incapaces de tomar el producto experimental según se estipula para toda la duración del estudio,
     pacientes que tengan criterios de abuso o dependencia de sustancias psicoactivas (según el DSM-IV)
    pacientes sometidos a inmunosupresión o que padezcan diabetes mellitus insulín-dependiente o diabetes mellitus no estabilizada con medidas dietéticas y/o hipoglucemiantes orales, enfermedad pulmonar obstructiva crónica, asma inestable, trastornos hematológicos u oncológicos recientes (≤ 2 años)
     antecedentes o procesos en curso, gastrointestinales, hepáticos o renales, o cualquier otro proceso que se sepa que interfiere con la absorción, distribución, metabolismo o excreción de los productos medicamentosos.
     antecedente de un episodio cardiovascular en los 6 meses previos.
     paciente con enfermedad aguda o crónica grave considerada por el investigador como incompatible con el cumplimiento del estudio.
     mujeres no menopáusicas.
    E.5 End points
    E.5.1Primary end point(s)
    Comparación entre los dos grupos del porcentaje de pacientes con un descenso en la puntuación ADAS-cog de 4 puntos o más comparado con la basal.
    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 No
    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 Information not present in EudraCT
    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.8.3 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El final del estudio es el día de la última visita del último paciente del ensayo.
    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
    E.8.9.2In all countries concerned by the trial months16
    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 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 state210
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 210
    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 Decision2008-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-12-16
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