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    Summary
    EudraCT Number:2007-000213-11
    Sponsor's Protocol Code Number:CENA713D2340
    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:2007-07-20
    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 number2007-000213-11
    A.3Full title of the trial
    Estudio aleatorizado, doble ciego, con grupos paralelos y de 48 semanas de duración para evaluar la eficacia comparativa, la seguridad y la tolerabilidad de Exelon® en parche de 10 y 15 cm2 en pacientes con enfermedad de Alzheimer que presentan deterioro cognitivo durante la fase inicial de tratamiento abierto.
    A.3.2Name or abbreviated title of the trial where available
    OPTIMA
    A.4.1Sponsor's protocol code numberCENA713D2340
    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 SponsorNovartis Farmacéutica
    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 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 nameExelon Patch (15 cm2)
    D.3.2Product code ENA713
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTransdermal use
    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.IMP: 2
    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 nameExelon Patch (10cm2)
    D.3.2Product code ENA713
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTransdermal use
    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.IMP: 3
    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 nameExelon Patch 5 cm2
    D.3.2Product code ENA713
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTransdermal use
    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 placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Demencia en enfermedad de Alzheimer
    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
    El objetivo primario de este estudio es comparar la eficacia de Exelon® en parche 10 cm2 objetivo vs. Exelon® en parche 15 cm2 objetivo en pacientes que han mostrado deterioro cognitivo en la fase inicial de tratamiento abierto (Exelon® en parche de 10 cm2) en relación con el cambio en la función cognitiva (evaluada mediante la puntuación ADAS-Cog) entre la visita basal de aleatorización doble ciego y la semana 48 de la fase de tratamiento doble ciego.
    E.2.2Secondary objectives of the trial
    1. Comparar la eficacia de Exelon® en parche de 10 cm2 dosis objetivo vs. Exelon® en parche de 15 cm2 dosis objetivo en pacientes que han mostrado un deterioro cognitivo en la fase inicial de tratamiento abierto (Exelon® en parche de 10 cm2)

    •Comparar la seguridad y tolerabilidad de Exelon® en parche de 10 cm2 dosis objetivo vs. Exelon® en parche de 15 cm2 dosis objetivo en la fase de tratamiento doble ciego .
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cada paciente cumplirá los criterios de inclusión siguientes en el momento de la visita basal (visita 2):
    1. Edad entre 50 y 85 años;
    2. Ser varón o mujer no potencialmente fértil (esterilización quirúrgica o al menos un año en estado post-menopáusico);
    3. Diagnóstico de demencia tipo Alzheimer conforme a los criterios DSM IV
    4. Diagnóstico clínico de Enfermedad de Alzheimer (EA) probable conforme a los criterios NINCDS/ADRDA. La RM o la TC cerebral empleadas para establecer que se cumplen estos criterios deben haberse realizado en los dos años previos a la visita basal;
    5. Puntuación basal del Mini-Mental State Examination (MMSE) ≥ 10 y ≤ 24
    6. Nivel cultural suficiente para poder leer, escribir y comunicarse de manera efectiva durante el estado premórbido;
    7. Actitud de cooperación, con voluntad de llevar a cabo todos los aspectos del estudio y estar capacitado para ello, ya sea solo o con la ayuda de un cuidador responsable;
    8. Vivir con alguna persona de la comunidad a lo largo de todo el estudio o, en caso de que se viva solo, que mantenga contactos regulares con su cuidador principal;
    9. Un cuidador principal dispuesto a asumir la responsabilidad de supervisar el tratamiento (por ej., aplicación y retirada del parche cada día aproximadamente a la misma hora), de evaluar el estado del paciente a lo largo de todo el estudio, y de aportar información para las evaluaciones de eficacia de acuerdo con todos los requerimientos del protocolo;
    10. Se permite tomar parte en este estudio a los pacientes que residan en viviendas asistidas siempre y cuando sean evaluados en el centro de estudio y cuenten con un cuidador que cumpla los requerimientos del protocolo.
    E.4Principal exclusion criteria
    Todo paciente no debe cumplir alguno de los criterios de exclusión siguientes en el momento de la visita basal (visita 2):
    1. Presencia de enfermedad en estadio avanzado, grave, progresiva o inestable de cualquier tipo que pueda interferir en las evaluaciones de la eficacia y seguridad o suponer un especial riesgo para el paciente;
    2. Cualquier patología médica o neurológica distinta a la EA que pueda explicar la demencia del paciente (por ej., pruebas funcionales tiroideas alteradas, déficit de vitamina B12 o de folato, estados post-traumáticos, enfermedad de Hungtinton, enfermedad de Parkinson, sífilis);
    3. Diagnóstico actual de demencia vascular probable o posible conforme a los criterios de National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l’Enseignement en Neurosciences (NINDS-AIREN);
    4. Diagnóstico actual conforme al DSM-IV de depresión mayor a no ser que se haya tratado satisfactoriamente con una dosis estable de un antidepresivo sin propiedades anticolinérgicas durante al menos 4 semanas;
    5. Cualquier otro diagnóstico en el eje 1 del DSM-VI que pueda interferir en la evaluación de la respuesta del paciente a la medicación del estudio, incluidas otras demencias neurodegenerativas primarias, esquizofrenia, o trastorno bipolar;
    6. Diagnóstico actual de trastorno convulsivo activo y no controlado;
    7. Historia en el último de año o diagnóstico actual de enfermedad cerebrovascular (por ej., accidente cerebrovascular o ictus; episodios isquémicos transitorios, aneurismas);
    8. Diagnóstico actual de enfermedad cardiovascular grave o inestable (por ej., cardiopatía coronaria inestable, arritmia cardíaca no controlada):
    9. Diagnóstico actual de bradicardia (< 50 latidos por minuto, síndrome del seno enfermo,
    defectos de conducción (bloqueo seno-auricular, bloqueo aurícula-ventricular de segundo o tercer grado);
    10. Diagnóstico actual de patologías asmáticas agudas, graves o inestables [por ej., enfermedad pulmonar obstructiva crónica grave (EPOC)];
    11. Diagnóstico actual de úlcera péptica activa no controlada o hemorragia gastrointestinal en los últimos tres meses:
    12. Obstrucción urinaria clínicamente significativa;
    13. Historia de neoplasia de algún órgano en los últimos 5 años a no ser que se compruebe que el paciente se halla estable y sin metástasis activas;
    14. Diagnóstico actual de lesión/trastorno cutáneo activo que impediría al paciente utilizar un parche transdérmico cada día;
    15. Historia de alergia a productos tópicos que contienen vitamina E;
    16. Discapacidad que pueda impedir al paciente llevar a cabo todos los requerimientos del estudio (por ej., ceguera, sordera, dificultad grave del lenguaje);
    17. Sensibilidad farmacológica exagerada documentada o hipersensibilidad a fármacos similares a la rivastigmina, o a otros compuestos colinérgicos (por ej., pilocarpina, betanecol, tacrina, donepezilo, velnacrina, metrifonato, galantamina, o fisostigmina);
    18. Haber tomado cualquiera de las sustancias siguientes antes de recibir el tratamiento de estudio:
    * Relajantes musculares tipo succinilcolina en las 2 semanas previas;
    * Litio durante las 2 semanas previas;
    * Un fármaco en investigación durante las 4 semanas previas;
    * Un fármaco o tratamiento que se conozca que causa toxicidad del sistema orgánico principal.
    * Cualquier medicación psicotrópica nueva o agente dopaminérgico o cualquier medicación psicotrópica o agente dopaminérgico que no se haya tomado en una dosis estable durante las 4 semanas previas;
    * Rivastigmina (parche oral o transdérmico), donepezilo, galantamina, otros inhibidores de la colinesterasa (por ej., tacrina, fisostigmina o piridostigmina), otros tratamientos aprobados para la enfermedad de Alzheimer durante las 2 semanas previas con excepción del tratamiento estable con memantina durante al menos 3 meses antes de la inclusión en el estudio (visita 1);
    • Fármacos anticolinérgicos de acción central incluidos los antidepresivos tricíclicos y
    tetracíclicos durante las 4 semanas previas;
    • Selegilina a no ser que el paciente reciba una dosis estable durante las 4 semanas previas;
    • Anticolinérgicos periféricos que no se han tomado en una dosis estable durante las 4 semanas previas.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy parameter: Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
    Secondary efficacy assessment parameters:
    • Alzheimer’s Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-Instrumental ADL)
    • Trail Making Test Part A & B
    • 10-item Neuropsychiatric Inventory (NPI-10).
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA86
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 660
    F.4.2.2In the whole clinical trial 1200
    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 Decision2007-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-04
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