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    Summary
    EudraCT Number:2018-002783-88
    Sponsor's Protocol Code Number:331-201-00182
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-10-25
    Trial 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 number2018-002783-88
    A.3Full title of the trial
    A 12-week, Multicenter, Active-treatment Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer’s Type
    Estudio de extensión con tratamiento activo, multicéntrico, de 12 semanas para evaluar la seguridad y la tolerabilidad del brexpiprazol en el tratamiento de sujetos con agitación asociada con la demencia de tipo Alzheimer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12-week, Multicenter, Active-treatment Extension Trial to check how safe, tolerable and effective Brexpiprazole is in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer’s Type
    Estudio de extensión con tratamiento activo, multicéntrico, de 12 semanas para evaluar la seguridad y la tolerabilidad del brexpiprazol en el tratamiento de sujetos con agitación asociada con la demencia de tipo Alzheimer
    A.4.1Sponsor's protocol code number331-201-00182
    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 SponsorOtsuka Pharmaceutical Development & Commercialization, 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 supportOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOtsuka Pharmaceutical
    B.5.2Functional name of contact pointJocelyn Ottinger
    B.5.3 Address:
    B.5.3.1Street Address2440 Research Boulevard
    B.5.3.2Town/ cityRockville
    B.5.3.3Post code20850
    B.5.3.4CountryUnited States
    B.5.6E-mailjocelyn.ottinger@otsuka-us.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 Yes
    D.2.1.1.1Trade name REXULTI®
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Development & Commercialization, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameBrexpiprazole
    D.3.2Product code OPC-34712
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBrexpiprazole
    D.3.9.1CAS number 913611-97-9
    D.3.9.2Current sponsor codeOPC-34712
    D.3.9.3Other descriptive nameBREXPIPRAZOLE
    D.3.9.4EV Substance CodeSUB91646
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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) 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 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 Yes
    D.2.1.1.1Trade name REXULTI®
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Development & Commercialization, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameBrexpiprazole
    D.3.2Product code OPC-34712
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBrexpiprazole
    D.3.9.1CAS number 913611-97-9
    D.3.9.2Current sponsor codeOPC-34712
    D.3.9.3Other descriptive nameBREXPIPRAZOLE
    D.3.9.4EV Substance CodeSUB91646
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) 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 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 Yes
    D.2.1.1.1Trade name REXULTI®
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Development & Commercialization, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameBrexpiprazole
    D.3.2Product code OPC-34712
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBrexpiprazole
    D.3.9.1CAS number 913611-97-9
    D.3.9.2Current sponsor codeOPC-34712
    D.3.9.3Other descriptive nameBREXPIPRAZOLE
    D.3.9.4EV Substance CodeSUB91646
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) 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 No
    D.IMP: 4
    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 REXULTI®
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Development & Commercialization, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameBrexpiprazole
    D.3.2Product code OPC-34712
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBrexpiprazole
    D.3.9.1CAS number 913611-97-9
    D.3.9.2Current sponsor codeOPC-34712
    D.3.9.3Other descriptive nameBREXPIPRAZOLE
    D.3.9.4EV Substance CodeSUB91646
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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) 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 No
    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
    Agitation Associated With Dementia of the Alzheimer's Type
    Agitación asociada a la demencia de tipo Alzheimer (AAD)
    E.1.1.1Medical condition in easily understood language
    Agitation in dementia due to Alzheimer's Disease
    Agitación en demencia debido a la enfermedad de Alzheimer
    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 PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult subjects with Agitation in Alzheimer’s dementia (AAD).
    Evaluar la seguridad y tolerabilidad a largo plazo del brexpiprazol oral como tratamiento de sujetos adultos con AAD.
    E.2.2Secondary objectives of the trial
    Exploratory:To assess the long-term efficacy of oral brexpiprazole as treatment in adult subjects with Agitation in Alzheimer’s dementia.
    Exploratorios: Evaluar la eficacia a largo plazo del brexpiprazol oral como tratamiento de adultos con AAD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.The investigator must assess the capacity of the subject to provide informed consent prior to enrollment. Once this determination is made by the investigator, the options for obtaining informed consent from or on behalf of the subject must be followed as provided in the protocol.
    2.Subjects who completed 12 weeks of post-randomization treatment in Trial 331-14-213.
    3.Institutionalized subjects with an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the subject’s symptoms and has direct observation of the subject’s behavior. The identified caregiver can be a staff member of the institutionalized setting or another individual (eg, family member, family friend, hired professional caregiver) who meets the caregiver requirements.
    Non-institutionalized subjects may not be living alone and must have an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the subject’s symptoms and has direct observation of the subject’s behavior.
    4.Subjects who are able to satisfactorily comply with the protocol requirements.
    1. Los investigadores deben valorar la capacidad del sujeto para proporcionar el consentimiento informado antes del reclutamiento. Una vez que el investigador ha hecho esta determinación, las opciones para obtener el consentimiento informado de o en nombre del sujeto deben ser seguidas como se indica en el protocolo.
    2. Sujetos que completaron 12 semanas de tratamiento después de la aleatorización en el estudio 331-14-213.
    3. Sujetos que viven en una institución con un cuidador identificado que tenga un contacto suficiente (mínimo de 2 horas al día durante 4 días a la semana) para describir los síntomas del sujeto y tenga observación directa de la conducta del sujeto. El cuidador identificado puede ser un miembro del personal de la institución u otro individuo (p.ej. familiar, amigo de la familia, cuidador profesional contratado) que cumpla los requisitos de cuidador.
    4. Sujetos que son capaces de cumplir satisfactoriamente con los requerimientos del protocolo.
    E.4Principal exclusion criteria
    1.Subjects who, in the opinion of the investigator, medical monitor, or sponsor, should not participate in the trial.
    2.Subjects with a substantial protocol violation during the course of their participation in the double-blind Trial 331-14-213. Lesser violations such as occasional visits outside of the acceptable window or a missing blood draw will not exclude a subject from participation in Trial 331-201-00182; however, continual lack of compliance with the visit schedule, trial assessments, or treatment regimen in the prior double-blind trial would be considered a substantial violation that would result in exclusion from Trial 331-201-00182. The medical monitor should be contacted if the investigator is unsure of a subject’s eligibility.
    1. Sujetos que, en opinión del investigador, monitor médico o promotor, no deban participar en el estudio clínico.
    2. Sujetos que cometan un incumplimiento importante del protocolo durante su participación en el estudio doble ciego 331 14-213. Los incumplimientos menores, por ejemplo, visitas esporádicas fuera del margen de tiempo permitido o pérdida de una extracción de sangre, no excluirán al sujeto de la participación en el estudio 331-201-00182, si bien la falta continuada de cumplimiento con el calendario de visitas, con las evaluaciones del estudio o con la pauta de tratamiento en el estudio precedente doble ciego se considerará un incumplimiento importante del protocolo que sí daría lugar a la exclusión del estudio 331-201-00182. Si el investigador no está seguro de la idoneidad del sujeto, debe contactar con el monitor médico.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome variable is the frequency and severity of adverse events (AEs; safety and tolerability of brexpiprazole).
    La variable principal de valoración es la frecuencia y gravedad de los acontecimientos adversos (AA; seguridad y tolerabilidad del brexpiprazol).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary safety analysis is the frequency and severity of AEs
    El análisis principal de seguridad es la frecuencia y gravedad de los AA
    E.5.2Secondary end point(s)
    Exploratory efficacy endpoints are as follows:
    •Change from baseline CMAI total score at Week 6, Week 12, and last available visit
    •Change from baseline Clinical Global Impression Severity of Illness (CGI-S) score, as related to agitation, at Week 6, Week 12, and last available visit
    Los criterios exploratorios de valoración de la eficacia se definen a continuación:
    • Cambio de la puntuación total CMAI inicial en la semana 6, semana 12 y última visita disponible
    • Cambio de la puntuación CGI-S inicial, relacionado con la agitación, en la semana 6, semana 12 y última visita disponible
    E.5.2.1Timepoint(s) of evaluation of this end point
    CMAI: Change from baseline CMAI total score at Week 6, Week 12, and last available visit
    CGI-S: Change from baseline CGI-S score at Week 6, Week 12, and last available visit
    CMAI: Cambio de la puntuación total CMAI inicial en la semana 6, semana 12 y última visita disponible
    CGI-S: Cambio de la puntuación CGI-S inicial, relacionado con la agitación, en la semana 6, semana 12 y última visita disponible
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Para preservar el ciego en el ensayo 331-14-213, las dosis en el estudio 331-201-00182 serán ciegas
    To preserve the blind in Trial 331-14-213, all doses in Trial 331-201-00182 will remain blinded.
    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
    Para preservar el ciego en el ensayo 331-14-213, las dosis en el estudio 331-201-00182 serán ciegas
    To preserve the blind in Trial 331-14-213, all doses in Trial 331-201-00182 will remain blinded
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Bulgaria
    Hungary
    Serbia
    Spain
    Ukraine
    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 trial date is defined as the last date of contact or the date of final contact attempt from the post-treatment follow-up eSource page for the last subject completing or withdrawing from the trial.
    La fecha de fin del ensayo se define como la última fecha de contacto o la fecha del intento de contacto final en la página de seguimiento posterior al tratamiento para el ultimo sujeto completado y discontinuado del ensayo.
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 205
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Due to the disease condition i.e. dementia due to Alzheimer's disease.
    Debido a las características de la enfermedad i.e. demencia debido a la enfermedad de Alzheimer
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with dementia fall under vulnerable group
    Pacientes con demencia entran en la categoría de vulnerables
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 225
    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 will revert to normal standard of care.
    Los pacientes volverán a la atención estandar normal
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-17
    P. End of Trial
    P.End of Trial StatusOngoing
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