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    Summary
    EudraCT Number:2015-002134-49
    Sponsor's Protocol Code Number:8931-019-07
    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:2015-11-04
    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 number2015-002134-49
    A.3Full title of the trial
    A Parallel-Group, Double-Blind, Long Term Safety and Efficacy Trial of MK-8931 (SCH 900931) in Subjects with Amnestic Mild Cognitive Impairment Due to Alzheimer?s Disease (Prodromal AD).
    This long term trial is an EXTENSION of the initial 104-week trial.
    Ensayo doble ciego, de grupos paralelos, de la eficacia y la seguridad a largo plazo de MK 8931 (SCH 900931) en sujetos con deterioro cognitivo leve amnésico por enfermedad de Alzheimer (EA prodrómica).
    Este estudio a largo plazo es una EXTENSIÓN del ensayo de 104 semanas inicial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Long Term Safety and Efficacy Trial of MK-8931 (SCH 900931) in Subjects with Prodromal AD (APECS).
    Ensayo de la eficacia y la seguridad a largo plazo de MK 8931 (SCH 900931) en sujetos con EA prodrómica.
    A.3.2Name or abbreviated title of the trial where available
    A Long Term Safety and Efficacy Trial of MK-8931 (SCH 900931) in Subjects with Prodromal AD (APECS)
    Ensayo de eficacia y la seguridad a largo plazo de MK 8931 (SCH 900931) en sujetos con EA prodrómica
    A.4.1Sponsor's protocol code number8931-019-07
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01953601
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España S.A.
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913210600
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.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 nameMK-8931
    D.3.2Product code MK-8931
    D.3.4Pharmaceutical form 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 INNMK-8931
    D.3.9.2Current sponsor codeMK-8931, SCH 900931
    D.3.9.3Other descriptive nameSCH 900931
    D.3.9.4EV Substance CodeSUB31364
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 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 nameMK-8931
    D.3.2Product code MK-8931
    D.3.4Pharmaceutical form 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 INNMK-8931
    D.3.9.2Current sponsor codeMK-8931, SCH 900931
    D.3.9.3Other descriptive nameSCH 900931
    D.3.9.4EV Substance CodeSUB31364
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Prodromal Alzheimer's Disease
    Enfermedad de Alzheimer (EA) prodrómica
    E.1.1.1Medical condition in easily understood language
    Early Alzheimer's Disease
    Enfermedad de Alzheimer temprana
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    -To evaluate the safety and tolerability of MK-8931 in the long term treatment of prodromal Alzheimer?s Disease (AD)
    -To compare the efficacy of MK-8931 administered to subjects for 30 months to that of subjects administered placebo for 24 months followed by MK-8931 for 6 months using the change from baseline score CDR-SB score at Week 130.
    -Evaluar la seguridad y la tolerabilidad de MK 8931 en el tratamiento a largo plazo de la enfermedad de Alzheimer (EA) prodrómica.
    -Comparar la eficacia de MK 8931 en sujetos tratados durante 30 meses con la observada en sujetos tratados con placebo durante 24 meses seguido de MK 8931 durante 6 meses mediante la variación con respecto al momento basal de la puntuación CDR-SB al cabo de 130 semanas.
    E.2.2Secondary objectives of the trial
    -There are no secondary objectives for this long term safety trial.
    -No hay objetivos secundarios para este ensayo de seguridad a largo plazo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Have tolerated study medication and completed the initial 104-week trial. Subjects who did not complete the initial 104-weeks of treatment but continued with and completed scheduled visits may be permitted to continue in the long term extension at the discretion of the Sponsor. Subjects who repeatedly deviate from protocol requirements will not be permitted to continue in this extension. In addition, subjects who are less than 75% compliant with trial medication during the initial 104-week trial will not be permitted to continue in the long term safety extension, except in special circumstances, which require Sponsor approval.
    -Have a trial partner who is reliable and competent. The trial partner must have a close relationship with the subject, have face to face contact at least 3 days/week for a minimum of 6 waking hours/week (or more, based on local requirements), be willing to accompany the subject to all trial visits, and be willing to monitor compliance of the administration of the trial medication. The trial partner should understand the nature of the trial and adhere to trial requirements (e.g. dose, visit scheduled and evaluations). It is recommended that the trial partner accompany the subject to all trial visits.
    -Sign (or legal representative signature) the informed consent in accordance with local requirements, after the scope and nature of the trial have been explained.
    -Haber tolerado la medicación del ensayo y completado el ensayo de 104 semanas inicial. Los sujetos que no hayan completado las 104 semanas iniciales de tratamiento, pero que hayan proseguido y completado las visitas programadas, podrán participar en esta extensión a largo plazo a criterio del promotor. Los sujetos que muestren desviaciones repetidas respecto a los requisitos del protocolo no podrán incorporarse a esta extensión. Además, los sujetos cuyo cumplimiento de la medicación del ensayo haya sido inferior al 75% durante el ensayo de 104 semanas inicial no podrán participar en la extensión a largo plazo, excepto en circunstancias especiales, que requerirán la aprobación del promotor (o, cuando se exija localmente, la aprobación del investigador en lugar del promotor).
    -Tener un acompañante para el ensayo que sea fiable y competente. Dicho acompañante deberá tener una relación estrecha con el sujeto, mantener encuentros cara a cara al menos 3 días/semana durante un mínimo de 6 horas de vigilia/semana (o más, dependiendo de los requisitos locales), estar dispuesto a acompañar al sujeto a todas las visitas del estudio y estar dispuesto a controlar el cumplimiento de la administración de la medicación del ensayo. También deberá comprender la naturaleza del ensayo y cumplir los requisitos del mismo (por ejemplo, dosis, fechas de las visitas y evaluaciones). Se recomienda que este acompañante para el ensayo acuda a todas las visitas con el sujeto.
    -Firmar (él mismo o su representante legal) el documento de consentimiento informado, de conformidad con los requisitos locales, tras habérsele explicado el ámbito y la naturaleza del ensayo.
    E.4Principal exclusion criteria
    -Is in imminent risk of self harm, based on clinical interview or on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Subjects who report suicidal ideation with intent, with or without a plan (e.g., suicidal ideation item 4 or 5 on the C-SSRS) in the past one (1) month or suicidal behavior in the past six (6) months should be excluded. Such subjects will be permitted to rescreen for entry into this study once in the Investigator?s opinion, this risk of harm to self or others is no longer present.
    -Has developed a recent or ongoing, uncontrolled, clinically significant medical or psychiatric condition that precludes participation in this protocol in the judgment of the investigator.
    -Based on results from the EOT Visit (Visit 12) in the initial 104-week trial has results of clinical laboratory tests (complete blood count [CBC], blood chemistries, and urinalysis) that are clinically unacceptable to the investigator.
    -Based on the results from the EOT Visit (Visit 12) has results of a physical examination, and vital signs that are clinically unacceptable to the investigator.
    -Has developed a form of dementia that is not Alzheimer's disease, including but not limited to, dementia due to HIV infection, head trauma, vascular disease, Parkinson's disease, frontotemporal dementia, or Huntington's disease, as determined by the investigator.
    -Anticipates receiving any of the treatments listed as prohibited.
    -Corre un riesgo inminente de autolesión, basándose en una entrevista clínica o en la Escala de valoración de la intensidad de la tendencia suicida de Columbia (C-SSRS), o de lesionar a terceros, según la opinión del investigador. Quedarán excluidos los sujetos que refieran ideación suicida con intención, con o sin un plan (por ejemplo, apartado de ideación suicida 4 o 5 en la escala C-SSRS), en el mes precedente o conductas suicidas en los seis meses precedentes. En estos sujetos podrá repetirse la selección para poder participar en este estudio una vez que, en opinión del investigador, ya no esté presente el riesgo de autolesión o de lesionar a terceros.
    -Ha contraído una afección médica o psiquiátrica de importancia clínica y no controlada, reciente o todavía activa, que impide la participación en este protocolo, a criterio del investigador.
    -A tenor de los resultados de la visita de FDT (visita 12) del ensayo de 104 semanas inicial, presenta unos resultados analíticos (hemograma completo, bioquímica sanguínea y análisis de orina) que son clínicamente inaceptables para el investigador.
    -A tenor de los resultados de la visita de FDT (visita 12), presenta unos resultados de la exploración física o las constantes vitales que son clínicamente inaceptables para el investigador.
    -Ha desarrollado una forma de demencia que no es enfermedad de Alzheimer, incluyendo, pero no limitado a demencia debida a la infección por el VIH, traumatismo craneoencefálico, vasculopatía, enfermedad de Parkinson, demencia frontotemporal o enfermedad de Huntington, según lo determinado por el investigador.
    -Prevé recibir alguno de los tratamientos que se citan en la tabla 1 del protocolo durante el presente ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline (CFB) in CDR-SB score at Week 130.
    La variable principal de la eficacia es la variación con respecto al momento basal (VRMB) de la puntuación CDR-SB al cabo de 130 semanas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Week 130.
    Visita basal y semana 130
    E.5.2Secondary end point(s)
    None
    Ninguno
    E.5.2.1Timepoint(s) of evaluation of this end point
    None
    Ninguno
    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 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
    grupos paralelos
    paralell groups
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Finland
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Netherlands
    New Zealand
    Norway
    Poland
    Spain
    Switzerland
    United Kingdom
    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 study is expected to last up to approximately five years or until a) MK-8931 becomes commercially available (locally), or b) when the MK-8931 program is terminated (whichever comes first).
    Se esperan que el estudio dure 5 años o hasta que el:
    -MK-8931 se comercialice localmente o cunado el programa MK-8931 se haya terminado (lo que ocurra antes).
    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 months60
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months60
    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: 236
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 709
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with mild cognitive impairment who may progress to dementia during the trial
    Pacientes con deterioro cognitivo medio que progrsen durante el estudio
    F.4 Planned number of subjects to be included
    F.4.1In the member state74
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 283
    F.4.2.2In the whole clinical trial 945
    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)
    None
    Ninguno
    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 Decision2016-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-04-17
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