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    Summary
    EudraCT Number:2019-000370-27
    Sponsor's Protocol Code Number:COR388-010
    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:2019-06-11
    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 number2019-000370-27
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo Controlled Study of COR388 HCl in Subjects with Alzheimer’s Disease
    Estudio Aleatorizado, Doble Ciego, Controlado con Placebo, de COR388 HCl en Sujetos con Enfermedad de Alzheimer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of COR388 in Subjects with Alzheimer’s Disease
    Estudio de COR388 en Sujetos con Enfermedad de Alzheimer
    A.4.1Sponsor's protocol code numberCOR388-010
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03823404
    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 SponsorCortexyme, 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 supportCortexyme, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWorldwide Clinical Trials
    B.5.2Functional name of contact pointMedical Affairs
    B.5.3 Address:
    B.5.3.1Street Address1st Floor Waterfron House, Beeston Business Park
    B.5.3.2Town/ cityBeeston
    B.5.3.3Post codeNG9 1LA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)115 956 7711
    B.5.5Fax number+44(0)115 922 0960
    B.5.6E-mailannette.janus@worldwide.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 nameCOR388 HCl 80 mg
    D.3.2Product code COR388
    D.3.4Pharmaceutical form Capsule
    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 INNCOR388 HCl
    D.3.9.2Current sponsor codeCOR388
    D.3.9.3Other descriptive nameCOR388
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 nameCOR388 HCl 40 mg
    D.3.2Product code COR388
    D.3.4Pharmaceutical form Capsule
    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 INNCOR388 HCl
    D.3.9.2Current sponsor codeCOR388
    D.3.9.3Other descriptive nameCOR388
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Alzheimer’s Disease
    Enfermedad de Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer’s Disease
    Enfermedad de Alzheimer
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the efficacy of 2 dose levels of COR388 HCl in Alzheimer’s disease (AD) subjects;
    Assess the safety and tolerability of 2 dose levels of COR388 HCl in AD subjects
    Evaluar la eficacia de 2 niveles de dosis de COR388 HCl en sujetos con enfermedad de Alzheimer (Alzheimer’s disease, AD);
    Evaluar la seguridad y la tolerabilidad de 2 niveles de dosis de COR388 HCl en sujetos con AD.
    E.2.2Secondary objectives of the trial
    Not applicable
    no aplicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The following sub-studies are part of the main Study Protocol v2.0 dated 11 Apr 2019:
    •Cerebrospinal fluid sub-study (subjects who agree to have LP):
    - CSF Aβ42, total Tau, and phosphorylated Tau;
    - Bacterial DNA in the CSF on quantitative polymerase chain reaction (qPCR); and
    - CSF inflammatory markers.
    •Magnetic resonance imaging sub-study (subjects who have MRIs done in conjunction with the study):
    - Hippocampal volume; and
    - Cortical thickness.
    •Clinical periodontitis sub-study (subjects enrolled at selected sites):
    - Pocket Depth (PD);
    - Clinical Attachment Level (CAL) at 6 sites per tooth (distobuccal [DB], buccal, mesiobuccal [MB], distolingual [DL], lingual [L], and mesiolingual [ML]);
    - The percentage of sites with Bleeding on Probing (BOP); and
    - Biomarkers of P. gingivalis infection and inflammation in subgingival plaque (SGP) and buccal cell swabs.
    • Subestudio de líquido cefalorraquídeo (sujetos que acepten someterse a una punción lumbar):
    o Aβ42, tau total y tau fosforilada en líquido cefalorraquídeo;
    o DNA bacteriano en líquido cefalorraquídeo mediante reacción en cadena de la polimerasa cuantitativa (qPCR); y
    o Marcadores inflamatorios en líquido cefalorraquídeo.
    • Subestudio de resonancia magnética (sujetos a los que se les realicen resonancias junto con el estudio):
    o Volumen del hipocampo; y
    o Grosor cortical.
    • Subestudio de periodontitis clínica (sujetos incluidos en determinados centros):
    o Profundidad de la bolsa (Pocket Depth, PD);
    o Nivel de inserción clínica (Clinical Attachment Level, CAL) en 6 puntos por pieza dental (distobucal [DB], bucal [B], mesiobuccal [MB], distolingual [DL], lingual [L] y mesiolingual [ML]);
    o Porcentaje de puntos con sangrado al sondaje (Bleeding on Probing, BOP); y
    o Biomarcadores de infección por P. gingivalis e inflamación en muestras de placa subgingival (subgingival plaque, SGP) y células bucales.
    E.3Principal inclusion criteria
    1.Subject has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, subject has provided assent and a legally authorized representative has provided full written informed consent on behalf of the subject.
    2.Caregiver has provided full written informed consent, on a separate informed consent form (ICF), on his/her own behalf prior to the performance of any protocol-specified procedure.
    3.Male and female subjects must be 55 years to 80 years of age, at the time of consent.
    4.Subject has probable AD dementia according to the NIA-AA criteria (McKhann 2011) with clinical evidence of progressive cognitive decline in the last year. Clinical decline will be determined based on serial cognitive test scores, if available, or subject/caregiver report as documented by the Investigator.
    5.Subject has an MMSE score between 12 and 22 inclusive at both screening and Visit 2 and a ≤2-point difference between these visits.
    6.Subject has a Modified Hachinski score ≤4 at screening.
    7.Subject has brain MRI scan consistent with the diagnosis of AD performed during the screening period. Computed Tomography scan can be used only if the subject has an absolute contraindication for MRI.
    8.Subject has a primary caregiver willing to accept responsibility for supervising the treatment (e.g., administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.
    9.Subject is not likely to experience a change in living conditions (e.g., institutionalization, moving to a different city, etc.), or change in primary caregiver, during participation in the trial.
    10.Subjects with background symptomatic therapy with acetylcholinesterase inhibitors, and/or memantine, are allowed as long as the dose has been stable for 90 days prior to screening and no changes are planned during the study.
    11.Subjects who have occasional use of sedative agents are acceptable, but these agents should not be given within 48 hours prior to cognitive assessments.
    12.Subjects who have background medications used for stable chronic illnesses that are not prohibited by the protocol are allowed. The dose of psychoactive drugs must be stable for 30 days prior to screening, and no changes must be planned during the study unless for safety reasons.
    13.Subject has body mass index <38 kg/m2 at Screening.
    14.Subject must be able to ingest oral medications and can swallow the study drug without breaking or crushing.
    15.Subject must be willing to undergo Apolipoprotein E genotype (ApoE) genetic testing (ApoE results may be disclosed after trial completion).
    16.Subjects participating in the study must meet one of the following criteria:
    a.Females: Surgically sterilized (e.g., hysterectomy, bilateral oophorectomy or tubal ligation) for at least 6 months or postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year). If not postmenopausal, agree to use a double method of contraception, one of which is a barrier method (e.g., intrauterine device plus condom, spermicidal gel plus condom) 30 days prior to dosing until 30 days after last dose and have negative human chorionic gonadotropin (β-hCG) test for pregnancy at screening.
    b.Males who have not had a vasectomy must use appropriate contraception methods (barrier or abstinence) from 30 days prior to dosing until 30 days after last dose.
    1.El sujeto ha otorgado su pleno consentimiento informado por escrito antes de que se realice cualquier procedimiento señalado en el protocolo; o, si es incapaz de hacerlo por su estado cognitivo, el sujeto ha dado su asentimiento y el representante legal ha otorgado el pleno consentimiento informado por escrito en nombre del sujeto.
    2.El cuidador ha otorgado su pleno consentimiento informado por escrito en un documento de consentimiento informado (informed consent form, ICF) aparte, como tal cuidador, antes de que se realice cualquier procedimiento señalado en el protocolo.
    3.El sujeto, mujer o varón, tiene una edad comprendida entre 55 y 80 años en el momento del consentimiento.
    4.El sujeto presenta demencia por AD probable según los criterios del NIA-AA (McKhann 2011), con manifestaciones clínicas de deterioro cognitivo progresivo en el último año. El deterioro clínico se determinará en función de las puntuaciones de pruebas cognitivas seriadas, si se dispone de ellas, o la información referida por el sujeto/cuidador y documentada por el Investigador.
    5.El sujeto presenta una puntuación del MMSE entre 12 y 22, ambos extremos incluidos, en la selección y en la Visita 2, con una diferencia ≤2 puntos entre estas visitas.
    6.El sujeto presenta una puntuación de Hachinski Modificada ≤4 en la selección.
    7.La resonancia magnética cerebral del sujeto realizada en el periodo de selección es compatible con el diagnóstico de AD. Solo podrá emplearse tomografía computarizada en caso de contraindicación absoluta para la resonancia magnética.
    8.El sujeto cuenta con un cuidador principal que está dispuesto a aceptar la responsabilidad de supervisar el tratamiento (por ejemplo, administrar el medicamento del estudio) y evaluar el estado del sujeto a lo largo del estudio en conformidad con todos los requisitos del protocolo.
    9.No es probable que vayan a variar las condiciones de vida del sujeto (por ejemplo, institucionalización, traslado a otra ciudad, etc.) ni que cambie el cuidador principal durante la participación en el ensayo.
    10.Se permite participar a los sujetos en tratamiento sintomático de fondo con inhibidores de la acetilcolinesterasa y/o memantina, siempre que la dosis se haya mantenido estable durante los 90 días anteriores a la selección y no esté previsto modificarla durante el estudio.
    11.Se permite que el sujeto tome sedantes de manera ocasional, pero no deberán administrarse en el plazo de las 48 horas previas a las evaluaciones cognitivas.
    12.Podrán participar sujetos que reciban medicamentos de fondo por enfermedades crónicas estables que no estén prohibidos por el protocolo. La dosis de los psicofármacos deberá haberse mantenido estable durante los 30 días anteriores a la selección y sin cambios previstos durante el estudio, salvo por motivos de seguridad.
    13.El sujeto presenta un índice de masa corporal ≤38 kg/m2 en la selección.
    14.El sujeto deberá ser capaz de ingerir medicamentos orales y tragar el medicamento del estudio sin romperlo ni machacarlo.
    15.El sujeto debe estar dispuesto a someterse a las pruebas genéticas del genotipo de Apolipoproteína E (ApoE; cuyos resultados podrían revelarse tras la finalización del ensayo).
    16.Los sujetos participantes en el estudio deben cumplir uno de los siguientes criterios:
    a.Mujeres: Esterilización quirúrgica (esto es, histerectomía, ooforectomía bilateral o ligadura de trompas) por lo menos 6 meses antes o posmenopausia (se precisa amenorrea desde por lo menos 1 año antes). Las mujeres no posmenopáusicas deben comprometerse a utilizar un método anticonceptivo doble que incluya un método de barrera (por ejemplo, dispositivo intrauterino más preservativo, gel espermicida más preservativo) desde 30 días antes del tratamiento hasta 30 días después de la última dosis, y deben presentar una prueba de embarazo de la gonadotropina coriónica humana (β hCG) negativa en la selección.
    b.Los varones no vasectomizados deberán emplear métodos anticonceptivos adecuados (de barrera o abstinencia) desde 30 días antes del tratamiento hasta 30 días después de la última dosis.
    E.4Principal exclusion criteria
    1.Subject has imaging consistent with other differential dementia diagnoses other than the diagnosis of AD.
    2.Subject has had an increase or restoration of cognition based on medical history.
    3.Subjects who meet the following imaging exclusion criteria will not be included in this study:
    a.Claustrophobia that will result in significant anxiety and difficulty lying still for brain imaging (MRI or CT scan)
    b.Severe motor problems or chronic pain indication that prevents the subject from lying still for brain imaging.
    4.Subject with history of cancer requiring systemic therapy in the last 5 years; except for localized basal cell carcinoma of the skin and in-situ cervical cancer successfully treated with surgical excision. Stable (for at least 90 days) prostate cancer is allowed.
    5.Subject has evidence of clinically significant unstable cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurologic or metabolic disease within 6 months prior to Screening.
    6.Subject has any of the following cardiovascular conditions:
    a.Unstable angina, uncompensated and/or symptomatic congestive heart failure (Grade 2 or higher on the New York Heart Association scale) or myocardial infarction within 6 months.
    b.Acute or poorly controlled blood pressure >180 mmHg systolic or >100 mmHg diastolic.
    c. Current, or recent history of, any of the following that are clinically significant in the investigator's judgment: arrhythmia, hypotension, heart block, bundle branch block, symptomatic ectopy, unstable arrhythmias including atrial fibrillation; stable atrial fibrillation is allowed.
    d. History of prolonged QT or prolonged QT on screening ECG (QTcF > or =500 msec).
    e. History of prolonged PR interval or prolonged PR interval on screening ECG (PR >210 msec).
    f. History of prolonged QRS interval or prolonged QRS interval on screening ECG (QRS >110 msec).
    g. Frequent supraventricular or ventricular ectopy on the screening ECG
    7.Subject with major stroke, uncontrolled seizure disorder, or other medical illnesses that in the Investigator’s opinion will increase the subject’s risk of participation in the study or confound study assessments.
    8.Subject with history or current evidence of major psychiatric illness such as schizophrenia, bipolar disorder, or major depressive disorder that may interfere with the patient’s ability to perform the study and all assessments.
    9.Subject with history of violent or aggressive behavior that requires medication to control.
    10.Subjects with active suicidal thoughts (Type 4 or 5 on the C SSRS) in the 6 months preceding screening or at baseline; or have a history of a suicide attempt in the previous 2 years, or more than 1 lifetime suicide attempt; or are at serious suicide risk in the Investigator’s clinical judgment.
    11.Subject with history of alcohol or drug use disorder within 12 months of screening as defined by the Diagnostic and Statistical Manual of Mental Disorders-5.
    12.Subject with previous treatment with investigational vaccine therapy for AD.
    13.Subject has participated in another Investigational New Drug (IND) research study involving small molecule drugs within 60 days or biological drugs within 90 days prior to the first dose of study drug or 5 half-lives of the investigational drug, whichever is longer.
    14.Subject has a history of epilepsy or seizure disorder requiring ongoing treatment, or any seizure or loss of consciousness within 6 months prior to enrollment.
    15.Subject has any of the following laboratory findings at screening:
    a.Alanine aminotransferase >3 x upper limit of normal (ULN), aspartate aminotransferase >3 x ULN, or history of clinically significant liver disease in the Investigator’s judgment.
    b.Hemoglobin < or = 10 g/dl.
    c.International Normalized Ratio (INR) >1.5 (if consented for LP).
    d.Creatinine clearance (CL) of <45 ml/min.
    e.Poorly controlled diabetes as defined by hemoglobin A1C (HbA1C) >8.
    f.Positive blood screen for Human Immunodeficiency Virus (HIV 1 and 2), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus antibodies (HCV-Ab) at Screening.
    g.Positive urine screen for drugs of abuse that include opiates, cocaine, amphetamines, or barbiturates.
    16.Subject has abnormal laboratory tests that suggest an alternate etiology for dementia, such as serum vitamin B12 deficiency, thyroid function abnormality, severe anemia, electrolyte abnormality, or positive syphilis serology. In these cases, the patient should be re-evaluated to determine if these potential causes of dementia have been addressed. Only if these causes have been ruled out as the cause of the dementia can the patient be enrolled.
    17.Use of systemic (i.e., oral, intravenous, etc., but not topical) antibiotics in the last 30 days or expected to need treatment with them during the study.
    1.El sujeto presenta exámenes de neuroimagen compatibles con otros diagnósticos de demencia distintos de la debida a AD
    2.El sujeto ha presentado un aumento o restauración de la cognición, a la vista de sus antecedentes médicos
    3.El sujeto cumple alguno de los siguientes criterios de imagen que excluyen de la participación en este estudio:
    a.Claustrofobia que supondría al sujeto importante ansiedad y dificultad para permanecer tumbado sin moverse para las pruebas de imagen cerebral
    b.Problemas motores importantes o dolor crónico que impidan al sujeto permanecer tumbado sin moverse para las pruebas de imagen cerebral
    4.El sujeto ha padecido en los últimos 5 años un cáncer que requirió tratamiento sistémico, excepto el carcinoma cutáneo basocelular localizado y el cáncer de cuello uterino in situ tratado con éxito mediante extirpación quirúrgica. Se permite el cáncer de próstata que se haya mantenido estable (desde hace como mínimo 90 días)
    5.El sujeto ha presentado una enfermedad cardiovascular, pulmonar, renal, hepática, gastrointestinal, neurológica o metabólica, clínicamente significativa e inestable, en el plazo de los 6 meses anteriores a la selección
    6.El sujeto padece alguno de los trastornos cardiovasculares siguientes:
    a.Angina inestable, insuficiencia cardiaca congestiva no compensada y/o sintomática o infarto de miocardio en los 6 meses anteriores
    b.Presión arterial sistólica>180 mmHg o distólica>100 mmHg, de forma aguda o mal controlada
    c.Historia actual o reciente de cualquiera de los siguientes procesos que, en opinión del investigador, sean clínicamente importantes: arritmia, hipotensión, bloqueo cardiaco, bloqueo de rama, extrasistolia sintomática, arritmias inestables incluida fibrilación auricular; se permite la fibrilación auricular estable
    d.Antecedentes de prolongación del QT o hallazgo de QT prolongado en el ECG de la selección (QTcF>o=500 ms)
    e.Antecedente de prolongación del intervalo PR u intervalo PR prolongado en el ECG de la selección (PR>210 ms)
    f.Antecedente de prolongación del intervalo QRS u intervalo QRS prolongado en el ECG de la selección (QRS>110 ms)
    g.Extrasistolia supraventricular o ventricular frecuentes en el ECG de la selección
    7.El sujeto presenta ictus importante, trastorno convulsivo no controlado u otras enfermedades médicas que, a juicio del Investigador, aumentarían el riesgo de la participación del sujeto en el estudio o confundirían las evaluaciones del estudio
    8.El sujeto presenta antecedentes o diagnóstico actual de enfermedad psiquiátrica importante, como esquizofrenia, trastorno bipolar o trastorno depresivo mayor, que pudiera alterar la capacidad del paciente para realizar el estudio y todas las evaluaciones
    9.El sujeto tiene antecedentes de comportamiento violento o agresivo que precisa medicación para controlarlo
    10.El sujeto ha presentado pensamientos suicidas activos (de tipo 4 o 5 según la C-SSRS) en los 6 meses previos a la selección o en el momento basal, o un intento de suicidio en los 2 años anteriores o más de un intento de suicido en toda su vida; o su riesgo de suicidio es importante, a juicio del Investigador
    11.El sujeto presenta antecedentes de trastorno por consumo de alcohol o drogas en el plazo de los 12 meses anteriores a la selección, según la definición del Manual diagnóstico y estadístico de los trastornos mentales 5.
    12.El sujeto ha recibido tratamiento previo con una vacuna en investigación para la AD
    13.El sujeto ha participado en otro estudio de investigación de Nuevos Medicamentos en Investigación que involucran medicamentos de moléculas pequeñas dentro de los 60 días previos o medicamentos biológicos en el plazo de los 90 días previos a la primera dosis ddel medicamento del estudio, o 5 semividas del medicamento en investigación, eligiéndose el mayor de estos plazos
    14.El sujeto tiene antecedentes de epilepsia o trastorno convulsivo que requiera tratamiento continuado, o ha sufrido una crisis o pérdida de la consciencia en el plazo de los 6 meses anteriores al momento de reclutamiento
    15.El sujeto presenta alguna de las siguientes alteraciones de laboratorio en los análisis de la selección:
    a.Alanina-aminotransferasa >3 veces el límite superior de la normalidad (ULN), aspartato-aminotransferasa >3 x ULN, o antecedentes de hepatopatía de importancia clínica a juicio del Investigador
    b.Hemoglobina <o=10g/dl
    c.Cociente internacional normalizado (INR) >1,5
    d.Aclaramiento (Clearance, CL) de creatinina <45 ml/min
    e.Diabetes mal controlada a juzgar por una hemoglobina A1C(HbA1C) >8
    f.Seropositividad para HIV 1 y 2, HBsAg o HCV-Ab en la selección
    g.Prueba de orina positiva para drogas de abuso que incluye opiáceos, cocaína, anfetaminas o barbitúricos
    16.El sujeto presenta valores anormales en las pruebas de laboratorio que sugieran otra causa para la demencia
    17.El sujeto ha recibido antibióticos sistémicos en los últimos 30 días o se prevé que los vaya a necesitarlos durante el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) from baseline to the end of treatment period.
    Variación media de la subescala cognitiva de la escala de evaluación de la enfermedad de Alzheimer (Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11, ADAS-Cog 11) entre el momento basal y el fin del periodo de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    54 weeks
    54 semanas
    E.5.2Secondary end point(s)
    •Change in Alzheimer’s Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL); and
    •Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB).
    • Variación de la escala de actividades cotidianas del grupo de estudio cooperativo de la enfermedad de Alzheimer (Alzheimer’s Disease Cooperative Study Group-Activities of Daily Living, ADCS-ADL); y
    • Variación de la escala de valoración clínica de la demencia-suma de casillas (Clinical Dementia Rating-Sum of Boxes, CDR-SB).
    E.5.2.1Timepoint(s) of evaluation of this end point
    54 weeks
    54 semanas
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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.8.2.4Number of treatment arms in the trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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
    Croatia
    Czech Republic
    France
    Italy
    Netherlands
    Poland
    Spain
    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
    LVLS
    LVLS
    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 months3
    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 months4
    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.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 423
    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
    Patients with Alzheimer’s Disease
    Pacientes con enfermedad de Alzheimer
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 573
    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 Decision2019-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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