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    Summary
    EudraCT Number:2013-004593-95
    Sponsor's Protocol Code Number:ECA4A
    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:2014-02-13
    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 number2013-004593-95
    A.3Full title of the trial
    Evaluating the effectiveness of the use of intravenous infusions of adenosine triphosphate (ATP) in patients with moderate Alzheimer's Disease and severe: Double-blind dose finding clinical trial.
    Evaluación de la eficacia del empleo de infusiones intravenosas de trifosfato de adenosina (ATP)en pacientes afectados de Enfermedad de Alzheimer moderada y grave: Ensayo clínico enmascarado doble ciego para búsqueda de dosificación
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ATP in Alzheimer Disease
    ATE en Enfermedad de Alzheimer
    A.4.1Sponsor's protocol code numberECA4A
    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 SponsorFundación ACE
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistry of Health, Social Services and Equality
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportFundación ACE
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trials Unit
    B.5.2Functional name of contact pointCTU CLINIC
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number00349322754003343
    B.5.5Fax number0034932279877
    B.5.6E-mailsvarea@clinic.ub.es
    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 Atepodin
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Medix, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameAtepodin
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdenosin triphosphate
    D.3.9.1CAS number 56-65-5
    D.3.9.3Other descriptive nameADENOSINE TRIPHOSPHATE
    D.3.9.4EV Substance CodeSUB12741MIG
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 50
    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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous 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] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    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
    a. Check whether systemic treatment with ATP alters the profile of cerebral metabolism in patients with Alzheimer's disease using MRS techniques (Magnetic Resonance Spectroscopy)
    b. Adjust the infusion (minimum effective dose) that promotes this metabolic change.
    a. Comprobar si el tratamiento sistémico con ATP altera el perfil de metabolismo cerebral en pacientes con Alzheimer mediante técnicas MRS (Espectroscopía por Resonancia Magnética)
    b. Ajustar la infusión (dosis mínima efectiva) que promueve este cambio metabólico
    E.2.2Secondary objectives of the trial
    a. Check whether systemic treatment with ATP enhances cognitive state of patients with severe or moderate.
    b. check carriers rs11870474 genetic marker locus have a differential response to treatment.
    c. Check changes in sinaptic activity after treatment administration.
    d. To assess the rate of complications associated with the administration of ATP
    a. Comprobar si el tratamiento sistémico con ATP mejora el estado cognitivo de los pacientes con EA grave o moderada.
    b. comprobar si los portadores del marcador genético del locus rs11870474 tienen una respuesta diferencial al tratamiento.
    c. Comprobar si se detectan cambios de actividad sináptica tras la administración del tratamiento en estudio
    d. Evaluar la tasa de complicaciones asociadas a la administración de ATP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women aged 55-85 years
    2. Diagnosis of possible or probable AD according to NIA-AA 2011 criteria.
    3. GDS Stadium 5-6 / 15-5 MMSE
    4. The patient is living with a family as a primary caregiver or a caregiver trained to accompany adequate and all intervention and follow-up visits. Patient and caregiver knowledge of local languages ??sufficient.
    5. The patient and caregiver willing to participate in the study. There is a high probability that patient and caregiver to complete the study.
    6. The patient has no sensory deficits preventing evaluation.
    7. The patient receives a stable EA conventional medication. No change in treatment at least 90 days prior to selection.
    8. The patient receives a conventional stable medication for possible comorbidities. No change in treatment at least 90 days prior to selection.
    9. The subject or his legal representative give prior informed consent that includes genetic studies of APOE and rs11870474.
    1. Varones y mujeres de edades comprendidas entre los 55-85 años
    2. Diagnóstico de EA posible o probable de acuerdo con los criterios NIA-AA 2011.
    3. Estadio GDS 5-6 / MMSE 15-5
    4. El paciente vive con un familiar como cuidador principal o con un cuidador adecuado y capacitado para acompañarlo a todas las visitas de intervención y seguimiento. Paciente y cuidador con conocimiento de los idiomas locales suficientes.
    6. El paciente no tiene déficits sensoriales que impidan su evaluación.
    7. El paciente recibe una medicación convencional para EA estable. Sin cambios de tratamiento al menos 90 días antes de la selección.
    8. El paciente recibe una medicación estable convencional para posibles comorbilidades. Sin cambios de tratamiento al menos 90 días antes de la selección.
    9. El sujeto o su representante legal otorgan un consentimiento informado previo que incluye la realización de estudios genéticos de APOE y rs11870474.
    E.4Principal exclusion criteria
    1. Concomitant severe neurological disease AD.
    2. Presence or history of psychiatric disorders with an emphasis on positive behavioral disorders associated with AD (aggressiveness, agitation, delusions, hallucinations, anxiety).
    3. Current Severe systemic disease that may prevent completion of the study.
    4. History STROKE.
    5. History of convulsions and use of anticonvulsants.
    6. History of myocardial infarction, angina pectoris, cardiac arrhythmias and other serious cardiovascular disorders such as congestive heart failure, and valvular aneurysms.
    7. Background Diabetes mellitus and / or pictures of hypoglycemia.
    8. Uncontrolled hypertension (systolic> 160 mmHg and / or Diastolic> 95 mmHg).
    9. Systemic hypotension (SBP <86 mmHg) or bradycardia (<50 beats per minute)
    10. Bronchial Asthma History or lung diseases that cause bronchospasm or bronchoconstriction
    11. Kidney failure (patients with medical restrictions or income parenteral intake of fluids).
    12. Liver failure.
    13. Respiratory failure (need supplemental oxygen supply)
    14. Blood donation in the last 90 days or anemia (Hb <10g/dL)
    15. Use connection (<30 days prior to screening) of antidepressants, sedatives and hypnotics.
    16. Using EA experimental drugs in the last 60 days prior to screening.
    17. Women who are pregnant or fertile
    18. Inadequate venous access to prevent parenteral administration of infusions.
    1. Enfermedad neurológica grave concomitante a EA.
    2. Presencia o antecedentes de trastornos psiquiátricos con especial énfasis a los trastornos de conducta positivos asociados a EA (agresividad, agitación, delirios, alucinaciones, ansiedad).
    3. Enfermedad sistémica grave actual que pueda impedir completar el estudio.
    4. Historial de ICTUS.
    5. Historial de convulsiones y uso de anticonvulsivantes.
    6. Historia de Infarto agudo de miocardio, angor pectoris, arritmias cardiacas y otros trastornos cardiovasculares graves como la insuficiencia cardiaca congestiva, aneurismas y valvulopatías.
    7. Antecedentes de Diabetes mellitus y/o cuadros de hipoglucemia.
    8. Hipertensión no controlada (sistólica > 160 MmHg y/o Distólica > 95 mmHG).
    9. Hipotensión sistémica (PAS<86 mmHG) o bradicardia (<50 latidos por minuto)
    10. Antecedentes de asma Bronquial o enfermedades pulmonares que provoquen broncoespasmo o broncoconstricción.
    11. Insuficiencia renal (pacientes con restricción médica de ingestión o ingreso parenteral de líquidos).
    12. Insuficiencia hepática.
    13. Insuficiencia respiratoria (necesita suministro suplementario de oxígeno)
    14. Donación de sangre en los últimos 90 días o anemia (Hb<10g/dL)
    15. Uso no estable (<30 días previos a la selección) de antidepresivos, sedantes e hipnóticos.
    16. Uso de medicamentos experimentales para EA en los últimos 60 días previos a la selección.
    17. Mujeres embarazadas o en período fértil
    18. Acceso venoso inadecuado que impida la administración parenteral de infusiones.
    E.5 End points
    E.5.1Primary end point(s)
    a. Detection of brain metabolic changes after ATP infusion by spectroscopy techniques (H + MRS)
    b. Changes in CalCAP (California Computerized Assessment Package).
    a. Detección de cambios metabólicos cerebrales tras la infusión con ATP mediante técnicas de Espectroscopía ( H+MRS)
    b. Cambios en CalCAP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    post treatment administration.
    post administración del tratamiento.
    E.5.2Secondary end point(s)
    Changes in CalCAP at 3 months compared to baseline.
    Changes in test MMSE (Mini-Mental State Examination) at 3 months compared to baseline.
    Changes in sinaptic activity after treatment administration
    Neurological examination, Physical Examination, ECG, Vital Signs, Biochemistry, CBC, Urine tests
    adverse events
    Los cambios en test MAT (Memory and Attention Test) a los 3 meses respecto al basal.
    Los cambios en test MMSE (Mini-Mental State Examination) a los 3 meses respecto al basal.
    Cambios en actividad sináptica post tratamiento
    Exploración neurológica, Exploración física, ECG, Constantes vitales, Bioquímica, Hemograma, Orina
    E.5.2.1Timepoint(s) of evaluation of this end point
    post treatment or 3 months post baseline (depending on endpoint)
    post- infusión o 3 meses post basal (según de qué variable secundaria se trate)
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Dose finding
    Búsqueda de dosis
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 trial4
    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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Patient last visit (LPLV)
    Última visita de último paciente
    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.1.2.1Number of subjects for this age range: 1
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    patients with moderate/severe alzheimer's disease
    pacientes con Enfermedad de Alzheimer moderada/grave
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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 Decision2014-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-16
    P. End of Trial
    P.End of Trial StatusCompleted
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