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    Summary
    EudraCT Number:2018-002319-86
    Sponsor's Protocol Code Number:DIAN-Obs-BCN
    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:2018-11-16
    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 number2018-002319-86
    A.3Full title of the trial
    Dominantly Inherited Alzheimer Network - DIAN
    Red de Alzheimer heredado de forma autosómica dominante (DIAN - Dominantly Inherited Alzheimer Network) - Barcelona
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Inherited Alzheimer Network
    Red de Alzheimer heredado
    A.4.1Sponsor's protocol code numberDIAN-Obs-BCN
    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 SponsorFundació Clínic per a la Recerca Biomèdica
    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 supportFundació Clínic per a la Recerca Biomèdica
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU CLINIC
    B.5.2Functional name of contact pointJoan Albert Arnaiz
    B.5.3 Address:
    B.5.3.1Street AddressC. Villarroel, 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number34932279838
    B.5.5Fax number34932279877
    B.5.6E-mailjaarnaiz@clinic.cat
    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 FARNA FDG 3000 MBq/ml solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderIBA MOLECULAR SPAIN, 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 namefludesoxiglucosa
    D.3.4Pharmaceutical form 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 INNfludesoxiglucosa
    D.3.9.1CAS number 0105851-17-0
    D.3.9.4EV Substance CodeSUB96345
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 400
    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 Yes
    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
    Alzheimer disease
    Enfermedad de Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer disease
    Enfermedad de Alzheimer
    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
    1. To evaluate the safety profile after a dose of FDG and GDP for the realization of PET in individuals with genetic risk of autosomal dominant Alzheimer's disease.
    2. To determine the frequency, extent and severity of alterations in PET patterns with FDG and PIB, MR parameters, biochemical and cognitive markers in subjects carrying mutations causing genetic Alzheimer's disease with respect to their non-carrier pairs.
    1. Evaluar el perfil de seguridad tras una dosis de FDG y PIB para la realización de un PET en individuos con riesgo genético de enfermedad de Alzheimer autosómica dominante.
    2. Determinar la frecuencia, extensión y severidad de las alteraciones en patrones de PET con FDG y PIB, parámetros de RM, marcadores bioquímicos y congnitivos en sujetos portadores de mutaciones causantes de enfermedad de Alzheimer genética respecto a sus pares no portadores.
    E.2.2Secondary objectives of the trial
    1. Participate in the DIAN international multicentre registry of biological adult children of a parent affected by an APP, PSEN1 or PSEN2 mutation causing autosomal dominant Alzheimer's disease and evaluate the participants with a standardized protocol (DIAN) biannually.
    2. Contribute to the collection of data as well as participate in the repository of biological samples to promote research in autosomal dominant Alzheimer's and analysis in several domains.
    3. Identify new diagnostic and prognostic biomarkers.
    1. Participar en el registro multicéntrico internacional DIAN de hijos adultos biológicos de un progenitor afecto por una mutación APP, PSEN1 o PSEN2 causante de la enfermedad de Alzheimer autosómica dominante y evaluar a los participantes con un protocolo uniformizado (DIAN) bianualmente.
    2. Contribuir a la recogida de datos así como participar en el repositorio de muestras biológicas para fomentar la investigación en Alzheimer autosómico dominante y el análisis en varios dominios.
    3. Identificar nuevos biomarcadores diagnósticos y pronósticos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signature of informed consent by the participant and companion of the study before carrying out any procedure related to the study
    2. Age ≥ 18 years and the child of an individual affected (clinically or by tests) of genetic Alzheimer's disease in a pedigree with a known mutation causing genetic Alzheimer's disease.
    3. Cognitively normal (Clinical dementia Rating scale, CDR = 0) or with cognitive impairment in mild phase (CDR 0.5 or 1).
    4. The participant has identified two people who are not their blood siblings who can serve as companions to the study.
    5. Sufficient knowledge of the Castilian language (equivalent to 6th grade of primary school).
    1. Firma del consentimiento informado por parte del participante y acompañante del estudio antes de realizar cualquier procedimiento relacionado con el estudio
    2. Edad ≥ 18 años e hijo de un individuo afectado (clínicamente o por pruebas) de enfermedad de Alzheimer genético en un pedigrí con una mutación conocida causante de enfermedad de Alzheimer genético.
    3. Cognitivamente normal (Clinical dementia Rating scale, CDR = 0) o con deterioro cognitivo en fase leve (CDR 0.5 or 1).
    4. El participante ha identificado a dos personas que no son sus hermanos de sangre que pueden servir como acompañantes del estudio.
    5. Conocimiento suficiente de la lengua castellana (equivalente a 6º de primaria).
    E.4Principal exclusion criteria
    1. The participant has a medical or psychiatric illness that would interfere according to clinical criteria in the initial evaluation and / or follow-up evaluations.
    2. The participant has an advanced cognitive impairment that requires admission to a long-term care center.
    3. The recruitment of a subject with cognitive impairment must be pre-approved by the Coordinating Group of DIAN.
    4. Women who are pregnant or breast-feeding or who have planned to become pregnant during the study period
    1. El participante tiene una enfermedad médica o psiquiátrica que interferiría según criterio clínico en la evaluación inicial y/o evaluaciones de seguimiento.
    2. El participante tiene un deterioro cognitivo avanzado que requiere ingreso en un centro asistencial de larga estancia.
    3. El reclutamiento de un sujeto con deterioro cognitivo debe ser pre-aprobado por la Grupo Coordinador de DIAN.
    4. Mujeres embarazadas o en periodo de lactancia o que hayan planeado quedarse embarazadas durante el periodo del estudio
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of adverse events after administration of a dose of [18F] FDG and [11C] PIB in individuals at risk of genetic Alzheimer's disease.
    2. Proportion of carriers of mutations causing genetic Alzheimer's disease that present alterations in FDG-PET, PIB-PET, MRI and in biochemical markers with respect to non-carrier pairs
    1. Incidencia de acontecimientos adversos tras la administración de una dosis de [18F]FDG y de [11C]PIB en individuos con riesgo de enfermedad de Alzheimer genético.
    2. Proporción de portadores de mutaciones causantes de enfermedad de Alzheimer genético que presentan alteraciones en el FDG-PET, PIB-PET, RM y en marcadores bioquímicos respecto a pares no portadores
    E.5.1.1Timepoint(s) of evaluation of this end point
    At any time during the follow-up (up to 36 months)
    En cualquier momento durante el seguimiento (hasta 36 meses)
    E.5.2Secondary end point(s)
    1. Relative age at which each marker begins to show pathological values in mutation carriers with respect to non-carrier pairs.
    2. Magnitude of longitudinal change in each of the biomarkers studied.
    1. Edad relativa a la que cada marcador empieza a mostrar valores patológicos en portadores de mutación respecto a pares no portadores.
    2. Magnitud de cambio longitudinal en cada uno de los biomarcadores estudiados.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At any time during the follow-up (up to 36 months)
    En cualquier momento durante el seguimiento (hasta 36 meses)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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
    Patient subjects with Alzheimer 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 state45
    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)
    no
    no
    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 Decision2019-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-14
    P. End of Trial
    P.End of Trial StatusOngoing
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